PATENT ABSTRACT
The invention provides a traditional chinese medicine and its&#39; method of making for anti-tumor. The Traditional Chinese Medicine preparation is composed of following materials (by weight portion):SemenHydnocarpil, Momordicae Semen 0.8-1.4, Squama Manitis 0.5-1.1, Radix et Rhizoma Rhei 0.8-1.3, Radix Glycyrrhizae 1-1.5. The invented preparation possesses good curative effect and low toxicity, and can be widely used to treat tumors such as digestive tract tumor including gastric carcinoma, intestines, liver cancer and esophagus, and tumors of lung, cervix, breast and skin etc. It has remarkable effect on gastric carcinoma and liver cancer.

PATENT DESCRIPTION
FIELD OF THE INVENTION  
       [0001]     This invention involves in the fields of Traditional Chinese Medicine, in particularly, involves in a kind of Traditional Chinese Medicine preparation, its preparative methods and applications in the procedure of preparing anti-tumor drugs.  
       BACKGROUND OF THE INVENTION  
       [0002]     Cancer is one of the most serious diseases which severely threaten our healths According to the statistical materials, at present there are more than 18 million cancer patients all over the world. It is predicted that the cancer incidence will increase by 50% than that of present level, there will be 15 million new cancer cases by the year 2020 when the average onset age of cancer patient will be about 40, while now it ranges from 50 to 60, in certain cities, onset age of gastric cancer is 35, it is quite frightening.  
         [0003]     In the field of cancer therapy, in addition to traditional therapy methods such as surgical excision, chemotherapy and radiotherapy, scientists and medical workers are now trying hard to explore and find new means and methods that can radically cure cancer, for example, cryotherapy under 180 degree below zero, heat therapy using microwave solidification; starve tumor treatment, that is to say, blocking the blood vessels and cutting the nutrition supply of tumor; adopting biotechnology, necrosis factors, gene therapy and many other methods to treat cancers, but considering the present technology level and medical conditions at home and abroad, all of the new anti-tumor methods mentioned above still can&#39;t reach scientific conclusions because of lacking prospective study, while hoping to find new drugs which can treat cancers from Traditional Chinese Medicines, which becomes the focus of international anti-cancer fields.  
         [0004]     Traditional Chinese Medicine and Traditional Chinese Medicine theories are one of the most precious cultural heritages, they are basic protections of ancient Chinese living and breeding, at the same time, those abounding experiences and theories are formed in the courses of fighting with diseases which still play important roles in modern civilized society.  
         [0005]     The anti-cancer effects of Traditional Chinese Medicine have been approved by Chinese people and western countries, however anti-cancer Traditional Chinese Medicine used in the whole clinical medication only account for 3-5%, meanwhile, there is no anti-cancer Traditional Chinese Medicine used for the treatment of gastric cancer.  
         [0006]     The idea of developing and inventing a kind of safe, effective and controllable anti cancer Traditional Chinese Medicine preparation (not prescription) which can be widely used in clinical work is the basic guiding throught of this invention.  
       SUMMARY OF THE INVENTION  
       [0007]     This invention is based on the Traditional Chinese Medicine theory on cancer: “Cancer is caused by stagnation of vital energy and blood stasis which further give rise to lump and tumor accumulation and should be treated with the strategies of promoting blood flow and removing blood stasis; eliminating toxic material and SanJie”, combined with modern medicine theories, using modern technology, carefully screening the herbs in order to meet three purposes: to supply a kind of anti-tumor traditional Chinese medicine preparation; to supply the preparative method; to supply its application in the preparation of anti-tumor drugs.  
         [0008]     The purpose of this invention is realized as follows: A kind of anti-tumor traditional Chinese medicine preparation, its&#39; feature is that this preparation is composed of following parts by weight of materials: 1 parts by weight of hydnocarpus, 0.8-1.4 parts by weight of cochinchina momordica seed, 0.5-1.1 parts by weight of pangolin scales, 0.8-1.3 parts by weight of rhubarb, 1-1.5 parts by weight of licorice root.  
         [0009]     Of which, the herb “hydnocarpus” is adopted which can enter liver spleen meridian, its fatty acid glycerolipid that has the functions of eliminating wind, depriving the evil wetness, expelling toxin, relieving sputum and accumulating water serves as principal drug.  
         [0010]     The herb “cochinchina momordica seed” is adopted which can enter spleen stomach meridian, its momordic acid that has the functions of detumescence, expelling toxin and promoting tissue regeneration serves as ministerial drug.  
         [0011]     The herb “pangolin scales” is adopted which can enter liver stomach meridian, its pangolin scales alkali that has the functions of detumescence, relieving ache, removing the wind, activating collaterals, treating crewels and ulcer and fighting papillary cancer cells serves as adjunctive drug.  
         [0012]     The herb “rhubarb” is adopted which can enter stomach intestine meridian, its emodin and rhrum tannic acids that have the functions of removing pyretic toxicity, breaking dyspeptic disease and improving microcirculation serves as adjunctive drug.  
         [0013]     The herb “licorice root” is adopted which can enter spleen stomach meridian, its enoxolone that has the functions of anti-cancer, neutralizing poison and coordinating the drug actions of a prescription serves as messenger drug. In this invention, the optimum dosage of each crude herb is 1 parts by weigh.  
         [0014]     Preparative methods of anti-tumor Traditional Chinese medicine preparation in this invention include the following steps:  
         [0015]     1) Weighing each crude herb, grinding to middle size particles,  
         [0016]     2) Adding 62% ethyl alocohol in a w/v of 1:2.5˜1:3.5 with crude herbs and soaking thoroughly,  
         [0017]     3) Heating and recirculating fully,  
         [0018]     4) Filtrating, filter liquor acquired is the active ingredient solution of the Traditional Chinese Medicine preparation mentioned in this invention.  
         [0019]     In this invention, to the residues and gruffs gotten in step 4, adding 62% ethyl alocohol in a w/v of 1:0.8˜1:1.5, heating again and recirculating thoroughly, filtrating, filter liquor aquired is combined with filter liquor aquired in the former steps, the combined liquid also is the active ingredient solution of the Traditional Chinese Medicine preparation mentioned in this invention.  
         [0020]     The optimum w/v in this method is 1:1.  
         [0021]     Heating and recirculating time mentioned in the method is 0.5-1 hour generally.  
         [0022]     Adjusting active ingredient solution with ethyl alocohol and water, making ethyl alocohol volume percentage to be 6.0-8.0%, adjusting pH to be 4.0-5.0, then the composition of the Traditional Chinese Medicine preparation mentioned in this invention is completely made.  
         [0023]     The best relative density of this composition of the Traditional Chinese Medicine preparation is 1.02-1.08. Or drying the active ingredient solution of the Traditional Chinese Medicine preparation mentioned above and making it into granula, filling granula into blank capsules, then the capsule of the Traditional Chinese Medicine preparation mentioned in this invention is completely made.  
         [0024]     Alternatively, drying the active ingredient solution of the Traditional Chinese Medicine preparation mentioned above and compressing into round lamellar shape, the tablets of the Traditional Chinese Medicine preparation in this invention is completely made.  
         [0025]     Hydnocarpus and cochinchina momordica seed are two poisonous herbs in the composition, the standard dosage and maximum dosage is 15 g each day, dosage more than 15 g will cause lowering blood pressure, short of breath, accelerating of heart beat, vomit, anepithymia, insomnia, haemolytic anemia, nephritis hyperproteinuria and erythrocyturia and other adverse reactions, on the contrary, if the dosage is less than 15 g each day, the anti-cancer effect will be poor or even ineffective completetly.  
         [0026]     The Traditional Chinese Medicine preparation in this invention has many advantages: the herb is well organized, compatibility is reasonable, principal, adjuvant, auxiliary and conductant ingredients are highlighted, dosage is accurate, safe and effective, any herb can not be added or reduced, increasing dosage will enhance toxicity, decreasing dosage will result in poor anti-cancer effects It not only has the functions of eliminating pathogen via promoting blood flow, improving microcirculation and counteracting toxic substance, but also has the functions of strengthening body resistance via rising WBC and promoting tissue regeneration this highly coincides with the Traditional Chinese Medicine theory of cancer therapy, that is, treating the malignant with poisonous agents, eliminating pathogen to support vital qi, it also coincides with modern medicine theory of enhancing phagocytosis function of macrophage, improving the immune system of the patients and inhibiting and killing cancer cells.  
         [0027]     The invention was substantiated by animal experiments and clinic trails, and was proved to be safe, effective and controllable.  
         [0028]     The invention surmount other drugs which has simple function such as strengthening body resistance, synergism or attenuation, it possess four founctions (eliminating pathogen, strengthening body resistance, synergism, altenuation) at the same time.  
         [0029]     The invention can solely be used as anti-cancer drug, it also can be combined to use with chemotherapy drugs, when combined to use, the Traditional Chinese Medicine preparation of this invention can not only greatly reduce severe adverse reactions of chemotherapy, but also greatly improve its short term therapeutic efficacy and prostecdtive efficacy (outweighing chemotherapy), thus could enhance anti-cancer effects.  
         [0030]     The Traditional Chinese Medicine preparation of this invention can be widely used for the treatment of tumor such as digestive tract tumor including gastric cancer, intestines cancer, liver cancer, esophageal cancer, other cancers like lung cancer, uterine cervix cancer, breast cancer, skin cancer etc, particularly, gastric cancer and liver cancer patients have good therapeutic response to the invention. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
     EXAMPLE 1  
     Preparation of Traditional Chinese Medicine Composition of the Invention  
       [0031]     150 g of hydnocarpus, 150 g of cochinchina momordica seed, 150 g of pangolin scales, 150 g of rhubarb and 150 g of licorice root. Grinding all above five herbs into middle size granula, adding 2500 ml of 62% ethyl alcohol, soaking for 12 hours, heating and recirculating for 1 hour, filtrating, adding 800 ml of 62% ethyl alcohol into gruffs and heating again, recirculating for 1 hour, filtrating and combining all of the filter liquors, decompressing and condensing to 950 ml, adjusting to 1000 ml with ethyl alcohol and water, making the volume of ethyl alcohol to be 6.0˜8.0%, adjusting pH to be 4.0˜5.5, regulating relative density to be 1.05, mixing evenly, standing still at 6-10° C. for 12 hours, centrifugating and extracting supernatant, bottling and thus getting the composition.  
       EXAMPLE 2  
     Preparation of Traditional Chinese Medicine Composition of the Invention  
       [0032]     150 g of hydnocarpus, 240 g of cochinchina momordica seed, 120 g of pangolin scales, 120 g of rhubarb and 225 g of licorice root. Grinding all above five herbs into middle size granula, adding 2600 ml of 62% ethyl alcohol, soaking for 18 hours, heating and recirculating for 1 hour, filtrating, adding 900 ml of 62% ethyl alcohol into gruffs and heating again, recirculating for 1 hour, filtrating and combining all of the filter liquors, decompressing and condensing to 950 ml, adjusting to 1000 ml with ethyl alcohol and water, making the volume of ethyl alcohol to be 6.0˜8.0%, adjusting pH to be 4.0˜5.5, regulating relative density to be 1.02, mixing evenly, standing still at 6-10° C. for 12 hours, centrifugating and extracting supernatant, bottling and thus getting the composition.  
       EXAMPLE 3  
     Preparation of Traditional Chinese Medicine Composition of the Invention  
       [0033]     80 g of hydnocarpus,75 g of cochinchina momordica seed, 50 g of pangolin scales, 75 g of rhubarb and 100 g of licorice root. Grinding all above five herbs into middle size granula, adding 950 ml of 62% ethyl alcohol, soaking for 12 hours, heating and recirculating for 1 hour, filtrating, adding 320 ml of 62% ethyl alcohol into gruffs and heating again, recirculating for 1 hour, filtrating and combining all of the filter liquors, decompressing and condensing to 950 ml, adjusting to 1000 ml with ethyl alcohol and water, making the volume of ethyl alcohol to be 6.0˜8.0%, adjusting pH to be 4.0˜5.5, regulating relative density to be 1.06, mixing evenly, standing still at 6-10° C. for 12 hours, centrifugating and extracting supernatant, bottling and thus getting the composition.  
       EXAMPLE 4  
     Preparation of Traditional Chinese Medicine Composition of the Invention  
       [0034]     120 g of hydnocarpus, 140 g of cochinchina momordica seed, 100 g of pangolin scales, 150 g of rhubarb and 180 g of licorice root. Grinding all above five herbs into middle size granula, adding 2000 ml of 62% ethyl alcohol, soaking for 12 hours, heating and recirculating for 1 hour, filtrating, adding 700 ml of 62% ethyl alcohol into gruffs and heating again, recirculating for 1 hour, filtrating and combining all of the filter liquors, decompressing and condensing to 950 ml, adjusting to 1000 ml with ethyl alcohol and water, making the volume of ethyl alcohol to be 6.0˜8.0%, adjusting pH to be 4.0˜5.5, regulating relative density to be 1.08, mixing evenly, standing still at 6-10° C. for 12 hours, centrifugating and extracting supernatant, bottling and thus getting the composition.  
       EXAMPLE 5  
     Preparation of Traditional Chinese Medicine Capsules of the Invention  
       [0035]     180 g of hydnocarpus, 180 g of cochinchina momordica seed, 90 g of pangolin scales, 150 g of rhubarb and 250 g of licorice root. Grinding all above five herbs into middle size granula, adding 2500 ml of 62% ethyl alcohol, soaking for 24 hours, heating and recirculating for 1 hour, filtrating, adding 1000 ml of 62% ethyl alcohol into gruffs and heating again, recirculating for 1 hour, filtrating and combining all of the filter liquors, drying and making into uniform granula and filling them into vacant capsules, thus forming hard capsules.  
       EXAMPLE 6  
     Preparation of Traditional Chinese Medicine Tablets of the Invention  
       [0036]     100 g of hydnocarpus, 80 g of cochinchina momordica seed, 110 g of pangolin scales, 130 g of rhubarb and 150 g of licorice root. Grinding all above five herbs into middle size granula, adding 1500 ml of 62% ethyl alcohol, soaking for 18 hours, heating and recirculating for 0.5 hour, filtrating, adding 750 ml of 62% ethyl alcohol into gruffs and heating again, recirculating for 1 hour, filtrating and combining all of the filter liquors, drying and compressing them into ground lamellar shape, thus getting the tablets.  
       TEST EXAMPLE 1  
     Pharmacodynamics Research of the Traditional Chinese Medicine Preparation of this Invention  
       [0000]     I Tested Drugs  
         [0037]     1 Preparation labeled dosage: 1 ml containing 0.55 g of crude drug  
         [0038]     2. Solvent: 0.5% CMC-Na  
         [0039]     3. Preparative methods: stock solution was diluted to demanding concentration with 0.5% CMC-Na, giving 0.5 ml of drug to each mouse each time.  
         [0000]     II Animals  
         [0040]     1. Name, source, Strain: BALB/c mice or F1 (ICR×BALB/c), mice and Kunming mice, animal group of our institute. C57BL/6 mice and nu/BALB/c mice were purchased from Shanghai laboratory animal center.  
         [0041]     2. Weight: 19±1 g, 6-8 weeks old.  
         [0042]     3. Sex: male or female, using the same sex for each study.  
         [0043]     4. Animal breeding and experiment conditions: Kunming mice, C57BL/6 mice and F1 mice were kept in Clean Animal Laboratory, nu/BALB/c mice were kept in lamina flow framework and raised according to SPF condition, administration was given in the lamina flow framework.  
         [0044]     5. The Number of Animal of Each Group:tested group, three dosage, Positive group, and blank group, 6 nu/BALB/c mice each group, 10 Kunming mice, 10 C57BL/6 mice and 10 F1 mice each group.  
         [0000]     III Test Method Choice  
         [0045]     According to &lt;&lt;Guideline for Traditional Chinese Medicine Research&gt;&gt;, performing study on eliminating pathogen to strengthen body resistance, attenuation and synergism function  
         [0046]     Considering that it is a compound preparation, it should adopt the whole animal test.  
         [0000]     IV Dosage  
         [0047]     po (take orally), 25.0, 12.5 and 6.25 ml/kg or 75, 37.5 and 18.75 ml/M2 for high dosage, middle dosage, low dosage respectively.  
         [0048]     ip (intraperitoneal injection) 10.0, 5.0 and 2.5 ml/kg for high dosage, middle dosage, low dosage respectively.  
         [0000]     V Administration Manner  
         [0049]     po×10 qd and ip×10 qd for studing on eliminating pathogen, strengthening body resistance, attenuation and synergism function, of which, po is the administration manner for clinical medication; Studying on strengthening body resistance function only use po path, implementing 12.5, 6.25, 3.125 ml/kg po×10 regimen  
         [0000]     VI Controls  
         [0050]     Blank: solvent 0.5% CMC-Na.  
         [0051]     Positive drug control: Considering that there is no suitable corresponding positive control, it should choose cyclophosphamide as positive control, in order to substantiate authenticity of each test.  
         [0000]     VII. Test Main Steps and Results  
         [0000]     1. Eliminating Pathogen Function Study  
         [0052]     Test on xenogeneic graft mice models of human gastric cancer cell line MKN and human liver cancer cell line QGY: Taking related cancer cells, preparing to homogenate containing 1-2×10 7  tumor cells/ml, chosing corresponding recipient mice, armpit hypodermic inoculation 0.2 ml or pedis hypodermic inoculation 0.05 ml of tumor cell suspension, randomization, giving therapy according to the administration regimen next day, dissecting each test group tumor after 2 weeks and comparing with control group, calculating inhibition ratio, all the procedure should be performed strictly under sterilized condition, results are shown in table 1-4 Inhibition test on animal-transplanted tumor such as mice colon carcinoma C26 and Lewis lung carcinoma, methods are the same as above, and the results are shown in table 5-10.  
         [0053]     note: “***” represents P&lt;0.01; “**” represents P&lt;0.05; “*” represents P&lt;0.1.  
                                                                                                                                                                       TABLE 1                           Therapeutic effects test of invented composition on xenogeneic graft mice       models of human gastric cancer cell line MKN via po            sample   dosage   administration   mice number   weight   tumor weight                group   ml/kg   ml/M 2     regimen   beginning   end   beginning   end     x  ± SD   inhibition ratio %                    invented composition   25   75   po × 10qd   6   6   17.6   17.1   0.317 ± 0.12    77.83***       invented composition   12.5   37.5   po × 10qd   6   6   17.7   17.7   0.717 ± 0.12    49.86***       invented composition   6.25   18.75   po × 10qd   6   6   17.8   17.4   1.12 ± 0.23   21.68            positive control   30 mg/kg                                   cyclophosphamide       ip × 7qd   6   6   17.7   16.6   0.17 ± 0.15   88.11***       negative control   solvent   po × 10qd   12   12   17.5   19.9   1.43 ± 0.24                  
 
         [0054]    
       
         
               
             
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
             
           
               
                 TABLE 2 
               
             
             
               
                   
               
               
                   
               
               
                 Therapeutic effects test of invented composition on xenogeneic graft mice models of human gastric 
               
               
                 cancer cell line MKN via peritoneal injection 
               
             
          
           
               
                 sample 
                 dosage 
                 administration 
                 mice number 
                 weight 
                 tumor weight 
                   
               
             
          
           
               
                 group 
                 ml/kg 
                 ml/M 2   
                 regimen 
                 beginning 
                 end 
                 beginning 
                 end 
                   x  ± SD 
                 inhibition ratio % 
               
               
                   
               
             
          
           
               
                 invented composition 
                 10 
                 30 
                 ip × 10qd 
                 6 
                 6 
                 18.3 
                 17.7 
                 0.25 ± 0.10 
                 80.47*** 
               
               
                 invented composition 
                 5 
                 15 
                 ip × 10qd 
                 6 
                 6 
                 18.5 
                 18.4 
                 0.53 ± 0.12 
                 58.59*** 
               
               
                 invented composition 
                 2.5 
                 7.5 
                 ip × 10qd 
                 6 
                 6 
                 18.2 
                 18.6 
                 0.90 ± 0.26 
                 26.69 
               
             
          
           
               
                 positive control 
                 30 mg/kg 
                   
                   
                   
                   
                   
                   
                   
               
               
                 cyclophosphamide 
                   
                 ip × 7qd 
                 6 
                 6 
                 18.0 
                 17.9 
                 0.14 ± 0.05 
                 89.06*** 
               
               
                 negative control 
                 solvent 
                 ip × 10qd 
                 12 
                 12 
                 18.1 
                 20.1 
                 1.28 ± 0.26 
               
               
                   
               
             
          
         
       
     
         [0055]    
       
         
               
             
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
             
           
               
                 TABLE 3 
               
             
             
               
                   
               
               
                   
               
               
                 Therapeutic effects test of invented composition on xenogeneic graft mice models of human liver 
               
               
                 cancer cell line QGY via po 
               
             
          
           
               
                 sample 
                 dosage 
                 administration 
                 mice number 
                 weight 
                 tumor weight 
                   
               
             
          
           
               
                 group 
                 ml/kg 
                 ml/M 2   
                 regimen 
                 beginning 
                 end 
                 beginning 
                 end 
                   x  ± SD 
                 inhibition ratio % 
               
               
                   
               
             
          
           
               
                 invented composition 
                 25 
                 75 
                 po × 10qd 
                 6 
                 6 
                 17.4 
                 17.9 
                 1.13 ± 0.22 
                 49.33*** 
               
               
                 invented composition 
                 12.5 
                 37.5 
                 po × 10qd 
                 6 
                 6 
                 17.7 
                 18.0 
                 1.48 ± 0.30 
                 33.63** 
               
               
                 invented composition 
                 6.25 
                 18.75 
                 po × 10qd 
                 6 
                 6 
                 17.5 
                 17.9 
                 1.65 ± 0.20 
                 26.00 
               
             
          
           
               
                 positive control 
                 30 mg/kg 
                   
                   
                   
                   
                   
                   
                   
               
               
                 cyclophosphamide 
                   
                 ip × 7qd 
                 6 
                 6 
                 17.6 
                 17.0 
                 0.25 ± 0.14 
                 88.79*** 
               
               
                 negative control 
                 solvent 
                 po × 10qd 
                 12 
                 12 
                 17.5 
                 19.4 
                 2.23 ± 0.31 
               
               
                   
               
             
          
         
       
     
         [0056]    
       
         
               
             
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
             
           
               
                 TABLE 4 
               
             
             
               
                   
               
               
                   
               
               
                 Therapeutic effects test of invented composition on xenogeneic graft mice models of human liver 
               
               
                 cancer cell line QGY via peritoneal injection 
               
             
          
           
               
                 sample 
                 dosage 
                 administration 
                 mice number 
                 weight 
                 tumor weight 
                   
               
             
          
           
               
                 group 
                 ml/kg 
                 ml/M 2   
                 regimen 
                 beginning 
                 end 
                 beginning 
                 end 
                   x  ± SD 
                 inhibition ratio % 
               
               
                   
               
             
          
           
               
                 invented composition 
                 10 
                 30 
                 ip × 10qd 
                 6 
                 6 
                 17.3 
                 18.1 
                 1.03 ± 0.29 
                 48.76*** 
               
               
                 invented composition 
                 5 
                 15 
                 ip × 10qd 
                 6 
                 6 
                 17.2 
                 18.7 
                 1.37 ± 0.23 
                 31.84** 
               
               
                 invented composition 
                 2.5 
                 7.5 
                 ip × 10qd 
                 6 
                 6 
                 16.8 
                 18.4 
                 1.60 ± 0.24 
                 20.40 
               
             
          
           
               
                 positive control 
                 30 mg/kg 
                   
                   
                   
                   
                   
                   
                   
               
               
                 cyclophosphamide 
                   
                 ip × 7qd 
                 6 
                 6 
                 17.0 
                 17.6 
                 0.22 ± 0.08 
                 89.05*** 
               
               
                 negative control 
                 solvent 
                 ip × 10qd 
                 12 
                 12 
                 17.3 
                 19.5 
                 2.01 ± 0.33 
               
               
                   
               
             
          
         
       
     
         [0057]    
       
         
               
             
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
             
           
               
                 TABLE 5 
               
             
             
               
                   
               
               
                   
               
               
                 Therapeutic effects test of invented composition on mice C26 colon solid tumor via po 
               
             
          
           
               
                 sample 
                 dosage 
                 administration 
                 mice number 
                 weight 
                 tumor weight 
                   
               
             
          
           
               
                 group 
                 ml/kg 
                 ml/M 2   
                 regimen 
                 beginning 
                 end 
                 beginning 
                 end 
                   x  ± SD 
                 inhibition ratio % 
               
               
                   
               
             
          
           
               
                 invented composition 
                 25 
                 75 
                 po × 10qd 
                 10 
                 10 
                 21.2 
                 24.7 
                 1.38 ± 0.22 
                 43.67*** 
               
               
                 invented composition 
                 12.5 
                 37.5 
                 po × 10qd 
                 10 
                 9 
                 21.4 
                 25.2 
                 1.71 ± 0.36 
                 30.2** 
               
               
                 invented composition 
                 6.25 
                 18.75 
                 po × 10qd 
                 10 
                 10 
                 21.3 
                 25.7 
                 2.24 ± 0.25 
                 8.6 
               
             
          
           
               
                 positive control 
                 30 mg/kg 
                   
                   
                   
                   
                   
                   
                   
               
               
                 cyclophosphamide 
                   
                 ip × 7qd 
                 10 
                 10 
                 21.3 
                 22.6 
                 0.22 ± 0.06 
                 91.02*** 
               
               
                 negative control 
                 solvent 
                 po × 10qd 
                 20 
                 20 
                 21.3 
                 26.2 
                 2.45 ± 0.57 
               
               
                   
               
             
          
         
       
     
         [0058]    
       
         
               
             
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
             
           
               
                 TABLE 6 
               
             
             
               
                   
               
               
                   
               
               
                 Therapeutic effects test of invented composition on mice C-26 colon 
               
               
                 solid tumor via peritoneal injection 
               
             
          
           
               
                 sample 
                 dosage 
                 administration 
                 mice number 
                 weight 
                 tumor weight 
                   
               
             
          
           
               
                 group 
                 ml/kg 
                 ml/M 2   
                 regimen 
                 beginning 
                 end 
                 beginning 
                 end 
                   x  ± SD 
                 inhibition ratio % 
               
               
                   
               
             
          
           
               
                 invented composition 
                 10 
                 30 
                 ip × 10qd 
                 10 
                 10 
                 20.1 
                 23.1 
                 1.36 ± 0.20 
                 49.91*** 
               
               
                 invented composition 
                 5 
                 15 
                 ip × 10qd 
                 10 
                 10 
                 20.3 
                 23.9 
                 1.70 ± 0.37 
                 37.98** 
               
               
                 invented composition 
                 2.5 
                 7.5 
                 ip × 10qd 
                 10 
                 10 
                 20.4 
                 23.4 
                 2.12 ± 0.47 
                 21.92 
               
             
          
           
               
                 positive control 
                 30 mg/kg 
                   
                   
                   
                   
                   
                   
                   
               
               
                 cyclophosphamide 
                   
                 ip × 7qd 
                 10 
                 10 
                 20.2 
                 21.0 
                 0.22 ± 0.06 
                 91.90*** 
               
               
                 negative control 
                 solvent 
                 ip × 10qd 
                 20 
                 20 
                 20.4 
                 24.8 
                 2.75 ± 0.45 
               
               
                   
               
             
          
         
       
     
         [0059]    
       
         
               
             
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
             
           
               
                 TABLE 7 
               
             
             
               
                   
               
               
                   
               
               
                 Therapeutic effects test of invented composition on mice C-26 colon carcinoma 
               
               
                 (pedis inoculation) via po 
               
             
          
           
               
                 sample 
                 dosage 
                 administration 
                 mice number 
                 weight 
                 tumor weight 
                   
               
             
          
           
               
                 group 
                 ml/kg 
                 ml/M 2   
                 regimen 
                 beginning 
                 end 
                 beginning 
                 end 
                   x  ± SD 
                 inhibition ratio % 
               
               
                   
               
             
          
           
               
                 invented composition 
                 25 
                 75 
                 po × 10qd 
                 10 
                 10 
                 19.3 
                 21.0 
                 0.41 ± 0.07 
                 54.95*** 
               
               
                 invented composition 
                 12.5 
                 37.5 
                 po × 10qd 
                 10 
                 10 
                 19.2 
                 21.7 
                 0.55 ± 0.11 
                 39.56*** 
               
               
                 invented composition 
                 6.25 
                 18.75 
                 po × 10qd 
                 10 
                 10 
                 19.1 
                 22.3 
                 0.70 ± 0.15 
                 23.08 
               
             
          
           
               
                 positive control 
                 30 mg/kg 
                   
                   
                   
                   
                   
                   
                   
               
               
                 cyclophosphamide 
                   
                 ip × 7qd 
                 10 
                 10 
                 19.1 
                 20.4 
                 0.19 ± 0.06 
                 79.12*** 
               
               
                 negative control 
                 solvent 
                 po × 10qd 
                 20 
                 20 
                 19.3 
                 24.9 
                 0.91 ± 0.18 
               
               
                   
               
             
          
         
       
     
         [0060]    
       
         
               
             
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
             
           
               
                 TABLE 8 
               
             
             
               
                   
               
               
                   
               
               
                 Therapeutic effects test of invented composition on mice C-26 colon carcinoma (pedis inoculation) 
               
               
                 via peritoneal injection 
               
             
          
           
               
                 sample 
                 dosage 
                 administration 
                 mice number 
                 weight 
                 tumor weight 
                   
               
             
          
           
               
                 group 
                 ml/kg 
                 ml/M 2   
                 regimen 
                 beginning 
                 end 
                 beginning 
                 end 
                   x  ± SD 
                 inhibition ratio % 
               
               
                   
               
             
          
           
               
                 invented composition 
                 10 
                 30 
                 ip × 10qd 
                 10 
                 10 
                 19.0 
                 21.7 
                 0.42 ± 0.06 
                 56.48*** 
               
               
                 invented composition 
                 5 
                 15 
                 ip × 10qd 
                 10 
                 10 
                 18.9 
                 21.4 
                 0.58 ± 0.11 
                 39.90*** 
               
               
                 invented composition 
                 2.5 
                 7.5 
                 ip × 10qd 
                 10 
                 10 
                 18.7 
                 22.3 
                 0.75 ± 0.20 
                 22.28 
               
             
          
           
               
                 positive control 
                 30 mg/kg 
                   
                   
                   
                   
                   
                   
                   
               
               
                 cyclophosphamide 
                   
                 ip × 7qd 
                 10 
                 10 
                 18.7 
                 20.0 
                 0.18 ± 0.06 
                 81.35*** 
               
               
                 negative control 
                 solvent 
                 ip × 10qd 
                 20 
                 20 
                 18.8 
                 23.1 
                 0.965 ± 0.18  
               
               
                   
               
             
          
         
       
     
         [0061]    
       
         
               
             
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
             
           
               
                 TABLE 9 
               
             
             
               
                   
               
               
                   
               
               
                 Therapeutic effects test of invented composition on mice Lewis lung solid tumor via po 
               
             
          
           
               
                 sample 
                 dosage 
                 administration 
                 mice number 
                 weight 
                 tumor weight 
                   
               
             
          
           
               
                 group 
                 ml/kg 
                 ml/M 2   
                 regimen 
                 beginning 
                 end 
                 beginning 
                 end 
                   x  ± SD 
                 inhibition ratio % 
               
               
                   
               
             
          
           
               
                 invented composition 
                 25 
                 75 
                 po × 10qd 
                 10 
                 9 
                 18.4 
                 19.4 
                 1.51 ± 0.90 
                 40.08*** 
               
               
                 invented composition 
                 12.5 
                 37.5 
                 po × 10qd 
                 10 
                 10 
                 18.7 
                 20.0 
                 1.72 ± 0.38 
                 31.75** 
               
               
                 invented composition 
                 6.25 
                 18.75 
                 po × 10qd 
                 10 
                 10 
                 18.5 
                 20.8 
                 1.92 ± 0.27 
                 23.81 
               
             
          
           
               
                 positive control 
                 30 mg/kg 
                   
                   
                   
                   
                   
                   
                   
               
               
                 cyclophosphamide 
                   
                 ip × 7qd 
                 10 
                 10 
                 18.8 
                 19.3 
                 0.29 ± 0.07 
                 88.49*** 
               
               
                 negative control 
                 solvent 
                 po × 10qd 
                 20 
                 20 
                 18.5 
                 22.0 
                 2.52 ± 0.61 
               
               
                   
               
             
          
         
       
     
         [0062]    
       
         
               
             
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
             
           
               
                 TABLE 10 
               
             
             
               
                   
               
               
                   
               
               
                 Therapeutic effects test of invented composition on mice Lewis lung solid tumor via peritoneal 
               
               
                 injection 
               
             
          
           
               
                 sample 
                 dosage 
                 administration 
                 mice number 
                 weight 
                 tumor weight 
                   
               
             
          
           
               
                 group 
                 ml/kg 
                 ml/M 2   
                 regimen 
                 beginning 
                 end 
                 beginning 
                 end 
                   x  ± SD 
                 inhibition ratio % 
               
               
                   
               
             
          
           
               
                 invented composition 
                 10 
                 30 
                 ip × 10qd 
                 10 
                 10 
                 18.3 
                 19.9 
                 1.18 ± 0.27 
                 44.86*** 
               
               
                 invented composition 
                 5 
                 15 
                 ip × 10qd 
                 10 
                 10 
                 18.3 
                 20.4 
                 1.41 ± 0.43 
                 34.11** 
               
               
                 invented composition 
                 2.5 
                 7.5 
                 ip × 10qd 
                 10 
                 10 
                 18.5 
                 20.7 
                 1.57 ± 0.53 
                 26.64 
               
             
          
           
               
                 positive control 
                 30 mg/kg 
                   
                   
                   
                   
                   
                   
                   
               
               
                 cyclophosphamide 
                   
                 ip × 7qd 
                 10 
                 10 
                 18.3 
                 19.4 
                 0.25 ± 0.07 
                 88.32*** 
               
               
                 negative control 
                 solvent 
                 ip × 10qd 
                 20 
                 20 
                 18.6 
                 22.7 
                 2.14 ± 0.27 
               
               
                   
               
             
          
         
       
     
         [0063]     Through vivo anti-tumor therapeutic effect study, it demonstrates that the Traditional Chinese Medicine composition of the invention has a relatively high tumor inhibition rate when used at a high dosage of 25 ml/kg po×10 and 10 ml/kg ip×10 on xenogeneic graft mice models of human gastric cancer cell line MKN, the average inhibition rate is 79.75% and 81.54% respectively, which is 2.7 times higher than the level of goverment regulation (30%), middle dosage 12.5 ml/kgpo×10 and 5 ml/kg ip×10 also have a moderate tumor inhibition rate, the average inhibition rate is 53.89% and 58.80% respectively. For other animal-transplanted tumor such as colon carcinoma C-26 and Lewis lung carcinoma, xenogeneic graft mice models of human liver cancer cell line QGY, high dosage of invented composition via po or ip both have a moderate anti-tumor effect. Of which, effect of peritoneal injection is better than that of po. Main pharmacodynamics study shows that the invented Traditional Chinese Medicine composition has obvious eliminating pathogen functions.  
         [0000]     2. Strengthening Body Resistance Function Study  
         [0064]     1) Influence of invented Traditional Chinese Medicine composition on phagocytosis function of macrophages exists in the Kunming mice abdominal cavities: Randomly dividing male Kunming mice into several groups, 10 mice each group. Giving composition via po for consecutive 10 days, once each day. Peritoneal injection 1.5 ml of 0.5% aminopeptodrate for each group of mouse after the last administration of composition, then 24 hours later, peritoneal injection 0.2 ml of chicken red blood cells suspension at a concentration of 1×10 6 /ml, 40 minutes later, washing and collecting mice peritoneal fluid with physiologic saline, centrifugated, collecting cell sediments and making into smear, mehanol fixation, Giemsa staining, mounting. Counting 100 macrophages using immersion objective. Counting the number of macrophage that phagocytized chicken red blood cells and counting total number of phagocytized chicken red blood cells. Calculating phagocytosis percentage and phagocytosis index according to following formula, and the results are shown in table 11.  
             phagocytosis           percentage         =               The   ⁢           ⁢   Number   ⁢           ⁢   of   ⁢           ⁢   macrophage   ⁢           ⁢   that   ⁢           ⁢   phagocytized               chicken   ⁢           ⁢   RBC   ⁢           ⁢   amomg   ⁢           ⁢   100   ⁢           ⁢   macrophages             100   ⁢           ⁢   macrophages       ×   100   ⁢   %         
             phagocytosis           index         =             total   ⁢           ⁢   number   ⁢           ⁢   of   ⁢           ⁢   phagocytized   ⁢           ⁢   chicken               RBC   ⁢           ⁢   among   ⁢           ⁢   100   ⁢           ⁢   macrophages             100   ⁢           ⁢   macrophage           
 
                                         TABLE 11                           Influence of invented composition on phagocytosis function of       macrophages exists in the Kunming mice abdominal cavities            sample   dosage   administration       phagocytosis percentage           group   ml/kg   regimen   mice number     x  ± SD %   phagocytosis index               composition   12.5   po × 10qd   10   38.4 ± 6.48**   0.77 ± 0.06***       control   solvent   po × 10qd   10   26.7 ± 7.32   0.53 ± 0.08       composition   12.5   po × 10qd   10   39.6 ± 5.10**   0.58 ± 0.05***       control   solvent   po × 10qd   10   29.2 ± 4.6   0.33 ± 0.07                  
 
         [0065]     2) Influence of invented Traditional Chinese Medicine composition on NK cell activity of the Lewis lung carcinoma bearing mice: hypodermic inoculating 1×106 Lewis lung carcinoma cell suspensions on C57BL/6 right pedis, regimen 12.5, 6.25 and 3.125 ml/kg po×7 qd was implemented on the following day with invented composition after all administration was finished, killing all the mice, taking out spleen and collecting spleen cells, making into effector cells at a concentration of 1×10 7 /ml. using cultured Yac-1 cells as target cells, concentration is 1×10 6 /ml, taking out these two cells 100 μl respectively and adding into 96 well plate, adding 1.75×104 Bq/well of  3 H-TdR and culturing for 24 hours, collecting cells, assaying cpm value of each well with Liquid Scintillation Counters and calculating the obvious difference between test groups and control groups(shown in table 12)  
                                                   TABLE 12                           Influence of invented composition on NK cell activity of       cancer bearing mice            sample   dosage   administration   CPM value       group   ml/kg   regimen     x  ± SD                    invented composition   12.5   po × 10qd   4213 ± 728**       invented composition   6.25   po × 10qd   3746 ± 835**       invented composition   3.125   po × 10qd   4306 ± 663**       control       po × 10qd   5996 ± 908        invented composition   12.5   po × 10qd   3628 ± 551**       invented composition   6.25   po × 10qd   3150 ± 908**       invented composition   3.125   po × 10qd    3726 ± 1141**       control       po × 10qd   4938 ± 871                   
 
         [0066]     The invented Traditional Chinese Medicine composition can obviously enhance the phagocytosis functions of macrophages in the mice abdominal cavities; at the same time, it can enhance NK cell activity of Lewis lung carcinoma bearing mice to some extent.  
         [0000]     3. Synergistic Effect Study  
         [0067]     Hypodermic inoculating S180 sarcomas homogenate on Kunming mice armpit, dividing mice into different groups next day, solely used group: the invented Traditional Chinese Medicine composition, 25.0, 12.5, 6.25 ml/kg po×10; combinely used group: 25.0, 12.5, 6.25 ml/kg po×10 plus 15 mg/kg cyclophosphamide ip×7, 12 days after inoculation, dissecting tumors, measuring average tumor weight of each group and calculating standard deviation, comparing test group with control group and calculating tumor inhibition rate, and the results demonstrate that high dosage of invented Traditional Chinese Medicine composition, combined with low dosage of cyclophosphamide, produces certain synergism effects on the treatment of S180 sarcomas (shown in table 13).  
                                                           TABLE 13                           Therapeutic effects of the invented composition combined with       cyclophosphamide on S 180              sample   dosage   administration   tumor weight (g)   inhibition       group   ml/kg   regimen     x  ± SD   rate %                    invented composition   25.0   po × 10   1.19 ± 0.36   61.73***       invented composition   12.5   po × 10   1.69 ± 0.29   45.66***       invented composition   6.25   po × 10   2.15 ± 0.27   30.87***       invented composition   25.0   po × 10   0.88 ± 0.31   71.70***       CTX   15.0 mg/kg   ip × 7       invented composition   12.5   po × 10   1.55 ± 0.40   50.16***       CTX   15.0 mg/kg   ip × 7       invented composition   6.25   po × 10   1.84 ± 0.24   40.84***       CTX   15.0 mg/kg   ip × 7       CTX   15.0 mg/kg   ip × 7   1.71 ± 0.25   45.02***       CTX   30.0 mg/kg   ip × 7   0.49 ± 0.12   84.24***       control   solvent   po × 10   3.10 ± 0.46       control   solvent   po × 10                  
 
 4. Attenuation Function Study 
 
         [0068]     Cyclophosphamide 100 mg/kg ip×2 was given to F1 mice, then randomly divided into three different groups, treated with 25.0, 12.5, 6.25 ml/kg po×10 qd of the invented Traditional Chinese Medicine composition, counting white blood cells every four days, getting average number and standard deviation, setting the WBC number of 0 day as 100%, calculating WBC percentage of each timepoint, it shows that the invented composition has no significant functions of rising WBC, at the same time, it also has no effects of enhancing WBC inhibition (shown in table 14).  
                                                                                                             TABLE 14                           Attenuation function of the invented composition on       WBC inhibition caused by cyclophosphamide            sample   dosage   administration   WBC percentage            group   ml/kg   regimen   0 d   3 d   6 d   9 d   12 d   15 d                    invented composition   25.0   po × 10qd   100   39.4   45.6   57.2   68.1   98.9       invented composition   12.5   po × 10qd   100   36.7   42.1   54.8   64.0   99.5       invented composition   6.25   po × 10qd   100   35.9   44.2   51.4   62.1   103.3       solvent       po × 10qd   100   33.1   42.8   48.3   59.4   92.6                  
 
       TEST EXAMPLE 2  
     In Vitro Anti-Tumor Cell Proliferation Test of the Invented Traditional Chinese Medicine Composition  
       [0069]     I. Tested Drugs  
         [0070]     1 Content potency: 1 ml containing 0.55 g of crude drug.  
         [0071]     2. Preparative methods: dissolved in the culture medium containing fetal bovine serum, preparing each time when used.  
         [0072]     II. Cell Strains  
         [0073]     Human lung cancer cell line (A1).  
         [0074]     Human cervical carcinoma cell line (Hela).  
         [0075]     Source: cell bank of Shanghai Institute of Cell Biology.  
         [0076]     III. Main Experiment Steps  
         [0077]     1. Seeding tumor cells into culture bottle, 130 thousand unit each bottle.  
         [0078]     2. Dividing into different dosage groups  
         [0079]     3. Adding culture medium containing specified dosage of tested composition and control drug respectively.  
         [0080]     4. Counting the number of cells in different group within in defined time.  
         [0081]     IV. Specification of Index and Time  
         [0082]     Observing inhibition rate of different dosage composition on tumor cells and drug concentration on inhibiting concentration (IC50), observing time is 4 days.  
         [0083]     V. Dosage Setting  
         [0084]     Five dosage, they are 0.55, 2.75, 5.5, 13.75, 27.5 mg/ml respectively.  
         [0085]     VI. Administration Manner  
         [0086]     Composition is added into culture medium and used to culture cells directly.  
         [0087]     VII. Controls  
         [0088]     chosing canelim capsule as control, ground into powder and steriled, dissolved into medium and centrifugated, divided into 0.3, 1.5, 3, 7.5, 15 mg/ml five dosage, administration manner is the same as above.  
         [0089]     VIII Results:  
         [0090]     The invented composition can inhibit human tumor cells Hela and A1 proliferation in a manner of dosage dependence, while the tumor cells in the group without adding the invented composition can proliferate infinitely, entering exponential phase of growth, half inhibiting concentration of test group and control group are shown in table 15.  
                             TABLE 15                           Half inhibiting concentration of the invented composition and canelim       capsule on tumor cell growth       (IC 50 ,  x  ± SD n = 3)            Cell line   Invented composition (mg/ml)   Canelim capsule (mg/ml)               Hela   4.06 ± 1.92   5.35 ± 2.19       Al   2.12 ± 0.41   5.51 ± 2.47                  
 
         [0091]     The invented composition has inhibition effects on vitro cultured human tumor cells (Hela, A1), half inhibiting concentration (IC 50 ) is about 2-5 mg/ml.  
       TEST EXAMPLE 3  
     Acute Toxicity Test of the Invented Traditional Chinese Medicine Composition  
       [0092]     I. Tested Drugs  
         [0093]     1. Preparation labeled dosage: 1 ml containing 0.55 g of crude drug.  
         [0094]     2. Preparative methods: stock solution was diluted to demanding concentration with sterile purified water.  
         [0095]     3. Solvent: sterile purified water  
         [0096]     II. Animal: mice  
         [0097]     1. Kunming mice, supplied by animal center, Shanghai institute of pharmaceutical industry  
         [0098]     2 Weight: 20±1 g, 6-7 weeks old.  
         [0099]     3. Mice number: 20 mice each group (10 male mice and 10 female mice)  
         [0100]     III. Test Methods  
         [0101]     1. Administration manner: ip  
         [0102]     2. Dosage group: 5 groups, calculation unit ml/kg.  
         [0103]     3. Volume: 0.5 ml per mouse.  
         [0104]     4. Solvent: sterile purified water  
         [0105]     5. Mice abnormal reactions: Mice immediately appear abdomen intense contraction, body stretching and twist, rebound, short of breath, then mice show action retardation, hair looseness, death appears 1 hour after administration, death climax appears 6 hours after administration. Individual mouse dies 3 days after administration (shown in table 16), dissecting dead mice, only mesentery congestion, lots of drug residues in abdominal cavities can be observed by naked eyes. Observing for 3 weeks, calculating LD50 with Bliss method.  
         [0106]     6. Results  
         [0107]     Ip×1 LD50 of the invented Traditional Chinese Medicine composition is shown in table 16. It demonstrates that LD 50  of the invented Traditional Chinese Medicine composition on Kunming mice has no significant difference between male and female mice (P&gt;0.05) (See table 17).  
                                                                                                                                             TABLE 16                           Animal death distribution of acute toxicity of the invented composition via ip                                LD 50  (95%           dosage       death distribution (date)       confidence limit)            sex   ml/kg    mice number   1   2   3   4   5   6   7. . . 21   death rate %   ml/kg                    male   25   10   9   1   0   0   0   0   0   100    16.7 (15.2-18.36)           20   10   5   3   0   0   0   0   0   80           16   10   2   1   0   1   0   0   0   40           12.8   10   0   1   0   0   0   0   0   10           10.24   10   0   0   0   0   0   0   0   0       female   25   10   10   0   0   0   0   0   0   100   17.08 (15.47-18.86)           20   10   5   2   0   0   0   0   0   70           16   10   3   1   0   0   0   0   0   40           12.8   10   0   1   0   0   0   0   0   10           10.24   10   0   0   0   0   0   0   0   0                  
 
         [0108]                                                                      TABLE 17                           Acute toxicity test results of the invented composition on mice via ip administration                LD 50     LD 5     LD 95              sex   ml/kg   (95% confidence limit)                    male   16.7 (15.2-18.36)   12.27 (10.34-14.56)   22.71 (19.12-26.97)       female   17.08 (15.47-18.86)   12.19 (10.17-14.62)   23.91 (19.87-28.77)       male and female   16.89 (15.77-18.09)   12.23 (10.79-13.85)   23.32 (20.55-26.46)                    
 6. Conclusion 
 
         [0109]     Acute toxicity LD50 of the invented composition on mice via ip administration is 16.89 ml/kg, which is equal to 9.29 g/kg of crude drug.  
       APPLICATION EXAMPLE 1  
     Summary of Clinical Trail of the Invented Composition on the Treatment of Primary Hepatic Carcinoma and Gastric Cancer  
       [0110]     Object and Method  
         [0000]     I. Choice of Eligible Tested Object  
         [0000]     1. Chinese Medicine Syndrome Diagnosis Symptom of Stagnation of Poison  
         [0111]     Gastric cavity full, hard lump, Stabbing pain, loss of appetite, fatigue, vomit, haematemesis, hemafecia, dark, dark red, purple, cyanochroia or ecchymosis texture of tongue, white or yellow coated tongue, extenuated, deep or astringent pulse.  
         [0000]     2. Western Medical Diagosis Criterion:  
         [0000]     Primary Hepatic Carcinoma  
         [0112]     1) Pathologic Diagnosis 
        (1) Liver histological examination proved to be primary hepatic carcinoma     (2) Histologic examination of extra-hepatic tissue proved to be primary hepatic carcinoma        
 
         [0115]     2) Clinical Diagnosis 
        (1) If there is no other evidence of hepatic carcinoma, AFP positive by convection method check or AFP≧400 ng/ml by radioimmunity method check, and persistent more than 4 weeks, excluding pregnancy, reactive hepatopathy, gonadal embryonal tumor and metastatic hepatic carcinoma.     (2) Have or have no clinical manifestation, B ultrasonic check and CT examination show definite intrahepatic parenchymatous occupying lesion, excluding hemangiomas of liver and metastatic hepatic carcinoma, plus any one of the followings: 
            {circle around (1)} AFP≧200 ng/ml or obviously high γ-GT.     {circle around (2)} Imageological manifestation of typical primary hepatic carcinoma.     {circle around (3)} No jaundice, but obviously high AKP or γ-GT.     {circle around (4)} Obvious metastasis in distant area, bloody ascites or finding cancer cells in the ascites.     {circle around (5)} Definite cirrhosis with type B hepatitis marker positive.    
               
 
         [0123]     3) Clinical Stage Criterion  
         [0124]     I: No definite symptoms and signs of hepatic carcinoma, CT, B ultrasonic examination finds single node, size less than 5 cm.  
         [0125]     II: Mild symptom, good general condition, exceeds criterion of stage I, while there is no evidence of stage  
         [0126]     III: any one of obvious cachexia, jaundice, ascites or extrahepatic metastasis  
         [0127]     Gastric Carcinoma 
        (1) Medical history and symptom: no symptom at earlier period, male, &gt;40, epigast discomfort for unknown reasons, pain, progressing anemia and emaciation, or regularity of ulcer changed, loss of appetite, vomit, haematemesis or hemafecia.     (2) Sign: epigast tenderness or lump palpable, at advantaged stage, superficial lymphadenectasis can be palpable, hard, ascites, anemia.     (3) Fecal occult blood test: Fecal occult blood test shows positive for consecutive 3 days.     (4) Gastric fluid analysis: gastric fluid decrease or hypchlorhydia.     (5) Upper gastrointestinal opacification: dysperistalsis, destroy of gastric mucos, changing of gastric emptying time (acceleration or retardation), abnormality of gastric contour, niche sign of irregular margin and filling defect.     (6) Gastric endoscope examination: tumor or large irregular ulcer can be visible.     (7) Exfoliative cytometer examination of gastric fluid: finding out typical cancer cells.     (8) Operation pathologic sample, biopsy of superficial lymph nodes, endoscope pathologic sample substantiated cases. 
 
 Clinical Stage Criterion of Gastric Carcinoma 
       
 
         [0136]     I: Superficial carcinoma with no lymph nodes metastasis and tumor infiltrated into less than ½ sector of the muscular layer.  
         [0137]     II: Superficial carcinoma with first station lymph nodes metastasis and carcinoma infiltrated into muscular layer, exceeded 1 sector, and T 3  tumor without or only with adjacent lymph nodes metastasis.  
         [0138]     III: Regardless of tumor size, tumor with distant superficial lymph nodes metastasis or with adjacent deep lymph nodes metastasis, or tumor only with adjacent superficial lymph nodes metastasis, even without lymph nodes metastasis, but the size of the tumor exceeded 1 sector of muscular layer or infiltrated into surrounding tissues.  
         [0139]     IV: Regardless of tumor size, tumor with distant metastasis or metastasis of hepatic hilum lymph nodes, para-arteria coeliaca lymph nodes, paraaortic lymoh nodes, para-arteria colica media lymph nodes or lymph nodes of root of mesentery.  
         [0000]     1. Inclusion Criterion  
         [0140]     (1) Stage I, II patients are reluctant to receive other treatments, participating clinical trails voluntarily.  
         [0141]     (2) Those patients who have received anti-cancer therapy (including total chemotherapy, arterial cannula chemotherapy and embolotherapy), partly radiotherapy, operations (excluding patients who relapsed after surgical radical correction), cryotherapy or injecting with absolute alcohol, need stop therapy for over 3 months.  
         [0142]     (3) Age&gt;18 years  
         [0143]     (4) Predicted survival time&gt;2 months, survival quality Karnofsky score≧50  
         [0000]     2. Excluding Case Criterion  
         [0000]    
       
         
           
              (1) Age&lt;18 years  
              (2) Pregnant or breast-feeding women.  
              (3) Patients with esophageal stenosis, polypi or tumor; gastroduodenal ulcer; reactive gastritis, atrophic gastritis, bile reflux gastritis; bowel obstruction; structural diseases of liver, cholecyst, pancreas, colon; patients can not receive medication via po.  
              (4) Signs of gastric perforation or bleeding.  
              (5) Combined heart, liver, kidney and hematopoietic system, immune system severe primary diseases, psychotic patients.  
              (6) Those who refuse therapy.  
              (7) Be considered as those are unsuitable for participating in clinical trail by researchers. 
 
 II. Methods of Clinical Trails 
 
           
         
       
     
         [0151]     1. Trail Design:  
         [0152]     According to Investigational New Drug Application (IND), performing clinical trails with the invented Traditional Chinese Medicine composition on treatment of primary hepatic carcinoma and gastric carcinoma, primary hepatic carcinoma cases are no less than 30 cases, gastric carcinoma cases are no less than 30 cases, without setting controls, in order to substantiate its anti-cancer effects.  
         [0153]     2. Adiministration Manner and Dosage:  
         [0154]     The invented Traditional Chinese Medicine composition, taken orally, twice each day, 15 ml each time (1 ml containing crude drugs 0.75 g), taken in the early morning and evening, taken with warm water.  
         [0155]     3. Course of treatment: 2 months.  
         [0156]     4. Observed items and methods 
        (1) Safety detection: blood, urine, faeces routine check; liver, kidney function, ECG are checked before and after therapy. In clinical trails, observe carefully the adverse reactions which may be caused by the invented composition, such as symptoms of digest, respiration, circulation, nerve and blood systems.     (2) Estimation of therapeutic efficacy: 
            {circle around (1)} Tumor foci: performing B ultrasonic, CT or/and MRI examination before and after treatment.     a Measurement of tumor foci size: multiply the two perpendicular maximum diameter.     b Multiple tumor foci are measured with sum of all products of multiplication (refer to product of two perpendicular maximum diameter).     c Diffused nodular tumor should be explained particularly.     d Recording with or without portal vein cancer cell embolism.     {circle around (2)} Clinical symptom observations:     a Main symptoms of primary heparic and gastric carcinoma: Hepatic region pain, lump in superior belly, fatigue, emaciation, jaundice and fever.     b Main symptoms of stagnation of poison:     Lump below the costal region, discomfortableness and pain, fever, dry mouth and bitter mouth, dry stool, constipation, body or eyestained yellow, dark red, purple or cyanochroia texture of tongue, yellow coated tongue, astrigent pulse.     c Survival quality: Karnofsky grade     d Other examination items: AFP, AKP, γ-GT, CD3, CD4, CD8 etc.    
               
 
         [0170]     Observing Methods:  
         [0171]     Observing methods:observing and recording symptoms, Karnofsky score, tongue and pulse regularly; Laboratory examination items including blood routine test, bleeding time and clotting time are checked once a week during or after treatment; urine routine test, faeces routine test, AFP, γ-GT, LDH, liver function and kidney function are checked once two weeks during or after treatment; Immunology index, ECC; heart function, chest X-Ray are checked once four weeks during or after treatment; the Examination of imageology is carried on once eight weeks during or after treatment, the examination can be carried on at any time when needed.  
         [0000]     III Therapeutic Efficacy Assessment Criterions  
         [0000]     1. Therapeutic efficacy assessment criterions of the tumor foci:  
         [0172]     (1) Complete Remission (CR): tumor disappeared and maintained for more than 1 month.  
         [0173]     (2) Partial Remission (PR): product of two maximum diameters of tumor minimized more than 50%, and maintained for more than 1 month.  
         [0174]     (3) Stable disease (SD): product of two maximum diameters minimized less than 50%, increased by no more than 25%, maintained for more than 1 month.  
         [0175]     (4) Progression disease (PD): product of two maximum diameters increased by more than 25%.  
         [0176]     Total remission rate=CR+PR  
         [0177]     1. survival quality assessment criterions:  
         [0178]     According to Karnofsky score criterions, it is compared before and after treatment.  
         [0179]     Karnofsky score criterions:  
                                       Normal, no discomfort or sign of disease   100       Normal activity, mild sign of disease   90       Nearly normal activity, certain symptoms or signs   80       Self care, can not maintain normal activity and work   70       Life need help occasionally, but can meet most individual demands   60       Need many help and medical care   50       Losing living ablities, need special help and care   40       Losing living ablities sevely, need treatment in hospital, no death   30       threat temporarily       Badly ill, need to be kept in hospital and given powerful   20       Supportive treatment       In great danger   10       Death   0                  
 
 IV. Handling and Summarizing of Clinical Trail Data 
 
         [0180]     Collecting all data, inputing the medical history into computers, constructing database using EPI INF06 software, making statistical treatment and analysis, writing summary of clinical trails, making objective assessment about clinical therapeutic effects and safety of the invented Traditional Chinese Medicine composition treatment on primary hepatic carcinoma and gastric carcinoma.  
       Results  
       [0181]     100 eligible cases, all belong to group treated with the invented composition solely; Of which 41 cases of primary hepatic carcinoma, 59 cases of gastric carcinoma diagnosed by western medicine, while being considered as the symptom of stagnation of poison  
         [0000]     I. General Condition  
         [0182]     1. Sex  
                                                       TABLE 1                           sex construction                male   female   total                            Primary hepatic carcinoma   33   8   41           Gastric carcinoma   44   15   59                      
 
         [0183]     2. Age  
                                                                   TABLE 2                           age block                34-40   41-50   51-60   61-78     x  ± SD                        Primary hepatic   6   10   12   13   53.9 ± 10.2       carcinoma       Gastric carcinoma   4   14   13   28   56.5 ± 9.5                  
 
         [0184]     3. Course of Disease  
                                                                   TABLE 3                           course of disease (month)                case*   1-3   4-6   7-12   13-50                        Primary hepatic   36   26   3   4   3       carcinoma       Gastric carcinoma   57   21   10   12   14                 *data of 5 cases of primary hepatic carcinoma and 2 cases of gastric carcinoma are lost.             
 
         [0185]     4. Past Treatment  
                                                                   TABLE 4                           past treatment*                case*   untreated   operation   TCM   TAI                        Primary hepatic carcinoma   40   27   6   2   5       gastric carcinoma   58   26   17   3   12                 *data of 1 case of primary hepatic carcinoma and 1 case of gastric carcinoma are lost             
 
         [0186]     5. Foci Type and Location  
         [0187]     Among 41 cases of primary hepatic carcinoma, massive type, nodular type and diffuse type are 17 cases (41.5%), 17 cases (41.5%) and 7 cases (17.1%) respectively, 3 cases (7.3%) of tumors located in left hepatic lobe, 29 cases (70.7%) of tumors located in right hepatic lobe, 9 cases (22%) of tumors located in both lobes.  
         [0188]     Among 59 cases of gastric carcinoma, carcinoma located in upper region, middle region, lower region or other regions of stomach are 4 cases (6.8%), 8 cases (13.6%), 18 cases (30.5%), 21 cases (35.6%) respectively, 7 cases (11.9%) of carcinoma located in multiple regions of stomach.  
         [0189]     6. Clinical Stage  
                                                                       TABLE 5                           clinical stage                cases   □   □   □   □                            Primary hepatic carcinoma   41   2   20   19   0           Gastric carcinoma   59   1   1   19   37                      
 
         [0190]     7. Karnofsky Score Before Treatment  
                                                                   TABLE 6                           Karnofsky score before treatment                cases   50-69   70-79   80-90     x  ± s                        Primary hepatic   41   9   21   11   69.8 ± 13.9       carcinoma       Gastric carcinoma   59   24   27   8   65.9 ± 8.9                  
 
         [0191]     8. Body Weight Before Treatment  
                                                                           TABLE 7                           Body weight(kg) before treatment                cases   36-50   51-60   61-70   71-76     x  ± s                        Primary hepatic   41   3   15   20   3   61.0 ± 7.9       carcinoma       Gastric   59   13   26   13   4   56.4 ± 8.8       carcinoma                  
 
         [0192]     9. Appetite Before Treatment  
                                                                           TABLE 8                           appetite before treatment (taels/day)                cases   1-4   4-5.9   6-7.9   8-12     x  ± s                        Primary hepatic   41   9   12   13   7   5.7 ± 1.6       carcinoma       Gastric carcinoma   59   19   8   24   6   5.3 ± 1.9                 *data of 1 case of gastric carcinoma are lost.             
 
         [0193]     10. AFP Test Before Treatment of Primary Hepatic Carcinoma  
                                                                   TABLE 9                           AFP (ug/ml) test before treatment of primary hepatic carcinoma                cases   &lt;30   30-399   ≧400     x  ± s                        primary hepatic   39   2   3   34   381.69 ± 126.13       carcinoma                  
 
         [0194]     11. γ-GT Test Before Treatment of Primary Hepatic Carcinoma  
                                               TABLE 10                           γ-GT test before treatment of primary hepatic carcinoma                cases     x  ± s (n)                            primary hepatic carcinoma   22   200.2 ± 103.7 (22)                      
 
 II. Therapeutic Efficacy 
 
         [0195]     1. Total Efficacy  
                                         TABLE 11                           total therapeutic efficacy            disease   cases*   CR(%)   PR(%)   SD(%)   PD(%)               primary hepatic   41   0(0.0%)   1(2.4%)   34(82.9%)   6(14.6%)       carcinoma       Gastric carcinoma   59   0(0.0%)   6(10.2%)   49(83.0%)   4(6.8%)                 CR, PR, SD, PD of primary hepatic carcinoma after treatment are 0, 2.4%, 82.9%, 14.6% respectively.            CR, PR, SD, PD of gastric carcinoma after treatment are 0, 10.2%, 83.0%, 6.8% respectively.             
 
         [0196]     2. Follow-Up Life Span, Survival Rate After Treatment  
                                                                                             TABLE 12                           Deaths 8 weeks after treatment                death (cause)                        hepatic       upper gastrointestinal               disease   cases   survival   coma   hepatorrhexis   bleeding   failure   others                    primary hepatic   41   39   0   0   0   1   1       carcinoma       gastric   59   45   0   0   1   12   1       carcinoma                  
 
         [0197]    
       
         
               
             
               
               
             
               
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
             
           
               
                 TABLE 13 
               
             
             
               
                   
               
               
                   
               
               
                 Deaths 1.5 year after treatment 
               
             
          
           
               
                   
                 death (cause) 
               
             
          
           
               
                   
                   
                   
                   
                   
                 upper 
                   
                   
                   
               
               
                   
                   
                   
                 hepatic 
                   
                 gastrointestinal 
                   
                 hepatorenal 
               
               
                 disease 
                 cases 
                 survival 
                 coma 
                 Hepatorrhexis 
                 bleeding 
                 failure 
                 syndrome 
                 others 
               
               
                   
               
             
          
           
               
                 primary 
                 41 
                 8 
                 5 
                 4 
                 8 
                 10 
                 2 
                 4 
               
               
                 hepatic 
               
               
                 carcinoma 
               
               
                 Gastric 
                 59 
                 25 
                 0 
                 0 
                 3 
                 28 
                 0 
                 3 
               
               
                 carcinoma 
               
               
                   
               
             
          
         
       
     
         [0198]    
       
         
               
             
               
               
               
               
               
             
               
               
               
               
               
             
           
               
                 TABLE 14 
               
             
             
               
                   
               
               
                   
               
               
                 life span(month), survival rate 1.5 years after treatment (I) 
               
             
          
           
               
                 disease 
                 cases 
                 Complete data cases 
                 censored 
                 % censored 
               
               
                   
               
             
          
           
               
                 primary hepatic 
                 41 
                 33 
                 8 
                 19.5% 
               
               
                 carcinoma 
               
               
                 Gastric carcinoma 
                 59 
                 34 
                 25 
                 42.4% 
               
               
                   
               
             
          
         
       
     
         [0199]    
       
         
               
             
               
               
               
               
             
               
               
               
               
               
               
             
           
               
                 TABLE 15 
               
             
             
               
                   
               
               
                   
               
               
                 life span(month), survival rate 1.5 years after treatment (II) 
               
             
          
           
               
                   
                 Average survival 
                 Median Survival Time 
                   
               
               
                   
                 time(month) 
                 (month) 
                 1 year survival rate 
               
             
          
           
               
                 disease 
                 cases 
                   x  ± se 
                   x  ± se 
                 % 
                 standard error 
               
               
                   
               
               
                 primary hepatic 
                 41 
                 7.7 ± 0.9 
                 5.0 ± 1.3 
                 16.5 
                 6.0 
               
               
                 carcinoma 
               
               
                 Gastric 
                 59 
                 10.7 ± 0.8  
                 11.0 ± 1.5  
                 33.0 
                 7.7 
               
               
                 carcinoma 
               
               
                   
               
             
          
         
       
     
         [0200]     3. Comparison of Changes of Tumor Foci Size Before and After Treatment  
                                 TABLE 16                           Comparison of changes of tumor foci sizes $  before and after treatment                before treatment   after treatment   difference (after − before)       disease     x  ± s (n)     x  ± s (n)     x  ± s (n)               primary hepatic carcinoma   39.4 ± 42.9 (37)   46.5 ± 53.1 (36)     6.4 ± 29.6 (36)*       Gastric carcinoma   19.2 ± 21.1 (59)   15.8 ± 14.4 (59)   −3.4 ± 12.0 (59) #                     $ Size of tumor foci: product of two perpendicular maximum diameters or sum of products of multiple foci (cm × cm).            *Primary hepatic carcinoma, t = 1.30, P = 0.203              # Gastric carcinoma, t = 2.17, P = 0.034             
 
         [0201]     For Primary hepatic carcinoma patients, there is no notable significance in the difference of tumor foci size before and after treatment  
         [0202]     For Gastric carcinoma patients, there is notable significance in the difference of tumor foci size before and after treatment.  
         [0203]     4. Changes of Karnofsky Score After Treatment  
                                 TABLE 17                           Changes of Karnofsky score after treatment                        difference           before treatment   after treatment   (after − before)       disease     x  ± s (n)     x  ± s (n)     x  ± s (n)               Primary hepatic   69.8 ± 13.9(41)   78.1 ± 8.7(31)    7.7 ± 16.1(31)*       carcinoma       Gastric carcinoma   65.9 ± 8.9(59)    77.1 ± 9.9(56)   11.6 ± 8.0(56) #                    *Primary hepatic carcinoma, t = 2.68, P = 0.012              # Gastric carcinoma, t = 10.80, P = 0.000             
 
         [0204]     For Primary hepatic carcinoma patients, there is notable significance in the difference of Karnofsky score before and after treatment  
         [0205]     For Gastric carcinoma patients, there is notable significance in the difference of Karnofsky score before and after treatment  
         [0206]     5. Changes of Body Weight After Treatment  
                                 TABLE 18                           Changes of body weight after treatment (Kg)                before treatment   after treatment   difference (after − before)       disease     x  ± s (n)     x  ± s (n)     x  ± s (n)               Primary hepatic carcinoma   61.0 ± 7.9 (41)   63.1 ± 7.3 (31)   0.9 ± 1.4 (31)*       Gastric carcinoma   56.4 ± 8.8 (59)   56.9 ± 8.3 (55)   1.0 ± 3.6 (52) #                   *Primary hepatic carcinoma, t = 3.50, P = 0.001              # Gastric carcinoma, t = 2.10, P = 0.040             
 
         [0207]     For Primary hepatic carcinoma patients, there is notable significance in the difference of body weight before and after treatment  
         [0208]     For Gastric carcinoma patients, there is notable significance in the difference of body weight before and after treatment,  
         [0209]     6. Changes of Appetite After Treatment  
                                 TABLE 19                           Changes of appetite after treatment (taels/day)                        difference           before treatment   after treatment   (after − before)       disease     x  ± s (n)     x  ± s (n)     x  ± s (n)               primary hepatic   5.7 ± 1.6(41)   6.7 ± 1.5(31)   1.2 ± 1.4(31)*       carcinoma       gastric carcinoma   5.3 ± 1.9(59)   6.7 ± 2.7(58)   1.5 ± 1.7(56) #                    *Primary hepatic carcinoma, t = 4.77, P = 0.000              # Gastric carcinoma, t = 6.47, P = 0.000             
 
         [0210]     For Primary hepatic carcinoma patients, there is notable significance in the difference of appetite before and after treatment.  
         [0211]     For Gastric carcinoma patients, there is notable significance in the difference of appetite before and after treatment.  
         [0212]     7. Improvements of Symptoms and Signs After Treatment  
                                                                           TABLE 20                           Improvement of fatigue after treatment*                            Improved   Improved   Improved       disease   cases   aggravation   no change   1 grade   2 grades   3 grades                    Primary hepatic carcinoma   30   1   14   7   8   0       Gastric carcinoma   58   2   20   19   10   7                 *Data of 11 cases of primary hepatic carcinoma and 1 case of gastric carcinoma are lost            Improved 1 grade: lowered 1 grade after treatment compared with before treatment, for example, fatigue is difficult to recover after activities, while it is improved to be easy to recover post-treatment.            Improved 2 grades: lowered 2 grades after treatment compared with before treatment, for example, feeling fatigue when rest, while post-treatment fatigue is easy to recover after activities.            Improved 3 grades: lowered 3 grades after treatment compared with before treatment, for example, Lying in bed, while post-treatment fatigue is easy to recover after activities.             
 
         [0213]     For primary hepatic carcinoma patients, improvement rate of fatigue is 50.0%.  
         [0214]     For gastric carcinoma patients, improvement rate of fatigue is 62.1%.  
         [0215]     8. Improvements of Symptoms and Signs After Treatment  
                                             TABLE 21                           improvement of epigastralgia (gastric carcinoma) after treatment                            Improved   Improved   Improved       disease   cases   aggravation   no change   1 grade   2 grades   3 grades               gastric carcinoma   55   3   14   18   16   4                 *Data of 4 cases of gastric carcinoma are lost.             
 
         [0216]     Improvement rate of epigastralgia is 69.1%  
                                             TABLE 22                           improvement of appetite after treatment (gastric carcinoma patients)*                            Improved   Improved   Improved       disease   cases   aggravation   no change   1 grade   2 grades   3 grades               gastric carcinoma   55   3   21   16   12   3                 *Data of 4 cases of gastric carcinoma are lost.             
 
         [0217]     Improvement rate of appetite after treatment is 56.4%.  
                                             TABLE 23                           improvement of dry mouth and thirsty after treatment*                            Improved 1   Improved 2   Improved 3       disease   cases   aggravation   no change   grade   grades   grades               primary hepatic carcinoma   31   0   20   8   2   1       gastric carcinoma   58   1   44   9   4   0                 *Data of 10 cases of primary hepatic carcinoma and 1 case of gastric carcinoma are lost            Improved 1 grade: thirst lowered 1 grade after treatment, for example, dry mouth and throat, no desire for drink, improved to only dry mouth after treatment.            Improved 2 grades: thirst lowered 2 grades after treatment, for example, dry mouth and throat, desire for drink, improved to only dry mouth.            Improved 3 grades: thirst lowered 3 grades after treatment, for example, dry mouth and sorethroat, improved to only dry mouth.             
 
         [0218]     For primary hepatic carcinoma patients, improvement rate of thirst is 35.5%.  
         [0219]     For gastric carcinoma patients, improvement rate of thirst is 22.4%.  
                                                                           TABLE 24                           Improvement of bitter mouth after treatment                            Improved   Improved   Improved       disease   cases   aggravation   no change   1 grade   2 grades   3 grades                    primary hepatic carcinoma   31   0   20   10   1   0       gastric carcinoma   57   0   45   9   3   0                 *Data of 10 primary hepatic carcinoma patients and 2 cases of gastric carcinoma are lost             
 
         [0220]     For primary hepatic carcinoma patients, improvement rate of bitter mouth is 35.5%.  
         [0221]     For gastric carcinoma patients, improvement rate of bitter mouth is 21.1%.  
                                                                           TABLE 25                           Improvement of spontaneous perspiration after treatment*                        no   Improved   Improved   Improved       disease   cases   aggravation   change   1grade   2 grades   3 grades                    primary hepatic carcinoma   31   0   24   5   1   1       gastric carcinoma   57   2   42   8   5   0                 *Data of 10 cases of primary hepatic carcinoma and 2 cases of gastric carcinoma are lost.            Improved 1 grade: spontaneous perspiration lowered 1 grade after treatment, for example, perspire immediately after activities, improved to perspire occasionally after activities.            Improved 2 grades: spontaneous perspiration lowered 2 grades after treatment, for example, perspire when rest, improved to perspire occasionally after activities.            Improved 3 grades: spontaneous perspiration lowered 3 grades after treatment, for example, perspire vehemently, improved to perspire occasionally after activities.             
 
         [0222]     For primary hepatic carcinoma patients, improvement rate of spontaneous perspiration is 22.6%.  
         [0223]     For gastric carcinoma patients, improvement rate of spontaneous perspiration is 22.8%.  
                                             TABLE 26                           Improvement of night sweat after treatment*                        no   Improved   Improved   Improved       disease   cases   aggravation   change   1 grade   2 grades   3 grades               primary hepatic carcinoma   31   0   24   7   0   0       gastric carcinoma   57   3   44   5   4   1                 *Data of 10 cases of primary hepatic carcinoma and 2 cases of gastric carcinoma are lost.            Improved 1 grade: night sweat lowered 1 grade after treatment, for example, night sweat usuaally, improved to night sweat occasionally.            Improved 2 grades: night sweat lowered 2 grades after treatment, for example, night sweat every night, improved to night sweat occasionally.            Improved 3 grades: night sweat lowered 3 grades after treatment, for example, night sweat can wet cloth, improved to night sweat occasionally.             
 
         [0224]     For primary hepatic carcinoma patients, improvement rate of night sweat is 22.6%.  
         [0225]     For gastric carcinoma patients, improvement rate of night sweat is 15.8%.  
                                                                           TABLE 27                           Improvement of upset and tantrum after treament*                        no   Improved   Improved   Improved       disease   cases   aggravation   change   1 grade   2 grades   3 grades                    primary hepatic carcinoma   31   0   26   5   0   0       gastric carcinoma   57   2   37   15   3   0                 *Data of 10 cases of primary hepatic carcinoma and 2 cases of gastric carcinoma are lost.            Improved 1 grade: upset and tantrum lowered 1 grade after treatment, for example, upset and self-uncontrollable, improved to be upset and self-controllable.            Improved 2 grades: upset and tantrum lowered 2 grades after treatment, for example, burning sensation of five centres and tantrum, improved to be upset and self-controllable.             
 
         [0226]     For primary hepatic carcinoma patients, improvement rate of upset and tantrum is 16.1%.  
         [0227]     For gastric carcinoma patients, improvement rate of upset and tantrum is 31.6%.  
                                                                           TABLE 28                           Improvement of dizziness after treatment*                        no   Improved   Improved   Improved       disease   cases   aggravation   change   1 grade   2 grades   3 grades                    primary hepatic carcinoma   31   1   26   4   0   0       gastric carcinoma   57   3   36   14   4   0                 *Data of 10 cases of primary hepatic carcinoma and 2 cases of gastric carcinoma are lost.            Improved 1 grade: dizziness lowered 1 grade after treatment, for example, dizzy usually, improved to dizzy occasionally.            Improved 2 grades: dizziness lowered 2 grades after treatment, for example, dizzy persistently, improved to dizzy occasionally.             
 
         [0228]     For primary hepatic carcinoma patients, improvement rate of dizziness is 12.9%.  
         [0229]     For gastric carcinoma patients, improvement rate of dizziness is 31.6%.  
                                             TABLE 29                           Improvement of jaundice after treatment*                        no   Improved   Improved   Improved       disease   cases   aggravation   change   1 grade   2 grades   3 gradea               primary hepatic carcinoma   31   2   28   1   0   0       gastric carcinoma   57   0   57   0   0   0                 *Data of 10 cases of primary hepatic carcinoma and 2 cases of gastric carcinoma are lost.            Improved 1 grade: jaundice lowered 1 grade after treatment, for example, albuginea oculi and skin stained yellow, improved to only albuginea oculi mildly stained yellow.             
 
         [0230]     For primary hepatic carcinoma patients, improvement rate of jaundice is 3.2%.  
         [0231]     For gastric carcinoma patients, improvement rate of jaundice is 0%.  
                                                                           TABLE 30                           Improvement of cancer pain after treatment*                        no   Improved   Improved   Improved       disease   cases   aggravation   change   1 grade   2 grades   3 grades                    primary hepatic carcinoma   31   1   14   8   7   1       gastric carcinoma   57   1   35   12   8   1                 *Data of 10 cases of primary hepatic carcinoma and 2 cases of gastric carcinoma are lost.            Improved 1 grade: cancer pain lowered 1 grade after treatment, for example, moderate cancer pain(bearable, no upset), improved to mild cancer pain(discomfort, no upset)            Improved 2 grades: cancer pain lowered 2 grades after treatment, for example, severe cancer pain(active body position, demand for painkiller), improved to mild cancer pain(discomfort, no upset)            Improved 3 grades: cancer pain lowered 3 grades after treatment, for example, uncontrollable pain(upset, passive position, need painkiller to relieve),. improved to mild cancer pain(discomfort, no upset)             
 
         [0232]     For primary hepatic carcinoma patients, improvement rate of cancer pain is 51.6%.  
         [0233]     For gastric carcinoma patients, improvement rate of cancer pain is 36.8%.  
                                                                           TABLE 31                           Improvement of abdominal distension after treatment*                        no   Improved   Improved   Improved       disease   cases   aggravation   change   1 grade   2 grades   3 grades                    primary hepatic carcinoma   31   1   16   10   3   1       gastric carcinoma   57   0   26   19   10   2                 *Data of 10 cases of primary hepatic carcinoma and 2 cases of gastric carcinoma are lost.            Improved 1 grade: abdominal distension lowered 1 grade after treatment, for example, abdominal distension, unrelieved after passage of gas by anus, improved to relief after passage of gas by anus after treatment, no ascites.            Improved 2 grades: abdominal distension lowered 2 grades after treatment, for example, obvious abdominal distension with small or moderate volume of ascites, improved to abdominal distension, relief after passage of gas by anus, no ascites after treatment.            Improved 3 grades: abdominal distension lowered 3 grades after treatment, for example, obvious abdominal distension with large volume of ascites, improved to abdominal distension, relief after passage of gas by anus, no ascites after treatment.             
 
         [0234]     For primary hepatic carcinoma patients, improvement rate of abdominal distension is 45.2%.  
         [0235]     For gastric carcinoma patients, improvement rate of abdominal distension is 54.4%.  
                                             TABLE 32                           Improvement of diarrhea after treatment*                        no   Improved   Improved   Improved       disease   cases   aggravation   change   1 grade   2 grades   3 grades               primary hepatic carcinoma   31   0   26   2   3   0       gastric carcinoma   57   2   54   1   0   0                 *Data of 10 cases of primary hepatic carcinoma and 2 cases of gastric carcinoma are lost.            Improved 1 grade: diarrhea lowered 1 grade after treatment, for example, bearable (&gt;2 d), improved to diarrhea transiently (&lt;2 d) after treatment.            Improved 2 grades: diarrhea lowered 2 grades after treatment, for example, unbearable diarrhea, improved to diarrhea transiently (&lt;2 d) after treatment.             
 
         [0236]     For primary hepatic carcinoma patients, improvement rate of diarrhea is 16.1%.  
         [0237]     For gastric carcinoma patients, improvement rate of diarrhea is 1.8%.  
         [0238]     9. Disappearance of Main Symptoms and Signs After Treatment  
                                                                   TABLE 33                           Disappearance of main symptoms after treatment                    total   beginning   disappeared   disappearance       symptoms   disease   cases   cases   cases   rate                    fatigue   primary hepatic carcinoma   31   26   10   61.5%           gastric carcinoma   58   50   18   36.0%       dry mouth   primary hepatic carcinoma   31   20   7   35.0%       and thirst   gastric carcinoma   58   17   11   64.7%       bitter mouth   primary hepatic carcinoma   31   15   9   60.0%           gastric carcinoma   58   13   9   69.2%       spontaneous   primary hepatic carcinoma   30   12   6   50.0%       perspiration   gastric carcinoma   58   17   10   58.8%       night sweat   primary hepatic carcinoma   31   13   7   53.8%           gastric carcinoma   58   12   10   83.3%       upset and   primary hepatic carcinoma   31   10   5   50.0%       tantrum   gastric carcinoma   58   20   15   75.0%       dizziness   primary hepatic carcinoma   31   7   3   42.9%           gastric carcinoma   58   24   14   58.3%       jaundice   primary hepatic carcinoma   31   10   1   10.0%           gastric carcinoma   58   2   0     0%       cancer pain   primary hepatic carcinoma   31   23   13   56.5%           gastric carcinoma   58   30   14   46.7%       abdominal   primary hepatic carcinoma   31   27   10   37.0%       distension   gastric carcinoma   57   41   16   39.0%       diarrhea   primary hepatic carcinoma   31   5   5    100%           gastric carcinoma   58   3   1   33.3%                 *Data of 10 or 11 cases of primary hepatic carcinoma and 1 or 2 cases of gastric carcinoma are lost.             
 
         [0239]     10. Changes of White Blood Cells (WBC) After Treatment  
                                             TABLE 52                           Changes of White Blood Cells(WBC) after treatment*                        no   Improved   Improved   Improved       disease   cases   aggravation   change   1 grade   2 grades   3 grades               primary hepatic carcinoma   29   3   25   1   0   0       gastric carcinoma   55   2   50   1   0   2                 *Grade WBC accurately according to “WHOgrade crterions for acute and subacute toxicity reactions of the anti-caner drugs” . . .            Aggravation: WBC grade increased more than 1 grade after treatment compared with before treatment            Improved 1 grade: WBC grade lowered 1 grade after treatment compared with before treatment.            Improved 2 grades: WBC grade lowered 2 grades after treatment compared with before treatment.            Improved 3 grades: WBC grade lowered 3 grades after treatment compared with before treatment.             
 
         [0240]     For primary hepatic carcinoma patients, improvement rate of WBC is 3.5%, aggravation rate of WBC is 10.3%.  
         [0241]     For gastric carcinoma patients, improvement rate of WBC is 5.5%, aggravation rate of WBC is 3.6%.  
         [0242]     11. Changes of Granulocytes After Treatment  
                                             TABLE 35                           Changes of granulocytes number after treatment*                        no   Improved   Improved   Improved       disease   cases   aggravation   change   1 grade   2 grades   3 grades               primary hepatic carcinoma   17   0   15   2   0   0       gastric carcinoma   53   1   52   0   0   0                 *Gradie granulocytes number accurately according to “WHO grade criteriions for acute and subacute toxicity reactions of the anti-cancer drugs”.            Aggravation: granulocytes number grade increased more than 1 grade after treatment compared with before treatment            Improved 1 grade: granulocytes number grade lowered 1 grade after treatment compared with before treatment.            Improved 2 grades: granulocytes number grade lowered 2 grades after treatment compared with before treatment.            Improved 3 grades: granulocytes number grade lowered 3 grades after treatment compared with before treatment.             
 
         [0243]     For primary hepatic carcinoma patients, improvement rate of granulocytes number is 11.8%, aggravation rate of granulocytes number is 0%.  
         [0244]     For gastric carcinoma patients, improvement rate of granulocytes is 0%, aggravation rate of granulocytes number is 1.9%.  
         [0245]     12. Changes of hemoglobin number after treatment  
                                             TABLE 36                           Changes of hemoglobin number after treatment*                        no   Improved   Improved   Improved       disease   cases   aggravation   change   1 grade   2 grades   3 grades               primary hepatic carcinoma   31   5   24   2   0   0       gastric carcinoma   55   9   36   8   1   1                 *Grade hemoglobin number accurately according to “WHOgrade criterions for acute and subacute toxicity reactions of the anti-cancer drugs”.            Aggravation: hemoglobin number grade increased more than 1 grade after treatment compared with before treatment            Improved 1 grade: hemoglobin number grade lowered 1 grade after treatment compared with before treatment.            Improved 2 grades: hemoglobin number grade lowered 2 grades after treatment compared with before treatment.            Improved 3 grades: hemoglobin number grade lowered 3 grades after treatment compared with before treatment.             
 
         [0246]     For primary hepatic carcinoma patients, improvement rate of hemoglobin number is 6.5%, aggravation rate of hemoglobin number is 16.1%.  
         [0247]     For gastric carcinoma patients, improvement rate of hemoglobin number is 18.2%, aggravation rate of hemoglobin number is 16.4%.  
         [0248]     13. Changes of Platelets Number After Treatment  
                                             TABLE 37                           Changes of platelets number after treatment*                        no   Improved   Improved   Improved       disease   cases   aggravation   change   1 grade   2 grades   3 grades               primary hepatic carcinoma   29   1   25   3   0   0       gastric carcinoma   55   1   51   1   1   1                 *Grading platelets number accurately according to “WHOgrade criterions for acute and subacute toxicity reactions of the anti-cancer drugs”.            Aggravation: platelets number grade increased more than 1 grade after treatment compared with before treatment            Improved 1 grade: platelets number grade lowered 1 grade after treatment compared with before treatment.            Improved 2 grades: platelets number grade lowered 2 grades after treatment compared with before treatment.            Improved 3 grades: platelets number grade lowered 3 grades after treatment compared with before treatment.             
 
         [0249]     For primary hepatic carcinoma patients, improvement rate of platelets number is 10.3%, aggravation rate of platelets number is 3.5%.  
         [0250]     For gastric carcinoma patients, improvement rate of platelets number is 5.5%, aggravation rate of platelets number is 1.8%.  
         [0251]     14. Comparison of Immunologic Index CD3 Before and After Treatment  
                                 TABLE 38                           Comparison of immunologic index CD3 before and after treatment                        difference           before treatment   after treatment   (after − before)       disease     x  ± s (n)     x  ± s (n)     x  ± s (n)               primary hepatic   53.5 ± 9.7(35)    55.9 ± 9.8(25)    1.8 ± 2.1(25)*       carcinoma       gastric carcinoma   60.2 ± 12.7(29)   61.6 ± 14.0(29)   1.3 ± 9.2(29) #                    *Primary hepatic carcinoma, t = 4.18, P = 0.000.              # Gastric carcinoma, t = 0.76, P = 0.452.             
 
         [0252]     For Primary hepatic carcinoma patients, there is notable significance in the difference of immunologic index CD3 before and after treatment.  
         [0253]     For Gastric carcinoma patients, there is no notable significance in the difference of immunologic index CD3 before and after treatment.  
         [0254]     15. Comparison of Immunologic Index CD4 Before and After Treatment  
                                 TABLE 39                           Comparison of immunologic index CD4 before and after treatment                        difference           before treatment   after treatment   (after − before)       disease     x  ± s (n)     x  ± s (n)     x  ± s (n)               primary hepatic   34.7 ± 5.0(35)   35.1 ± 3.9(25)   1.4 ± 1.4(25)*       carcinoma       gastric carcinoma   40.5 ± 9.5(29)   37.9 ± 8.4(29)   −2.6 ± 5.4(29) #                    *Primary hepatic carcinoma, t = 5.23, P = 0.000.              # Gastric carcinoma, t = 2.65, P = 0.013.             
 
         [0255]     For Primary hepatic carcinoma patients, there is notable significance in the difference of immunologic index CD4 before and after treatment.  
         [0256]     For Gastric carcinoma patients, there is notable significance in the difference of immunologic index CD4 before and after treatment.  
         [0257]     16. Comparison of Immunologic Index CD8 Before and After Treatment  
                                                   TABLE 40                           Comparasion of immunologic index CD8 before and after treatment                        difference           before treatment   after treatment   (after − before)             x  ± s (n)     x  ± s (n)     x  ± s (n)                        primary hepatic   30.2 ± 5.8(35)   29.2 ± 4.5(25)   −1.1 ± 3.9(25)*       carcinoma       gastric carcinoma   31.2 ± 8.1(29)   28.9 ± 8.3(29)   −2.3 ± 4.4(29) #                    *Primary hepatic carcinoma, t = 1.47, P = 0.154.              # Gastric carcinoma, t = 2.75, P = 0.010.             
 
         [0258]     For Primary hepatic carcinoma patients, there is no notable significance in the difference of immunologic index CD8 before and after treatment.  
         [0259]     For Gastric carcinoma patients, there is notable significance in the difference of immunologic index CD8 before and after treatment.  
         [0260]     17. Comparison of Immunologic Index CD4/CD8 Before and After Treatment  
                                                   TABLE 41                           Comparison of immunologic index CD4/CD8 before and after       treatment                        difference           before treatment   after treatment   (after − before)             x  ± s (n)     x  ± s (n)     x  ± s (n)                        primary hepatic   1.23 ± 0.55(34)   1.25 ± 0.35(25)   0.11 ± 0.26(33)*       carcinoma       gastric carcinoma   1.35 ± 0.44(29)   1.46 ± 0.47(29)   0.00 ± 0.31(29) #                    *Primary hepatic carcinoma, t = 2.20, P = 0.037.              # Gastric carcinoma, t = 1.51, P = 0.145.             
 
         [0261]     For Primary hepatic carcinoma patients, there is notable significance in the difference of immunologic index CD4/CD8 before and after treatment.  
         [0262]     For Gastric carcinoma patients, there is no notable significance in the difference of immunologic index CD4/CD8 before and after treatment.  
         [0263]     18. Comparison of Primary Hepatic Carcinoma γ-GT Before and After Treatment  
                                 TABLE 42                           Comparison of primary hepatic carcinoma γ-GT before and       after treatment                        difference           before treatment   after treatment   (after − before)       disease     x  ± s (n)     x  ± s (n)     x  ± s (n)               primary hepatic   200.2 ± 103.7(22)   207.6 ± 101.8(58)   −7.4 ± 24.2(22)       carcinoma                 t = 1.437, P = 0.165;             
 
 III. Results of Imageology Examination After Treatment: 
 
         [0264]     1. B Type Ultrasonic Examination:  
         [0265]     Totally there are 36 cases of primary hepatic carcinoma received B type ultrasonic examination, all show abnormalities, after treatment, rechecked and still show abnormalities. 37 cases of gastric carcinoma patients received B type ultrasonic examination, of which, 17 cases are normal, 20 cases show abnormalities, rechecked after treatment, no obvious changes.  
         [0266]     2. CT and MRI Examinations  
         [0267]     14 cases of primary hepatic carcinoma patients received CT or MRI examinations, 4 cases are normal, 10 cases are abnormal, rechecked after treatment, no obvious changes. 8 cases of gastric carcinoma patients received CT or MRI examinations, all are abnormal, rechecked after treatment, 1 case is normal, 7 cases are abnormal.  
         [0000]     IV. Safety Inspection  
         [0268]     All safety indexs are normal before treatment, abnormalities appeared after treatment are recorded in following table  
                                           positive           doubtful adverse reaction   cases/total cases   incidence rate                   Hemoglobin number reduction   7/96   7.3%       RBCnumber reduction   3/93   3.2%       WBCnumber reduction   2/95   2.1%       Granulocytes number reduction   1/83   1.2%       Platelet number reduction   1/95   1.1%       Bilirubin increase   0/91   0.0%       AKP rising   2/94   2.1%       GPT rising   3/93   3.2%       BUN rising   1/94   1.1%       serum creatinine rising   0/94   0.0%       Abnormal urine protein   2/79   2.5%       Abnornal urine RBC   5/79   6.3%       fecal occult blood   3/80   3.8%                  
 
         [0269]               Adverse Event Observations  
         [0270]     During the courses of clinical trails, doubtful adverse reaction occurred to many cases, including fever, alopecie, choking, short of breath, non cancer pain, nausea and vomit. constipation and fecal occult blood, see details in following tables  
                                                                         doubtful adverse events   cases(n = 100)   incidence rate                                        fever   7   7.0%           alopecie   1   1.0%           oral cavity ulcer   0   0.0%           cutaneous reaction   0   0.0%           choking and short of breath   2   2.0%           non cancer pain   3   3.0%           hypersensitiveness   0   0.0%           nausea and vomit   11   11.0%           constipation   22   22.0%           bleeding   3   3.0%                      
 
         [0271]     During the courses of treatment, doubtful adverse reaction occurred to some patients, such as fever, alopecie, choking, short of breath, non cancer pain, nausea, vomit, constipation and bleeding, the incidence rate is shown in above table. For 36 cases, at least one doubtful adverse reaction appears, total incidence rate of doubtful adverse reaction is 36.0% ( 36/100).  
       Conclusions  
       [0272]     100 suitable cases, of which, 41 cases of primary hepatic carcinoma, 59 cases of gastric carcinoma are considered as symptoms of stagnation of poison by Traditional Chinese Medicine  
         [0273]     CR, PR, SD and PD rate of treatment on primary hepatic carcinoma are 0, 2.4%, 82.9%, 14.6% respectively; CR, PR, SD and PD rate of treatment on gastric carcinoma are 0, 10.2%, 83.0%, 6.8% respectively.  
         [0274]     Results of 1.5 years follow-up after treatment show that 1 year survival rates of primary hepatic carcinoma patients and gastric carcinoma patients are 16.5% and 31.7% respectively, median life spans of primary hepatic carcinoma patients and gastric carcinoma patients are 5 months and 11 months respectively, average survival time are 7.7 months and 10.7 months respectively.  
         [0275]     Gastric carcinoma patients enrolled into this clinical trails are mainly in advanced stage, of which, stage III, 19 cases (32.2%); stage IV, 37 cases (62.7%), above therapeutic efficacy on gastric carcinoma demonstrates that the invented Traditional Chinese Medicine composition has relative better effects on gastic carcinoma (considered as symptom of stagnation of poison by Traditional Chinese Medinine). PR rate is 10.2%, SD rate is 83.0%, 1 year survival rate is 31.7%, median life span is 11 months.  
         [0276]     Results of solid tumor foci size assessment indicate:  
         [0277]     Comparison of tumor foci size of primary hepatic carcinoma before and after treatment, there is notable significance in the difference.  
         [0278]     Comparison of tumor foci size of gastric carcinoma before and after treatment, there is notable significance in the difference. Tumor foci size is minimized obviously after treatment, suggesting the invented Traditional Chinese Medicine composition can minimize tumor foci when used to treat gastric carcinoma (considered as symptom of stagnation of poison by Tradtional Chinese medicine)  
         [0279]     Therapeutic Effects on Main Symptoms Demonstrate:  
         [0280]     After treated with the invented Traditional Chinese Medicine composition, Karnofsky scores, body weights, appetites of the primary hepatic carcinoma patients and gatric carcinoma patients increased obviously compared with before treatment. There is notable significance in their differences.  
         [0281]     After treated with the invented Traditional Chinese Medicine composition, symptoms such as fatigue, dry mouth, thirst, dizziness, gastric discomfortableness, loss of apptite, bitter taste of mouth, spontaneous perspiration, night sweat, upset, tantrum, choking, short of breath, cancer pain, abdominal distension, are all improved compared with before treatment.  
         [0282]     Above results indicate that the invented Traditional Chinese Medicine composition can improve survival qualities of patients and ameliorate clinical symptoms of patients when used to treat primary hepatic carcinoma and gastric carcinoma (considered as ymptom of stagnation of poison by Traditonal Chinese Medicine)  
         [0283]     Results of Laboratory Examination Show:  
         [0284]     As to immunological index, Comparison results before and after treatment demonstrate that changes of CD3, CD4, CD4/CD8 of the primary hepatic carcinoma patients have significant difference; while CD4, CD8 of the gastric carcinoma patients are lower than those of before treatment, CD4/CD8 has no obvious changes. It suggests that the invented Traditional Chinese Medicine composition can enhance cellular immune functions of primary hepatic carcinoma patients, while it may not enhance cellular immune functions of gastric carcinoma patients.  
         [0285]     WBC, granulocytes, platelets of primary hepatic carcinoma patients and gastric patients have no obvious augmentations after treatment.  
         [0286]     In summary, results of 100 cases of clinical trails without control demonstrate that the therapeutic effects of the invented Traditional Chinese Medicine composition on primary hepatic carcinoma are not so obvious, PR rate is only 2.4%, however, Karnofsky scores, body weights, appetites of the primary hepatic carcinoma patients increased obviously compared with before treatment, at the same time, symptoms such as fatigue, dry mouth, thirst, cancer pain, dizziness, abdominal distension and cellular immune functions are improved to some extent compared with those of before treatment. The invented Traditional Chinese Medicine composition has better clinical effects on treatment of gastric carcinoma, PR rate is 10.2%, Karnofsky scores, body weights, appetites of the gastric carcinoma patients increased obviously compared with those of before treatment, at the same time, symptoms such as fatigue, gastric discomfort, loss of appetite, dry mouth, thirst, cancer pain, dizziness, abdominal distension are ameliorated compared with before treatment.  
         [0287]     During the course of treatment, few patients were damaged in liver, kidney functions and hematopoietic systems, some patients had suspicious adverse reactions including fever, alopecie, choking, short of breath, non cancer pain, nausea and vomit, constipation and bleeding, but they still do not stop using the test composition.  
       APPLICATION EXAMPLE 2  
     Clinical Trail Summary of Adjunctive Therapy Using the Invented Traditonal Chinese Medicine Composition on Primary Hepatic Carcinoma  
       [0288]     Object and Method  
         [0289]     I Choice of Tested Object  
         [0290]     1. Chinese medicine syndrome diagosis criterion: the same as example 1  
         [0291]     2. Western medicine diagnosis criterion: the same as diagnosis criterion of primary hepatic carcinoma mentioned in application example 1.  
         [0292]     3. Inclusion Criterion 
        (1) Patients of stage □ without taboo of intervention and chemothery.     (2) Others are the same as application example 1        
 
         [0295]     4. Excluding Case Criterion 
        The same as application example 1 except condition mentioned in (4)        
 
         [0297]     II. Methods of Clinical Trails  
         [0298]     1. Trail Design:  
         [0299]     Adopting randomized controlled trial.  
         [0300]     Dividing into different groups via simple and random methods, The researchers acquired random number through operating random key (IVN,RAN) on Casio (fx-3600p) calculators, making into random allocated cards, sealed in the envelopes, serial number of envelope is the same as that of card, certificated. Suitable cases entered into trail, according to entering time sequence, opened the envelope and divided according to the cards properly. 5. Adiministration Manner and Dosage:  
         [0301]     Treat group  
         [0302]     Begin to take the invented Traditional Chinese Medicine composition orally 1 week before the first hepatic artery intervention chemotherapy plus embolism therapy, twice each day, 15 ml each time (1 ml containing crude drugs 0.75 g), taken once in the early morning and evening, taken with warm water, performing the second hepatic artery intervention chemotherapy plus embolism therapy after 4 weeks, performing twice together. The invented Traditional Chinese Medicine composition is taken for consecutive 2 months.  
         [0303]     Control group:  
         [0304]     4 weeks after first time hepatic artery intervention chemotherapy plus embolism therapy, performing second hepatic artery intervention chemotherapy plus embolism, performing twice togather.  
         [0305]     6. Chemotherapy Regimen:  
                                                       DDP   60 mg/M 2             ADM   40 mg/M 2             5-Fu   600 mg/M 2                        
 
         [0306]     7. Embolism Methods: Iodized Oil Plus Gelatin Sponge  
         [0307]     Dosages of iodized oil and gelatin sponge should be recorded in details in clinical observation label.  
         [0308]     8. Course of Treatment: 2 months. (the treatment course of Stage II III patients will also be 2 months for the convience of future statistical analysis of data.)  
         [0309]     9. Observed Items and Methods:  
         [0310]     The same as application example 1  
         [0311]     III. Therapeutic Effects Assessment Criterions.  
         [0312]     1. The same as application example 1.  
         [0313]     2. Assessments of life spans and survival rates:  
         [0314]     life spans after treatment refer to the time from beginning of treatment to death or the last follow-up.  
         [0315]     Follow-up need at least 1 year after treatment.  
         [0316]     IV. Handling and Summarizing of Clinical Trail Data  
         [0317]     Collecting all data, inputting into computers, constructing database using EPI INF06 software, making statistical treatment and analysis, summarize clinical trails, making objective assessment about clinical adjunctive therapeutic effects and safety of the invented Traditional Chinese Medicine composition on primary hepatic carcinoma.  
         [0318]     Statistical method: enumeration data are analyzed by X 2  test, ranked data are analyzed by Wilcoxon rank sum test, two sample means are checked by t-test. Logistic regression analysis is also used to analyze enumeration data. Life span and survival rate are analyzed using life table method and Kaplan-Meier method.  
       Results  
       [0000]     I. General Data  
         [0319]     183 suitable cases, 124 cases for treat group, 59 cases for control group; all are diagnosed as primary hepatic carcinoma by westen medicine and as symptom of stagnation of poison by Traditional Chinese Medicine. Please refer to the comparable analysis for information about sex, age and disease.  
         [0000]     II Comparable Check of Two Groups  
         [0320]     1. Sex Construction Comparison of Two Groups  
                                                           TABLE 1                           sex comparison of two groups                group   cases   male   female                            treat group   124   110   14           control   59   51   8                   X 2  = 0.195   P = 0.659                      
 
         [0321]     Sex comparison of two groups, there is no notable significance in the difference.  
         [0322]     2. Age Block Comparison of Two Groups  
                                                                           TABLE 2                           Age block (year) comparison of two groups            group   cases   21-40   41-50   51-60   61-75     x  ± s                    treat   124   19   40   42   23   51.2 ± 10.0       group       control   59   13   19   17   10   50.1 ± 10.6                   X 2  = 1.400           t = 0.650                   P = 0.705           P = 0.516                  
 
         [0323]     Age block comparison of two groups, there is no notable significance in the difference.  
         [0324]     3. Disease Course Comparison of Two Groups  
                                                                   TABLE 3                           Disease course comparison of two groups (month)            group   cases   1-3   4-6   7-12   13-64                    treat group   118   87   13   6   12       Control group   58   40   10   4   4               X 2  = 1.958   P = 0.581                 *6 cases in treat group and 1 case in control group are not recorded.             
 
         [0325]     Disease course comparison of two groups, there is no notable significance in the difference.  
         [0326]     4. Past Treatment Comparison of Two Groups  
                                                                                     TABLE 4                           Past treatment comparison of two groups            group   cases*   untreated   operation   TCM   TAI                    treat group   113   85   15   0   13       Control   58   44   8   3   3                Fisher&#39;s exact test   P = 0.07                         *11 cases in treat group and 1 case in control group are not recorded.             
 
         [0327]     Past treatment comparison of two groups, there is no notable significance in the difference.  
         [0328]     5. Foci of Liver Cancer Type Comparison of Two Groups  
                                                           TABLE 5                           Foci of Liver Cancer type comparison of two groups            group   cases   massive type   nodular type   diffuse type                    treat group   124   76   38   10       control   59   35   20   4               Fisher&#39;s exact test   P = 0.879                  
 
 Pathological diagnosis comparison of two groups, there is no notable significance in the difference. 
 
         [0329]     6. Clinical Stage Comparison of Two Groups  
                                                                                 TABLE 6                           Clinical stage comparison of two groups                group   cases   I   II   III                            treat group   124   6   92   26           control   59   1   51   7                Fisher&#39;s    P = 0.210           exact test                      
 
         [0330]     Clinical stage comparison of two groups, there is no notable significance in the difference.  
         [0331]     7. Tumor Foci Size Comparison of Two Groups  
                                                   TABLE 7                           Tumor foci size* comparison of two groups                group   cases     x  ± s                            treat group   112   71.46 ± 63.23           control   55   78.03 ± 57.04           rank sum test   u = 1.054   P = 0.292                         *12 cases in treat group and 4 cases in control groups are massive type, not calculate size. Tumor foci size is measured by product of two perpendicular maximum diameters of tumor or sum of products of multiple foci (cm × cm).             
 
         [0332]     Tumor foci size comparison of two groups, there is no notable significance in the difference.  
                                                           TABLE 8                           Portal vein tumor embolism comparison of two groups                group   cases   negative   positive                            treat group   124   104   20           control   59   46   13                   X 2  = 0.943   P = 0.331                      
 
         [0333]     Portal vein tumor embolism comparison of two groups, there is no notable significance in the difference.  
         [0334]     8. Karnofsky Score, Body Weight and Appetite Comparison of Two Groups  
                                                                                             TABLE 9                           Karnofsky score comparison of two groups before treatment            group   cases   60-69   70-79   80-89   90-100     x  ± s                    treat group   124   8   56   55   5   74.7 ± 7.0       control   59   2   22   20   15   78.4 ± 8.4                Fisher&#39;s exact test       t = 3.095           P = 0.000       P = 0.002                      
 
         [0335]     Karnofsky score comparison of two groups before treatment, there is notable significance in the difference, Karnofsky score of treat group is lower than that of control group before treatment.  
                                                                                             TABLE 10                           Body weight (Kg) comparison of two groups before treatment            group   cases   40-50   51-60   61-70   71-87     x  ± s                    treat group   123*   6   27   52   38   66.0 ± 9.1       control   59   1   27   26   5   62.6 ± 6.8                Fisher&#39;s exact test       t′ = 2.816           P = 0.000       P = 0.006                         *Data of 1 case in treat group is lost.             
 
         [0336]     Body weight comparison of two groups before treatment, there is notable significance in the difference, body weight of treat group is higher than that of control group.  
                                                                                             TABLE 11                           Appetite (taels/day) comparison of two groups before treatment            group   cases   2˜4   4˜5.9   6˜7.9   8˜10     x  ± s                    treat group   124   14   44   41   25   6.0 ± 1.6       control   59   9   7   31   12   6.1 ± 1.6                X 2  = 12.358       t = 0.464           P = 0.006       P = 0.643                      
 
         [0337]     Appetite comparison of two groups before treatment, there is no notable significance in the difference.  
         [0338]     9. Main Symptoms and Signs Comparison of Two Groups Before Treatment.  
                                                                           TABLE 12                           Fatigue comparison of two groups before treatment*            group   cases   grade 0   grade□   grade□   grade□   grade□                    treat   124   34   47   27   16   0       group       control   59   21   30   6   2   0                   rank sum test   u = 2.457   P = 0.014                 *Grade 0: none            Grade I: Be fatigue after activities, easy to recover            Grade II: Be fatigue after activities, difficult to recover            GradeIII: be fatigue during rest            GradeIV: Lying in bed             
 
         [0339]     Fatigue comparison of two groups before treatment, there is notable significance in the difference, fatigue level of treat group is severer than that of control goup.  
                                                                           TABLE 13                           Dry mouth, thirst comparison of two groups before treatment*            group   cases   grade 0   grade□   grade□   grade□   grade□                    treat   124   98   20   6   0   0       group       control   59   41   15   2   1   0                   rank sum test   u = 1.531   P = 0.177                 *Grade 0: none            Grade I: dry mouth            Grade II: dry mouth and throat, no desire for drink.            Grade III: dry mouth and throat, desire for drink.            Grade IV: dry mouth, sore throat.             
 
         [0340]     Dry mouth, thirst comparison of two groups before treatment, there is no significant difference.  
                                                                           TABLE 14                           Bitter mouth comparison of two groups before treatment            group   cases   grade 0   grade□   grade□   grade□   grade□                    treat   124   86   28   4   6   0       group       control   59   50    7   2   0   0                   rank sum test   u = 2.253   P = 0.024                  
 
         [0341]     Bitter taste of mouth comparison of two groups before treatment, there is notable significance in the difference, Bitter taste of mouth of treat group is severer than control group.  
                                                                           TABLE 15                           Spontaneous perspiration comparison of two groups before treatment*            group   cases   grade0   grade□   grade□   grade□   grade□                    treat   124   110   13   1   0   0       group       control   59   57    2   0   0   0                   rank sum test   u = 1.769   P = 0.077                 *Grade 0: none            Grade I: sweat occasionally after activities.            Grade II: sweat immediately after activities.            Grade III: sweat during rest            Grade IV: sweat vehemently.             
 
         [0342]     Spontaneous perspiration comparison of two groups before treatment, there is no notable significance in the difference.  
                                                                           TABLE 16                           Night sweat comparison of two groups before treatment*            group   cases   grade 0   grade□   grade□   grade□   grade□                    treat   124   111   10   3   0   0       group       control   59   55    3   1   0   0                   rank sum test   u = 0.801   P = 0.423                 *Grade 0: none            Grade I: occasionally            Grade II: often            Grade III: every night            Grade IV: wet cloth.             
 
         [0343]     Night sweat comparison of two groups before treatment, there is no notable significance in the difference.  
                                                                           TABLE 17                           Upset and tantrum comparison of two groups before treatment*            group   cases   grade0   grade□   grade□   grade□   grade□                    treat   124   106   9   9   0   0       group       control   59   52   7   0   0   0                   rank sum test   u = 0.643   P = 0.520                 *Grade 0: none            Grade I: upset, self-controllable            Grade II: upset, self-uncontrollable            Grade III: burning sensation of five centres, irritable            Grade IV: manic             
 
         [0344]     Upset and tantrum comparison of two groups before treatment, there is no notable significance in the difference.  
                                                                           TABLE 18                           Dizziness comparison of two groups before treatment*            group   cases   grade0   grade□   grade□   grade□   grade□                    treat   124   112   7   5   0   0       group       control   59   51   6   2   0   0                   rank sum test   u = 0.739   P = 0.460                 *Grade 0: none            Grade□: dizzy occasionally            Grade□: dizzy regularly            Grade□: dizzy persistently            Grade□: need lie in bed             
 
         [0345]     Dizziness comparison of two groups before treatment, there is no notable significance in the difference.  
                                                                           TABLE 19                           Jaundice comparison of two groups before treatment*            group   cases   grade0   grade□   grade□   grade□   grade□                    treat   124   113   7   4   0   0       group       Control   59   54   3   2   0   0                   rank sum test   u = 0.082   P = 0.934                 *Grade 0: none            Grade□: albuginea oculi mildly stained yellow            Grade□: albuginea oculi and skin mildly stained yellow            Grade□: albuginea oculi and skin stained saffron yellow            Grade□: albuginea oculi and skin stained deep yellow             
 
         [0346]     Jaundice comparison of two groups before treatment, there is no notable significance in the difference.  
                                                                           TABLE 20                           Cancer pain comparison of two groups before treatment*            group   cases   grade0   grade□   grade□   grade□   grade□                    treat   124   46   48   29   1   0       group       control   58   23   31    4   0   0                   rank sum test   u = 1.509   P = 0.131                 *Grade 0: none            Grade□: mild (discomfort, no upset)            Grade□: moderate (bearable, no upset)            Grade□: sereve (positive position, demand painkiller)            Grade□: uncontrollable (upset, passive position, need painkiller to relieve)             
 
         [0347]     Cancer pain comparison of two groups before treatment, there is no notable significance in the difference  
                                                                           TABLE 21                           Abdominal distension comparison of two groups before treatment*            group   cases   grade0   grade□   grade□   grade□   grade□                    treat   124   47   57   12   8   0       group       control   59   32   21    3   3   0                   rank sum test   u = 2.052   P = 0.040                 *Grade 0: none            Grade□: abdominal distension, relieved after passage of gas by anus, no ascites.            Grade□: abdominal distension, unrelieved after passage of gas by anus, no ascites.            Grade□: obvious abdominal distension with small or moderate volume of ascites.            Grade□: obvious abdominal distension with large volume of ascites             
 
         [0348]     Abdominal distension comparison of two groups before treatment, there is notable significance in the difference, abdominal distension of treat group is severer than control group.  
         [0349]     10. Ascites and Abdomen Circumference Size Comparison of Two Groups Before Treatment.  
                                                           TABLE 22                           Ascites comparison of two groups before treatment.                group   cases   without   with                            treat group   124   113   11           control   59   51   8                   X 2  = 0.944   P = 0.331                      
 
         [0350]     Ascites comparison of two groups before treatment, there is no notable significance in the difference.  
                                 TABLE 23                           Abdomen circumference size comparison of two groups before treatment                group   cases     x  ± s                       treat group   94   82.89 ± 8.22           control   36   80.86 ± 9.59           rank sum test   u = 1.272   P = 0.203                         *Data of 30 cases in treat group and 23 cases in control group are lost.             
 
         [0351]     Abdomen circumference size comparison of two groups before treatment, there is no notable significance in the difference.  
         [0352]     11. Tongue Picture and Pulse Tracings Comparison of Two Groups Before Treatment  
                                                                                     TABLE 24                           Tongue Picture comparison of two groups before treatment                    thin and   thin and   yellow and   yellow and       group   cases   white   yellow   greasy   thick                    treat group   123   29   47   41   6       control   59   17   25   13   4                Fisher&#39;s exact test   P = 0.426                      
 
         [0353]     Tongue Picture comparison of two groups before treatment, there is no notable significance in the difference.  
                                                                   TABLE 25                           Tongue texture comparison of two groups before treatment                            dark red/                           purple dark/   petechia/       group   cases   carmoisine   red   cyanochroia   ecchymosis                    treat group   123   2   23   86   12       control   59   0   2   55   2                   Fisher&#39;s   P = 0.0024                   exact test                  
 
         [0354]     Tongue texture comparison of two groups before treatment, there is notable significance in the difference.  
                                                                                         TABLE 26                           Pulse tracings comparison of two groups before treatment            group   cases   even   astringent   string   smooth   week                    treat group   123   4   35   69   12   3       control   59   0   15   28   11   5                Fisher&#39;s exact   P = 0.089           test                      
 
 Pulse tracings comparison of two groups before treatment, there is no notable significance in the difference. 
 
         [0355]     12. AFP, γ-GT, and LDH Level Comparison of Two Groups Before Treatment  
                                                                   TABLE 27                           AFP (ug/ml) comparison of two groups before treatment            group   cases   &lt;30   30-399   ≧400     x  ± s                    treat group   123   15   35   73   380.5 ± 367.0       control   58   2   20   36   408.8 ± 332.7               X 2  = 3.73   P = 0.155                  
 
         [0356]     AFP comparison of two groups before treatment, there is no notable significance in the difference.  
                                 TABLE 28                           γ-GT comparison of two groups before treatment                group   cases     x  ± s                       treat group   96   179.75 ± 133.86           control   43   170.79 ± 171.69               t = 0.333   P = 0.739                      
 
         [0357]     γ-GT comparison of two groups before treatment, there is no notable significance in the difference.  
                                 TABLE 29                           comparison of two groups before treatment                group   cases     x  ± s                       treat group   59   220.31 ± 126.70           control   24   210.00 ± 135.57               t = 0.334   P = 0.739                      
 
 LDH comparison of two groups before treatment, there is no notable significance in the difference. 
 
         [0358]     Above results of comparability check show that sex, age, disease courses, past treatment methods, tumor type, clinical stage, coated tongue and pulse tracings of two groups have no significant differences, except Karnofsky scores, body weights, fatigue, bitter taste of mouth, abdominal distension, tongue textures. Though comparison of Karnofsky scores, body weights, fatigue, bitter taste of mouth, abdominal distension, treat group are worse than those of control groups, considering these factors may influence therapeutic effects conparison, so Logistic regression analysis is necessary when comparing therapeutic effects.  
         [0000]     III. Therapeutic Effects Comparison  
         [0359]     1. Total Therapeutic Effects Comparison  
                                                                   TABLE 30                           Total therapeutic effects comparison            group   cases   CR(%)   PR(%)   SD(%)   PD(%)                    treat group   124   0   19   97   8               0%   15.3%   78.2%   6.5%       control   59   0   4   44   11               0%   6.8%   74.6%   18.6%               rank sum test   u = 2.723   P = 0.006                  
 
         [0360]    
       
         
               
             
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
             
           
               
                 TABLE 31 
               
             
             
               
                   
               
               
                   
               
               
                 Logistic regression analysis of total therapeutic effects* 
               
             
          
           
               
                   
                   
                   
                   
                   
                   
                 95% confidence interval 
               
               
                 factor 
                 coefficient 
                 Wald 
                 D/F 
                 P value 
                 RR 
                 of RR 
               
               
                   
               
             
          
           
               
                 group 
                 1.540 
                 8.533 
                 1 
                 0.003 
                 4.66 
                  1.66˜13.11 
               
               
                 Karnofsky scores 
                 0.102 
                 7.705 
                 1 
                 0.006 
                 1.11 
                 1.03˜1.19 
               
               
                 constant 
                 −6.303 
                 5.228 
                 1 
                 0.022 
               
               
                   
               
               
                   *Dividing clinical therapeutic effects into two categories, that is, more than stability and progession disease. variable including group, Karnofsky scores, body weight, appetite, bitter taste of mouth, abdominal distension, tongue texture, using backward method to select variables, select results show that only group and Karnofsky scores have notable significance. Hosmer &amp; Lemeshow test of model, X 2  = 0.199, P = 0.995, indicating model fitting is good.    
               
             
          
         
       
     
         [0361]     CR, PR, SD and PD rates of treat group are 0%, 15.3%, 78.2%, 6.5% respectively, CR, PR, SD and PD rates of control group are 0%, 6.8%, 74.6% and 18.6% respectively. There is notable signicance in the difference between two groups.  
         [0362]     Considering that factors including Karnofsky scores, body weight, fatigue, bitter mouth, abdominal distension may influence therapeutic effects, so Logistic regression analysis is necessary when comparing therapeutic effects. Results indicate that therapeutic effects between two groups have notable significance in their differences, relative risk (RR) of control group to treat group is 4.66, suggesting that the risk of disease progression of control group is 4.66 times of the treat group.  
         [0363]     2. Life Spans and Survival Rates Comparison of Two Groups After Treatment.  
                                                                                                               TABLE 32                           Death comparasion of two groups 8 weeks after treatment                death (cause)                        hepatic   Hepatorrhe-   upper gastrointestinal               group   cases   survival   coma   xis   bleeding   failure   others                    treat group   124   102   3   6   4   7   2       control   59   48   2   1   5   2   1            combined   X 2  = 0.022   P = 0.882           death cases                  
 
         [0364]     Death comparasion of two groups 8 weeks after treatment, there is no notable significance in the difference.  
                                                                                                                       TABLE 33                           Death comparasion of two groups 1.5 years after treatment                death (cause)                                upper                               hepatic   Hepatorrhe-   gastrointestinal       hepatorenal       group   cases   survival   coma   xis   bleeding   failure   syndrome   others                    Treat group   124   40   8   5   18   38   3   12       Control   59   21   3   4   10   11   3   7            combined death cases   X 2  = 0.20   P = 0.655                  
 
         [0365]     Death comparasion of two groups 1.5 years after treatment, there is no notable significance in the difference.  
                                                           TABLE 34                           Life span and survival rate comparison of two groups 1.5 year after       treatment(-)*            group   cases   complete data   censored   % censored                    Treat group   122   83   39   32.0       control   58   38   20   34.5                 *Data of 2 cases in treat group and 1 case of control group are lost.             
 
         [0366]    
       
         
               
             
               
               
               
               
             
               
               
               
               
               
               
             
               
               
               
               
               
               
             
           
               
                 TABLE 35 
               
             
             
               
                   
               
               
                   
               
               
                 Life span and survival rate comparison of two groups 1.5 year after 
               
               
                 treatment(  - )* 
               
             
          
           
               
                   
                 Average survival 
                 Median survival 
                 1 year 
               
               
                   
                 time (month) 
                 time (month) 
                 survival rate 
               
             
          
           
               
                 group 
                 cases 
                   x  ± se 
                   x  ± se 
                 % 
                 se 
               
               
                   
               
             
          
           
               
                 treat group 
                 122 
                 11 ± 1 
                 11 ± 2 
                 40.25 
                 4.48 
               
               
                 control 
                 58 
                 11 ± 1 
                 10 ± 4 
                 45.75 
                 6.63 
               
               
                   
               
               
                   short term effect Breslow test, statistic = 0.04, P = 0.851    
               
               
                   Long term effect Log-rank test, statistic = 0.00, P = 0.983    
               
               
                   survival rate Comparison of two groups, Gehan test, statistic = 0.035, P = 0.852    
               
             
          
         
       
     
         [0367]     Life span and survival rate comparison of two groups 1.5 year after treatment: 1 year survival rate of treat group and control group are 40.25%, 45.75% respectively, there is no notable significance in the difference between two groups.  
         [0368]     3. Tumor Foci Size Comparison of Two Groups After Treatment  
                                                           TABLE 36                           Tumor foci size comparison of two groups after treatment*                            difference               before treatment   after treatment   (after − before)       group   cases     x  ± s     x  ± s     x  ± s                    treat group   112   71.5 ± 63.2   53.8 ± 48.4   −17.6 ± 29.9       control   55   78.0 ± 57.0   71.8 ± 56.8    −6.9 ± 23.7                 *Tumor foci size is measured by product of two perpendicular maximum diameters of tumor or sum of products of multiple foci (cm × cm). 10 cases in treat group and 4 cases in control groups are diffuse type, Data of 2 cases in treat group are lost.             
 
         [0369]     Comparison of treat group before and after treatment, t=6.24, P=0.000;  
         [0370]     Comparison of control group before and after treatment, t=2.14, P=0.037;  
         [0371]     Difference (after-before) comparison of two groups, t=2.31, P=0.022.  
         [0372]     Tumor foci size comparison of treat group before and after treatment, there is notable significance in the difference.  
         [0373]     Tumor foci size comparison of control group before and after treatment, there is notable significance in the difference.  
         [0374]     Tumor foci size difference (after-before) comparison of two groups, there is notable significance in the difference.  
         [0375]     4. Karnofsky Scores Comparison of Two Groups After Treatment  
                                 TABLE 37                           Karnofsky scores comparison of two groups after treatment                        difference           before treatment   after treatment   (after − before)       group     x  ± s (n)     x  ± s (n)     x  ± s (n)               Treat group   74.7 ± 7.0(124)   85.7 ± 9.1(108)   11.8 ± 7.2(108)       control   78.4 ± 8.4(59)    77.5 ± 11.5(55)   −0.5 ± 8.5(55)                   
 
         [0376]     Comparison of treat group before and after treatment, t=16.87, P=0.000;  
         [0377]     Comparison of control group before and after treatment, t=0.396, P=0.694;  
         [0378]     Difference (after-before) comparison of two groups, t=9.584, P=0.000;  
         [0379]     Karnofsky scores comparison of treat group before and after treatment, there is notable significance in the difference.  
         [0380]     Karnofsky scores comparison of control group before and after treatment, there is no notable significance in the difference.  
         [0381]     Karnofsky scores difference (after-before) comparison of two groups, there is notable significance in the difference.  
         [0382]     5. Body weight comparison of two groups after treatment  
                                 TABLE 38                           Body weight (Kg) t comparison of two groups after treatment                        difference           before treatment   after treatment   (after − before)       group     x  ± s (n)     x  ± s (n)     x  ± s (n)               Treat group   66.0 ± 9.1(123)   66.5 ± 8.5(108)     1.3 ± 2.8(107)       Control   62.6 ± 6.8(59)    62.2 ± 7.2(54)    −0.5 ± 2.4(54)                   
 
         [0383]     Comparison of treat group before and after treatment, t=0.04, P=0.965;  
         [0384]     Comparison of control group before and after treatment, t=1.73, P=0.108;  
         [0385]     Difference (after-before) comparison of two groups, t=9.584, P=0.000;  
         [0386]     Body weight comparison of treat group before and after treatment, there is no notable significance in the difference.  
         [0387]     Body weight comparison of control group before and after treatment, there is no notable significance in the difference.  
         [0388]     Body weight difference (after-before) comparison of two groups, there is notable significance in the difference.  
         [0389]     6. Appetite Comparison of Two Groups After Treatment  
                                 TABLE 39                           Appetite (taels/day) comparison of two groups after treatment                        difference           before treatment   after treatment   (after − before)       group     x  ± s (n)     x  ± s (n)     x  ± s (n)               Treat group   6.0 ± 1.6(124)   6.9 ± 1.6(112)     1.1 ± 1.7(112)       Control   6.1 ± 1.6(59)    6.4 ± 1.6(55)    −0.3 ± 1.6(55)                   
 
         [0390]     Comparison of treat group before and after treatment, t=4.98, P=0.000;  
         [0391]     Comparison of control group before and after treatment, t=5.92, P=0.000;  
         [0392]     Difference (after-before) comparison of two groups, t=2.61, P=0.010.  
         [0393]     Appetite comparison of treat group before and after treatment, there is notable significance in the difference.  
         [0394]     Appetite comparison of control group before and after treatment, there is notable significance in the difference.  
         [0395]     Appetite difference (after-before) comparison of two groups, there is notable significance in the difference.  
         [0396]     7. Main Clinical Symptoms and Signs Improvement Comparison of Two Groups After Treatment  
                                                                                             TABLE 40                           Fatigue comparison of two groups after treatment*                    aggra-       Improved   Improved   Improved       group   cases   vation   no change   1 grade   2 grades   3 grades                    Treat   113   4   32   42   21   14       group       Control   55   3   30   18   4   0                rank sum   u = 3.98   P = 0.000           test                         *Data of 11 cases in treat group and 4 cases of control group are lost.             
 
         [0397]     Meaning of Improved grade is the same as application example 1.  
         [0398]     Fatigue comparison of two groups after treatment, there is notable significance in the difference.  
                                                                                             TABLE 42                           Dry mouth and thirst improvement comparison of two groups after       treatment*                    aggra-       Improved   Improved   Improved       group   cases   vation   no change   1 grade   2 grades   3 grades                    Treat   113   2   88   17   6   0       group       control   55   0   43   12   0   0                rank sum test   u = 0.25   P = 0.806                         *Data of 11 cases in treat group and 4 cases in control group are lost.             
 
         [0399]     Meaning of Improved grade is the same as application example 1.  
         [0400]     Mouth and thirst improvement comparison of two groups after treatment, There is no notable significance in the difference.  
                                                                                             TABLE 43                           Bitter mouth improvement comparison of two groups after treatment                            Im-                       aggra-   no   proved   Improved   Improved       group   cases   vation   change   1 grade   2 grades   3 grades                    Treat group   113   0   77   26   4   6       control   55   1   49   5   0   0                rank sum   u = 3.45   P = 0.001           test                         *Data of 11 cases in treat group and 4 cases in control group are lost.             
 
         [0401]     Bitter mouth improvement comparison of two groups after treatment, there is notable significance in the difference.  
                                                                                             TABLE 44                           Spontaneous perspiration improvement comparison       of two groups after treatment*                    aggra-   no   Improved   Improved   Improved       group   cases   vation   change   1 grade   2 grades   3 grades                    treat group   113   1   101   11   0   0       control   55   1   52   2   0   0                rank sum   u = 1.46   P = 0.143           test                         *Data of 11 cases in treat group and 4 cases in control group are lost.             
 
         [0402]     Meaning of Improved grade is the same as application example 1.  
         [0403]     Spontaneous perspiration improvement of comparison of two groups after treatment, there is no notable significance in the difference.  
                                                                                             TABLE 45                           Night sweat improvement comparison of two groups after treatment*                    aggra-   no   Improved   Improved   Improved       group   cases   vation   change   1 grade   2 grades   3 grades                    treat group   113   1   103   9   0   0       control   55   1   50   4   0   0                rank sum   u = 0.33   P = 0.743           test                         *Data of 11 cases in treat group and 4 cases in control group are lost.             
 
         [0404]     Meaning of Improved grade is the same as application example 1.  
         [0405]     Night sweat improvement comparison of two groups after treatment, there is no notable significance in the difference.  
                                                                                             TABLE 46                           Upset and tantrum improvement comparison of two groups after treatment                    aggra-   no   Improved   Improved   Improved       group   cases   vation   change   1 grade   2 grades   3 grades                    treat group   114   0   96   9   9   0       control   54   0   48   6   0   0                rank sum   u = 0.96   P = 0.339           test                         *Data of 10 cases in treat group and 5 cases in control group are lost.             
 
         [0406]     Improved 1 grade: Upset and tantrum lowered 1 grade after treatment, for example, upset and self-uncontrollable, improved to be upset and self-controllable.  
         [0407]     Improved 2 grades: upset and tantrum lowered 2 grades after treatment, for example, burning sensation of five centres and tantrum, improved to be upset and self-controllable.  
         [0408]     Improved 3 grades: upset and tantrum lowered 3 grades after treatment, for example, vesania, improved to be upset and self-controllable.  
         [0409]     Upset and tantrum improvement comparison of two groups after treatment, there is no notable significance in the difference.  
                                                                                             TABLE 47                           Dizziness improvement comparison of two groups after treatment                    aggra-   no   Improved   Improved   Improved       group   cases   vation   change   1 grade   2 grades   3 grades                    treat group   114   1   101   8   4   0       control   54   3   48   3   0   0                rank sum   u = 1.77   P = 0.077           test                         *Data of 10 cases in treat group and 5 cases in control group are lost.             
 
         [0410]     Meaning of Improved 1 grade and 2 grades are the same as application example 1.  
         [0411]     Improved 3 grades means dizziness lowered 3 grades compared with before treatment, for example, need lie in bed, or improve to be dizzy occasionally.  
         [0412]     Dizziness improvement of comparison of two groups after treatment, there is no notable significance in the difference.  
                                                                                             TABLE 48                           Jaundice improvement comparison of two groups after treatment                    aggra-   no   Improved   Improved   Improved       group   cases   vation   change   1 grade   2 grades   3 grades                    treat group   114   4   103   5   2   0       control   54   5   47   1   1   0                rank sum   u = 1.52   P = 0.128           test                         *Data of 10 cases in treat group and 5 cases in control group are lost.             
 
         [0413]     Improved 1 grade: Jaundice lowered 1 grade after treatment, for example, albuginea oculi and skin slightly stained yellow, improved to only albuginea oculi slightly stained yellow.  
         [0414]     Improved 2 grades: Jaundice lowered 2 grades after treatment, for example, albuginea oculi and skin stained saffron yellow, improved to only albuginea oculi slightly stained yellow.  
         [0415]     Improved 3 grades: Jaundice lowered 3 grades after treatment, for example, albuginea oculi and skin stained deep yellow or dark yellow, improved to only albuginea oculi slightly stained yellow.  
         [0416]     Jaundice improvement comparison of two groups after treatment, there is no notable significance in the difference.  
                                                                                             TABLE 49                           Cancer pain improvement comparison of two groups after treatment                    aggra-   no   Improved   Improved   Improved       group   cases   vation   change   1 grade   2 grades   3 grades                    treat group   114   0   44   47   22   1       control   53   1   26   23   3   0                rank sum   u = 2.20   P = 0.028           test                         *Data of 10 cases in treat group and 6 cases in control group are lost.             
 
         [0417]     Meaning of Improved grade is the same as application example 1.  
         [0418]     Cancer pain improvement comparison of two groups after treatment, there is notable significance in the difference.  
                                                                                             TABLE 50                           Abdominal distension improvement comparison       of two groups after treatment                    aggra-   no   Improved   Improved   Improved       group   cases   vation   change   1 grade   2 grades   3 grades                    treat group   114   3   43   56   9   3       control   53   5   33   12   1   2                rank sum   u = 3.70   P = 0.000           test                         *Data of 10 cases in treat group and 6 cases in control group are lost.             
 
         [0419]     Meaning of Improved grade is the same as application example 1.  
         [0420]     Abdominal distension improvement comparison of two groups after treatment, there is notable significance in the difference.  
         [0421]     8. Main symptoms and signs disappearance rates comparison of two groups after treatment  
                                                                           TABLE 51                           Main symptoms and signs disappearance rates comparison of two groups after treatment                    total   original   disappearance   disappearance           symptoms   group   cases   cases   cases   rate                    fatigue   treat   113*   82   72   87.8   X 2  = 6.35           group                   P = 0.009           control    55   35   22   62.9       dry mouth   treat   113*   24   23   95.8   Fisher&#39;s exact test       thirst   group                   P = 0.040           control    55   15   11   73.3       bitter   treat   113*   37   36   97.3   Fisher&#39;s exact test       mouth   group                   P = 0.103           control    55   7   4   57.1       spontaneous   treat   113*   11   11   100.0       perspiration   group           control    55   2   2   100.0       night sweat   treat   113*   10   9   90.0   Fisher&#39;s exact test           group                   P = 0.549           control    55   4   3   75.0       upset and   treat   114 #     18   18   100.0       tantrum   group           control    54   6   6   100.0       dizziness   treat   114 #     12   11   91.7   Fisher&#39;s exact test           group                   P = 0.037           control    54   7   3   42.9       jaundice   treat   114 #     10   7   70.0   Fisher&#39;s exact test           group                   P = 0.657           control    54   3   1   33.3       cancer pain   treat   114 +     72   66   91.7   Fisher&#39;s exact test           group                   P = 0.199           control    53   32   26   81.3       abdominal   treat   114 +     70   66   94.3   Fisher&#39;s exact test       distension   group                   P = 0.001           control    53   25   14   56.0                 *Data of 11cases in treat group and 4 cases in control group are lost.              # Data of 10 cases in treat group and 5 cases in control group are lost.              + Data of 10cases in treat group and 6 cases in control group are lost.             
 
         [0422]     Disappearance rates comparison of fatigue, dry mouth, thirst, dizziness, abdominal distension of two groups after treatment, there is notable significance in the difference. Disappearance rates comparison of bitter mouth spontaneous perspiration, night sweat, upset, tantrum, jaundice, cancer pain of two groups after treatment, there is no notable significance in the difference.  
         [0423]     9. WBC Counting Comparison of Two Groups After Treatment  
                                                                                                 TABLE 52                           WBC counting comparison of two groups after treatment*                            Im-   Im-   Im-               ag-       proved   proved   proved       group   cases   gravation   no change   1 grade   2 grades   3 grades                    treat group   114   6   91   8   8   1       control   54   5   44   5   0   0                rank sum test   u = 1.45   P = 0.148                         *Grade WBC accurately according to “WHOgrade criterions for acute and subacute toxicity reactions of the anti-cancer drugs”, see details in application example 1.             
 
         [0424]     WBC counting comparison of two groups after treatment, there is no notable significance in the difference.  
         [0425]     10. Granulocytes Counting Comparison of Two Groups After Treatment  
                                                                                                 TABLE 53                           Granulocytes counting comparison of two groups after treatment*                    aggra-       Improved   Improved   Improved       group   cases   vation   no change   1 grade   2 grades   3 grades                    treat   117   2   103   6   6   0       group       control   59   5   51   1   1   1                rank sum test   u = 2.07   P = 0.039                         *Grade granulocytes accurately according to “WHOgrade criterions for acute and subacute toxicity reactions of the anti-cancer drugs”, see details in application example 1.             
 
         [0426]     Granulocytes counting comparison of two groups after treatment, there is notable significance in the difference.  
         [0427]     11. Hemoglobin Comparison of Two Groups After Treatment  
                                                                                                 TABLE 54                           Hemaglobin comparison of two groups after treatment*                    aggra-       Improved   Improved   Improved       group   cases   vation   no change   1 grade   2 grades   3 grades                    treat   118   16   91   10   1   0       group       control   59   11   40   6   0   2                rank sum test   u = 0.16   P = 0.870                         *Grade hemoglobin accurately according to WHO“grade criterions for acute and subacute toxicity reactions of the anti-cancer drugs”, see details in application example 1.             
 
         [0428]     Hemoglobin comparison of two groups after treatment, there is no notable significance in the difference.  
         [0429]     12. Platelets Counting Comparison of Two Groups After Treatment  
                                                                                                 TABLE 55                           Platelets counting comparison of two groups after treatment*                    aggra-       Improved   Improved   Improved       group   cases   vation   no change   1 grade   2 grades   3 grades                    treat   117   12   83   12   8   2       group       control   59   7   47   4   1   0                rank sum test   u = 1.48   P = 0.139                         Grade platelets accurately according to “WHOgrade criterions for acute and subacute toxicity reactions of the anti-cancer drugs”, see details in application example 1.                Phatelets counting comparison of two groups after treatment, there is no notable significance in the difference.             
 
         [0430]     13. Immune Function Comparison of Two Groups After Treatment  
                                     TABLE 56                           CD3 comparison of two groups before and after treatment                    Before   8 weeks after   difference               treatment   treatment   (after − before)       group   cases     x  ± s     x  ± s     x  ± s               treat group   58   46.6 ± 21.0   50.8 ± 21.5     4.3 ± 8.0       control   22   58.9 ± 7.0    55.5 ± 7.6    −3.4 ± 8.2                  
 
         [0431]     Comparison of treat group before and after treatment, t=4.06, P=0.000;  
         [0432]     Comparison of control group before and after treatment, t=1.95, P=0.065;  
         [0433]     Difference (after-before) comparison of two groups, t=3.80, P=0.000.  
         [0434]     CD3 comparison of treat group before and after treatment, there is notable significance in the difference  
         [0435]     CD3 comparison of control group before and after treatment, there is no notable significance in the difference.  
         [0436]     CD3 (after-before) comparison of two groups, there is notable significance in the difference.  
                                     TABLE 57                           CD4 comparison of two groups before and after treatment                        8 weeks after   difference               Before treatment   treatment   (after − before)       group   cases     x  ± s     x  ± s     x  ± s               treat group   58   31.4 ± 14.2   36.0 ± 15.4   4.6 ± 5.1       control   22   39.4 ± 7.4    40.8 ± 7.6    1.4 ± 7.8                  
 
         [0437]     Comparison of treat group before and after treatment, t=6.90, P=0.000;  
         [0438]     Comparison of control group before and after treatment, t=0.83, P=0.416;  
         [0439]     Difference (after-before) comparison of two groups, t′=1.81, P=0.080.  
         [0440]     CD4 comparison of treat group before and after treatment, there is notable significance in the difference  
         [0441]     CD4 comparison of control group before and after treatment, there is no notable significance in the difference.  
         [0442]     CD4difference (after-before) comparison of two groups, there is no notable significance in the difference.  
                                     TABLE 58                           CD8 comparison of two groups before and after treatment                        8 weeks after   difference               Before treatment   treatment   (after − before)       group   cases     x  ± s     x  ± s     x  ± s               treat group   58   28.0 ± 12.7   27.7 ± 12.2   −0.4 ± 3.6       control   22   36.3 ± 7.8    35.2 ± 9.1    −1.0 ± 6.0                  
 
         [0443]     Comparison of treat group before and after treatment, t=0.83, P=0.412;  
         [0444]     Comparison of control group before and after treatment, t=0.82, P=0.422;  
         [0445]     Difference (after-before) comparison of two groups, t′=0.49, P=0.632.  
         [0446]     CD8 comparison of treat group before and after treatment, there is no notable significance in the difference.  
         [0447]     CD8 comparison of control group before and after treatment, there is no notable significance in the difference.  
         [0448]     CD8 (after-before) comparison of two groups, there is no notable significance in the difference.  
                                     TABLE 59                           CD4/CD8 comparison of two groups before and after treatment                        8 weeks after   difference               Before treatment   treatment   (after − before)       group   cases     x  ± s     x  ± s     x  ± s               treat group   56   1.12 ± 0.28   1.32 ± 0.22   0.19 ± 0.18       control   21   1.11 ± 0.23   1.23 ± 0.19   0.11 ± 0.13                  
 
         [0449]     Comparison of treat group before and after treatment, t=7.96, P=0.000;  
         [0450]     Comparison of control group before and after treatment, t=3.89, P=0.022;  
         [0451]     Difference (after-before) comparison of two groups, t=1.77, P=0.080.  
         [0452]     CD4/CD8 comparison of treat group before and after treatment, there is notable significance in the difference.  
         [0453]     CD4/CD8 comparison of control group before and after treatment, there is notable significance in the difference.  
         [0454]     CD4/CD8 difference (after-before) comparison of two groups, there is no notable significance in the difference.  
                                                           TABLE 60                           NK cell comparison of two groups before and after treatment                        8 weeks after   difference               Before treatment   treatment   (after − before)       group   cases     x  ± s     x  ± s     x  ± s                    treat group   30   32.6 ± 15.1   39.7 ± 14.8   7.1 ± 10.2       control   9   49.4 ± 13.1   39.3 ± 9.5    −10.1 ± 10.7                     
 
         [0455]     Comparison of treat group before and after treatment, t=3.83, P=0.001;  
         [0456]     Comparison of control group before and after treatment, t=2.84, P=0.022;  
         [0457]     Difference (after-before) comparison of two groups, t=4.40, P=0.000.  
         [0458]     NK cell comparison of treat group before and after treatment, there is notable significance in the difference.  
         [0459]     NK cell comparison of control group before and after treatment, there is notable significance in the difference.  
         [0460]     NK cell difference (after-before) comparison of two groups, there is notable significance in the difference.  
         [0461]     14. γ-GT Comparison of Two Groups After Treatment  
                                 TABLE 61                           γ-GT comparison of two groups after treatment                    8 weeks   difference           Before treatment   after treatment   (after − before)       group     x  ± s (n)     x  ± s (n)     x  ± s (n)               treat   179.75 ± 133.86(96)   148.75 ± 111.50(96)   −31.00 ± 112.02(96)       group       con-   170.79 ± 171.69(43)   164.37 ± 138.24(41)    −8.58 ± 170.05(41)       trol                  
 
         [0462]     Comparison of treat group before and after treatment, t=2.711, P=0.008;  
         [0463]     Comparison of control group before and after treatment, t=0.323, P=0.748;  
         [0464]     Difference (after-before) comparison of two groups, t=0.911, P=0.364.  
         [0465]     γ-GT comparison of treat group before and after treatment, there is notable significance in the difference.  
         [0466]     γ-GT comparison of control group before and after treatment, there is no notable significance in the difference.  
         [0467]     γ-GT difference (after-before) comparison of two groups, there is no notable significance in the difference.  
         [0468]     15. LDH Comparison of Two Groups After Treatment  
                                 TABLE 62                           LDH comparison of two groups after treatment                    8 weeks   difference           Before treatment   after treatment   (after − before)       group     x  ± s (n)     x  ± s (n)     x  ± s (n)               treat   220.31 ± 126.70(59)   190.05 ± 128.29(58)   −45.54 ± 98.30(57)       group       control   210.00 ± 135.57(24)   194.09 ± 130.45(23)   −19.39 ± 84.72(23)                  
 
         [0469]     Comparison of treat group before and after treatment, t=3.498, P=0.001;  
         [0470]     Comparison of control group before and after treatment, t=1.098, P=0.284;  
         [0471]     Difference (after-before) comparison of two groups, t=1.118, P=0.267.  
         [0472]     LDH comparison of treat group before and after treatment, there is notable significance in the difference.  
         [0473]     LDH comparison of control group before and after treatment, there is no notable significance in the difference  
         [0474]     LDH difference (after-before) comparison of two groups, there is no notable significance in the differences  
         [0000]               Results of Imageology Examinations After Treatment  
         [0475]     1. B Type Ultrasonic Examination:  
         [0476]     116 cases in treat group and 55 cases in control group are rechecked by B type ultrasonic examination after treatment.  
         [0477]     2. CT and MRI Examination:  
         [0478]     83 cases in treat group and 33 cases in control group are rechecked by CT.  
         [0479]     18 patients in treat group and 7 patients in control group are rechecked by MRI.  
         [0000]               Safety Assessment  
         [0480]     All safety indexes are normal before treatment, the abnormal cases after treatment are recorded in following table.  
                                                                                                                   treat group   control group                    positive       positive                       cases/       cases/   inci-       Doubtful adverse   total   incidence   total   dence       P       reaction   cases   rate   cases   rate   RR   value                    Hemoglobin   16/124    12.9%   8/59   13.6%   0.95   0.902       reduction       RBC reduction   0/121   0.0%   0/59   0.0%   —       WBC reduction   6/120   5.0%   5/55   9.1%   0.55   0.325       Granulocyte   1/119   0.8%   4/59   6.8%   0.12   0.042       reduction       Platelet reduction   12/124    9.7%   5/59   8.5%   1.14   0.793       Bilirubin increase   4/112   3.6%   7/53   13.2%   0.27   0.039       AKP rising   0/123   0.0%   2/58   3.4%   —       GPT rising   7/116   6.0%   2/58   3.4%   1.75   0.720       BUN rising   0/119   0.0%   0/54   0.0%   —       serum creatinine   2/123   1.6%   0/59   0.0%   —       rising       Abnormal urine   0/123   0.0%   0/59   0.0%   —       protein       Abnornal urine   0/120   0.0%   0/59   0.0%   —       RBC   1/120   0.8%   0/59   0.0%   —       fecal occult blood                  
 
         [0481]     Safety study results of two groups after treatment demonstrate that incidence rates of granulocyte reduction, BUN rising of treat group is lower than those of control group (P&lt;0.05). Iincidence rates, RR of other items of two groups and statistical analysis results, there is no notable significance in the difference. See details in above table.  
         [0000]               Adverse Event Observations  
         [0482]     Results of adverse event observations of two groups after treatment are shown in followint table:  
                                                                                                                   treat group   control group               (n = 124)   (n = 59)                    inci-       inci-               doubtful adverse   positive   dence   positive   dence       P       events   cases*   rate   cases**   rate   RR   value                    fever   57   45.9%   26   44.1%   1.04   0.810       alopecie   21   16.9%   14   23.7%   0.71   0.275       oral cavity ulcer   0   0.0%   1   1.7%   —       cutaneous reaction   0   0.0%   1   1.7%   —       choking and short of   1   0.8%   8   13.6%   0.06   0.000       breath       non cancer pain   31   25.0%   16   27.1%   0.92   0.759       hypersensitiveness   1   0.8%   0   0.0%   —       nausea and vomit   49   39.5%   34   57.6%   0.67   0.021       constipation   2   1.6%   8   13.6%   0.12   0.002       bleeding   0   0.0%   1   1.7%   .                 *positive cases: if one patient had one symptom, recorded as one case, if one patient had two symptoms, recorded as two cases.             
 
         [0483]     During the courses of treatment, some patients in both groups had adverse effects including alopecie, oral cavity ulcer etc, incidence rate and RR of each symptom, statistical analysis results are shown in above table.  
         [0484]     During the courses of treatment, incidence rates comparison of choking, short of breath, cancer pain, nausea and vomit, constipation of two groups, there is notable significance in the difference. Judging from incidence rate and RR, the treat group is lower than those of control group. other symptoms comparison of two groups, there is no notable significance in the difference.  
         [0485]     There are 90 cases in treat group who had at least one doubtful adverse reaction, total incidence of doubtful adverse reaction is 72.6% ( 90/124), there are 53 cases in control group who had at least one doubtful adverse reaction, total incidence of doubtful adverse reaction is 89.8% ( 53/59), the relative risk (RR) of doubtful adverse reaction of treat group is 0.808 (95% confidence interval: 0.704˜0.928), indicating the risk of doubtful adverse reaction of treat group is lower than that of control group.  
       Conclusions  
       [0486]     183 eligible patients entered into the clinical trails, of which 124 cases for treat group, 59 cases for control group, all were diagnosed as primary hepatic carcinoma by westen medicine, and as symptom of stagnation of poison by Traditioanl Chinese Medicine.  
         [0487]     Results of comparability test before treatment show that the comparison of Karnofsky scores, body weights, fatigue, bitter mouth, abdominal distension, tongue textures of two groups before treatment, there is notable significance in the difference. But the comparison of sex, age, disease courses, past treatment methods, tumor type, clinical stage, coated tongue and pulse tracings of two groups, there is no notable significance in the difference. Though comparison of Karnofsky scores, body weights, fatigue, bitter mouth, abdominal distension, treat group are worse than those of control groups, considering that these factors may influence therapeutic effects, so we performed logistic regression analysis when comparing therapeutic effects in the research, to determine the influences of these factors on therapeutic effects comparison of two groups.  
         [0488]     CR, PR, SD and PD rates of treat group are 0%, 15.3%, 78.2%, 6.5% respectively, CR, PR, SD and PD rates of control group are 0%, 6.8%, 74.6% and 18.6% respectively. After comparsion of two groups, there is notable significance in the difference.  
         [0489]     Considering that such factors as Karnofsky scores, body weight, fatigue, bitter mouth, abdominal distensionthe may influence therapeutic effects, so we performed logistic regression analysis when comparing therapeutic effects, introducing the above variables to the model and choosing them by retreating method. Selected Results indicate that there is notable significance in difference of group and Karnofsky scores. There is notable significance in the difference of therapeutic effects of groups. Relative risk scale (RR) of control group to treat group is 4.66, suggesting that the risk of disease progression of control group is 4.6 times of treat group.  
         [0490]     Above results indicate that the invented Traditional Chinese Medicine composition, serving as adjunctive therapy on intervention chemotherapy and embolism treatment of primary hepatic carcinoma, has better clinical therapeutic effects, exerting certain synergistic functions.  
         [0491]     After 1.5 years of follow-up, 1 year survival rate of treat group and control group are 40.3%, 45.8% respectively, results of survival analysis show that both short term effect (Breslow test) and long term effect (Log-rank test) of two groups, there is no notable significance in the difference of survial time. Indicating that the invented Traditional Chinese Medicine composition adjunctive therapy on primary hepatic carcinoma patients who received intervention and embolism treatments failed to elongate the survival time, compared with treatment of solely intervention and embolism.  
         [0492]     Results of solid tomor foci size assessment show:  
         [0493]     Tumor foci size difference (after-before) comparison of two groups shows that there is notable significance in the difference, minimized extent of the tumor foci size of treat group is greater than that of control group. Tumor foci size comparison of treat group before and after treatment shows that there is notable significance in the difference, tumor minimized obviously after treatment compared with before treatment; Tumor foci size comparison of control group before and after treatment aslo shows that there is notable significance in the difference, tumor minimized obviously after treatment compared with before treatment. Suggesting that the invented Traditional Chinese Medicine composition, serving as adjunctive therapy on intervention chemotherapy and embolism treatment of primary hepatic carcinoma patients, can minimize tumor foci obviously, which outweighs therapeutic effects of the group received sole intervention chemotherapy and embolism treatment.  
         [0494]     Results of main symptoms improvement show:  
         [0495]     Karnofsky score of treat group increased obviously after treatment compared with that of before treatment, and the Karnofsky score increase extent of treat group is greater than control group, Karnofsky score of control group has no obvious increase after treatment compared with that of before treatment; Fatigue of patients in both groups improved obviously after treatment, fatigue improvement extent and fatigue disappearance rate of treat group is greater than that of control group.  
         [0496]     Appetite of patients in both groups increased obviously after treatment, symptoms including dry mouth, thirst, bitter taste of mouth, spontaneous perspiration, night sweat, upset, tantrum, dizziness, jaundice, cancer pain, abdominal distension are all improved or have high disappearance rates, for improvement extent of bitter mouth, cancer pain and dizziness, treat group is higher than that of control group; for disappearance rates of dry mouth, thirst, dizziness, abdominal distension, treat group is higher than those of control group, other symptoms comparison in improvement extent and disappearance rate of two groups shows that there is no notable significance in the differences.  
         [0497]     Above results indicate that the invented Traditional Chinese Medicine composition, serving as adjunctive therapy on intervention chemotherapy and embolism treatment of primary hepatic carcinoma patients, can ameliorate patients survival qualities, improve clinical symptoms, has better adjunctive therapeutical effects.  
         [0498]     Laboratory examination results demonstrate:  
         [0499]     CD3, CD4, CD4/CD8 and NK cells of treat group increased obviously after treatment compared with those of before treatment (P&lt;0.05), furthermore, the CD3 and NK cell difference (after-before) of treat group are higher than those of control group (P&lt;0.05), while changes of CD3, CD4, CD4/CD8 and NK cells of control group are not so obvious before treatment, NK cells of control group reduced obviously after treatment compared with that of before treatment.  
         [0500]     Above results indicate that the invented Traditional Chinese Medicine composition, serving as adjunctive therapy on intervention chemotherapy and embolism treatment of primary hepatic carcinoma patients, has certain functions of stimulating immune responses, can assist intervention chemotherapy and embolism treatment to inhibit cancer cells.  
         [0501]     Results of this randomized controlled trial demonstrate that the invented Traditional Chinese Medicine composition, serving as adjunctive therapy on intervention chemotherapy and embolism treatment of primary hepatic carcinoma patients, has better clinical therapeutic effects, can exert synergistic functions, can ameliorate patients survival qualities, improve clinical symptoms of patients and enhance cellular immune function of patients, can be used as adjunctive therapy on intervention chemotherapy and embolism treatment of patients primary hepatic carcinoma (considered as sympton of stagnation of poison by Traditinal Chinese Medicine), clinical application is quite safe.  
       APPLICATION EXAMPLE 3  
     Clinical Trail Summary of Adjunctive Therapy Using the Invented Traditonal Chinese Medicine Composition on Gastric Carcinoma  
       [0502]     Object and Method  
         [0503]     Chosing of Eligible Tested Object  
         [0504]     1. Chinese medicine syndrome diagosis criterion: the same as application example 1  
         [0505]     2. Western medicine diagosis criterion: same as diagosis criterion of gastric carcinoma and stage criterion mentioned in application example 1.  
         [0506]      3 . Inclusion criterion  
         [0507]     Voluntary patients.  
         [0508]     Staged□, □, □ of gastric carcinoma patients unsuitable for surgical operation or reluctant to operation.  
         [0509]     Operations researcher of gastric carcinoma.  
         [0510]     (4) Relapse patients of gastric carcinoma after operation unsuitable for surgical operation or reluctant to operation.  
         [0511]     (5) Those patients who have received anti-cancer therapy, need stop therapy for more than 2 months.  
         [0512]     Age&gt;18 years  
         [0513]     Predicted life span&gt;3 months, survival quality Karnofsky score ≧50  
         [0514]     4. Exclusing criterion 
        (1) Patients with esophageal stenosis, cardia of stomach obstruction, pyloric obstruction, polypi, tumor, bowel obstruction; structural diseases of liver, cholecyst, pancreas, colon; gastric carcinoma like “linitis plastica” patients can not receive medication via po.     (2) Others are the same as □, □, □˜□ of application example 1. 
 
 Methods of clinical trails 
       
 
         [0517]     1. Trail design: The same as application example 2.  
         [0518]     2. Adiministration manner and dosage:  
         [0519]     Treat Group  
         [0520]     Taking the invented Traditional Chinese Medicine composition orally at the right time of beginning chemotherapy, twice each day, 15 ml each time (1 ml containing crude drugs 0.75 g), taken in the early morning and evening, taken with warm water. The invented Traditional Chinese Medicine composition is taken for consecutive 2 months.  
         [0521]     Control group: sole chemotherapy of gastric carcinoma  
         [0522]     3. Chemotherapy regimen: MF regimen  
                                                           5-Fu   500 mg/M 2 ,   V.D., d1-5           MMC    8 mg/M 2 ,   i.v., d1           28 days × 2                      
 
         [0523]     4. Course of treatment: 2 months, observing for 1 month after treatment.  
         [0524]     5. Observed items and methods:  
         [0525]     (1) safety detection: The same as application example 1  
         [0526]     (2) Therapeutic effects assessment: 
        1 Tumor foci: Performing B type ultrasonic, X-Ray barium meal examination, air-barium double contrast examination, gastroscope, CT examination before and after treatment. 
            a. Measurement of tumor size: multiply the two perpendicular maximum diameter.     b. Multiple tumor foci are measured with sum of all products of multiplication (refer to products of two perpendicular maximum diameter).     c. Diffused nodular tumor, explaining particularly.    
               
 
         [0531]     Clinical symptom observations:  
         [0532]     a. Main symptoms of gastric carcinoma  
         [0533]     Lump, abdominal pain, anorexia, hemafecia, nausea, vomit, fatigue, emaciation, ascites, swollen, jaundice etc.  
         [0534]     b. Main symptoms of stagnation of poison:  
         [0535]     gastric discomfort, hard lump, pain, fatigue, progressing emaciation, vomit, haematemesis, hemafecia, dark red, purple or cyanochroia texture of tongue, white or yellow coated tongue, weak, astringent or deep pulse.  
         [0536]     c. Karnofsky grade  
         [0537]     Laboratory examinations:  
         [0538]     a X-Ray barium meal examination, air-barium double contrast examination (obligatory)  
         [0539]     b Gastroscope (obligatory)  
         [0540]     c fecal occult blood (obligatory)  
         [0541]     d CEA (part)  
         [0542]     e B type ultrasonic (obligatory)  
         [0543]     f CT (done when need)  
         [0544]     g Immunologic test: CD3, CD4, CD8, NK cell etc.  
         [0545]     Observing methods: 
        Observing and recording symptoms, picture of the tongue and pulse tracings once every 2 days, observing and recording Karnofsky score and body weight once every week, blood routine test is checked at the time of beginning visit, every week after treatment; urine routine test, faeces routine test, fecal occult blood test, liver function and kidney function are checked at the time of beginning visit, every two weeks after treatment; Immunology index, ECG, heart function are checked at the time of beginning visit, every four weeks after treatment; X-Ray barium meal examination, air-barium double contrast examination, gastroscope, B type ultrasonic, CEA, bleeding time and clotting time are checked at least once at the time of beginning visit and after treatment, performing examination at any time when needed     Follow-up once every 1-2months after treatment, Follow-up lasts at least 1 year 
 
 Therapeutic Efficacy Assessment Criterions 
       
 
         [0548]     1. Therapeutic efficacy assessment criterions of the tumor foci: 
        (1) Complete Remission (CR): tumor disappeared.     (2) Partial Remission (PR): products of two maximum diameters minimized more than 50%.     (3) Stable disease (SD): products of two maximum diameters minimized less than 50%, increased no more than 25%.     (4) Progression disease (PD): products of two maximum diameters increased more than 25%. Total remission rate=CR+PR        
 
         [0553]     2. Assessments of life spans and survival rates:  
         [0554]     Life spans after treatment refer to the time from beginning of treatment to death or the last follow-up.  
         [0555]     Follow-up at least 1 year after treatment.  
         [0556]     3. the change of health condition: make a comparison before and after treatment, according to Karnofsky score criterions. As for Karnofsky score criterions, see details in application example 1.  
         [0000]               Handling and Summarizing of Clinical Trail Data  
         [0557]     Collecting all data, inputting medical histroy into computers, constructing database using EPI INF06 software, making statistical treatment and analysis, writing summary of clinical trails, making objective assessment about clinical adjunctive therapeutic effects and safety of the invented Traditional Chinese Medicine composition on gastric carcinoma.  
         [0558]     Statistical method: enumeration data are analysed by X 2  test, ranked data are analysed by Wilcoxon rank sum test, two sample means are checked by t-test. Life span and survival rate are analysed using life table method and Kaplan-Meier method.  
       Results  
       [0000]     General Data  
         [0559]     129 suitable cases, 87 cases in treat group, 42 cases in control group; all are diagnosed as gastric carcinoma by westen medicine and as symptom of stagnation of poison by Traditonal Chinese medicine. 15 outpatient cases, 114 inpatient cases.  
         [0000]               Comparability Analysis of Two Groups  
         [0560]     1. Sex Comparison of Two Groups  
                                     TABLE 1                           sex comparison of two groups                group   cases   male   female                       treat group   87   61   26           control   42   26   16                   X 2  = 0.87   P = 0.35                      
 
         [0561]     Sex comparison of two groups, there is no notable significance in the difference.  
         [0562]     2. Age (Year) Comparison of Two Groups  
                                                                                             TABLE 2                           Age (year) comparison of two groups            group   cases   18-29   30-49   50-65   66-70     x  ± s                    treat group   87   0   14   65   8   56.2 ± 8.0        control   42   1   8   29   4   54.6 ± 10.8                Fisher&#39;s exact test       t = 0.95           P = 0.566       P = 0.35                      
 
         [0563]     Age (year) comparison of two groups, there is no notable significance in the difference.  
         [0564]     3. Disease Courses Comparison of Two Groups  
                                                                                             TABLE 3                           Disease courses (month) comparison of two groups            group   cases   ≦3   4-6   7-12   13-24   &gt;24                    treat group   87   43   19   12   7   6       control   42   24   7   6   4   1                Fisher&#39;s   P = 0.803               exact test                      
 
         [0565]     Disease courses comparison of two groups, there is no notable significance in the difference.  
         [0566]     4. Past Treatment Comparison of Two Groups  
                                                                   TABLE 4                           Past treatment comparison of two groups*            group   cases   untreated   operation   radiotherapy   chemotherapy   TCM   others               treat group   85   56   17   1   2   1   8       control   42   24   10   0   1   3   4                Fisher&#39;s exact test   P = 0.517                         *2 cases in treat group are not recorded; “others” refer to combined therapy (including 1 case received intervention chemotherapy)             
 
         [0567]     Past treatment comparison of two groups, there is no notable significance in the difference.  
         [0568]     5. Past Treatment Effects Comparison of Two Groups  
                                                                   TABLE 5                           Past treatment effects comparison of two groups*                group   cases   effective   ineffective   relapse                            treat group   85   8   60   17           control   42   2   33   7                   X 2  = 1.18   P = 0.55                         *2 cases in treat group are not recorded.             
 
         [0569]     Past treatment effects comparison of two groups, there is no notable significance in the difference.  
         [0570]     6. Gastric Carcinoma Pathologic Diagnosis Comparison of Two Groups  
                                 TABLE 6                           Gastric carcinoma pathologic diagnosis comparison of two groups                        undifferentiated       group   cases   adencarcinoma   carcinoma               treat group   87   86   1       control   42   38   4           Fisher&#39;s exact test   P = 0.038                  
 
         [0571]     Gastric carcinoma pathologic diagnosis comparison of two groups, there is notable significance in the difference.  
         [0572]     7. Gastric Carcinoma Clinical Stage Comparison of Two Groups  
                                         TABLE 7                           Clinical stage comparison of two groups                group   cases   stage II   stageIII   stageIV                       treat group   87   2   16   69           control   42   1   13   28                   Fisher&#39;s exact test   P = 0.278                      
 
         [0573]     Clinical stage comparison of two groups, there is no notable significance in the difference.  
         [0574]     8. Tumor Foci Size Comparison of Two Groups Before Treatment  
                                 TABLE 8                           Tumor foci size comparison of two groups before treatment*                group   cases     x  ± s                       treat group   83**   27.10 ± 22.29           control   40**   26.48 ± 48.58               t = 0.097   P = 0.92                         *Tumor foci size is measured by product of two perpendicular maximum diameters of tumor or sum of products of multiple foci (cm × cm).                **4 cases in treat group and 2 cases in control groups tumor foci size can not be measured:                Treat group: 1 gastric carcinomar case widely metastasized in abdominal cavity, 1 case is pathologically diagnosed as “cancer cells in ulcerative necrosis tissue”, 1 case is diagnosed as“ diffused, ulcerative, infiltrating carcinoma of gastric body and sinus ventriculi”, 1 case is diagnosed as “poorly differentiated adenocarcinoma of cardia of stomach, with metastasis of middle and inferior esophagus”.                Control group: 1 case with wide bone metastasis, 1 case is diagnosed as“ diffused, ulcerative, infiltrating carcinoma of gastric body and sinus ventriculi”            
 
         [0575]     Tumor foci size comparison of two groups before treatment, there is no notable significance in the difference.  
                                                                                             TABLE 9                           Tumor foci location comparison of two groups before treatment*                    cardia of   gastric   sinus               group   cases   stomach   body   ventriculi   Gastrojejunal   others                    treat   87   24   28   13   1   21       group       control   42   6   12   5   1   18                Fisher&#39;s exact test   P = 0.197                         *others: two or more than two tumor foci locations, metastasized to other locations after Gastric operation             
 
         [0576]     Tumor foci location comparison of two groups before treatment, there is no notable significance in the difference.  
                                     TABLE 10                           Metastasis comparison of two groups before treatment                group   cases   metastasis   no metastasis                       treat group   87   25   62           control   42   15   27                   X 2  = 0.64   P = 0.42                      
 
         [0577]     Metastasis comparison of two groups before treatment, there is no notable significance in the difference  
                                                               TABLE 11                           Numbers of tumor foci comparison of two groups before treatment                group   cases   1              2              &gt;2                                  treat group   87   74   4   9           control   41   34   6   1                Fisher&#39;s exact test       P = 0.061                      
 
         [0578]     Numbers of tumor foci comparison of two groups before treatment, there is no notable significance in the difference.  
         [0579]     9. Karnofsky Score Comparison of Two Groups Before Treatment  
                                                                   TABLE 12                           Karnofsky score comparison of two groups before treatment            group   cases   50-59   60-69   70-79   80-89     x  ± s               treat   87   6   34   29   18   66.78 ± 8.83       group       control   42   1   15   15   11   69.04 ± 9.32                rank sum   u = 1.045       t = 1.34           test   P = 0.296       P = 0.18                      
 
         [0580]     Karnofsky score comparison of two groups before treatment, there is no notable significance in the difference.  
         [0581]     10. Body Weight Comparison of Two Groups Before Treatment  
                                                                                                         TABLE 13                           Body weight (Kg) comparison of two groups before treatment            group   cases   35-39   40-49   50-59   60-69   &gt;70     x  ± s                    treat   87   2   12   40   26   7   57.21 ±       group                           9.01       control   42   1   6   17   15   3   57.31 ±                                   8.48                rank   u = 0.298       t = 0.06           sum   P = 0.766       P = 0.95           test                      
 
 Body weight comparison of two groups before treatment, there is no notable significance in the difference. 
 
         [0582]     11. Appetite Comparison of Two Groups Before Treatment  
                                                                                                 TABLE 14                           Appetite comparison of two groups before treatment            group   cases   &lt;4   4-5.9   6-7.9   &gt;7.9     x  ± s                    treat group   87   7   37   33   10   5.46 ± 2.02       control   42   2   13   23   4   5.81 ± 1.29                rank sum   u = 1.253       t = 1.026           test   P = 0.210       P = 0.307                      
 
         [0583]     Appetite comparison of two groups before treatment, there is no notable significance in the difference.  
         [0584]     12. Clinical Symptoms and Signs Comparison of Two Groups Before Treatment  
                                                                                                   TABLE 15                           Clinical symptoms comparison of two groups before treatment            symptoms   group   cases   grade0   grade□   grade□   grade□   grade□   u   P                    gastric pain   treat group   87   10   12   32   27   6   0.88   0.38           control   42   3   11   16   9   3       anorexia   treat group   87   14   21   24   24   4   1.22   0.22           control   42   5   14   18   4   1       fatigue   treat group   87   13   17   37   16   4   1.25   0.08           control   42   9   12   15   6   0       dry mouth   treat group   87   53   21   13   0   0   0.97   0.33       thirst   control   42   29   9   4   0   0       bitter taste of   treat group   87   53   24   8   2   0   1.64   0.10       mouth   control   42   31   10   1   0   0       spontaneous   treat group   87   55   14   13   5   0   1.06   0.29       perspiration   control   42   30   6   6   0   0       night sweat   treat group   87   57   16   11   3   0   1.71   0.088           control   42   33   7   2   0   0       upset and   treat group   87   58   17   10   2   0   1.46   0.15       tantrum   control   42   32   10   0   0   0       dizziness   treat group   87   65   19   2   1   0   0.49   0.62           control   42   33   8   1   0   0       cancer pain   treat group   87   14   18   35   17   3   3.25   0.001           control   42   13   13   15   1   0       nausea and   treat group   87   49   17   18   2   1   0.66   0.51       vomit   control   42   26   9   4   3   0       abdominal   treat group   87   32   20   28   7   0   0.25   0.80       distension   control   42   17   10   10   2   3                  
 
         [0585]     Cancer pain extent of treat group is higher than control group before treatment. other symptoms comparison of two groups before treatment, there is no notable significance in the difference.  
                                 TABLE 16                           Abdominal lump size (cm × cm) comparison       of two groups before treatment                group   cases     x  ± s                       treat group   20   51.95 ± 40.48           control   12   61.08 ± 82.77               t = 0.419   P = 0.678                      
 
         [0586]     Abdominal lump size (cm×cm) comparison of two groups before treatment, there is no notable significance in the difference.  
                                                                   TABLE 17                           Abdominal lump texture comparison of two groups before treatment                group   cases   hard   tenacious   soft                            treat group   20   12   6   2           control   12   9   3   0               rank sum test   u = 0.98   P = 0.33                      
 
         [0587]     Abdominal lump texture comparison of two groups before treatment, there is no notable significance in the difference.  
                                                           TABLE 18                           Abdominal lump tenderness comparison of two groups before treatment                group   cases   no tenderness   tenderness                            treat group   20   2   18           control   12   4   8               Fisher&#39;s exact test   P = 0.165                      
 
         [0588]     Abdominal lump tenderness comparison of two groups before treatment, there is no notable significance in the difference.  
         [0589]     13. Tongue Demonstration Comparison of Two Groups Before Treatment  
                                                                                             TABLE 19                           Tongue demonstration comparison of two groups before treatment                    thin and   thin and   yellow and   yellow           group   cases   white   yellow   greasy   and thick   others                    treat group   87   9   34   29   14   1       control   42   3   11   19   9   0                Fisher&#39;s exact test   P = 0.469                      
 
         [0590]     Tongue demonstration comparison of two groups before treatment, there is no notable significance in the difference.  
                                                                   TABLE 20                           Tongue texture comparison of two groups before treatment                                purple               group   cases   carmoisine   red   dark red   black   cyanochroia   petechia, ecchymosis               treat group   87   0   5   43   29   7   3       control   42   2   6   14   13   4   3                Fisher&#39;s exact test   P = 0.099                      
 
         [0591]     Tongue texture comparison of two groups before treatment, there is no notable significance in the difference.  
         [0592]     14. Pulse Tracings Comparison of Two Groups Before Treatment  
                                                                                                     TABLE 21                           Pulse tracings comparison of two groups before treatment            group   cases   even   astringent   string   smooth   deep   weak                    treat group   87   0   25   8   6   19   29       control   42   1   16   6   7   4   8                Fisher&#39;s exact test   P = 0.048                      
 
         [0593]     Pulse tracings comparison of two groups before treatment, there is notable significance in the difference.  
         [0594]     15. Hematology Examinations of Two Groups  
         [0595]     85 cases in treat group received WBC counting before treatment, 80 cases are normal, 3 cases WBC within 3.0-3.9×10 9 /L, 2 cases WBC&gt;10.0×10 9 /L.  
         [0596]     41 cases in control group received WBC counting before treatment, 35 cases are normal, 4 cases WBC within 3.0-3.9×10 9 /L, 2 cases WBC&gt;10.0×10 9 /L.  
         [0597]     42 cases in treat group received granulocyte counting before treatment, 41 cases are normal, 1 case granulocyte&lt;2.0×10 9 /L  
         [0598]     25 cases in control group received granulocyte counting before treatment, 23 cases are normal, 2 cases granulocyte&lt;2.0×10 9 /L.  
         [0599]     85 cases in treat group received hemoglobin test before treatment, 1 case&lt;60 g/L, 5 cases within 60-79 g/L, 31 cases within 80-109 g/L, 48 cases≧110 g/L.  
         [0600]     42 cases in control group received hemoglobin test before treatment, 4 cases within 60-79 g/L, 18 cases within 80-109 g/L, 20 cases≧110 g/L.  
         [0601]     84 cases in treat group received platelet counting before treatment, 81 cases are normal, 3 case platelets&lt;10.0×10 9 /L.  
         [0602]     42 cases in control group received platelet counting before treatment, 38 cases are normal, 4 case platelets&lt;10.0 ×10 9 /L.  
         [0603]     16. Imageology Examinations of Two Groups Before Treatment  
         [0604]     In treat group, 72 cases reiceived gastroscope examination, 50 cases received X-Raybarium meal examination or air-barium double contrast examination, 65 cases received B type ultrasonic examination, 18 cases received CT examination.  
         [0605]     In control group, 26 cases reiceived gastroscope examination, 23 cases received X-Raybarium meal examination or air-barium double contrast examination, 28 cases received B type ultrasonic examination, 12 cases received CT examination.  
         [0606]     Above results of comparability check show that there is no notable significance in the difference resulted from the comparison of sex, age, disease courses, past treatment methods, tumor type, tumor location, number and size, main clinical symptoms and signs, tongue demonstration of two groups before treatment, except that cancer pain extent of treat group is higher than that of control group. Suggesting that prognostic factors are uniform between two groups.  
         [0000]     Therapeutic Effects Comparison  
         [0607]     1. Total Therapeutic Effects Comparison.  
                                                                   TABLE 22                           Total therapeutic effects comparison            group   cases   CR(%)   PR(%)   SD(%)   PD(%)                    treat group   87   1   15   63   8               (1.1)   (17.2)   (72.4)   (9.2)       control   42   0   1   29   12               (0.0)   (2.4)   (69.0)   (28.6)               rank sum test   u = 3.510   P = 0.000                  
 
 CR, PR, SD and PD rates of treat group are 1.1%, 17.2%, 72.4%, 9.2% respectively, total remission rate is 18.3%; CR, PR, SD and PD rates of control group are 0%, 2.4%, 69.0% and 28.6% respectively, total remission is 2.4%. There is notable signicance in the difference between two groups. 
 
         [0608]     1 complete remission case in treat group, male, 64 years old, two years before enrollment, was diagnosed as: gastric carcinoma (adenocarcinoma), received subtotal gastrectomy. The patient feel obstruction after meal, and aggravated gradually, then visited Changzhou cancer hospital, no measurable tumor foci, pathologic diagnosis showed: cancer cells are in ulcerative necrosis tissue (maybe adenocarcinoma). According to the trail regimen, treated the patient with the invented Traditional Chinese Medicine composition combined with chemotherapy. After treatment, pathologic examination showed: moderate reactive gastritis. Follow-up 7 months later and rechecked, the pathological examination showed: inflammation changes of mucosa. Therapeutic effects assessed as complete remission. Considering that the therapeutic effects assessment of this patient was not so confirm, so adopting “concessional conservation method” classified the effect as “Stable Disease”, then performed clinical therapeutic effects comparison results is shown in following table.  
                                                                   TABLE 23                           Total therapeutic effects comparison (“concessional conservation method”)            group   cases   CR(%)   PR(%)   SD(%)   PD(%)                    treat group   87   0   15   64   8               (0.0)   (17.2)     (73.6)   (9.2)       control   42   0   1   29   12               (0.0)   (2.4)   (69)   (28.6)               rank sum test   u = 3.445   P = 0.001                  
 
         [0609]     Above results show that there is notable significance in the difference of total therapeutic effects resulted from comparison of two groups (u=3.445, P=0.001), after adding 1 CR case into SD case via “concessional conservation method”.  
         [0610]     2. Therapeutic Effects Comparison of Gastric Carcinoma Without Metastasis Between Two Groups  
                                         TABLE 24                           Therapeutic effects comparison of gastric carcinoma       without metastasis between two groups            group   cases   CR (%)   PR (%)   SD (%)   PD (%)               treat group   62   1 (1.6)   10 (16.1)   45 (72.6)   6 (9.7)        control   27   0 (0.0)   1 (3.7)   18 (66.7)   8 (29.6)               rank sum test   u = 2.723   P = 0.006                  
 
 CR, PR, SD and PD rates of treat group are 1.6%, 16.1%, 72.6%, 9.7% respectively, total remission rate is 17.7%; CR, PR, SD and PD rates of control group are 0%, 3.7%, 66.7% and 29.6% respectively, total remission is 3.7%. There is notable signicance in the difference between two groups. 
 
         [0611]     3. Therapeutic Effects Comparison of Gastric Carcinoma with Metastasis Between Two Groups  
                                         TABLE 25                           Therapeutic effects comparison of gastric carcinoma       with metastasis between two groups            group   cases   CR(%)   PR(%)   SD(%)   PR(%)               treat group   25   0 (0.0)   5 (20)    18 (72)     2 (8)         control   15   0 (0.0)   0 (0.0)   11 (73.3)   4 (26.7)               rank sum test   u = 2.228   P = 0.026                  
 
 CR, PR, SD and PD rates of treat group are 0.0%, 20.0%, 72.0%, 8.0% respectively, total remission rate is 20.0%; CR, PR, SD and PD rates of control group are 0%, 0.0%, 73.3% and 26.7% respectively, total remission is 0.0%. There is notable signicance in the difference between two groups. 
 
         [0612]     4. Follow-Up Life Span and Survival Rate Comparison of Two Groups  
                                                                                               TABLE 26                           Death comparison of two groups 1.5 years after treatment                death (cause)                        upper gastrointestinal               group   cases   survival   bleeding   failure   others                    treat group   87   16   10   60   1       control   42   6   11   21   4            Combine death   X 2  = 0.34   P = 0.56           cases                  
 
         [0613]     Death comparison of two groups 1.5 years after treatment, there is no notable significance in the difference.  
                                                           TABLE 27                           Life span and survival comparison of two groups       1.5 year after treatment (-)*            group   cases   complete data cases   censored   % cencored                    treat group   87   71   16   (18.4)       control   41   35   6   (14.6)                 *1 case in control group did not finish treatment course, died 1 month after treatment.             
 
         [0614]    
       
         
               
             
               
               
               
               
             
               
               
               
               
               
               
             
               
               
               
             
           
               
                 TABLE 28 
               
             
             
               
                   
               
               
                   
               
               
                 Life span and survival comparison of two groups 
               
               
                 1.5 year after treatment ( - )* 
               
             
          
           
               
                   
                 Average live 
                 Median live 
                 1 year 
               
               
                   
                 time(month) 
                 time(month) 
                 survival rate 
               
             
          
           
               
                 group 
                 cases 
                   x  ± s 
                   x  ± s 
                 % 
                 
                           
                 
               
               
                   
               
               
                 treat group 
                 87 
                 10 ± 1 
                 10 ± 1 
                 32.83 
                 5.1 
               
               
                 control 
                 41 
                  8 ± 1 
                  6 ± 1 
                 24.39 
                 6.7 
               
             
          
           
               
                 short term effect: Breslow test, 
                 P = 0.040 
                   
               
               
                 statistic = 4.22 
               
               
                 Long term effect:Log-rank test, 
                 P = 0.1597 
               
               
                 statistic = 1.98 
               
               
                   
               
               
                   *1 case in control group did not finish treatment course, died 1 month after treatment.    
               
             
          
         
       
     
         [0615]     Life span and survival comparison of two groups 1.5 year after treatment:survival rate of treat group and control group are 32.83%, 24.39% respectively, there is notable significance in the difference of short term effect resulted from comparison of two groups; but there is no notable significance in the difference of Long term effect resulted from comparison of two groups. Indicating short term effect of treat group is better than that of control group.  
         [0616]     5. Life Span and Survival Rate Comparison of Gastric Carcinoma Without Metastasis Between Two Groups After Treatment  
                                                           TABLE 29                           Life span and survival rate comparison of gastric carcinoma       without metastasis between two groups after treatment (-)            group   cases   complete data cases   censored   % censored                    treat group   62   49   13   (21)         control   27   21   6   (22.2)                  
 
         [0617]    
       
         
               
             
               
               
               
               
             
               
               
               
               
               
               
             
               
               
               
             
           
               
                 TABLE 30 
               
             
             
               
                   
               
               
                   
               
               
                 Life span and survival rate comparison of gastric carcinoma without 
               
               
                 metastasis between two groups after treatment ( - ) 
               
             
          
           
               
                   
                 Average live 
                 Median live 
                   
               
               
                   
                 time(month) 
                 time(month) 
                 1 year survival rate 
               
             
          
           
               
                 group 
                 cases 
                   x  ± s 
                   x  ± s 
                 % 
                 se 
               
               
                   
               
               
                 treat group 
                 62 
                 10 ± 1 
                 10 ± 1 
                 31.27 
                 0.061 
               
               
                 control 
                 27 
                 10 ± 1 
                 7 ± 2 
                 33.33 
                 0.091 
               
             
          
           
               
                 short term effect: Breslow test, 
                 P = 0.824 
                   
               
               
                 statistic = 4.22 = 0.05 
               
               
                 Long term effect: Log-rank test, 
                 P = 0.454 
               
               
                 statistic = 1.98 = 0.56 
               
               
                   
               
             
          
         
       
     
         [0618]     Life span and survival rate comparison of two groups 1.5 year after treatment: survival rate of treat group and control group are 31.27%, 33.33% respectively, There is no notable significance in the difference of short term effect and long term effect resulted from comparison of two groups. Short term effect and long term effects on gastric carcinoma without metastasis, treat group are equal to control group after treatment.  
         [0619]     6. Life Span and Survival Rate Comparison of Gastric Carcinoma with Metastasis Between Two Groups After Treatment  
                                     TABLE 31                           Life span and survival rate comparison of gastric carcinoma with       metastasis between two groups after treatment (-)*            group   cases   complete data cases   censored   % censored               treat group   25   22   3   (12)         control   14   14   0   (0.0)                 *1 case in control group did not finish therapy course, died 1 month after treatment.             
 
         [0620]    
       
         
               
             
               
               
               
               
             
               
               
               
               
               
               
             
               
               
               
               
               
               
             
               
               
               
             
           
               
                 TABLE 32 
               
             
             
               
                   
               
               
                   
               
               
                 Life span and survival rate comparison of gastric carcinoma with 
               
               
                 metastasis between two groups after treatment (-)* 
               
             
          
           
               
                   
                 Average live 
                 Median live 
                   
               
               
                   
                 time(month) 
                 time(month) 
                 1 year survival rate 
               
             
          
           
               
                 group 
                 cases 
                   x  ± s 
                   x  ± s 
                 % 
                 se 
               
               
                   
               
             
          
           
               
                 treat group 
                 25 
                 9 ± 1 
                 7 ± 2 
                 36.0 
                 0.096 
               
               
                 control 
                 14 
                 5 ± 1 
                 4 ± 1 
                 7.14 
                 0.069 
               
             
          
           
               
                 short term effect: Breslow test, 
                 P = 0.0168 
                   
               
               
                 statistic = 5.72 
               
               
                 Long term effect: Log-rank test, 
                 P = 0.0060 
               
               
                 statistic = 7.56 
               
               
                   
               
               
                   *1 case in control group did not finish therapy course, died 1 month after treatment.    
               
             
          
         
       
     
         [0621]     Life span and survival rate comparison of two groups 1.5 year after treatment:survival rate of treat group and control group are 36.0%, 7.14% respectively. There is no notable significance in the difference of short term effect and long term effect resulted form comparison of two groups. Short term effects and long term effects on gastric carcinoma with metastasis, treat group are better than control group after treatment.  
         [0622]     7. Tumor Foci Size Comparison of Two Groups After Treatment  
                                             TABLE 33                           Tumor foci size comparison of two groups after treatment                    before treatment   after treatment   difference (after − before)               group   cases     x  ± s     x  ± s     x  ± s   t   P               treat group   83   27.04 ± 22.32   21.92 ± 23.65   −5.12 ± 8.86   5.262   0.000       control   40   26.44 ± 48.58   26.00 ± 46.44   −0.44 ± 7.31   0.378   0.708               t = 0.095   t = 0.646   t = 2.897               P = 0.925   P = 0.519   P = 0.004                  
 
         [0623]     Tumor foci size comparison of treat group before and after treatment, there is notable significance in the difference.  
         [0624]     Tumor foci size comparison of control group before and after treatment, there is no notable significance in the difference.  
         [0625]     Tumor foci size difference (after-before) comparison of two groups, there is notable significance in the difference.  
         [0626]     8. Karnofsky Scores Comparison of Two Groups After Treatment  
                                                                           TABLE 34                           Karnofsky scores comparison of two groups after treatment                    before treatment   after treatment   difference (after − before)               group   cases     x  ± s     x  ± s     x  ± s   t   P                    treat group   87   66.78 ± 8.83   81.15 ± 8.13    14.37 ± 10.53   12.72   0.000       control   42   69.05 ± 9.32   74.06 ± 11.06    5.00 ± 13.84   2.34   0.024               t = 1.340   t = 8.434   t = 4.261               P = 0.180   P = 0.000   P = 0.000                  
 
         [0627]     Karnofsky scores comparison of treat group before and after treatment, there is notable significance in the difference.  
         [0628]     Karnofsky scores comparison of control group before and after treatment, there is notable significance in the difference.  
         [0629]     Karnofsky scores difference (after-before) comparison of two groups, there is notable significance in the difference.  
         [0630]     9. Body Weight Comparison of Two Groups After Treatment  
                                             TABLE 35                           Body weight (Kg) comparison of two groups after treatment                            difference                       before   after   (after −                       treatment   treatment   before)       group   cases     x  ± s     x  ± s     x  ± s   t   P               treat   87   57.21 ± 9.01   58.16 ± 9.04   0.95 ± 6.66   1.34   0.19       group       control   42   57.31 ± 8.48   58.36 ± 8.24   1.05 ± 7.59   0.89   0.38               t = 0.06   t = 0.119   t = 0.071               P = 0.95   P = 0.906   P = 0.943                  
 
         [0631]     Body weight comparison of treat group before and after treatment, there is no notable significance in the difference.  
         [0632]     Body weight comparison of control group before and after treatment, there is no notable significance in the difference.  
         [0633]     Body weight difference (after-before) comparison of two groups, there is no notable significance in the difference.  
         [0634]     10. Appetite Comparison of Two Groups After Treatment  
                                             TABLE 36                           Appetite (taels/day) comparison of two groups after treatment                            difference                       before   after   (after −                       treatment   treatment   before)       group   cases     x  ± s     x  ± s     x  ± s   t   P               treat   87   5.47 ± 2.01   7.93 ± 6.36   2.46 ± 5.79   3.97   0.000       group       control   42   5.81 ± 1.29   6.62 ± 1.81   0.81 ± 2.23   2.35   0.024               t = 0.995   t = 1.309   t = 1.782               P = 0.322   P = 0.193   P = 0.077                  
 
         [0635]     Appetite comparison of treat group before and after treatment, there is notabe significance in the difference.  
         [0636]     Appetite comparison of control group before and after treatment, there is notabe significance in the difference.  
         [0637]     Appetite difference (after-before) comparison of two groups, there is no notable significance in the difference.  
         [0638]     11. Fatigue Improvement Comparison of Two Groups After Treatment  
                                                                       TABLE 37                           Fatigue improvement comparison of two groups after treatment                        no   Improved   Improved   Improved   Improved       group   cases   aggravation   change   1 grade   2 grades   3 grades   4 grades               treat group   74   1   7   27   32   5   2       control   33   3   5   16   6   3   0                rank sum test   u = 2.42   P = 0.015                         * Improved 1 grade: lowered 1 grade after treatment compared with before treatment.                Improved 2 grades: lowered 2 grades after treatment compared with before treatment.                Improved 3 grades: lowered 3 grades after treatment compared with before treatment.                Improved 4 grades: lowered 4 grades after treatment compared with before treatment.             
 
         [0639]     Fatigue improvement comparison of two groups after treatment, there is notabe significance in the difference.  
         [0640]     12. Clinical Symptoms and Signs Improvement Comparison of Two Groups After Treatment  
                                                                                                           TABLE 38                           Clinical symptoms and signs improvement comparison of two groups after treatment*                            no   Improved   Improved   Improved   Improved               symptoms   group   cases   aggravation   change   1 grade   2 grades   3 grades   4 grades   u   P                    gastric   treat   77   0   9   23   32   13   0   2.43   0.02       pain   group           control   39   2   7   16   11   2   1       anorexia   treat   73   0   10   24   29   9   1   2.82   0.01           group           control   37   3   6   19   7   1   1       dry   treat   34   0   3   24   7   0   0   0.61   0.54       mouth   group       thirst   control   13   1   2   7   3   0   0       bitter   treat   34   0   5   22   5   2   0   2.47   0.01       taste of   group       mouth   control   11   1   4   6   0   0   0       spontaneous   treat   32   0   1   17   10   4   0   1.48   0.14       perspiration   group           control   12   1   2   5   4   0   0       night   treat   30   0   3   18   7   2   0   2.20   0.03       sweat   group           control   9   2   2   4   1   0   0       upset and   treat   29   0   2   15   11   1   0   3.02   0.01       tantrum   group           control   10   1   3   6   0   0   0       dizziness   treat   22   0   2   17   2   1   0   1.39   0.17           group           control   9   2   1   5   1   0   0       cancer   treat   73   1   6   29   23   12   2   2.41   0.02       pain   group           control   29   2   2   17   8   0   0       nausea   treat   38   0   1   22   12   2   1   2.35   0.02       and vomit   group           control   16   0   5   8   2   1   0       abdominal   treat   55   1   5   29   14   6   0   1.24   0.22       distension   group           control   25   2   5   11   4   0   3                 *Improved 1 grade: lower 1 grade after treatment compared with before treatment, for example, grade □ of anorexia“without appetite, appetite decreased &gt;½”; improved to grade □ of anorexia“without appetite, appetite decreased within ⅓ to ½”, analogized sequentially.             
 
         [0641]     Improventment extent comparison of gastric discomfort, anorexia, bitter mouth, night sweat, upset and tantrum, cancer pain, nausea between two groups after treatment, there is notable significance in the difference.  
         [0642]     Improventment extent comparison of dry mouth, thirst, spontaneous perspiration, dizziness and abdominal distension between two groups after treatment, there is no notable significance in the difference  
         [0643]     13. Main Symptoms and Signs Disappearance Rates Comparison of Two Groups After Treatment  
                                                               TABLE 39                           Main symptoms and signs disappearance rates comparison of two       groups after treatment (-)                            dry mouth       group   gastric discomfort   anorexia   fatigue   thirst                    treat   original cases   77   73   74   34       group   disappearance cases   30   35   39   26           disappearance rate   38.96   47.95   52.7   76.47       control   original cases   39   37   33   13           disappearance cases   16   18   16   10           disappearance rate   41.03   48.65   48.48   76.92           X 2  (correction)   0.05   0.00   0.16   Fisher&#39;s exact test           P   0.83   0.94   0.69   1.00                  
 
         [0644]    
       
         
               
             
               
               
               
               
               
             
               
               
               
               
               
               
             
           
               
                 TABLE 40 
               
             
             
               
                   
               
               
                   
               
               
                 Main symptoms and signs disappearance rates comparison of two groups after treatment (  - ) 
               
             
          
           
               
                   
                   
                 spontaneous 
                   
                 upset and 
               
               
                 group 
                 bitter mouth 
                 perspiration 
                 night sweat 
                 tantrum 
               
               
                   
               
             
          
           
               
                 treat 
                 original cases 
                 34 
                 32 
                 30 
                 29 
               
               
                 group 
                 disappearance 
                 27 
                 28 
                 23 
                 26 
               
               
                   
                 cases 
               
               
                   
                 disappearance rate 
                 79.41 
                 87.5 
                 76.67 
                 89.66 
               
               
                 control 
                 original cases 
                 11 
                 12 
                 9 
                 10 
               
               
                   
                 disappearance 
                 6 
                 8 
                 5 
                 6 
               
               
                   
                 cases 
               
               
                   
                 disappearance rate 
                 54.55 
                 66.67 
                 55.56 
                 60 
               
               
                   
                 X 2  (correction) 
                 Fisher&#39;s exact test 
                 Fisher&#39;s exact test 
                 Fisher&#39;s exact test 
                 Fisher&#39;s exact test 
               
               
                   
                 P 
                 0.24 
                 0.18 
                 0.23 
                 0.057 
               
               
                   
               
             
          
         
       
     
         [0645]    
       
         
               
             
               
               
               
               
               
             
               
               
               
               
               
               
             
           
               
                 TABLE 41 
               
             
             
               
                   
               
               
                   
               
               
                 Main symptoms and signs disappearance rates comparison of two groups after treatment            
               
             
          
           
               
                   
                   
                   
                   
                 abdominal 
               
               
                 group 
                 dizziness 
                 Cancer pain 
                 nausea and vomit 
                 distension 
               
               
                   
               
             
          
           
               
                 treat 
                 original cases 
                 22 
                 73 
                 38 
                 55 
               
               
                 group 
                 disappearance 
                 20 
                 44 
                 31 
                 35 
               
               
                   
                 cases 
               
               
                   
                 disappearance rate 
                 90.91 
                 60.27 
                 81.58 
                 63.64 
               
               
                 control 
                 original cases 
                 9 
                 29 
                 16 
                 25 
               
               
                   
                 disappearance 
                 6 
                 16 
                 8 
                 11 
               
               
                   
                 cases 
               
               
                   
                 disappearance rate 
                 66.67 
                 55.17 
                 50 
                 44 
               
               
                   
                 X 2  (correction) 
                 Fisher&#39;s exact test 
                 0.22 
                 Fisher&#39;s exact test 
                 2.71 
               
               
                   
                 P 
                 0.13 
                 0.64 
                 0.043 
                 0.099 
               
               
                   
               
             
          
         
       
     
         [0646]     Disappearce rates comparison of nausea and vomit, there is notable significance in the difference.  
         [0647]     Disappearce rates comparison of gastric discomfort, anorexia, fatigue, dry mouth, thirst, dizziness, bitter mouth, spontaneous perspiration, night sweat, upset and tantrum, dizziness, cancer pain, abdominal distension of two groups after treatment, there is no notable significance in the difference.  
         [0648]     14. WBC Counting Comparison of Two Groups After Treatment  
                                     TABLE 42                           WBC counting comparison of two groups after treatment*                            Improved       group   cases   aggravation   no change   1 grade               treat group   83   2   80   1       control   39   5   33   1           rank sum test   u = 1.757   P = 0.079                 *Grade WBC accurately according to “WHOgrade criterions for acute and subacute toxicity reactions of the anti-cancer drugs”, .see details in application example 1.             
 
         [0649]     There is no notable significance in the difference of WBC counting.  
         [0650]     15. Granulocytes Counting Comparison of Two Groups After Treatment  
                                                                   TABLE 43                           Granulocytes counting comparison of two groups after treatment*                    aggrava-   no   Improved   Improved   Improved       group   cases   tion   change   1 grade   2 grades   3 grades               treat   41   1   39   1   0   0       group       control   22   2   18   1   0   1                rank sum test   u =   P = 0.99                   0.01                         *Grade granulocytes accurately according to “WHOgrade criterions for acute and subacute toxicity reactions of the anti-cancer drugs”, see details in application example 1.             
 
         [0651]     There is no notable significance in the difference of Granulocytes counting.  
         [0652]     16. Hemoglobin Comparison of Two Groups After Treatment  
                                             TABLE 44                           Hemoglobin comparison of two groups after treatment*                    aggrava-   no   Improved   Improved   Improved       group   cases   tion   change   1 grade   2 grades   3 grades               treat   83   8   53   15   5   2       group       control   40   9   25    2   3   1               rank   u =   P = 0.054               sum test   1.927                 *Grade hemoglobin accurately according to “WHOgrade criterions for acute and subacute toxicity reactions of the anti-cancer drugs”. see details in application example 1.             
 
         [0653]     There is no notable significance in difference of Hemoglobin (P=0.054 close to the clinical value), Hemoglobin of treat group has tend to be increased, compared with control group.  
         [0654]     17. Platelets Counting Comparison of Two Groups After Treatment  
                                             TABLE 45                           Platelets counting comparison of two groups after treatment*                    aggrava-   no   Improved   Improved   Improved       group   cases   tion   change   1 grade   2 grades   3 grades               treat   82   1   79   2   0   0       group       control   40   3   34   3   0   0               rank   u =   P = 0.824               sum test   0.223                 *Grade platelets accurately according to “WHOgrade criterions for acute and subacute toxicity reactions of the anti-cancer drugs”, see details in application example 1.             
 
         [0655]     There is no notable significantce in the difference of Platelets counting.  
         [0656]     18. Immune Function Comparison of Two Groups After Treatment  
                                                                           TABLE 46                           CD3 comparison of two groups before and after treatment                        8 weeks after   difference                       before treatment   treatment   (after − before)       group   cases     x  ± s     x  ± s     x  ± s   t   p                    treat group   52   52.51 ± 8.16   57.67 ± 9.04   4.84 ± 5.64   6.12   0.000       control   21   50.44 ± 9.64   48.19 ± 9.43   −1.25 ± 6.19   0.808   0.432               t = 0.93   t = 3.62   t = 3.68               P = 0.35   P = 0.00057   P = 0.00047                  
 
         [0657]     CD3 comparison of two groups before treatment, there is no notable significance in the difference.  
         [0658]     CD3 comparison of two groups after treatment, there is notable significance in the difference.  
         [0659]     CD3 difference (after-before) comparison of two groups, there is notable significance in the difference.  
         [0660]     CD3 comparison of treat group before and after treatment, there is notable significance in the difference (t=6.12, P=0.000).  
         [0661]     CD3 comparison of control group before and after treatment, there is no notable significance in the difference. (t=0.808, P=0.432).  
                                             TABLE 47                           CD4 comparison of two groups before and after treatment                            difference                       before treatment   8 weeks after   (after − before)       group   cases     x  ± s   treatment  x  ± s     x  ± s   t   p               treat group   52   36.08 ± 7.08   40.18 ± 6.87     3.78 ± 4.22   6.41   0.000       control   21   31.94 ± 9.30   32.00 ± 9.54   −0.63 ± 6.44   0.39   0.703               t = 2.06   t = 3.77   t = 3.19               P = 0.043   P = 0.00036   P = 0.0022                  
 
         [0662]     CD4 comparison of two groups before treatment, there is notable significance in the difference.  
         [0663]     CD4 comparison of two groups after treatment, there is notable significance in the difference.  
         [0664]     CD4 after-before) of comparison of two groups, there is notable significance in the difference.  
         [0665]     CD4 comparison of treat group before and after treatment. (t=6.41, P=0.000), there is notable significance in the difference.  
         [0666]     CD4comparison of control group before and after treatment (t=0.39, P=0.703), there is no notable significance in the difference.  
                                                                           TABLE 48                           CD8 comparison of two groups before and after treatment                        8 weeks                           before treatment   after treatment   difference (after − before)       group   cases     x  ± s     x  ± s     x  ± s   t   p                    treat group   51   28.67 ± 8.54    25.69 ± 4.35    −3.00 ± 8.06   2.66   0.011       control   21   28.25 ± 10.32   26.06 ± 10.34   −1.19 ± 3.62   1.31   0.21               t = 0.18   t = 0.21   t = 0.87               P = 0.85   P = 0.83   P = 0.39                  
 
         [0667]     CD8 comparison of two groups before treatment, there is no notable significance in the difference.  
         [0668]     CD8 comparison of two groups after treatment, there is no notable significance in the difference.  
         [0669]     CD8 (after-before) comparison of two groups, there is no notable significance in the difference.  
         [0670]     CD8 of comparison of treat group before and after treatment (t=2.66, P=0.011), there is notable significance in the difference.  
         [0671]     CD8 comparison of control group before and after treatment (t=1.31, P=0.21), there is no notable significance in the difference.  
                                                                           TABLE 49                           CD4/CD8 comparison of two groups before and after treatment                            difference                       before   8 weeks after   (after −                       treatment   treatment   before)       group   cases     x  ± s     x  ± s     x  ± s   t   p                    treat   51   1.31 ± 0.32   1.59 ± 0.38   0.22 ± 0.42   6.85   0.000       group       control   21   1.19 ± 0.26   1.28 ± 0.38   0.06 ± 0.25   0.61   0.55               t = 1.54   t = 2.84   t = 1.39               P = 0.13   P = 0.0059   P = 0.17                  
 
         [0672]     CD4/CD8 comparison of two groups before treatment, there is no notable significance in the difference.  
         [0673]     CD4/CD8 comparison of two groups after treatment, there is notable significance in the difference.  
         [0674]     CD4/CD8 (after-before) comparison of two groups, there is no notable significance in the difference.  
         [0675]     CD4/CD8 comparison of treat group before and after treatment (t=6.85, P=0.000), there is notable significance in the difference.  
         [0676]     CD4/CD8 comparison of control group before and after treatment (t=0.61, P=0.55), there is no notable significance in the difference.  
                                             TABLE 50                           NK cell comparison of two groups before and after treatment                            difference                       before   8 weeks after   (after −                       treatment   treatment   before)       group   cases     x  ± s     x  ± s     x  ± s   t   p               treat   12   16.17 ± 1.80   18.18 ± 3.36     2.00 ± 1.71   4.05   0.002       group       control   11   16.65 ± 6.22   15.73 ± 3.12   −1.33 ± 1.75   1.79   0.134               t = 0.26   t = 1.49   t = 3.88               P = 0.80   P = 0.16   P = 0.0013                  
 
         [0677]     NK cell comparison of two groups before treatment, there is no notable significance in the difference.  
         [0678]     NK cell comparison of two groups after treatment, there is no notable significance in the difference  
         [0679]     NK cell (after-before) comparison of two groups, there is notable significance in the difference  
         [0680]     NK cell comparison of treat group before and after treatment (t=4.05, P=0.002), there is notable signficance in the difference.  
         [0681]     NK cell comparison of control group before and after treatment (t=1.79, P=0.134), there is no notable significance in the difference.  
         [0682]     19. CEA Comparison of Two Groups Before and After Treatment  
                                             TABLE 51                           CEA comparison of two groups before and after treatment                    before treatment   8 weeks after   difference (after − before)               group   cases     x  ± s   treatment  x  ± s     x  ± s   t   p               treat group   68   18.69 ± 20.27   17.15 ± 18.27   −1.27 ± 12.41   0.69   0.49       control   31   17.58 ± 19.79   17.04 ± 20.17   0.37 ± 4.81   0.40   0.69               t = 0.25   t = 0.03   t = 0.37               P = 0.79   P = 0.98   P = 0.72                  
 
         [0683]     CEA comparison of two groups before treatment, there is no notable significance in the difference  
         [0684]     CEA comparison of two groups after treatment, there is no notable significance in the difference  
         [0685]     CEA (after-before) comparison of two groups, there is no notable significance in the difference.  
         [0686]     CEA comparison of treat group before and after treatment (t=0.69, P=0.49), there is no notable significance in the difference.  
         [0687]     CEA comparison of control group before and after treatment (t=0.40, P=0.69), there is no notable significance in the difference.  
         [0688]     20. Bleeding Time and Coagulation Time Comparison of Two Groups Before and After Treatment  
                                             TABLE 52                           Bleeding time (second) comparison of two groups before and after treatment                    before treatment   8 weeks after   difference (after − before)               group   cases     x  ± s   treatment  x  ± s     x  ± s   t   p               treat group   40   115.08 ± 22.35   117.76 ± 20.19   2.68 ± 18.49   0.88   0.38       control   20   107.25 ± 29.36   109.17 ± 35.74   3.33 ± 22.29   0.63   0.53               t = 1.15   t = 1.14   t = 0.12               P = 0.26   P = 0.26   P = 0.91                  
 
         [0689]     Bleeding time comparison of two groups before treatment, there is no notable significance in the difference.  
         [0690]     Bleeding time comparison of two groups after treatment, there is no notable significance in the difference  
         [0691]     Bleeding time (after-before) comparison of two groups, there is no notable significance in the difference  
         [0692]     Bleeding time comparison of treat group before and after treatment (t=0.88, P=0.38), there is no notable significance in the difference.  
         [0693]     Bleeding time comparison of control group before and after treatment (t=0.63, P=0.53), there is no notable significance in the difference.  
                                             TABLE 53                           Coagulation time (second) comparison of two groups before and after treatment                    before treatment   8 weeks after   difference (after − before)               group   cases     x  ± s   treatment  x  ± s     x  ± s   t   p               treat group   40   156.33 ± 28.09   154.51 ± 31.91   −0.70 ± 15.69   0.27   0.79       control   20   158.50 ± 40.91   154.72 ± 42.51     1.94 ± 16.64   0.49   0.63               t = 0.24   t = 0.02   t = 0.58               P = 0.81   P = 0.98   P = 0.57                  
 
         [0694]     Coagulation time comparison of two groups before treatment, there is no notable significance in the difference.  
         [0695]     Coagulation time comparison of two groups after treatment, there is no notable significance in the difference  
         [0696]     Coagulation time difference (after-before) comparison of two groups, there is no notable significance in the difference  
         [0697]     Coagulation time comparison of treat group before and after treatment (t=0.27, P=0.79), there is no notable significance in the difference.  
         [0698]     Coagulation time comparison of control group before and after treatment (t=0.49, P=0.63), there is no notable significance in the difference.  
         [0000]               Safety Assessment  
         [0699]     All safety indexes are normal before treatment, the safety assessment results of the abnormal after treatment are recorded in following table:  
                                                                                                                   treat group   control group                    positive   inci-   positive   inci-               doubtful adverse   cases/   dence   cases/   dence               reaction   total cases   rate   total cases   rate   RR   P                    Hemoglobin   3/48   6.3%   4/20   20.0%   0.31   0.182       reduction       WBC reduction   2/80   2.5%   4/35   11.4%   0.22   0.069       Granulocyte   1/42   0.5%   1/26   3.8%   0.62   1.00       reduction       Platelet reduction   1/81   1.2%   3/38   7.9%   0.16   0.095       Bilirubin increase   5/72   6.9%   4/35   11.4%   0.61   0.470       AKP rising   5/56   8.9%   5/36   13.9%   0.64   0.505       GPT rising   2/79   2.5%   1/37   2.7%   0.94   1.00       BUN rising   2/81   2.5%   5/38   13.2%   0.19   0.033       serum creatinine   0/85   0.0%   2/42   4.8%       0.108       rising       Abnormal urine   1/85   1.2%   1/39   2.6%   0.46   0.532       protein       Abnornal urine   0/86   0.0%   1/42   2.4%       0.328       WBC       Abnornal urine   0/85   0.0%   1/41   2.4%       0.325       RBC       mucous stool   0/79   0.0%   3/41   7.3%       0.038       faeces RBC   2/79   2.5%   3/41   7.3%   0.35   0.337       abnormality       faeces WBC   3/86   3.5%   3/42   7.1%   0.49   0.393       abnormality       fecal occult blood   0/51   0.0%   1/22   4.5%       0.301                  
 
         [0700]     Safety indexes assessment results of two groups after treatment demonstrate that incidence rates of BUN rising, mucous stool of treat group are lower than those of control group (P&lt;0.05); The statistical analysis results of incidence rate demonstrate that there is no notable significance in the difference of other items of two groups. See details in above table.  
         [0701]               Adverse Event Observations  
                                                               TABLE 54                           Results of adverse event observations of two groups after treatment                treat group   control group               (n = 87)   (n = 42)                    inci-       inci-               doubtful adverse   positive   dence   positive   dence               reaction   cases*   rate   cases*   rate   RR   P               alopecie   9   10.3%    4   9.5%   1.09   1.000       oral cavity ulcer   1   1.1%   1   2.4%   0.48   0.547       cutaneous reaction   1   1.1%   0     0%       1.000       choking and short   4   4.6%   2   4.8%   0.97   1.000       of breath       jaundice   1   1.1%   4   9.5%   0.12   0.039       non cancer pain   4   4.6%   6   14.3%    0.32   0.077       hypersensitiveness   3   3.4%   2   4.8%   0.72   0.660       hemafecia   2   2.3%   3   7.1%   0.32   0.329       constipation   1   1.1%   2   4.8%   0.24   0.247       diarrhea   5   5.7%   4   9.5%   0.60   0.472       haematemesis   0     0%   0     0%                 *positive cases: if one patient had one symptom, recorded as one case, if one patient had two symptoms, recorded as two cases.               
         [0702]     During the courses of treatment, some patients in both groups had adverse reaction including baldness, oral ulcer. The incidence rates of symptoms and statistical comparison results of two groups demonstrate that jaundice incidence rate of treat group is lower than that of control groups, and there is no notable significance in difference of other adverse reaction of two groups, see details in above table.  
         [0703]     There are 25 cases in treat group who has at least one doubtful adverse reaction, and total incidence of doubtful adverse reaction is 28.7% ( 25/87); there are 17 cases in control group who had at least one doubtful adverse reaction, and total incidence of doubtful adverse reaction is 40.5% ( 17/42), there is no notable significance in difference of adverse reaction of two groups (RR=0.71, P=0.182).  
       Conclusions  
       [0704]     129 eligible tested object, of which, 87 cases in treat group, 42 cases in control group; all are diagnosed as gastric carcinoma by westen medicine and as symptom of stagnation of poison by Traditional Chinese Medicine. 15 outpatient cases, 114 inpatient cases.  
         [0705]     Results of comparability check show that there is no notable significance in differences of sex, age, disease courses, past treatment methods, tumor type, tumor location, number and size, main clinical symptoms and signs, tongue demonstration of two groups before treatment, except that cancer pain of treat group is more than that of control group. It suggests that prognostic main factors are uniform between two groups with comparability.  
         [0706]     Results of total clinical therapeutic effects demonstrate:  
         [0707]     CR, PR, SD and PD rates of treat group are 1.1%, 17.2%, 72.4%, 9.2% respectively, total remission rate is 18.3%; CR, PR, SD and PD rates of control group are 0%, 2.4%, 69.0% and 28.6% respectively, total remission is 2.4%. There are notable significance in difference of two groups.  
         [0708]     Clinical therapeutic effects results on gastric carcinoma without metastasis show that CR, PR, SD and PD rates of treat group are 1.6%, 16.1%, 72.6%, 9.7% respectively, total remission rate is 17.7%; CR, PR, SD and PD rates of control group are 0%, 3.7%, 66.7% and 29.6% respectively, total remission is 3.7%. There are notable significance in difference of two groups.  
         [0709]     Clinical therapeutic effects results on gastric carcinoma with metastasis show that CR, PR, SD and PD rates of treat group are 0.0%, 20.0%, 72.0%, 8.0% respectively, total remission rate is 20.0%; CR, PR, SD and PD rates of control group are 0%, 0.0%, 73.3% and 26.7% respectively, total remission is 0.0%. There are notable significance in difference of two groups.  
         [0710]     Therapeutic effect of 1 case in treat group shown as “complete remission”. Considering that the therapeutic effects assessment of this patient was not confirmed, so we adopted “concessional conservation method” and classified the effect as “Stable Disease”, then performed clinical therapeutic effects comparison. There is notable significance in difference of the two groups (u=3.445, P=0.001), and results are shown in table 23.  
         [0711]     Above results indicate that the invented Traditional Chinese Medicine composition, combined with chemotherapy on treatment of gastric carcinoma (belonging to the sympton of stagnation of poison), has better clinical therapeutic effects, exerting certain synergistic functions and adjunctive therapeutic functions.  
         [0712]     Results of life span and survival rate assessment:  
         [0713]     1.5 year follow-up after treatment, survival rate of treat group and control group are 32.83%, 24.39% respectively, there is notable significance in difference of short term effect of two groups; there is no notable significance in difference of long term effect of two groups  
         [0714]     For gastric carcinoma without metastasis patients, 1.5 year follow-up after treatment, survival rate of treat group and control group are 31.27%, 33.33% respectively, there is no notable significance in difference of short term effect of two groups; there is no notable significance in difference of long term effect of two groups.  
         [0715]     For gastric carcinoma metastasis patients, 1.5 year follow-up after treatment, survival rate of treat group and control group are 36.0%, 7.14% respectively, there is notable significance in difference of short term effect of two groups; there is notable significance in difference of long term effectof two groups.  
         [0716]     Indicating that the invented Traditional Chinese Medicine composition, serving as adjunctive therapy on chemotherapy of gastric carcinoma (considered as symptom of stagnation of poison by Traditional Chinese Medicine) short term effect is better than sole chemotherapy, long term effect is equal to sole chemotherapy (for gastric carcinoma patients with metastasis, short term effect and long term effect all are better than sole chemotherapy).  
         [0717]     Results of solid tomor foci size assessment show:  
         [0718]     There is notable significance in difference of tumor foci size difference (after-before) of two groups, minimized extent of the tumor foci size of treat group is greater than that of control group. There is notable significance in difference of tumor foci size of treat group before and after treatment, tumor minimized obviously after treatment compared with before treatment; There is no notable significance in difference of tumor foci size of control group before and after treatment. Suggesting that the invented Traditional Chinese Medicine composition, serving as adjunctive therapy on chemotherapy of gastric carcinoma (considered as symptom of stagnation of posison by Traditional Chinese Medicine), can minimize tumor foci obviously, which outweighs therapeutic effects of sole chemotherapy.  
         [0719]     Results of main symptoms improvement show:  
         [0720]     Karnofsky score of both treat group and control group increased obviously after treatment compared with that of before treatment, and the Karnofsky score increased extent of treat group is greater than control group; Fatigue of patients in both groups are improved obviously after treatment, fatigue improvement extent of treat group is greater than that of control group.  
         [0721]     Appetite of patients in both groups increased obviously, symptoms including gastric discomfort, anorexia, dry mouth, thirst, bitter mouth, spontaneous perspiration, night sweat, upset, tantrum, cancer pain, nausea and vomit, abdominal distension, are all improved or have high disappearance rates, for improvement extent of gastric discomfort, anorexia, bitter mouth, night sweat, upset, tantrum, cancer pain, nausea and vomit, treat group is higher than that of control group; There is no notable significance in difference of improvement and disappearance rates of other symptoms between two groups.  
         [0722]     Above results indicate that the invented Traditional Chinese Medicine composition, serving as adjunctive therapy on chemotherapy of gastric carcinoma, can ameliorate patients survival qualities, improve clinical symptoms and has better adjunctive therapeutical effects.  
         [0723]     Laboratory examination results demonstrate:  
         [0724]     WBC, RBC, platelet of two groups did not incease obviously after treatment compared with before treatment, hemoglobin of two groups increased obviously after treatment, and there is notable significance in difference of hemoglobin comparison of two groups after treatment (P=0.054), Hemoglobin of treat group has tend to be increased, compared with control group.  
         [0725]     CD3, CD4, CD4/CD8 and NK cells of treat group increased obviously after treatment compared with those of before treatment (P&lt;0.05), furthermore, the CD3, CD4 and NK cell difference (after-before) of treat group are higher than those of control group (P&lt;0.05), while changes of CD3, CD4, CD4/CD8 and NK cells of control group are not so obvious.  
         [0726]     Above results indicate that the invented Traditional Chinese Medicine composition, serving as adjunctive therapy on chemotherapy of gastric carcinoma, has certain functions of stimulating immune responses, and can assist intervention chemotherapy to inhibit cancer cells.  
         [0727]     Results of safety assessment show:  
         [0728]     After treatment, some patients in two groups had hemoglobin reduction, WBC reduction, bilirubin rising, AKP rising, ALT rising, BUN rising(see details in “safety assessment”), incidence rates of BUN rising, mucous stool of treat group are lower than those of control group (P&lt;0.05), there is notable significance in difference of other items of two groups. Considering that treat group received the invented Traditional Chinese Medicine composition based on chemotherapy, while control group received sole chemotherapy, it has already reported that the above side effects could also be seen during chemotherapy, so above safety assessment has not determined yet that the invented Traditional Chinese Medicine composition can damage hematopoietic systems and heart, liver functions. We should perform aggregate analysis using safety assessment data of sole treatment of primary hepatic carcinoma and gastric carcinoma with the invented Traditional Chinese Medicine composition (data23-1)  
         [0729]     Results of adverse event demonstrate:  
         [0730]     During the courses of treatment, some patients in two groups had adverse reactions including alopecie, dental ulcer, scytitis, choking and short of breath, jaundice, hypersensitivity etc (see details in table 54), jaundice incidence rate of treat group is lower than that of control groups, there is no notable significance in differences of other adverse events of two groups There are 25 cases in treat group who had at least one doubtful adverse reaction, total incidence of doubtful adverse reactions is 28.7% ( 25/87), there are 17 cases in control group who had at least one doubtful adverse reaction, total incidence of doubtful adverse reactions is 40.5% ( 17/42). There is no notable significance in difference of two groups (RR=0.71, P=0.182).  
         [0731]     In summary, results of this randomized controlled trial demonstrate that the invented Traditional Chinese Medicine composition, combined with chemotherapy on treatment of gastric carcinoma, has better clinical therapeutic effects, can exert synergistic functions, can ameliorate patients survival qualities, improve clinical symptoms of patients and enhance cellular immune function of patients, it can be used as adjunctive therapy on chemotherapy of gastric carcinoma patients (considered as sympton of stagnation of poison by Traditional Chinese Medicine) and clinical application is quite safe.