bluuebunny/crossref_metadata_2025 huggingface dataset:
Sulphadiazine/Trimethoprim Once Daily in Maxillary Sinusitis: A Randomized Double-Blind Comparison with Sulphamethoxazole/Trimethoprim B.I.D.
Authors: Federspil Pierre , Bamberg Peter
Published: January 2017

In a randomized double-blind study fifty-four patients suffering from acute maxillary sinusitis were treated for 10 days with daily doses of sulphadiazine/trimethopim (1 g) and sulphamethoxazole/trimethoprim (1.92 g), respectively. The efficacy was evaluated clinically at two follow-up visits. X-ray investigations were performed at admission and after the therapy. Of thirty-nine patients finally evaluated, thirty-seven showed a favourable result. After 6–8 days of therapy there was significant difference in cure rates in favour of sulphadiazine/trimethoprim (p < 0.05) while the outcome as evaluated after treatment was similar for both drugs.
Tolmetin Sodium in Clinical Practice: A Survey of 32,207 Treated Patients
Authors: Sarchi C , Cioffl T , Bertelletti D , Guslandi M
Published: January 2017

A total of 32,207patients with various rheumatic disorders were treated with the non-steroidal antiphlogistic tolmetin in the course of a post-marketing survey performed in Italy with the co-operation of 4,205 general practitioners. The treatment proved effective in about 90% of patients treated. The tolerability of the drug was excellent or good in 91% of cases. Side-effects involving mostly the gastro-intestinal tract occurred in 12.3% of cases, but treatment was discontinued in only 3.6% of patients. The results confirm the remarkable therapeutic activity and the good tolerability of tolmetin sodium.
Tizanidine (DS 103-282) in the Treatment of Acute Paravertebral Muscle Spasm: A Controlled Trial Comparing Tizanidine and Diazepam
Authors: Fryda-Kaurimsky Z , Müller-Fassbender H
Published: January 2017

In a double-blind trial tizanidine (DS 103-282: S-Chloro-4-(2-imidazolin-2-yl-amino)-2,1,3-benzothiadiazole), a new muscle relaxant, was compared with diazepam in twenty in-patients suffering from acute paravertebral muscle spasm. All the patients had suffered from degenerative spinal disease for some years. Ten patients received tizanidine and the other ten received diazepam. Both drugs were administered t.i.d. for a period of 7 days. Significant improvements were reported in eight of the sixteen variables. Tizanidine was significantly superior to diazepam for two of these variables (lateral flexion of the lumbar spine, right and left).

A centrally mediated blood-pressure-lowering effect was observed with both drugs. Tizanidine was generally better tolerated, only two patients reporting transient side-effects compared with five patients in the diazepam group. Like diazepam, tizanidine is a suitable drug for the treatment of acute paravertebral muscle spasm.
Sublingual Buprenorphine versus Oral Dihydrocodeine in Post-Operative Pain
Authors: Masson A H B
Published: January 2017

The effect of sublingual buprenorphine (0.4 mg) was compared with that of oral dihydrocodeine (60 mg) in patients experiencing post-operative pain following general surgery.

Pain relief was significantly greater for buprenorphine than for dihydrocodeine, based on both peak effect and total effect. Both treatments were effective from 30 minutes. There was evidence that buprenorphine had a slightly slower onset of action, but a distinctly longer duration of action, than dihydrocodeine. Unwanted effects were similar for both treatments.
Benzbromarone Therapy in Hyperuricaemia; Comparison with Allopurinol and Probenecid
Authors: Schepers Gerrit Willem
Published: January 2017

The purpose of this study was to compare the serum uric acid lowering effect of benzbromarone (Minuric®), allopurinol, probenecid and placebo in patients suffering from confirmed hyperuricaemia.

This was a multiple dose, placebo-controlled, crossover study in six hyperuricaemic patients to compare the effects on uric acid of three different active treatments: benzbromarone 100 mg daily, probenecid 1000 mg daily and allopurinol 300 mg daily.

Each patient was assessed clinically and biochemically before and after the study and blood samples for serum uric acid determinations were taken thirteen times during the study period. For the six trialists it was found that benzbromarone is superior to both probenecid and allopurinol in the lowering of serum uric acid, and that probenecid is also superior to allopurinol.
Comparative Pharmacokinetics of 400 mg Bezafibrate after a Single Oral Administration of a New Slow-Release Preparation and the Currently Available Commercial Form
Authors: Ledermann H , Kaufmann B
Published: January 2017

Bezafibrate is a new lipid-lowering agent with a more pronounced pharmacological effect, a different metabolism and a much shorter apparent half-life than clofibrate. The serum concentration curves and the urinary excretion were determined in seventeen healthy volunteers after administration of 400 mg of a new slow-release preparation. The results were compared with those of a similar experiment in twenty healthy volunteers who received 400 mg as a single dose in the form of 2 tablets of Cedur®, which is the currently marketed form in Germany (each tablet contains 200 mg bezafibrate).

The areas under the serum concentration curves were not statistically significantly different (median of 31.3 mg.h/l for the slow-release and of 39.4 mg.h/l for the marketed preparation). Renal clearance differed only within the margin of biological variation.

It can be assumed that the relative biological availability of both preparations is similar.

In none of the volunteers were subjective or objective side-effects observed.
Sources of Human Plasma Cyclic AMP. Examinations before and after Beta2 Adrenergic Stimulation
Authors: Endres Peter , Klock Christine , Günther Rolf
Published: January 2017

Plasma cyclic AMP was measured in different vessels in seventeen volunteers before and after stimulation with terbutaline. Differences between arterial blood and blood from the hepatic vein, right ventricle, inferior vena cava and a cubital vein could not be demonstrated. Only in the renal vein was the concentration of cyclic AMP decreased. Our results indicate that cyclic AMP is not generated from any specific isolated organ and that changes in cyclic AMP after subcutaneous injection of terbutaline reflect a general influence of this drug.
A Fixed Combination of Metoprolol Slow-Release and Chlorthalidone, Given Once Daily, in the Long-Term Treatment of Arterial Hypertension
Authors: Floris Bruno , Franchetta Gianni , Palestini Nicola , Sonaglioni Giulio , Verdecchia Paolo , Bichisao Ettore
Published: January 2017

A fixed combination of metoprolol slow-release 200 mg and chlorthalidone 25 mg was given once daily over a 3 months period in forty out-patients with mild-to-moderate arterial hypertension stage I or II WHO.

The combination elicited a clear-cut antihypertensive effect lasting at least 24 hours after drug. As compared with pre-treatment values, systolic and diastolic blood pressures were gradually reduced within the first month of treatment, remaining nearly constant in the following 2 months.

Treatment was well tolerated by all patients. Neither serum potassium nor any other laboratory test (creatinine, glucose, uric acid, etc.) showed significant changes.

In conclusion, slow-release metoprolol in fixed association with chlorthalidone provides a safe and effective treatment of arterial hypertension even on a long-term basis. The once daily dosing schedule may considerably improve patient's compliance.
Long-Term Treatment of Essential Hypertension with Nadolol and Hydrochlorothiazide: A Two-Year Follow-Up
Authors: El-Mehairy M M , Shaker A , Ramadan M , Hamza S , Tadros S S
Published: January 2017

After 3 weeks of placebo administration, thirty-two mildly or moderately hypertensive patients were treated with hydrochlorothiazide (HCZ) for 3 weeks, then with HCZ plus nadolol, a new beta-adrenergic blocker, for 2 years. The dose of HCZ was 50 mg once daily for all except two patients, who received 50 mg twice a day. The dose of nadolol ranged from 40 mg to 240 mg, once daily.

The average supine blood pressure decreased from 182/110 mm Hg at the end of the placebo period to 170/104 mm Hg at the end of treatment with HCZ alone. Nadolol was added to the regimen, and the average supine blood pressure decreased further to 132/88 mm Hg at the end of 3 months of combined therapy. It remained essentially unchanged for the duration of the 2-year study, and no increases in the dosage of either drug were needed. Side-effects were mild, and none required a change in dosage.

A once-daily dose of nadolol combined with HCZ appears to be safe and effective therapy for the long-term treatment of mild or moderate essential hypertension.
Nimesulide in the Short-Term Treatment of Osteoarthrosis: A Pilot Study for Assessing the Minimal Effective Dose
Authors: Reiner Michele
Published: January 2017

Eleven patients suffering from osteoarthritis of the cervical spine were admitted to a pilot study aimed at establishing the effective dose and the tolerability of Nimesulide.

The patients received a basic treatment of Nimesulide 100 mg/day, increasable up to 300 mg/day, in conformity with the patient's need.

The treatment over a period of 15 days showed that Nimesulide 200 mg/day has good anti-inflammatory and analgesic properties. Several critical parameters were significantly improved. The incidence of usually mild side-effects was very low.
Indoprofen versus Indomethacin in Acute Painful Shoulder and other Soft-Tissue Rheumatic Complaints
Authors: Soave G , Bruni G , Lavezzari M , Parrinello L
Published: January 2017

In a double-blind, parallel-group study indoprofen 800 mg daily was compared with indomethacin 100 mg daily in forty patients suffering from acute painful shoulder and other soft-tissue rheumatic complaints.

Both drugs were administered orally for 14 days. Clinical assessments, carried out at baseline and on Days 4, 8 and 15, included pain (at rest, upon pressure, on motion under load), quality of sleep, range of active motion and patient's opinion.

A significant improvement in all variables was found for both indoprofen and indomethacin at each time of observation, almost reaching its maximum within the first week. Excellent or good results, as judged by the patients, were obtained in 90% of cases in both treatment groups. No significant differences were observed between the two drugs. One patient taking indomethacin developed headache and dizziness, requiring discontinuation of treatment; three patients on indoprofen complained of mild or moderate gastric pain.
A New Thienodiazepine, Brotizolam, for the Treatment of Insomnia
Authors: Sanchez-Martinez Jaime , Landa-Palos Julia
Published: January 2017

A double-blind crossover study was carried out in twenty hospitalized inpatients who, apart from their primary diagnosis, suffered from non-psychiatric chronic insomnia. The patients received 0·5 mg brotizolam or 30 mg flurazepam for a 2-week period. Both drugs improved the induction and continuity of sleep, and increased the total sleep time, although better results were observed with brotizolam in all the parameters studied.
Bioavailability of d-pseudoephedrine and Azatadine from a Repeat Action Tablet Formulation
Authors: Lin C , Lim J , Symchowicz S
Published: January 2017

The objective of this study was to compare in man the bioavailability of d-pseudoephedrine and azatadine from a repeat action tablet* formulation and from conventional tablets. The repeat action tablet, containing 1 mg of azatadine maleate in the coat, and 60 mg of d-pseudoephedrine sulfate in both the coat and the core, was given at 0 hour. A conventional tablet of 60 mg of d-pseudoephedrine sulfate was given at 0 and 4 hours and a conventional tablet of 1 mg of azatadine maleate was given at 0 hour. The plasma levels of d-pseudoephedrine were measured by gas-liquid chromatography and the amount of azatadine in the urine was determined by a mass fragmentographic procedure. The results showed that there were no statistically significant differences in the measured bioavailability parameters (area under plasma concentration-time curve, maximum plasma concentration and time to reach maximum plasma concentration) for pseudoephedrine from repeat action tablets and conventional d-pseudoephedrine sulfate tablets; neither was there any statistically significant difference in the cumulative urinary excretion of azatadine from the repeat action tablets and conventional azatadine maleate tablets (p > 0·10). These data clearly demonstrate the bioequivalence of the repeat action tablets and the conventional tablets of d-pseudoephedrine and azatadine.
Comparative Bioavailability of d-pseudoephedrine from a Conventional d-pseudoephedrine Sulfate Tablet and from a Repeat Action Tablet
Authors: Lin C , Lim J , Symchowicz S
Published: January 2017

The bioavailability of a single dose of d-pseudoephedrine sulfate administered to male volunteers in repeat action tablet* form (60 mg d-pseudoephedrine sulfate in the coat and 60 mg d-pseudoephedrine sulfate in the core) was compared with the bioavailability of an equivalent quantity of the drug given as two 60 mg conventional tablets, one given at 0 hour and the second 6 hours later. There was no significant difference (p > 0·10) between the conventional tablets and the repeat action tablet formulation in area under the plasma concentration-time curve and the maximum plasma concentration of d-pseudoephedrine. Based on the data, we conclude that the repeat action tablet formulation and the conventional tablet are bioequivalent.
A Double-Blind Comparison of Zimelidine and Amitriptyline in Depressive Out-Patients
Authors: Syvälahti E , Salminen J , Lehtinen V
Published: January 2017

A double-blind, randomized clinical study was conducted in thirty-four outpatients suffering from major depressive disorders comparing zimelidine with amitriptyline. The dosage was flexible, maintenance doses varying between 50–150 mg in the amitriptyline group and 50–300 mg in the zimelidine group. After a wash-out period of at least a week the mean score in Hamilton Rating Scale for depression (HRS) was 22·2 for zimelidine and 21·9 for amitriptyline. During the treatment period of 6 weeks, zimelidine and amitriptyline appeared to be equally effective as antidepressants in HRS and Global Ratings. The zimelidine group showed significantly less somnolence and dry mouth. No clinically important changes were seen in the laboratory parameters during the study.
A Study to Ascertain Whether Hydrocortisone 17-butyrate (Locoid®) 0·1% Cream Has Any Effect on the Hypothalamic-Pituitary-Adrenal Axis in Children with Skin Diseases
Authors: Herz G
Published: January 2017

A study was conducted in eight children requiring topical corticosteroid treatment for dermatological disorders. The trial was carried out with hydrocortisone 17-butyrate (Locoid®) 0·1% cream. The children were treated twice daily with Locoid cream applied to areas involving at least 20% of the body surface for a period of 2 to 3 weeks. Statistical analysis did not reveal any significant changes in plasma cortisol levels after treatment compared to pre-treatment baseline levels. No side-effects were reported.
Platelet Release Reaction and Prostaglandin Pathway Activation in Angina Patients during Exercise: Effect of Indobufen
Authors: Pogliani E M , Fantasia R , Savino R , Montani M
Published: January 2017

Platelet 14C-serotonin release induced by collagen, and platelet malondialdehyde (M.D.A.) generation induced by thrombin were assessed in twenty patients with stable angina, before and after exercise with a bicycle ergometer. The patients received a single oral 200 mg dose of indobufen or placebo according to a crossover design in double-blind conditions. The M.D.A. concentration increased when exercise was carried out after placebo, whereas indobufen markedly inhibited M.D.A. production and 14C-serotonin release.

These results suggest that effort may be an important factor in activation of the platelet prostaglandin pathway and that the use of antithrombotic drugs may be appropriate in patients with angina.
Antiaggregant Effect of Indobufen (K3920) Measured by the Platelet Aggregate Filtration Pressure Test (PAFP)
Authors: Visonà A , Davanzo S , Bruno R , Pagnan A
Published: January 2017

The platelet aggregate filtration pressure test (PAFP) was used to study the aggregant activity of single doses of 200 mg indobufen, administered either orally or by i.v. injection. This double-blind study using placebo in a crossover design was conducted in twelve patients whose baseline aggregation values were high.

The compound showed markedly different antiaggregant activity from placebo at the various observation times after administration.

The two administration routes did not produce any significant differences.

The PAFP test can be useful in identifying atherosclerotic patients with platelet hyperaggregation, and for clinical pharmacology studies with platelet antiaggregant drugs.
Three-Day Clotrimazole Therapy for Vulvo-Vaginal Mycosis
Authors: Higashide Kohji , Kawaguchi Choji , Tomoda Yutaka
Published: January 2017

A self-medication therapy with clotrimazole vaginal tablets, application of two tablets at bedtime on 3 consecutive days, was carried out to find out whether vulvo-vaginal mycoses can be treated more effectively and with fewer drop-outs when treatment is simpler and shorter.

Our study included forty-one patients, seventeen of whom were in their second or third trimester of pregnancy. There was no significant difference between the efficacy rates in the pregnant (82·4%) and non-pregnant (83·3%) women. In 36 infections caused by various Candida species the cure rate was 91·7%; in 8 infections due to Torulopsis glabrata it was 75%. For thirty-three women with primary infections the cure rate was 84·8% and for eight women with recurrent infections it was 75%. The cure rate for the entire group of patients was 82·9% (thirty-four out of forty-one cases). Failures were seen in six out of thirty cases, i.e. in 16·7%. In one case burning was experienced after the insertion of the vaginal tablet so that treatment was discontinued.
Biliary Excretion of Piperacillin
Authors: Taylor E W , Poxon V , Alexander-Williams J , Jackson D
Published: January 2017

The excretion of piperacillin sodium in bile was studied after intravenous injection of 2 g (n = 5) and 4 g (n = 7). All patients had undergone cholecystectomy and exploration of the common bile duct for cholelithiasis. Bile, serum and urine concentrations were measured by a microbiological technique. Peak concentrations of piperacillin were found in bile at 150 minutes after 4 g and at 210 minutes after 2 g. Both the concentration of piperacillin in bile at the end of a 6 1/2 hour study and the calculated mean bile concentration of piperacillin were above the minimum inhibitory concentration (MIC) of this drug for organisms commonly found in acute biliary tract infections. We believe piperacillin may be useful in the management of such conditions.
Acute Gonococcal Urethritis: Treatment with a Single Dose of Rifampicin
Authors: Belli Luis , Ambrona Mario S , Gennaro Emilio A , Isola Enrique H , Rescigno Gilberte R González
Published: January 2017

A total of 103 patients with acute gonococcal urethritis were treated with a single 1,200 mg dose of rifampicin. A 91·3% cure rate was obtained, as proved by the negative bacteriological controls effected on the 7th and 14th days after the initiation of therapy.

Three pharyngeal infections and one ano-rectal infection responded successfully to the treatment.

No signs of drug intolerance were detected with the stated dose. Reactivity to the VDRL test was not impaired during the duration of the study and three reactive cases were discovered.

In previous studies of gonorrhoea we had observed a significant discrepancy between urine cultures and the urethral smears and, in view of this, it was decided to adopt the latter alone as a routine procedure.

The proposed dose does not originate resistance to rifampicin in either the Hansen or Koch bacilli.
Tolerance and Efficacy of Erythromycin Stearate Tablets versus Enteric-Coated Erythromycin Base Capsules in the Treatment of Patients with Acne Vulgaris
Authors: Bleeker Johan
Published: January 2017

In a randomized, and for the investigator, blind study side-effects and efficacy of two oral erythromycin preparations have been compared. Twenty patients with acne vulgaris, predominantly of the face, received erythromycin stearate tablets and another twenty patients received erythromycin enteric-coated base capsules. All patients were given 500 mg twice a day for 2 weeks. An improvement was seen in both groups, most pronounced in patients treated with the stearate tablets. Twenty per cent of the patients given the base preparation withdrew from therapy due to gastro-intestinal side-effects, as compared to 10% in the erythromycin stearate group.
Nimesulide in the Short-Term Treatment of Inflammatory Process of Dental Tissues: A Double-Blind Controlled Trial against Oxyphenbutazone
Authors: Pais José Manuel , Rosteiro Filomena Maria
Published: January 2017

One hundred out-patients with inflammatory process of dental tissues due to tooth extraction, root abscess alveolitis and periodontitis, were randomly assigned, according to a double-blind design, to one of two treatment groups with nimesulide (200 mg/day) or oxyphenbutazone (400 mg/day). By means of a seff-rating record, each patient rated his pain, difficulty of chewing, redness and swelling before starting, during and at the end of treatment.

Nimesulide and oxyphenbutazone were both well tolerated and effective, but the improvements during the first and the second day of treatment were of greater magnitude in the nimesulide-treated patients.

Nimesulide, being well tolerated, rapid acting and effective, could be considered as a drug of choice for the treatment of inflammatory process of dental tissues.
Clinical Trial of Pirprofen in Arthrosis of the Knee Joint: A Double-Blind Comparison with Indomethacin
Authors: Diverse P , Franchimont P
Published: January 2017

Thirty-nine patients suffering front arthrosis of the knee were randomly allocated to either pirprofen 400 mg b.i.d. or indomethacin 50 mg b.i.d., the treatment being double-blind. Assessments for pain and joint stiffness were made after 2 and 4 weeks. Both treatments appeared to be equally effective and induced side-effects in a limited number of patients. Similar observations were made in those patients who continued the treatment over longer periods of time.
Our Experience with the Use of Buflomedil Chlorhydrate in a Mixed Population of Vasculopathic Patients
Authors: Battaglia L , Valgiusti D , Di Paola F M
Published: January 2017

In the Observation Department of S. Giacomo Hospital the authors carried out a study on 242 patients, in whom they found a latent vascular pathology in some cases and a manifest vascular pathology in other cases.

The patients were divided into two groups:

patients at risk manifestly vasculopathic patients and they were then subdivided according to the compromised region.

The subjects underwent sero-haematological and radiological tests, instrumental tests not involving operations such as Doppler ultrasonography and rheography, and tests involving operations such as angiography.

Both medical and surgical therapeutic means were used. Then the authors carried out a therapeutic trial with buflomedil chlorhydrate on subjects with obliterative vasculopathy with different aetiologies.
Treatment of Essential Hypertension with Beta-Blocker plus Diuretic: A Study of 1402 Patients Treated by General Practitioners with Acebutolol 200 mg Combined with Hydrochlorothiazide 12·5 mg (‘Secadrex’) Once Daily for 3 Months
Authors: McGowan G K , Baker P G
Published: January 2017

One thousand four hundred and two patients with essential hypertension were treated by their general practitioners for 3 months with one tablet daily consisting of 200 mg acebutolol plus 12·5 mg hydrochlorothiazide: 813 were newly diagnosed and 589 were known hypertensives already on treatment. There was no ‘wash-out’ period before the latter changed to the study treatment. Newly diagnosed hypertensives had an average initial mean arterial pressure (MAP) of 129·9 mm Hg which fell on average by 18·2% during the study: 79% of patients had good results with final MAP levels less than 113 mm Hg (equivalent to e.g., 160/90 mm Hg), and a further 7% also had good results in that MAP fell more than 15%, another 12·5% had moderate results (falls of 5% to 15%): and only 1·5% had poor results (fell less than 5%). Known hypertensives had an average MAP of 127 mm Hg on previous treatment, which fell on average by 15·4% during this study: 70% of patients had good results with final MAP levels less than 113 mm Hg and a further 7% also had good results in that MAP fell more than 15%: 18% had moderate results and 3% poor results. Pulse rate fell by 12·5% in newly diagnosed and 10% in known treated hypertensives.

If allowance is made for withdrawals due to side-effects and to the need for more than one tablet of Secadrex daily, then over all 75·7% had a good blood pressure response to study medication, 13·7% a moderate response and 10·7% a poor response.

Adverse effects caused the withdrawal of 4% of newly diagnosed and 5% of treated hypertensives, predominantly nausea/vomiting, lassitude/fatigue and malaise. Adverse symptoms not causing withdrawal occurred in newly diagnosed patients with a frequency of 17·1 per 100 patients prior to the study when untreated and 14·1 during the study: in treated hypertensives the figures were 53·1 per 100 patients on previous treatment and 18·2 during the study.
Efficacy of Iron Therapy: A Comparative Evaluation of Four Iron Preparations Administered to Anaemic Pregnant Women
Authors: Fochi F , Ciampini M , Ceccarelli G
Published: January 2017

The authors conducted a clinical investigation on sixty-nine pregnant women, anaemic and non-anaemic, the purpose being to assess the effect of 50 days treatment with four different medicinal iron preparations, namely, ferrous sulphate, iron chondroitinsulfuric acid complex, and ferritin alone or associated with folinic acid and cobamamide, on various haematological parameters (Hb, RCC, Ht, CV, Iron, and Transferrin IBC).

The four products demonstrated a similar efficacy in maintaining anaemic conditions under control; moreover, the results confirmed our hypothesis of the absorption of iron ferritin. While three products were well tolerated, ferrous sulphate induced, in some cases, side-effects.
A Double-Blind Controlled Subjective Study of a New Pharmaceutical Preparation of Lormetazepam versus Placebo in Patients with Chronic Sleep Disturbances
Authors: Meco G , Lestingi L , Barbieri M R , Bove R , Maltese A
Published: January 2017

A double-blind crossover trial was carried out on the sleep-inducing activity of a new preparation (oral drops) of lormetazepam versus placebo. Twenty patients were included and requested to subjectively evaluate their sleep, both by analogue scales and semiquantitative ratings, during 2-night administration of the two products.

Also, the usual parameters, sleep duration, sleep latency and number of awakenings were evaluated.

Lormetazepam drops appeared to exert the same actions as the capsules' preparation, being significantly different from those of the placebo.
Evaluation of Reproterol's Effectiveness in Preventing Exercise-Induced Bronchospasm in Children
Authors: Verini M , Ansaloni A , Di Vincenzo M G , Napoleone M , Morgese G
Published: January 2017

The authors have evaluated the effectiveness of the protection of a new beta2-adrenergic compound, reproterol, against broncho-constriction induced by physical exercise in a group of individuals of paediatric age sensitive to broncho-stimulation.

This study has been carried out comparing reproterol with salbutamol, using placebo as a control, following a randomized single-blind crossover trial. The provocation test has been performed following the instructions of the Italian Society of Paediatrics. The drugs have been administered in the oral liquid form at the dose of 0·28 mg/kg and 0·1 mg/kg of reproterol and salbutamol, respectively.

The two substances have shown a similar preventive effectiveness in controlling exercise-induced asthma up to 2 hours from administration with reproterol having a stronger action at the beginning of the observation.
The Role of Ketotifen in Children with Recurrent Bronchitis
Authors: Suwanjutha Subharee , Chantarojanasiri Teerachai
Published: January 2017

The efficacy and safety of ketotifen in the treatment of recurrent bronchitis were studied in twenty Thai children with an average age of 5·3 years. Symptoms studied were cough, hypersecretion and wheezing and 4-point rating scores were assigned to each of the symptoms with regard to their frequency, severity and duration. Score per dose of the symptomatic agents used was also given. The symptoms and the use of symptomatic agents were recorded during a full year prior to ketotifen treatment and during a further full year study period. PEFR measurement was performed in the children above the age of 6 years at 2-weekly intervals under the supervision of the authors at the clinic.

Assessment of efficacy was done by comparing monthly symptom scores and medication scores during the study period with the mean value of the previous year. Thirteen children received ketotifen for the whole year while seven children who were almost symptom-free after 4 months ketotifen treatment, were then only observed for a further 8 months. At the end of the study period, ketotifen treatment was rated very good and good in 85% of children, satisfactory in 10% and poor in 5%. Drowsiness was the only side-effect reported in a few cases but then only initially. There were no abnormalities in any laboratory parameters studied.
Piretanide, a Potassium Stable Diuretic, in the Treatment of Essential Hypertension: A Double-Blind Comparison of Two Formulations
Authors: Dols W , Verho M , Rangoonwala B , Jaeger S
Published: January 2017

In a randomized double-blind parallel group study the effects of two formulations of piretanide (standard tablet and slow-release capsule) were compared in patients with mild to moderate essential hypertension. Forty patients entered the study and thirty-seven completed it. Both formulations of piretanide produced a significant reduction in erect and supine blood pressure which was evident at 2 weeks and was maintained and further enhanced over the ensuing trial period. A mean maximal fall in supine diastolic pressure of 22% was observed in the piretanide tablet group, and of 20% in the slow-release piretanide group. Blood pressure fell more quickly at the beginning of treatment with the tablet preparation, such that there was a significant difference between the groups up to the fourth week. After this point the blood pressure lowering effect was very similar in both groups and there was a progressive reduction in supine blood pressures over the 12-week active-treatment period. Slow-release piretanide produced a smoother effect than the tablet formulation.

There were no significant changes in serum potassium and serum magnesium in either treatment group. Minor changes were seen in some other biochemical and haematological variables but these were of no clinical significance. Three patients were withdrawn from the study because of side-effects: one because of an excessive antihypertensive response to the tablet formulation; and two because of allergic reactions to the slow-release preparation. Side-effects were otherwise mild and infrequent.
The Effectiveness of Glycosaminoglycans in Peripheral Vascular Disease Therapy: A Clinical and Experimental Trial
Authors: Corsi C , Bocci L , Cipriani C , Gazzini A , Marrapodi E
Published: January 2017

Thirty patients suffering from peripheral vascular disease (stage–II according to Fontaine) were included in a double-blind study aimed at assessing the efficacy of a high-dose glycosaminoglycan (GAG) (Sulodexide) both in terms of laboratory parameters, such as lipid metabolism and blood coagulation components, and instrumental procedures (strain-gauge plethysmography).

Compared with the fifteen control patients (treated with placebo), the fifteen patients treated with Sulodexide showed a signficant decrease in blood triglycerides and fibrinogen as well as a significantly increased HDL-cholesterol, and positive instrumental changes: at the end of treatment Peak and Rest Flow values – and consequently also Winsor's index – were significantly increased only in patients treated with Sulodexide.
The Treatment of Senile Dementia Associated with Cerebrovascular Insufficiency: A Comparative Study of Buflomedil and Dihydrogenated Ergot Alkaloids
Authors: Jansen Winfried , Bruckner G W , Jansen P
Published: January 2017

Seventy-six patients took part in a randomized, comparative study of the efficacy of buflomedil hydrochloride and dihydrogenated ergot alkaloids in the treatment of senile dementia associated with cerebrovascular insufficiency. Efficacy was assessed by the patients' performance in four psychometric tests. The results showed that a trend in favour of the buflomedil group in three of the tests became statistically significant in the fourth. Both drugs appeared to be safe, causing no marked adverse reactions. In conclusion, buflomedil is as effective or more effective than dihydrogenated ergot alkaloids in the treatment of senile dementia associated with cerebrovascular insufficiency and could prove a valuable addition to long-term therapy if further studies support the trend shown in this study.
Ibuprofen: Plasma Concentrations in Man
Authors: Janssen G M E , Venema J F
Published: January 2017

The plasma levels of Ibuprofen were measured in five healthy subjects who took 600 mg tablets of Ibuprofen twice daily, three times daily and four times daily in a crossover study.

Peak plasma levels were obtained 1 hour after the first dose in all but one subject (slow absorber), the mean peak value being 51·3 μg.ml−1 (range 39·4–63·7 μg.ml−1).

After the repeated dose regimens of two, three or four times daily of ibuprofen, the peak levels achieved were in a similar range to those seen after the first dose:

Twice daily 39·4–66·4 μg.ml−1 Three times daily 43·6–63·3 μg.ml−1 Four times daily 44·1–58·4 μg.ml−1 There was no evidence of accumulation of the drug and no side-effects occurred during the trial.
Intravenous Flunitrazepam (Rohypnol) in Conservative and Restorative Dentistry
Authors: Breen T F
Published: January 2017

The study was undertaken to assess the suitability of intravenous flunitrazepam (Rohypnol) in patients requiring sedative cover for prolonged dental surgery. Fifty patients received up to 2 mg flunitrazepam to induce a satisfactory level of sedation. Further maintenance doses and local anaesthesia were given if required. The results showed the level of sedation and working conditions, as assessed by anaesthetist and surgeon, to be satisfactory in all but one patient. The majority of patients remained slightly drowsy the following morning but all stated they would undergo a similar procedure again.
A Comparative Study of Once versus Twice Daily Treatment of Superficial Dermatophyte and Yeast Infections with Tioconazole (1%) Cream
Authors: Kashin Philip , Phyfferoen Monique C , Gibbs David L
Published: January 2017

Two open, multicentre studies were performed to evaluate the efficacy of 1% tioconazole cream (Trosyd®, Pfizer) as a once daily treatment for patients with common superficial dermatophyte and yeast infections (t. Pedis, t. versicolor, t. corporis, t. cruris, candidiasis). In Study I, forty-eight patients were treated once daily and forty-nine were treated twice daily. The clinical response rate at the last treatment visit was 96% and 98%, respectively, in the two treatment groups. In Study II, all 107 patients were treated once daily, and the clinical response rate was 95% at the last treatment visit. The mycological cure rates were 85% and 91% in the Study I groups, and 94% in Study II. At the long-term follow-up evaluation (approximately 4 weeks after treatment) favourable clinical responses were seen in 88% of patients in both the Study I groups, and in 94% of patients in Study II. Long-term mycological cures were seen in 80% of patients in both groups of Study I, and in 94% of patients in Study II. Side effects of treatment were generally transient, mild and coincident with disease symptoms, and occurred in six patients (6%) in Study I and in four patients (4%) in Study II. The results of both studies have shown no clinically or statistically significant differences in toleration or efficacy between once daily and twice daily treatment regimens with 1% tioconazole cream for the treatment of superficial dermatophyte infections.
Effects of the Antitussive Fominoben (PB89) on Hypoxia in Chronic Obstructive Lung Disease: Comparison with Dextromethorphan Using a Double-Blind Method
Authors: Sasaki Takao , Sugiyama Masaharu , Sasaki Hidetada , Suzuki Shunsuke , Takishima Tamotsu
Published: January 2017

We studied the effects of a non-narcotic, centrally acting antitussive, fominoben (PB89), on hypoxia in sixty patients suffering from chronic obstructive lung diseases (COLD), utilizing a double blind method and using the antitussive dextromethorphan as a reference drug. By the oral administration of a dose of 2 fominoben tablets (160 mg) three times a day for 2 weeks, a significant increase in arterial O2 pressure (PaO2), a decrease in arterial CO2 pressure (PaCO2), and a rise in pH were observed. However, alveolar-arterial O2 difference (A-aDO2) was not improved. On the other hand, after administration of a dose of 2 dextromethorphan tablets (30 mg) three times a day for 2 weeks, no increase in PaO2, no decrease in PaCO2 and no improvement in A-aDO2 were observed, although a rise in pH was seen. The increase in PaO2 by fominoben was marked in COLD with dyspnoea. No improvement of A-aDO2 despite a decrease in PaCO2 suggests that fominoben might increase alveolar ventilation, in spite of its effect as an antitussive, exerting a favourable effect on hypoxia. It is, therefore, speculated that the cough centre and the respiratory centre are capable of functioning independently of each other.
A Double-Blind Comparison of Acebutolol (Sectral) and Propranolol (Inderal) in the Treatment of Hypertension in Black Nigerian Patients
Authors: Abengowe C U
Published: January 2017

Acebutolol and propranolol were compared in forty-five Black African patients in a double-blind randomized trial carried out at Ahmadu Bello University Teaching Hospital in Kaduna, Nigeria. After a wash-out period of 6 weeks, including placebo administration for the last 4 of those weeks, twenty-seven patients were given acebutolol once daily and eighteen were given propranolol twice daily for 12 weeks, followed by a tapering-off period of 2 weeks, making a total of 14 weeks on active treatment.

The two beta-receptor blocking drugs were effective in controlling hypertension with final daily doses ranging from 160 to 320 mg in the propranolol group and 400 to 800 mg in the acebutolol group. The supine systolic blood pressure responses with acebutolol were statistically significant and better than those elicited by propranolol. Acebutolol produced less (resting) bradycardia than did propranolol; this may be related to acebutolol's intrinsic sympathomimetic activity. The only unpleasant side effects reported in this study were slight dizziness in two patients treated with propranolol and slight tiredness in one patient treated with acebutolol. No significant abnormal changes were noted in laboratory tests or chest X-rays. Electrocardiography detected supraventricular tachyarrythmia in five patients: this disappeared by the end of the study. Acebutolol was shown to be a safe, effective and reliable antihypertensive drug, at least comparable to and probably slightly better than, propranolol in the treatment of hypertension in Black Nigerians. It has the added advantage of a once-daily dose schedule.
Intramuscular Piroxicam, a New Dosage Form, in the Treatment of Acute Musculoskeletal Disorders
Authors: Wiseman R L , Kilgour M
Published: January 2017

Ten investigators in Austria, Belgium, Denmark, Germany and Switzerland participated in an open trial of intramuscular piroxicam involving 135 patients with selected acute sprains, tendinitis or low back pain. The drug was given in the recommended regimen of 40 mg once daily for 2 days and 20 mg once daily thereafter. Statistically significant improvement from baseline in pain was evident within 1 hour of the initial dose, an effect which was enhanced over a 12-hour period and which lasted for 24 hours. After 3 days of intramuscular injections, pain, tenderness, morning stiffness and back elongation were markedly improved. Subsequent treatment with either intramuscular or oral piroxicam further improved these symptoms and most patients recovered their normal physical activity within a week.

The drug was well tolerated; twenty-five patients (18·5%) reported side-effects possibly related to piroxicam. Nearly all were mild or moderate in severity with only six resulting in disruption of therapy. Most adverse reactions involved the upper gastrointestinal tract, but there were no reports of gastric bleeding. Except for a few patients with injection site pain, the side-effect profile was similar to that established with the oral dosage form. Toleration was regarded as excellent or good in about 84% of the patients.

The results indicate that intramuscular piroxicam can provide rapid and effective therapy with good toleration in the treatment of acute musculoskeletal disorders.
Lack of Effect of Ambroxol, a Bronchial Secretolytic Agent, on Gastric Mucus in Man
Authors: Guslandi M , Zanoni M E
Published: January 2017

The effect of ambroxol, a bronchial mucolytic agent, on gastric mucus was investigated in man.

Ten patients with bronchial hypersecretion were treated with ambroxol 30 mg t.i.d. by the oral route for 10 days. Before and after treatment the amount of total mucoproteins in the gastric juice was measured and a ‘mucoprotective index’ was calculated. Neither quantitative nor qualitative changes in gastric mucus were observed after ambroxol treatment. Our results show that the drug does not exert lytic effects on the gastric mucus layer and hence is devoid of damaging activity on the gastric mucosa.
A Comparison of Flunisolide Inhaler and Beclomethasone Dipropionate Inhaler in Bronchial Asthma
Authors: Dry J , Sors C , Gervais P , van Straaten L , Perrin-Fayolle M , Paramelle B
Published: January 2017

Ninety-nine patients, who had never previously taken inhaled steroids were enrolled in a randomized, single-blind, parallel study, the aim of which was to compare the efficacy and safety of flunisolide inhalation, 500 meg twice daily, with beclomethasone dipropionate inhaler 100 meg four times daily for the treatment of chronic asthma. The treatment period was for 6 weeks. The patients were examined clinically at entry, week 3 and week 6 and both treatment groups showed a marked improvement in almost all parameters during the course of the study. Flunisolide was statistically significantly superior to beclomethasone dipropionate for wheezing at week 6, coughing at week 6 and chest tightness at weeks 3 and 6. The number of asthma attacks per day decreased significantly more with flunisolide treatment than with beclomethasone dipropionate. The over-all evaluation of efficacy by both doctors and patients also showed flunisolide to be superior to beclomethasone dipropionate. In several other parameters there was a trend shown favouring flunisolide, and beclomethasone dipropionate did not show a superiority over flunisolide in any efficacy parameter. Both drugs were well-tolerated, with unpleasant taste being the most frequent complaint in the flunisolide group. No patient in either group withdrew from the study because of adverse events. In this study, flunisolide inhaler was more effective than beclomethasone dipropionate inhaler for the treatment of chronic asthma exhibited by patients who had never been treated with inhaled steroids.
Pharmacokinetics of the Bronchodilator Tulobuterol in Man after Repeated Oral Doses
Authors: Chasseaud L F , Wood S G
Published: January 2017

Plasma levels and elimination half-life of tulobuterol, a new beta-adrenergic agonist, were determined in ten healthy male volunteers after repeated dosing with 2mg, twice daily, for seven days. Peak plasma levels attained (2.8 ±0.8 ng/ml), the time to peak plasma concentration (1.0 ±0.3 hr) and the elimination half-life (2.4 ±0.4 hr) were generally unchanged from the first to the final study dose. This suggests that tulobuterol does not accumulate in plasma after repeated administration of a dose regimen known to be clinically effective.
Tulobuterol in Childhood Asthma: Single Dose Ranging and Repeated Oral Dose Comparative Studies
Authors: Javier Miguel A T , Noche Miguel L
Published: January 2017

Fifteen asthmatic patients participated in a dose-ranging study using tulobuterol* syrup in single doses of 10 to 60 mcg/kg. A second trial was performed to compare tulobuterol and terbutaline in 64 asthmatic children. The tulobuterol dosages were 30 and 40 mcg/kg twice daily; the terbutaline dosage was 75 mcg/kg three times daily. The dose-ranging study showed that tulobuterol had a rapid and prolonged bronchodilator action, even at the lower doses. Tulobuterol had a more prolonged duration of action than terbutaline in the comparative study. Both drugs had statistically comparable magnitudes of effect. Adverse reactions were minimal. No laboratory abnormalities occurred, and blood pressure and pulse rate were clinically unaffected by either drug. Tulobuterol twice daily had an equal or greater positive clinical effect on pulmonary function in asthmatic children than terbutaline three times a day.
Efficacy and Clinical Tolerance of a New Combination of Trimethoprim with Sulphonamide
Authors: Celotti Fabio , Nüdemberg Franklin , Magni Osvaldo , Piaia Francesca
Published: January 2017

To obtain a direct clinical evaluation of a new sulpha-trimethoprim combination product (Kelfiprim®) from general practitioners or specialist practitioners, an extensive post-marketing survey has been organized in Brazil involving 1,177 doctors and 5,885 patients.

These experienced different infections susceptible to oral antimicrobial chemotherapy with a sulpha-trimethoprim combination. The results indicated that the product was very effective (91.2% cure rate) and well tolerated (4% incidence of side-effects). Side-effects were usually mild and transient. No life-threatening adverse reactions were observed. The results obtained support those already published in clinical trials involving 1,119 patients.
Evaluation Clinique de la Flucloxacilline* dans le Traitement des Infections Staphylococciques Graves Chez l'Enfant
Authors: Saied H , Ben Attia Docteur M
Published: January 2017

Vingt neuf malades au total ont été admis dans le service de pédiatrie avec une infection staphylococcique confirmée ou presumée; ils ont ensuite été traités par un antibiotique à spectre étroit – la flucloxacilline. En dépit de la gravité de leur condition, une guerison a été observée chez tous les malades sauf deux. Il n'a pas été observé d'effets secondaires associés au traitement.

A total of twenty-nine children were admitted to the paediatric unit with confirmed or presumed staphylococcal infection and subsequently treated with the narrow spectrum antibiotic – flucloxacillin. Despite the gravity of their condition all but two patients made a satisfactory recovery. There were no side-effects associated with this treatment.