Comparison of budesonide Turbuhaler with budesonide aqua in the treatment of seasonal allergic rhinitis . Rhinocort Study Group . OBJECTIVE To compare the effect of budesonide Turbuhaler 400 microg/day with budesonide aqua 256 microg/day in the treatment of seasonal allergic rhinitis ( SAR ) . Secondarily to ascertain patients ' preferences for the two nasal devices and to assess quality of life . DESIGN Randomized , multicentre , double-blind , double- dummy , parallel groups study . SETTING Private practices and hospital clinics in Ontario , Quebec and Manitoba . POPULATION Two hundred and eighty-four out-patients with SAR , who were symptomatic during the ragweed season , volunteered for enrolment ( 243 randomized ) . RESULTS Mean daily nasal symptom scores were significantly reduced with treatment . There were no statistically significant changes from baseline for eye symptoms . Most patients ( more than 80 % ) achieved substantial control of their symptoms with budesonide . The most common nasal and non-nasal adverse events for both groups were epistaxis and headache . Turbuhaler was easier to use and more convenient to carry , had less of an unpleasant taste , and caused less nasal irritation than the aqua spray . More than twice as many patients preferred Turbuhaler to the aqua spray ( 69 % versus 31 % ) . Improvement in quality of life from baseline to clinic visits was statistically significant in both groups . CONCLUSION Once daily use of 256 mg of budesonide aqua and 400 mg of budesonide Turbuhaler are equally safe and efficacious in the treatment of SAR . Patients preferred the budesonide powder formulation delivered via Turbuhaler two to one over the aqua formulation .

budesonide Turbuhaler

budesonide aqua

budesonide Turbuhaler

budesonide aqua

budesonide .

Turbuhaler

Turbuhaler

aqua spray

budesonide aqua

budesonide Turbuhaler

budesonide powder

Turbuhaler

aqua

patients ' preferences

quality of life

Mean daily nasal symptom scores

eye symptoms .

nasal and non-nasal adverse events

epistaxis

headache .

nasal irritation

quality of life

safe

efficacious

seasonal allergic rhinitis .

Two hundred and eighty-four

out-patients

SAR

symptomatic during the ragweed season

SAR .


Anti-emetic efficacy of prophylactic granisetron compared with perphenazine for the prevention of post-operative vomiting in children . We have compared the efficacy of granisetron with perphenazine in the prevention of vomiting after tonsillectomy with or without adenoidectomy in children . In a prospective , randomized , double-blind study , 90 paediatric patients , ASA I , aged 4-10 years , received granisetron 40 mg kg-1 or perphenazine 70 mg kg-1 ( n = 45 each ) intravenously immediately after an inhalation induction of anaesthesia . A standard general anaesthetic technique was employed throughout . A complete response , defined as no emesis with no need for another rescue antiemetic , during the first 3 h ( 0-3 h ) after anesthesia was 87 % with granisetron and 78 % with perphenazine ( P = 0.204 ) . The corresponding incidence during the next 21 h ( 3-24 h ) after anaesthesia was 87 % and 62 % ( P = 0.007 ) . No clinically serious adverse events were observed in any of the groups . We conclude that granisetron is a better anti-emetic than perphenazine for the long-term prevention of post-operative vomiting in children undergoing general anaesthesia for tonsillectomy .

granisetron

perphenazine

granisetron

perphenazine

granisetron

perphenazine

granisetron

perphenazine

granisetron

perphenazine

Anti-emetic

efficacy

prevention

efficacy

corresponding incidence

adverse events

long-term prevention

post-operative vomiting

children .

children

paediatric patients

ASA I

aged 4-10 years

children undergoing general anaesthesia

for tonsillectomy


The role of somatostatin ( octreotide ) in the regulation of melatonin secretion in healthy volunteers and in patients with primary hypothyroidism . Somatostatin has been found in the pineal gland of several animal species , which suggests that it may be involved in the regulation of melatonin secretion . Whether somatostatin has regulatory influence on melatonin secretion in man has never been unequivocally shown . We studied the nocturnal melatonin secretion in 8 healthy volunteers , and 6 women with untreated primary hypothyroidism , a disease state that is associated with increased nocturnal secretion of melatonin . The participants were given subcutaneous injections at 18:00 h and 23:00 h of either saline or octreotide ( Sandostatin ; each injection 50 microg ) . During the nights when the healthy volunteers were given octreotide , melatonin secretion was similar to that recorded during administration of saline . Also the urinary excretion of melatonin was of similar magnitude at these two occasions . By contrast , the GH secretion was significantly lower the nights the healthy controls were given octreotide ( GH AUC 22.6+/-5.4 mU/l x h during octreotide and 126.6+/-21.9 mU/l x h during saline ; p < 0.01 ) . The patients with hypothyroidism also showed similar nocturnal melatonin secretion during octreotide and saline . Urinary excretion of melatonin also remained unchanged , as did GH secretion . The total nocturnal secretion of TSH was , however , significantly reduced by octreotide ( TSH AUC 562+/-136 mU/l x h during octreotide and 851+/-185 mU/l x h during saline ; p < 0.05 ) , thus suggesting that 100 microg of octreotide should be sufficient to inhibit also the pinealocytes if their function were regulated by somatostatin . Since exogenous somatostatin -- in the form of octreotide -- fails to influence nocturnal secretion and urinary excretion of melatonin in normal subjects and in patients with primary hypothyroidism , it is reasonable to assume that endogenous somatostatin may not be an important regulator of melatonin secretion in man .

somatostatin ( octreotide )

Somatostatin

somatostatin

saline

octreotide ( Sandostatin ;

octreotide

saline .

octreotide

octreotide

saline ;

octreotide

saline .

octreotide

octreotide

saline ;

octreotide

somatostatin .

somatostatin

octreotide

somatostatin

melatonin secretion

melatonin secretion .

melatonin secretion

nocturnal melatonin secretion

melatonin secretion

urinary excretion of melatonin

GH secretion

nocturnal melatonin secretion

Urinary excretion of melatonin

total nocturnal secretion of TSH

healthy volunteers

women

untreated primary hypothyroidism

healthy volunteers

patients with hypothyroidism


Effects of soy intake on sex hormone metabolism in premenopausal women . Studies suggest that phytoestrogens in soy products may impart hormonal effects that protect women against breast cancer . Limited research suggests that intake of soy products high in isoflavonoid phytoestrogens affects sex hormone metabolism , but it is unknown whether phytoestrogens in soy have any effect on menstrual function or serum sex hormones in women on common hormone therapies , such as oral contraceptives ( OC ) . We studied the effects of soy in 36 premenopausal women , 20 of whom used OC . Subjects consumed their normal diet for two menstrual cycles and added a soy beverage containing 20 g of protein and 38 mg of total isoflavones to their usual diet for another two menstrual cycles . No significant differences were observed in serum estrone , estradiol , sex hormone-binding globulin , dehydroepiandrosterone sulfate , prolactin , or progesterone concentrations with soy feeding in the non-OC or the OC group . No changes in menstrual cycle length or the urinary estrogen metabolite ratio of 2-hydroxyestrone to 16 alpha-hydroxyestrone were seen with soy feeding in the non-OC or the OC group . Levels of urinary estrogen metabolites were significantly different between the non-OC and the OC group . Thus soy consumption had no significant effect on the menstrual cycle , serum sex hormones , or urinary estrogen metabolite ratio in premenopausal OC or non-OC users .

soy

soy

soy

soy

soy beverage

soy

soy

sex hormone metabolism

sex hormone metabolism

urinary estrogen metabolites

premenopausal

women

premenopausal

women

used OC

premenopausal OC

non-OC users .


Clinical effects of root instrumentation using conventional steel or non-tooth substance removing plastic curettes during supportive periodontal therapy ( SPT ) . Although root instrumentation has been accepted as the most important cause-related treatment of periodontal diseases , repeated scaling and root planing may over time result in substantive loss of tooth substance and increased sensitivity of the teeth . In an effort to minimize these side effects of therapy , non-root substance removing curettes have been developed . However , the clinical effects of such plastic curettes with regard to the control of the periodontal infection has not yet been established . The aims of this study were , therefore , to compare the effects of root instrumentation using plastic curettes ( Universal Perio Soft Scaler , Hawe-Neos Dental , Bioggio , TI , Switzerland ) versus conventional steel curettes on the periodontal conditions during supportive periodontal therapy . 40 subjects participated in this parallel , randomized , double blind , prospective longitudinal clinical study following active peridontal therapy . 20 subjects served as a control group and were treated with conventional steel curettes during a supportive periodontal care visit ( SPT ) . The other 20 subjects , the experimental group , were treated using plastic curettes during a similar SPT visit . Clinical parameters , such as bleeding on probing ( BOP ) and probing pocket depth ( PPD ) , were assessed at baseline and 3-6 months later at the next regular SPT visit . In addition , the BOP percentage was determined 10 days following baseline . The results showed that there were no statistically significant differences between the 2 treatment modalities regarding BOP and PPD at any observation time . Both treatments were effective in reducing the BOP percentage which ranged from 17-42 % at baseline by about 40 % after 10 days ( mean BOP baseline : 26 % , mean BOP after 10 days : 16 % ) . This clinical study suggests that non-root substance removing curettes may be valuable instruments for periodontally treated patients during maintenance care , thus minimizing trauma on the hard structures of the teeth .

plastic curettes

conventional steel curettes

conventional steel curettes

plastic curettes

non-root substance removing curettes

Clinical effects

clinical effects

BOP percentage

BOP and PPD

BOP percentage

BOP

BOP

40 subjects


[ Improving wound healing after nose surgery by combined administration of xylometazoline and dexpanthenol ] . BACKGROUND The aim of this study was the examination of efficacy and tolerability of an application-form of the new combination of Xylometazoline with Dexpanthenol ( Nasic ) versus Xylometazoline alone . PATIENTS AND METHODS Randomized verum controlled parallel-group-comparison of two weeks treatment of a nasal-spray . 61 inpatients with the diagnosis Rhinitis following nasal operation were included in this study and 30 patients were treated with verum and placebo each . The assessment of nasal-breathing-resistance according to scores was defined as target-parameter . Confirmatory statistical analysis was carried out according to Wilcoxon-Mann-Whitney-U two-sided at alpha < or = 0.05 . MAIN OUTCOME MEASURE The superiority of the combination of Xylometazoline-Dexpanthenol nasal-spray versus Xylometazoline nasal spray could be proven for the target-parameter as clinically relevant and statistically significant . The clinically proven efficacy is emphasized by good tolerability of both treatments . Due to easy handling of the nasal-spray a good compliance was confirmed . CONCLUSION Distinct improvement of symptoms in patients following nasal operations underlines the efficacy of both medications . With respect to the tolerability therapy with the combination is more beneficial in comparison to the alternative therapy . The result of this controlled clinical study confirms that the combination Xylometazoline-Dexpanthenol is an enlargement and improvement of effective medicinal treatment of rhinitis following nasal operation in comparison to therapy with Xylometazoline alone .

xylometazoline

dexpanthenol ]

Xylometazoline

Dexpanthenol ( Nasic )

Xylometazoline

verum

placebo

Xylometazoline-Dexpanthenol

Xylometazoline

Xylometazoline-Dexpanthenol

Xylometazoline

wound healing

efficacy

tolerability

efficacy

tolerability

compliance

improvement

efficacy

tolerability

after nose surgery

patients following nasal operations

rhinitis following nasal operation


Intrathecal morphine suppresses NK cell activity following abdominal surgery . PURPOSE The effects of morphine on natural killer ( NK ) cell activity were investigated in patients who underwent hysterectomy . METHODS Forty patients were divided into four groups of ten . The groups received intrathecal 0.5 mg morphine ( Group IT0.5 ) , intrathecal 0.1 mg morphine ( Group IT0.1 ) or 10 mg morphine i.v . ( Group IV ) . The remaining ten patients served as controls and received inhalation anesthesia alone ( Group C ) . Blood samples were withdrawn before and two hours after surgery and on postoperative days one and two to determine the blood NK cell activity using a chromium release assay with K562 cells as targets , plasma catecholamines and cortisol levels . The postoperative pain score and side effects were studied in the four groups . RESULTS In Group IT0.5 , the NK cell activity was lower on postoperative day 1 ( 23.9 +/- 8.4 % ) than the baseline level ( 45.7 +/- 13 % ) before surgery , and recovered on postoperative day 2 . In Groups IT0.1 , C and IV , the NK cell activities showed no significant changes . In all four groups , neither plasma adrenaline nor noradrenaline concentrations changed . In all four groups , the plasma cortisol levels increased after surgery , on postoperative days 1 and 2 . The pain score was lower two hours after surgery and on postoperative day 1 in Group IT0.5 than in the other groups . CONCLUSION These results suggest that long-lasting analgesic effects of intrathecal 0.5 mg morphine suppress the immune response following abdominal surgery .

morphine

morphine

morphine

morphine

morphine

morphine

NK cell activity

natural killer ( NK ) cell activity

NK cell activity

NK cell activities

plasma adrenaline

noradrenaline concentrations

plasma cortisol levels

pain score

underwent hysterectomy


Effects of low-dose aspirin on clinic and ambulatory blood pressure in treated hypertensive patients . Collaborative Group of the Primary Prevention Project ( PPP ) -- Hypertension study . Nonsteroidal antiinflammatory drugs may affect blood pressure ( BP ) control in hypertensive patients receiving drug treatment , but data on the effects of low-dose aspirin are scanty . This study assessed the effects of chronic treatment with low doses of aspirin ( 100 mg/day ) on clinic and ambulatory systolic ( SBP ) and diastolic ( DBP ) BP in hypertensives on chronic , stable antihypertensive therapy . The study was conducted in the framework of the Primary Prevention Project ( PPP ) , a randomized , controlled factorial trial on the preventive effect of aspirin or vitamin E in people with one or more cardiovascular risk factors . Fifteen Italian hypertension units studied 142 hypertensive patients ( 76 men , 66 women ; mean age 59 +/- 5.9 years ) treated with different antihypertensive drugs : 71 patients were randomized to aspirin and 71 served as controls . All patients underwent a clinic BP evaluation with an automatic sphygmomanometer and a 24-h ambulatory BP monitoring , at baseline and after 3 months of aspirin treatment . At the end of the study the changes in clinic SBP and DBP were not statistically different in treated and untreated subjects . Ambulatory SBP and DBP after 3 months of aspirin treatment were similar to baseline : deltaSBP -0.5 mmHg ( 95 % confidence intervals [ CI ] from -1.9 to +2.9 mm Hg ) and deltaDBP -1.1 mm Hg ( 95 % CI from -2.5 to +0.3 mm Hg ) . The pattern was similar in the control group . No interaction was found between aspirin and the most used antihypertensive drug classes ( angiotensin converting enzyme inhibitors and calcium antagonists ) . Despite the relatively small sample size our results seem to exclude any significant influence of low-dose aspirin on BP control in hypertensives under treatment .

aspirin

aspirin

aspirin

aspirin

vitamin E

aspirin

aspirin

aspirin

aspirin

aspirin

clinic and ambulatory blood pressure

blood pressure ( BP ) control

clinic BP

24-h ambulatory BP monitoring

clinic SBP and DBP

Ambulatory SBP and DBP

BP

treated hypertensive patients .

hypertension

hypertensive

76 men

66 women

mean age 59 +/- 5.9 years


Randomized trial of intensive early intervention for children with pervasive developmental disorder . Young children with pervasive developmental disorder were randomly assigned to intensive treatment or parent training . The intensive treatment group ( 7 with autism , 8 with pervasive developmental disorder not otherwise specified -- NOS ) averaged 24.52 hours per week of individual treatment for one year , gradually reducing hours over the next 1 to 2 years . The parent training group ( 7 with autism , 6 with pervasive developmental disorder NOS ) received 3 to 9 months of parent training . The groups appeared similar at intake on all measures ; however , at follow-up the intensive treatment group outperformed the parent training group on measures of intelligence , visual-spatial skills , language , and academics , though not adaptive functioning or behavior problems . Children with pervasive developmental disorder NOS may have gained more than those with autism .

intensive early intervention

intensive treatment

parent training

intensive treatment

parent training

parent training

intensive treatment

parent training

intelligence

visual-spatial skills

language

academics

adaptive functioning

behavior problems .

children

pervasive developmental disorder

Young children

pervasive developmental disorder

autism

with autism

Children

pervasive developmental disorder


Efficacy and safety of selamectin against fleas and heartworms in dogs and cats presented as veterinary patients in North America . A series of randomized , controlled , masked field studies was conducted to assess the efficacy and safety of selamectin in the treatment of flea infestations on dogs and cats , and in the prevention of heartworm infection in dogs . In addition , observations were made on the beneficial effect of selamectin treatment on dogs and cats showing signs of flea allergy dermatitis ( FAD ) . In all studies selamectin was applied topically , once per month , in unit doses providing a minimum dosage of 6mgkg ( -1 ) . Dogs and cats with naturally occurring flea infestations , some of which also had signs associated with FAD , were assigned randomly to receive three months of topical treatment with selamectin ( 220 dogs , 189 cats ) or a positive-control product ( dogs : fenthion , n=81 ; cats : pyrethrins , n=66 ) . Selamectin was administered on days 0 , 30 , and 60 . Day 0 was defined as the day that the animal first received treatment . Flea burdens were assessed by flea comb counts and clinical evaluations of FAD were performed before treatment , and on days 14 , 30 , 60 , and 90 . On days 30 , 60 , and 90 , mean flea counts in selamectin-treated dogs were reduced by 92.1 , 99.0 , and 99.8 % , and mean flea counts in fenthion-treated dogs were reduced by 81.5 , 86.8 , and 86.1 % , respectively , compared with day 0 counts . Also , on days 30 , 60 , and 90 , mean flea counts in selamectin-treated cats were reduced by 92.5 , 98.3 , and 99.3 % , and mean flea counts in pyrethrin-treated cats were reduced by 66.4 , 73.9 , and 81.3 % , respectively , compared with day 0 counts . Selamectin also was beneficial in alleviating signs in dogs and cats diagnosed clinically with FAD . A total of 397 dogs free of adult heartworm infection from four heartworm-endemic areas of the USA were allocated randomly to six months of treatment with selamectin ( n=298 ) or ivermectin ( n=99 ) . Selamectin achieved a heartworm prevention rate of 100 % , with all dogs testing negative for microfilariae and adult heartworm antigen on days 180 and 300 . Selamectin was administered to a total of 673 dogs and 347 cats having an age range of 6 weeks to 19 years ( 3954 doses ) . The animals included 19 purebred or crossbred Collies ( Bearded , Border , and unspecified ) . There were no serious adverse events . Results of these studies indicated that selamectin was highly effective in the control of flea infestations in dogs and cats without the need for simultaneous treatment of the environment or of in-contact animals and also was beneficial in alleviating signs associated with FAD . Selamectin also was 100 % effective in preventing the development of canine heartworms and was safe for topical use in dogs and cats .

selamectin

selamectin

selamectin

selamectin

selamectin

fenthion

pyrethrins

Selamectin

selamectin-treated

Selamectin

selamectin

ivermectin

Selamectin

Selamectin

selamectin

Selamectin

Efficacy

safety

efficacy

safety

flea comb counts

clinical evaluations of FAD

mean flea counts

mean flea counts

mean flea counts

mean flea counts

heartworm prevention rate

adverse events .

effective

signs associated with FAD .

heartworms

safe

dogs and cats

220 dogs , 189 cats

673 dogs and 347 cats

dogs and cats

dogs and cats .


Oral ciprofloxacin vs. intramuscular ceftriaxone as empiric treatment of acute invasive diarrhea in children . BACKGROUND Acute invasive diarrhea is a potentially serious condition in children . Because of the increasing resistance of enteric pathogens to commonly used oral antibiotics , intramuscular ceftriaxone has become the routine drug in the treatment of acute invasive diarrhea requiring an emergency visit in southern Israel . The inconvenience of this parenteral regimen created an increased need for oral pediatric formulations for the treatment of invasive diarrhea . OBJECTIVES To evaluate the efficacy and safety of a suspension formulation of ciprofloxacin in the treatment of acute invasive diarrhea in infants and children . PATIENTS AND METHODS From July 1996 through December 1997 , 201 evaluable children ages 6 months to 10 years ( 35 % < 1 year ; 70 % < 3 years ) presenting with acute invasive diarrhea at the Pediatric Emergency Room were randomized to receive either ciprofloxacin suspension ( 10 mg/kg twice a day + im placebo ; n = 95 ) or im ceftriaxone ( 50 mg/kg/day + placebo suspension ; n = 106 ) for 3 days in a double blind manner . Stool cultures for Shigella , Salmonella , Campylobacter spp . and diarrheagenic Escherichia coli were obtained on Days 1 , 3 , 4 to 5 and 21 +/- 5 . Clinical response and safety were assessed on Days 1 , 2 , 3 , 4 to 5 and 21 +/- 5 . RESULTS We isolated 127 pathogens from 121 ( 60 % ) patients : 73 ( 57 % ) Shigella ; 23 ( 18 % ) Salmonella ; 18 ( 14 % ) E. coli ; and 13 ( 10 % ) Campylobacter . Overall bacteriologic eradication on Day 4 to 5 was 99 % for Shigella , 77 % for Salmonella and 77 % for Campylobacter , with no difference between the 2 groups . Clinical cure or improvement was observed in 100 and 99 % of the ciprofloxacin and ceftriaxone groups , respectively . Serum ciprofloxacin values determined on Day 3 of the treatment were higher in the majority of patients than were the MIC50 and MIC90 values for the Shigella and Salmonella spp . isolated . Possible drug-related adverse events occurred in 13 patients [ ciprofloxacin , 8 ( 8 % ) ; ceftriaxone , 5 ( 4.7 % ) ] and were mild and transient . Joint examination was normal during and after completion of therapy in all patients . CONCLUSION Oral ciprofloxacin was as safe and effective as intramuscular ceftriaxone for the empiric treatment of acute invasive diarrhea in ambulatory pediatric patients requiring an emergency room visit .

ciprofloxacin

ceftriaxone

ceftriaxone

ciprofloxacin

ciprofloxacin

ceftriaxone

ciprofloxacin

ceftriaxone

ciprofloxacin

ciprofloxacin

ceftriaxone

ciprofloxacin

ceftriaxone

efficacy

safety

Clinical response and

safety

Clinical cure or improvement

adverse events

Joint examination

safe

effective

acute invasive diarrhea

children

children .

acute invasive diarrhea

infants and children


Effect of antipyretic drugs in children with malaria . A comparison of different antipyretics in children with malaria showed a small effect of naproxen , but not of metamizol , on the reduction of fever peaks . Antipyretic treatment had no effect on fever clearance and therefore should be used cautiously in the treatment of malaria .

antipyretic drugs

antipyretics

naproxen

metamizol

Antipyretic

reduction of fever peaks .

fever clearance

children

malaria

children

malaria

malaria .


Effect of the essential oils of garlic and onion on alimentary hyperlipemia . SUMMARY The effect of garlic and onion on alimentary hyperlipemia , induced by feeding 100 g butter , has been studied in 10 healthy subjects . The freshly extracted juice of 50 g of garlic or onion , as well as an equivalent amount of their ether-extracted essential oils , was administered randomly on four different days during a one-week period . Garlic and onion have a significant protective action against fat-induced increases in serum cholesterol and plasma fibrinogen and decreases in coagulation time and fibrinolytic activity . The essential oil fraction , which contains all the taste and odour , exactly duplicated the beneficial effects of whole garlic and onion . It is , therefore , concluded that the active principle of garlic and onion is the essential oil , which chemically is a combination of sulphur-containing compounds , mainly allyl propyl disulphide and diallyl disulphide .

essential oils of garlic and onion

garlic and onion

garlic or onion

essential oils

Garlic and onion

garlic

onion .

garlic and onion

serum cholesterol and plasma fibrinogen

coagulation time

fibrinolytic activity .

effects

healthy subjects


Economic evaluation of aquatic exercise for persons with osteoarthritis . OBJECTIVES To estimate cost and outcomes of the Arthritis Foundation aquatic exercise classes from the societal perspective . DESIGN Randomized trial of 20-week aquatic classes . Cost per quality-adjusted life year ( QALY ) gained was estimated using trial data . Sample size was based on 80 % power to reject the null hypothesis that the cost/QALY gained would not exceed $ 50,000 . SUBJECTS AND METHODS Recruited 249 adults from Washington State aged 55 to 75 with a doctor-confirmed diagnosis of osteoarthritis to participate in aquatic classes . The Quality of Well-Being Scale ( QWB ) and Current Health Desirability Rating ( CHDR ) were used for economic evaluation , supplemented by the arthritis-specific Health Assessment Questionnaire ( HAQ ) , Center for Epidemiologic Studies-Depression Scale ( CES-D ) , and Perceived Quality of Life Scale ( PQOL ) collected at baseline and postclass . Outcome results applied to life expectancy tables were used to estimate QALYs . Use of health care facilities was assessed from diaries/questionnaires and Medicare reimbursement rates used to estimate costs . Nonparametric bootstrap sampling of costs/QALY ratios established the 95 % CI around the estimates . RESULTS Aquatic exercisers reported equal ( QWB ) or better ( CHDR , HAQ , PQOL ) health-related quality of life compared with controls . Outcomes improved with regular class attendance . Costs/QALY gained discounted at 3 % were $ 205,186 using the QWB and $ 32,643 using the CHRD . CONCLUSION Aquatic exercise exceeded $ 50,000 per QALY gained using the community-weighted outcome but fell below this arbitrary budget constraint when using the participant-weighted measure . Confidence intervals around these ratios suggested wide variability of cost effectiveness of aquatic exercise .

aquatic exercise

aquatic exercise classes

aquatic classes .

aquatic classes .

Aquatic exercisers

Aquatic exercise

aquatic exercise .

Economic evaluation

cost

outcomes

cost/QALY

Quality of Well-Being Scale ( QWB )

QALYs

Use of health care facilities

Medicare reimbursement rates

costs/QALY ratios

QWB

CHDR

, HAQ ,

PQOL

Costs/QALY

QWB

CHRD

QALY

persons with osteoarthritis .

adults

from Washington State

aged 55 to 75


Why were the results of the Heart Outcomes Prevention Evaluation ( HOPE ) trial so astounding ? The Heart Outcomes Prevention Evaluation ( HOPE ) study was important because it showed the benefits of ramipril - an angiotensin-converting enzyme ( ACE ) inhibitor - in patients at high risk for cardiovascular events . Treatment with ramipril significantly reduced the rates of death , myocardial infarction , stroke , coronary revascularization , cardiac arrest and heart failure , as well as the risk of diabetes-related complications and of diabetes itself . The effects of therapy with vitamin E were also evaluated , but no statistical benefits were shown . The benefits of ACE inhibitor therapy that were observed were likely due to a variety of mechanisms , not just a reduction in blood pressure .

ramipril

ramipril

vitamin E

ACE inhibitor


Additive IOP-reducing effect of latanoprost in patients insufficiently controlled on timolol . PURPOSE To evaluate the effect on intraocular pressure ( IOP ) of switching from timolol to latanoprost or adding latanoprost to timolol in patients with open angle glaucoma or ocular hypertension where IOP is not adequately controlled with timolol . METHODS This was a 6-week , double-masked , randomised multi-centre study . 53 patients with primary open angle glaucoma , capsular glaucoma , or ocular hypertension with an IOP of at least 21 mmHg on current therapy were recruited . After a run-in period of at least 2 weeks on timolol , 5 mg/ml twice daily , patients were randomised to one of three groups . One group continued on timolol , one switched from timolol to latanoprost , 50 microg/ml once daily , and a third group received latanoprost in addition to timolol . The efficacy was evaluated by comparing IOP at 9 AM at baseline and after 6 weeks of treatment . RESULTS IOP at baseline and after 6 weeks of treatment ( mean +/- SEM ) were 24.2 +/- 0.9 and 23.8 +/- 1.0 mmHg ( n = 16 ) for patients continuing on timolol , 26.3 +/- 1.2 and 19.6 +/- 1.1 mmHg ( n = 17 ) for patients switching to latanoprost , and 23.2 +/- 1.0 and 17.5 +/- 0.8 mmHg ( n = 17 ) for patients with combined treatment . Adding latanoprost to timolol reduced IOP with 5.9 +/- 0.9 mmHg ( p < 0.001 ) and switching from timolol to latanoprost reduced IOP with 5.0 +/- 0.9 mmHg ( p < 0.001 ) , which caused in each group a significant IOP reduction of about 25 % . CONCLUSIONS The effect of latanoprost was additive to that of timolol , and a good effect on IOP reduction was also achieved by switching from timolol to latanoprost , suggesting that a switch in many patients is an effective alternative to combination treatment .

timolol

latanoprost

latanoprost

timolol

timolol

timolol

timolol

latanoprost

latanoprost

timolol .

IOP-reducing

intraocular pressure ( IOP )

IOP

IOP

IOP

IOP

IOP

IOP


Recurrent epithelial ovarian carcinoma : a randomized phase III study of pegylated liposomal doxorubicin versus topotecan . PURPOSE To compare the efficacy and safety of pegylated liposomal doxorubicin ( PLD ) and topotecan in patients with epithelial ovarian carcinoma that recurred after or did n't respond to first-line , platinum-based chemotherapy . PATIENTS AND METHODS Patients with measurable and assessable disease were randomized to receive either PLD 50 mg/m ( 2 ) as a 1-hour infusion every 4 weeks or topotecan 1.5 mg/m ( 2 ) /d for 5 consecutive days every 3 weeks . Patients were stratified prospectively for platinum sensitivity and for the presence or absence of bulky disease . RESULTS A total of 474 patients were treated ( 239 PLD and 235 topotecan ) . They comprised the intent-to-treat population . The overall progression-free survival rates were similar between the two arms ( P =.095 ) . The overall response rates for PLD and topotecan were 19.7 % and 17.0 % , respectively ( P =.390 ) . Median overall survival times were 60 weeks for PLD and 56.7 weeks for topotecan . Data analyzed in platinum-sensitive patients demonstrated a statistically significant benefit from PLD for progression-free survival ( P =.037 ) , with medians of 28.9 for PLD versus 23.3 weeks for topotecan . For overall survival , PLD was significantly superior to topotecan ( P =.008 ) , with a median of 108 weeks versus 71.1 weeks . The platinum-refractory subgroup demonstrated a nonstatistically significant survival trend in favor of topotecan ( P =.455 ) . Severe hematologic toxicity was more common with topotecan and was more likely to be associated with dosage modification , or growth factor or blood product utilization . CONCLUSION The comparable efficacy , favorable safety profile , and convenient dosing support the role of PLD as a valuable treatment option in this patient population .

pegylated liposomal doxorubicin

topotecan .

pegylated liposomal doxorubicin ( PLD )

topotecan

PLD

topotecan

PLD

topotecan

PLD

topotecan

PLD

topotecan

PLD

PLD

topotecan .

PLD

topotecan

topotecan

topotecan

PLD

efficacy

safety

overall progression-free survival rates

overall response rates

Median overall survival times

overall survival

Severe hematologic toxicity

efficacy

safety


Oral contraceptive use is associated with increased cardiovascular reactivity in nonsmokers . Women who smoke and take oral contraceptives ( OCs ) have significantly increased risk of cardiovascular disease , but the exact mechanismsfor the increased risk are not known . Cardiovascular reactivity to psychological stress may be one mechanism for the enhanced risk , but the small number of studies examining whether OC users who smoke have greater reactivity have produced mixed results . The purpose of this study was to examine the effect of chronic cigarette smoking , acute nicotine administration , and OC use on cardiovascular and lipid reactivity . Sixty healthy women , half of whom had been using OCs for at least the previous 6 months , participated in the study . Approximately two thirds were smokers and were randomized to be tested after either a 12-hr nicotine deprivation or administration of nicotine gum . One third were nonsmokers . Heart rate , blood pressure , and lipid measures were taken at rest , during a videotaped speech task , and during recovery from the task . Results indicated that , among OC nonusers , there was no effect of smoking status or nicotine administration on cardiovascular reactivity . However , among OC users , nonsmokers had significantly greater heart rate and diastolic blood pressure reactivity to stress . These data show that acute nicotine administration , in the form of nicotine gum , has no effect on cardiovascular or lipid stress reactivity in women . However OC use among nonsmoking women is associated with greater cardiovascular reactivity to stress .

Oral contraceptive

oral contraceptives ( OCs )

nicotine

nicotine

OC

nicotine

OC

nicotine

nicotine

OC

cardiovascular reactivity

cardiovascular and lipid reactivity .

cardiovascular reactivity

Sixty

two thirds were smokers

One third were nonsmokers .


[ Neoton and thrombolytic therapy of myocardial infarction ] . AIM To evaluate neoton therapy effects in acute myocardial infarction ( MI ) on systolic function of the left ventricle , arrhythmia and clinical symptoms in patients on thrombolytic therapy ( TLT ) . MATERIAL AND METHODS 106 males with Q-MI entered the study . 47 received treatment without TLT and neoton , 30 patients received TLT with streptokinase preparations , 29 patients were given streptokinase preparations and neoton . Left ventricular systolic function was measured by echocardiography on day 1 , 3 , 7 , 14 , 21 and 28 ; arrhythmia was analysed at Holter monitoring in day 1 and 2 of MI . RESULTS TLT failed to arrest progression of left ventricular dilation by the end of the hospital stay . Patients given neoton in acute period of MI had no increase in the end systolic and diastolic volumes of the left ventricle in the course of the first months after MI onset . Antiarrhythmic action of neoton manifested on MI day 2 . CONCLUSION Neoton given to MI patients receiving TLT prevents progression of left ventricular systolic dysfunction and establishment of predictors of unfavourable outcome .

Neoton

thrombolytic therapy

neoton

thrombolytic therapy ( TLT )

TLT

neoton

TLT

streptokinase

streptokinase preparations

neoton .

neoton

neoton

Neoton

Left ventricular systolic function

arrhythmia

systolic and diastolic volumes

left ventricular systolic dysfunction

myocardial infarction

males

Q-MI


Antioxidant supplementation and exercise-induced oxidative stress in the 60-year-old as measured by antipyrine hydroxylates . The effects of 12 weeks of antioxidant supplementation on exercise-induced oxidative stress were investigated in older adults ( 60 ( SE 1 ) years ; BMI 26 ( SE 1 ) kg/m ( 2 ) ) . Subjects were randomly divided in two groups : supplementation ( n 11 ) with 100 mg dl-alpha-tocopheryl acetate , 200 mg ascorbic acid , and 2 mg beta-carotene , and placebo ( n 9 ) . Before and after the 12 week supplementation period , subjects cycled for 45 min at submaximal intensity ( 50 % maximal workload capacity ) . Antipyrine was used as marker for oxidative stress . Antipyrine reacts quickly with hydroxyl radicals to form para- and ortho-hydroxyantipyrine . The latter metabolite is not formed in man through the mono-oxygenase pathway of cytochrome P450 . Daily supplementation significantly increased plasma concentrations of alpha-tocopherol and beta-carotene in the supplemented group ( Delta 14.4 ( SE 3.2 ) and 0.4 ( se 0.1 ) micromol/l ; P < 0.001 and P < 0.01 ) . No significant differences , within and between groups , were observed in the exercise-induced increase in the ratios para- and ortho-hydroxyantipyrine to antipyrine . In addition , supplementation did not affect the exercise-induced increase in thiobarbituric acid reactive substances in plasma . In conclusion , in 60-year-old subjects antioxidant supplementation had no effect on the exercise-induced increase in oxidative stress as measured by free radical products of antipyrine .

Antioxidant supplementation

antipyrine

antioxidant supplementation

dl-alpha-tocopheryl acetate

ascorbic acid

beta-carotene

placebo

Antipyrine

antioxidant supplementation

free radical products of antipyrine .

the 60-year-old

60-year-old subjects


The course of depression in recent onset rheumatoid arthritis : the predictive role of disability , illness perceptions , pain and coping . BACKGROUND This study aimed to investigate the course of depression for patients with recently diagnosed rheumatoid arthritis ( RA ) and to investigate predictors of depression . METHODS Twenty-two patients with a history of recently diagnosed RA of less than 2 years were assessed on a variety of clinical outcome and process measures on six assessment occasions over a 21-month period . These 22 patients constituted the control group of a controlled trial and received standard outpatient clinic treatment during follow-up . RESULTS Patients became significantly more depressed over time . A set of five factors were found to consistently predict depression at the following assessment . These were initial level of depression , disability , pain , beliefs about the consequences of arthritis and coping strategies . CONCLUSIONS The results confirm the importance of psychological factors in early RA and their relative independence from physical findings . This is the first study to document the importance of illness perceptions in recent onset RA .

standard outpatient clinic treatment

disability

illness perceptions

pain

coping

depression

clinical outcome and process measures

predict depression

recent onset rheumatoid arthritis :

Twenty-two

22 patients


A pilot study on the effect of progressive muscle relaxation training of patients after stoma surgery . Eighteen patients who had undergone stoma surgery were assessed with respect to their anxiety level and self-reported quality of life ( QoL ) on three occasions ; namely , immediately after surgery , 5 weeks after surgery , and 10 weeks after surgery . The patients were randomised into a control group ( n = 10 ) and an experimental group ( n = 8 ) . A 20-min set of audiotaped instructions on progressive muscle relaxation training ( PMRT ) was given to the patients in the experimental group for home practice . Assessment instructions included the Chinese State-Trait Anxiety Inventory ( C-STAI ) , the Quality of Life Index for Colostomy ( QoL-Colostomy ) and the Hong Kong Chinese version of the World Health Organisation Quality of Life Scale ( WHOQoL ) . Results indicated that there was a significant decrease in both the C-STAI score ( F = 4.66 , P < 0.05 ) and the WHOQoL score ( F = 4.74 , P < 0.05 ) in the experimental group . Among the domains of WHOQoL , a significant difference was shown in physical health/independence and general perception of QoL , with the experimental group demonstrating better functioning . For the QoL-Colostomy , however , there was no significant difference between the control and experimental groups . The results suggest that the use of PMRT could enhance quality of life and decrease state anxiety in patients after stoma surgery .

progressive muscle relaxation training

PMRT

anxiety level and

self-reported quality of life ( QoL )

and

C-STAI score

WHOQoL score

WHOQoL

QoL

QoL-Colostomy

quality of life

anxiety

patients after stoma surgery .

Eighteen

patients after stoma surgery .


Comparison of weakness progression in inclusion body myositis during treatment with methotrexate or placebo . We investigated whether 5 to 20mg per week oral methotrexate could slow down disease progression in 44 patients with inclusion body myositis in a randomized double-blind placebo-controlled study over 48 weeks . Mean change of quantitative muscle strength testing sum scores was the primary study outcome measure . Quantitative muscle strength testing sum scores declined in both treatment groups , -0.2 % for methotrexate and -3.4 % for placebo ( 95 % confidence interval = -2.5 % to +9.1 % for difference ) . There were also no differences in manual muscle testing sum scores , activity scale scores and patients ' own assessments after 48 weeks of treatment . Serum creatine kinase activity decreased significantly in the methotrexate group . We conclude that oral methotrexate did not slow down progression of muscle weakness but decreased serum creatine kinase activity .

methotrexate

placebo .

methotrexate

methotrexate

placebo

methotrexate

methotrexate

weakness progression

disease progression

patients ' own assessments

Serum creatine kinase activity

progression of muscle weakness

serum creatine kinase activity .

inclusion body myositis

patients with inclusion body myositis


[ Limbal epithelial autograft transplantation in treatment of pterygium ] . OBJECTIVE To observe the therapeutic effects of limbal epithelial autograft transplantation and pterygium excision in the treatment of pterygium . METHODS A prospective randomized paired-eye trial was studied . There were 208 patients ( 229 eyes ) with initial pterygium , and they were allocated to two groups : excision of pterygium with limbal epithelial autograft transplantation surgery ( A group , 106 cases and 124 eyes ) and simple pterygium excision ( B group , 102 cases and 105 eyes ) . The criteria for recovery were corneal transparency with stable epithelial healing and no abnormal proliferation of pterygium-like tissue . The post-operative follow-up periods ranged from 18 approximately 28 ( 22.4 +/- 4.9 ) months . RESULTS Some of the patients lost follow-up . In the eyes followed up , 5 of 11 2 eyes ( 4.5 % ) in A group and 41 of 96 eyes ( 42.7 % ) in B group were recurred , the difference being very significant ( P < 0.001 ) . CONCLUSION To provide a new stem cell source , limbal epithelial autograft transplantation , for an injured limb us is a reasonable therapeutic method for the treatment of pterygium .

pterygium excision

excision of pterygium

simple pterygium excision

epithelial healing

pterygium

pterygium .

208 patients

initial pterygium


Clinical performance of the Reichert AT550 : a new non-contact tonometer . The aim of the present study was to assess the level of accuracy for measurements of intra-ocular pressure ( IOP ) obtained with a new non-contact tonometer ( NCT ) the Reichert AT550 . Measurements were compared against those obtained with the Reichert Xpert Plus , Goldmann applanation tonometer and Perkins tonometer . Thirty-five university students were assessed with the four tonometers in a randomised order , with non-contact tonometry performed first . Each of the four measurement devices had its own trained clinical observer . Plots of differences of IOP as a function of the mean for each pair of instruments were obtained . No statistically significant differences were found when comparing the AT550 NCT with contact applanation tonometry ( AT ) ( p > 0.05 ) , displaying the closest level of agreement ( as represented by the lowest mean difference and the narrowest confidence interval ) with the Goldmann tonometer ( limits of agreement , 0.12+/-2.17 ) . In conclusion , readings of IOP with the AT550 NCT are clinically comparable with those obtained with Goldmann tonometry in a population with IOP within the normal range .

Reichert AT550 :

Reichert AT550 .

Reichert Xpert Plus

Goldmann applanation tonometer

Perkins tonometer .

AT550 NCT

Goldmann tonometer

AT550 NCT

Goldmann tonometry

Clinical performance

level of accuracy

measurements

IOP

Thirty-five

university students were assessed


Is a 2-week duration sufficient for stenting in endopyelotomy ? PURPOSE Internal stenting is an integral part of endopyelotomy . Studies in animals show good healing after 1 to 2 weeks of ureterotomy . Inherent stent related problems warrant a minimum possible duration of stenting without compromising the results of endopyelotomy . We performed a prospective randomized trial to evaluate the optimum duration of stenting after endopyelotomy . MATERIALS AND METHODS A total of 57 consecutive patients with primary ureteropelvic junction obstruction were randomized to undergo 7/14Fr internal endopyelotomy stent placement for 2 ( group 1 ) and 4 ( group 2 ) weeks . A symptom based questionnaire was administered to all patients at stent removal . Followup was done with diuretic scanning at 3 , 6 , 9 and 12 months and then yearly , and thereafter with diuretic renography . RESULTS In each group 26 patients were available for evaluation . The 2 groups were comparable in terms of age , sex , symptoms and ipsilateral glomerular filtration rate . Mean followup was 22.3 ( range 12 to 36 ) and 21.3 months ( range 12 to 35 ) in groups 1 and 2 , respectively . At the end of 1 year 24 group 1 ( 92.3 % ) and 23 group 2 ( 90.3 % ) patients had an improved drainage pattern . This difference was not significant . Stent related symptoms were present in a good proportion of patients in groups 1 and 2 but there was a significant difference in the incidence of urinary tract infections ( 11.5 % versus 38.1 % , p = 0.04 ) . Of the group 2 patients 64 % preferred 2 weeks of stenting . CONCLUSIONS Two weeks seems to be a sufficient duration to allow functional restoration across the ureteropelvic junction after endopyelotomy and decrease stent related complications .

stenting

Internal stenting

stenting

optimum duration of stenting

symptoms

drainage pattern .

Stent related symptoms

urinary tract infections

duration

stent related complications


Phase III study of concurrent chemoradiotherapy versus radiotherapy alone for advanced nasopharyngeal carcinoma : positive effect on overall and progression-free survival . PURPOSE Nasopharyngeal carcinoma ( NPC ) is a radiosensitive and chemosensitive tumor . This randomized phase III trial compared concurrent chemoradiotherapy ( CCRT ) versus radiotherapy ( RT ) alone in patients with advanced NPC . PATIENTS AND METHODS From December 1993 to April 1999 , 284 patients with 1992 American Joint Committee on Cancer stage III to IV ( M0 ) NPC were randomly allocated into two arms . Similar dosage and fractionation of RT was administered in both arms . The investigational arm received two cycles of concurrent chemotherapy with cisplatin 20 mg/m ( 2 ) /d plus fluorouracil 400 mg/m ( 2 ) /d by 96-hour continuous infusion during the weeks 1 and 5 of RT . Survival analysis was estimated by the Kaplan-Meier method and compared by the log-rank test . RESULTS Baseline patient characteristics were comparable in both arms . After a median follow-up of 65 months , 26.2 % ( 37 of 141 ) and 46.2 % ( 66 of 143 ) of patients developed tumor relapse in the CCRT and RT-alone groups , respectively . The 5-year overall survival rates were 72.3 % for the CCRT arm and 54.2 % for the RT-only arm ( P =.0022 ) . The 5-year progression-free survival rates were 71.6 % for the CCRT group compared with 53.0 % for the RT-only group ( P =.0012 ) . Although significantly more toxicity was noted in the CCRT arm , including leukopenia and emesis , compliance with the combined treatment was good . The second cycle of concurrent chemotherapy was refused by nine patients and was delayed for > or = 1 week for another nine patients . There were no treatment-related deaths in either arm . CONCLUSION We conclude that CCRT is superior to RT alone for patients with advanced NPC in endemic areas .

concurrent chemoradiotherapy

radiotherapy

concurrent chemoradiotherapy ( CCRT )

radiotherapy ( RT )

chemotherapy

cisplatin

fluorouracil

CCRT

RT-alone

CCRT

RT-only

CCRT

RT-only

CCRT

CCRT

RT

overall and progression-free survival .

Survival analysis

tumor relapse

5-year overall survival rates

5-year progression-free survival rates

toxicity

leukopenia

emesis

treatment-related deaths

advanced nasopharyngeal carcinoma :

patients with advanced NPC .

From December 1993 to April 1999

patients with advanced NPC


Development of renal disease in people at high cardiovascular risk : results of the HOPE randomized study . In people with diabetes , renal disease tends to progress from microalbuminuria to clinical proteinuria to renal insufficiency . Little evidence has been published for the nondiabetic population . This study retrospectively analyzed changes of proteinuria over 4.5 yr in the HOPE ( Heart Outcomes and Prevention Evaluation ) study , which compared ramipril 's effects to placebo in 9297 participants , including 3577 with diabetes and 1956 with microalbuminuria . This report is restricted to 7674 participants with albuminuria data at baseline and at follow-up . Inclusion criteria were known vascular disease or diabetes plus one other cardiovascular risk factor , exclusion criteria included heart failure or known impaired left ventricular function , dipstick-positive proteinuria ( > 1+ ) , and serum creatinine > 2.3 mg/dl ( 200 microM ) . Baseline microalbuminuria predicted subsequent clinical proteinuria for the study participants overall ( adjusted odds ratio [ OR ] , 17.5 ; 95 % confidence interval [ CI ] , 12.6 to 24.4 ) , in participants without diabetes ( OR , 16.7 ; 95 % CI , 8.6 to 32.4 ) , and in participants with diabetes ( OR , 18.2 ; 95 % CI , 12.4 to 26.7 ) . Any progression of albuminuria ( defined as new microalbuminuria or new clinical proteinuria ) occurred in 1859 participants ; 1542 developed new microalbuminuria , and 317 participants developed clinical proteinuria . Ramipril reduced the risk for any progression ( OR , 0.87 ; 95 % CI , 0.78 to 0.97 ; P = 0.0146 ) . People without and with diabetes who are at high risk for cardiovascular disease are also at risk for a progressive rise in albuminuria . Microalbuminuria itself predicts clinical proteinuria in nondiabetic and in diabetic people . Ramipril prevents or delays the progression of albuminuria .

ramipril 's

placebo

Ramipril

Ramipril

clinical proteinuria

progression of albuminuria

microalbuminuria

clinical proteinuria .

progression

albuminuria .

progression of albuminuria .

people at high cardiovascular risk

people with diabetes

nondiabetic and in diabetic people .


Conscious analgesia/sedation with remifentanil and propofol versus total intravenous anesthesia with fentanyl , midazolam , and propofol for outpatient colonoscopy . BACKGROUND This study tested the hypothesis that , for colonoscopy , analgesia/sedation with remifentanil and propofol might be more effective compared with anesthesia by intravenous administration of midazolam , fentanyl , and propofol . METHODS In a prospective , randomized trial , 100 adult patients received either conscious analgesia/sedation ( Sedation group ) or total intravenous anesthesia ( TIVA group ) . Analgesia/sedation was achieved by infusion of remifentanil ( 0.20 to 0.25 microg/kg/min ) and propofol in titrated doses . TIVA was induced by intravenous administration of fentanyl ( 2 microg/kg ) , midazolam ( 0.05 mg/kg ) and propofol ( dosage titrated ) . Cardiorespiratory parameters and bispectral index were monitored and recorded . The quality of the analgesia was assessed with a Numerical Pain Rating Scale ( NRS ) ; recovery level and return of psychomotor efficiency were evaluated with , respectively , the Aldrete scale and a Modified Post Anesthesia Discharge Scoring ( MPADS ) system . RESULTS Both groups of 50 patients were comparable with respect to demographic data , initial parameters , and duration of colonoscopy . All patients in the TIVA group found the colonoscopy painless ( NRS score 0 ) . In the Sedation group , the average pain intensity score was 0.4 ( 0.8 ) . There was a marked difference between the Sedation and TIVA groups with respect to the time from the end of the procedure until the maximum MPADS score was reached : respectively , -6.9 ( 4.0 ) versus 25.7 ( 8.4 ) minutes ( p < 0.001 ) . In the TIVA group , changes in mean arterial pressure and heart rate and signs of respiratory depression were significant ( p < 0.05 ) . CONCLUSIONS Combined administration of remifentanil and propofol for colonoscopy provides sufficient analgesia , satisfactory hemodynamic stability , minor respiratory depression , and rapid recovery , and allows patients to be discharged approximately 15 minutes after the procedure .

remifentanil

propofol

fentanyl

midazolam

propofol

remifentanil

propofol

midazolam

fentanyl

propofol

remifentanil

propofol

fentanyl

midazolam

propofol

remifentanil

propofol

Cardiorespiratory parameters

bispectral index

Numerical Pain Rating Scale ( NRS )

recovery level

return of psychomotor efficiency

Aldrete scale

pain intensity score

maximum MPADS score

analgesia

hemodynamic stability

respiratory depression

rapid recovery

outpatient colonoscopy .

adult patients


Reduced platelet thromboxane formation after long-term administration of a dihydropyridine calcium channel blocker : a prospective , double-blind , placebo-controlled study with nitrendipine in borderline hypertensive patients with IDDM-type diabetes mellitus . Twenty-nine IDDM patients with borderline hypertension were randomly allocated to placebo or nitrendipine treatment . Nitrendipine was given orally at a dosage of 20 mg once daily over 4 weeks . Stimulated platelet thromboxane formation at rest and after standardized , non exhausting exercise was measured by standard methods . In addition , plasma levels of platelet factor 4 and aggregation responses to collagen and ADP were determined . In the treatment group thromboxane formation after stimulation with collagen ( 0.3 and 1.0 micrograms/ml ) and 1 mM arachidonic acid ( AA ) was reduced in the resting state . Exercise induced change of thromboxane synthesis in response to 1.0 micrograms/ml collagen was significantly lower as compared to placebo ( p < 0.05 ) . In parallel , PF4 plasma levels were significantly lowered ( p < 0.05 ) . Whole blood aggregation after collagen stimulation ( 1.0 micrograms/ml ) was reduced after 4 weeks of nitrendipine treatment , but ADP ( 5 microM ) induced aggregation was not . These effects of nitrendipine were not seen in platelet rich plasma . In conclusion long-term nitrendipine treatment may inhibit collagen dependent platelet activation in the blood of diabetic patients with borderline hypertension .

dihydropyridine calcium channel blocker

nitrendipine

placebo

nitrendipine

Nitrendipine

placebo

nitrendipine

nitrendipine

nitrendipine

platelet thromboxane formation

thromboxane formation

PF4 plasma levels

aggregation

collagen dependent platelet activation

Twenty-nine


Gastric dysrhythmia in infants with gastrointestinal diseases measured by epigastric impedance . BACKGROUND Gastrointestinal symptoms have been reported in association with myoelectrical dysrhythmia , where different types of gastric electrical activity have been described . These types of gastric myoelectrical activity and dysrhythmia can be measured by electrogastrography using cutaneous electrodes . Epigastric impedance is a non-invasive method used to study gastric emptying time and gastric phasic activity . At present no study of gastric dysrhythmia , measured with epigastric impedance , has been presented , and the purpose of the present study was to investigate gastric rhythms by means of impedance gastrography in control infants , compared to infants with different gastrointestinal diseases , before and after treatment of their disease . METHOD 21 patients ( age 0-2 months ) and 40 healthy infants ( age 0-2 months ) were investigated . The patients suffered from partial or total intestinal obstruction , necrotizing enterocolitis or pyloric stenosis.All infants were fasting and studied during periods of at least one hour . The patients were examined in the acute state and after treatment when possible . RESULTS A pathologic result was found in 90 % of the patients . A persistent phasic activity pattern was found in 19 of the 21 patients , high frequency phasic activity in 11 of the 21 patients . Short-term phasic activity was only found in 13 out of 40 of the normal infants ( 32.5 % ) . CONCLUSION Using epigastric impedance we found that infants with partial or total intestinal obstruction had gastric phasic activity , which was not found in the control infants . The origin of the gastric phasic activity patterns is unknown , but they may be related to electrical control activity .

epigastric impedance

Epigastric impedance

epigastric impedance

epigastric impedance

epigastric impedance

phasic activity

frequency phasic activity

phasic activity

infants

gastrointestinal diseases

patients

age 0-2 months

healthy

infants

age 0-2 months


Prospective study of short and ultrashort regimens of gonadotropin-releasing hormone agonist in an in vitro fertilization program . OBJECTIVE To assess the usefulness of the ultrashort regimen of gonadotropin-releasing hormone agonist ( GnRH-a ) in ovulation induction in an in vitro fertilization ( IVF ) program . DESIGN A prospective randomized trial comparing short and ultrashort regimens of GnRH-a . SETTING Aberdeen Assisted Reproduction Unit . PATIENTS Forty-eight patients having IVF for the first time were randomized between the two protocols . MAIN OUTCOME MEASURES Response to ovarian stimulation and occurrence of spontaneous luteinizing hormone ( LH ) surges . RESULTS In ovulation induction , fertilization , and pregnancy rates the ultrashort regimen produces results that were no different to the short regimen but it did not always prevent an LH surge . CONCLUSION The ultrashort regimen can be a useful alternative for ovarian stimulation of patients undergoing IVF .

gonadotropin-releasing hormone agonist

GnRH-a .

usefulness

LH surge .

in vitro fertilization ( IVF )

Forty-eight

patients having IVF for the first time

undergoing IVF


Long-term survival in a phase III , randomised study of topotecan versus paclitaxel in advanced epithelial ovarian carcinoma . BACKGROUND We have continued to monitor the survival of patients randomised in a previously reported multicentre phase III study of topotecan versus paclitaxel in patients with advanced epithelial ovarian cancer who had failed one prior platinum-based regimen . PATIENTS AND METHODS Patients with bidimensionally measurable disease were randomised to topotecan ( 1.5 mg/m ( 2 ) /day for 5 days ) or paclitaxel ( 175 mg/m ( 2 ) /day as a 3-h infusion ) every 21 days . Patients were eligible for treatment with the alternate therapy at third line . The European Organisation for Research and Treatment of Cancer Quality of Life ( EORTC QOL ) -C30 questionnaire was also used to measure eight symptoms at baseline and during each course ( pain , anorexia , diarrhoea , fatigue , nausea and vomiting , dyspnea , constipation and insomnia ) . RESULTS A total of 226 patients were evaluable for response . Demographic characteristics were similar in both treatment groups , as were results of the EORTC QOL-30 questionnaire . For the topotecan group , median time to progression was 18.9 weeks ( range < 1 to 92.6+ weeks ; 25 % censored ) , and , for paclitaxel , 14.7 weeks ( range < 1 to 137.3+ weeks ; 12.3 % censored ) ; P = 0.076 . At 4 years post-randomisation , median survival in the topotecan group was 63.0 weeks ( range < 1 to 238.4+ weeks ; 20.5 % censored ) and , for paclitaxel , 53.0 weeks ( range < 1 to 226.3+ weeks ; 12.3 % censored ) ; P = 0.44 . CONCLUSION Topotecan continues to demonstrate comparable efficacy and survival to paclitaxel with manageable and non-cumulative haematological toxicity . Non-haematological toxicity was generally mild for both groups . The long-term survival rate indicates substantial therapeutic benefit for this group of patients receiving topotecan at relapse of ovarian cancer .

topotecan

paclitaxel

topotecan

paclitaxel

topotecan

paclitaxel

topotecan

paclitaxel

topotecan

paclitaxel

Topotecan

paclitaxel

topotecan

pain

anorexia

diarrhoea

fatigue

nausea

vomiting

dyspnea

constipation

insomnia

progression

median survival

efficacy

survival

advanced epithelial ovarian carcinoma .

ovarian cancer .


Raising high-density lipoprotein in humans through inhibition of cholesteryl ester transfer protein : an initial multidose study of torcetrapib . OBJECTIVE The ability of the potent cholesteryl ester transfer protein ( CETP ) inhibitor torcetrapib ( CP-529,414 ) to raise high-density lipoprotein cholesterol ( HDL-C ) levels in healthy young subjects was tested in this initial phase 1 multidose study . METHODS AND RESULTS Five groups of 8 subjects each were randomized to placebo ( n=2 ) or torcetrapib ( n=6 ) at 10 , 30 , 60 , and 120 mg daily and 120 mg twice daily for 14 days . Torcetrapib was well tolerated , with all treated subjects completing the study . The correlation of plasma drug levels with inhibition ( EC50=43 nM ) was as expected based on in vitro potency ( IC50 approximately 50 nM ) , and increases in CETP mass were consistent with the proposed mechanism of inhibition . CETP inhibition increased with escalating dose , leading to elevations of HDL-C of 16 % to 91 % . Total plasma cholesterol did not change significantly because of a reduction in nonHDL-C , including a 21 % to 42 % lowering of low-density lipoprotein cholesterol at the higher doses . Apolipoprotein A-I and E were elevated 27 % and 66 % , respectively , and apoB was reduced 26 % with 120 mg twice daily . Cholesteryl ester content decreased and triglyceride increased in the nonHDL plasma fraction , with contrasting changes occurring in HDL . CONCLUSIONS These effects of CETP inhibition resemble those observed in partial CETP deficiency . This work serves as a prelude to further studies in subjects with low HDL , or combinations of dyslipidemia , in assessing the role of CETP in atherosclerosis .

torcetrapib .

placebo

torcetrapib

Torcetrapib

plasma drug levels

Total plasma cholesterol

nonHDL-C

low-density lipoprotein cholesterol

Apolipoprotein A-I and E

apoB

Cholesteryl ester content

triglyceride

healthy

young

Five groups of 8 subjects each


A selective angiotensin receptor antagonist , Valsartan , produced regression of left ventricular hypertrophy associated with a reduction of arterial stiffness . We investigated whether a selective angiotensin II receptor blocker ( ARB ) would have a regressive effect on left ventricular hypertrophy ( LVH ) in patients on continuous ambulatory peritoneal dialysis ( CAPD ) . In a double-blind study , 24 CAPD patients with LVH [ left ventricular mass index ( LVMi ) > 110 g/m2 for women and LVMi > 137 g/m2 for men ] were randomized to 12 months ' administration of either the ARB valsartan ( n = 14 ) or a placebo ( n = 10 ) . The target blood pressure ( BP ) was 140/90 mmHg or lower in both groups . The following parameters were measured before and at the end of the study : aortic and large-artery compliance and arterial wave reflections [ pulse wave velocity ( PWV ) and augmentation index ( AI ) application tonometry ] and cardiac echocardiography . Periodically recorded were body weight , BP ( mercury sphygmomanometer ) , serum creatinine , electrolytes , complete blood cell counts , urine volume , drainage volume , and weekly creatinine clearance . Two-way analysis of variance for repeated measurements was used for statistical analysis . Systolic and diastolic BP were both reduced in patients treated with ARB . The LVMi was significantly reduced in patients treated with ARB ( to 121 +/- 4 from 145 +/- 5 ) but not in those receiving placebo ( to 137 +/- 3 from 152 +/- 3 , p < 0.05 ) . The decrease in LVMi was associated with a reduction in PWV and AI . In CAPD patients with LVH , ARB reduced LVMi in association with alterations in arterial hemodynamics .

Valsartan

ARB valsartan

placebo

ARB .

ARB

placebo

ARB

blood pressure ( BP )

aortic and large-artery compliance

cardiac echocardiography .

Systolic and diastolic BP

LVMi

LVMi

PWV

AI

LVMi

left ventricular hypertrophy

LVMi > 137 g/m2 for men


A pooled analysis of eastern cooperative oncology group and intergroup trials of adjuvant high-dose interferon for melanoma . PURPOSE Nearly 2000 patients with stage IIB and III melanoma have participated in four multicenter , randomized trials , conducted by the Eastern Cooperative Oncology Group and the Intergroup , investigating adjuvant high-dose IFN-alpha 2b therapy . The objectives of this study were to update the analyses of each individual trial and to analyze prognostic factors and treatment effects based on pooled data . EXPERIMENTAL DESIGN Survival and disease status were updated to April 2001 . Analysis of prognostic factors using optimized statistical models was based on data from patients in E1684 , E1690 , E1694 , and E2696 . Analysis of treatment effects versus observation ( Obs ) was based on data from 713 patients randomized to high-dose IFN-alpha 2b ( HDI ) or Obs in Trials E1684 and E1690 . RESULTS Updated analysis of E1684 , E1690 , and E1694 confirmed their original conclusions , now at median follow-up intervals of 2.1-12.6 years . Based on two-sided univariate log-rank analysis of pooled data from E1684 and E1690 ( median follow-up , 7.2 years ) , relapse-free survival ( RFS ) -but not overall survival ( OS ) -was significantly prolonged ( two-sided log-rank P value = 0.006 ) for patients treated with HDI versus Obs . Among all patients , prognostic factors that significantly negatively impacted RFS and OS included ulceration , recurrent disease at entry , enrollment in E1684 , and age > 49 years . Multivariate statistical models adjusting for these factors confirmed the statistically significant RFS benefit of HDI versus Obs but did not demonstrate a significant OS benefit in the pooled populations . CONCLUSIONS In patients with high-risk resected melanoma , HDI is effective adjuvant therapy with strong evidence for improved RFS and evidence for moderate improvement in OS based on two prospective randomized studies but not the pooled analysis . Analyses of predictors of relapse and response are now needed to improve the therapeutic value of this modality .

interferon

IFN-alpha 2b

IFN-alpha 2b ( HDI )

Obs

HDI

Obs

HDI

Obs

relapse-free survival ( RFS )

overall survival ( OS )

RFS

OS

RFS

OS

Nearly 2000


A randomized comparison of alternative techniques to achieve coronary sinus cannulation during biventricular implantation procedures . INTRODUCTION Biventricular pacing system implantation is a time-consuming and challenging procedure . A critical step in biventricular pacemaker implantation is coronary sinus ( CS ) cannulation . CS cannulation can be achieved either using dedicated guiding catheters ( guiding catheter alone positioning strategy , GCA ) or with the aid of an electrophysiology catheter advanced inside the guiding catheter ( electrophysiology catheter aided positioning strategy , EPA ) . AIM OF THE STUDY To evaluate whether the EPA technique is useful for reducing CS cannulation time compared to a conventional GCA technique . METHODS Thirty-four consecutive patients were randomly assigned to the GCA ( 18 patients ) or EPA ( 16 patients ) CS cannulation strategy . RESULTS Time to successful catheterization of CS was 5.0 +/- 2.4 min in the EPA group versus 10.1 +/- 5.4 min in the GCA group p = 0.004 . Fluoroscopy time was 4.6 +/- 2.3 min in the EPA group versus 9.2 +/- 4.9 min in the GCA group p = 0.004 . Total contrast dye volume to search and engage the CS ostium was 0.0 ml in the EPA group versus 14.3 +/- 3.4 ml in the GCA group p < 0.001 . CONCLUSIONS Cannulation of CS with the adjunct of an electrophysiology catheter to dedicated delivery systems significantly reduces procedural time , fluoroscopy time and contrast dye volume compared to a conventional strategy .

catheters

guiding catheter alone

GCA

electrophysiology catheter advanced

electrophysiology catheter aided

EPA

GCA

GCA

EPA

EPA

GCA

EPA

GCA

EPA

GCA

CS cannulation time

Fluoroscopy time

contrast dye volume

procedural time , fluoroscopy time

contrast dye volume

biventricular implantation

Thirty-four

consecutive patients


Combined descriptive and explanatory information improves peers ' perceptions of autism . Authors examined the combined effects of descriptive and explanatory information on peers ' perceptions and behavioral intentions toward an unfamiliar child with autism . Children ( N = 576 ; M age = 10.06 ) were randomly assigned to view two videotapes of a boy engaging in typical and autistic behaviors receiving either descriptive ( AUT-D ) or descriptive and explanatory information ( AUT-D + E ) . Children responded to measures of attitudes ( Adjective Checklist ) and behavioral intentions ( Shared Activities Questionnaire ) . Children rated the typical boy more favorably than the boy showing autistic symptoms . When compared to descriptive information alone , the combination of descriptive and explanatory information resulted in improved third- and fourth-graders ' but not fifth-graders ' attitudes toward the child with autism . Combined information improved behavioral intentions across grades ; however , girls ( vs. boys ) were more responsive to information as evidenced by differences in academic intentions . The combination of descriptive and explanatory information about autism appears to have a positive effect on children 's attitudes and behavioral intentions . Implications of the findings are briefly discussed as well as study limitations and recommendations for future research .

descriptive ( AUT-D )

descriptive and explanatory information

peers ' perceptions

peers ' perceptions

behavioral intentions

( Adjective Checklist )

( Shared Activities Questionnaire )

children 's attitudes

behavioral intentions

peers

peers

child with autism .

Children

M age = 10.06

children 's


Superior visual search in adults with autism . Recent studies have suggested that children with autism perform better than matched controls on visual search tasks and that this stems from a superior visual discrimination ability . This study assessed whether these findings generalize from children to adults with autism . Experiments 1 and 2 showed that , like children , adults with autism were superior to controls at searching for targets . Experiment 3 showed that increases in target-distractor similarity slowed the visual search performance of the control group significantly more than that of the autism group , suggesting that the adults with autism have a superior visual discrimination ability . Thus , these experiments replicate in adults previous findings in children with autism . Superior unique item detection in adults with autism , stemming from enhanced discrimination , is discussed in the light of the possible role of stimulus processing disturbances in the disorder in general .

searching for targets .

visual search performance

visual discrimination ability .

unique item detection

adults with autism .

adults with autism .

adults with autism


[ Postural biofeedback and locomotion reeducation in stroke patients ] . AIMS To compare , in post-acute hemiparetic patients , gait improvement after conventional physical therapy alone or with a specialised balance retraining program . PATIENTS Twenty-six patients within 3 months of onset of stroke were randomised to receive physical therapy ( control group ) or therapy and retraining ( experimental group ) , most of the patients in both groups with left hemiplegia . The experimental group was significantly older than the control group . METHOD Thirteen patients received early conventional therapy , and 13 received therapy combined with standing balance training by biofeedback ( BPM Monitor ) . Clinical measures were collected at entry ( J0 ) , once when subjects began to walk ( JM ) and 30 days later ( JM + 30 ) . Gait spatiotemporal parameters were collected by use of the Vicon system at JM and JM + 30 . RESULTS Whatever the method of rehabilitation , the clinical scores improved significantly between J0 and JM + 30 , except for spasticity . The time between stroke and the beginning of walking was not significantly different between both groups . Gait velocity increased significantly between JM and JM + 30 in both groups , with no difference between groups . The walking pattern was improved for both groups , with a significant increase of the duration of the paretic limb single stance . The experimental group significantly improved the duration of the reception double stance on the paretic limb between JM and JM + 30 compared with the control group ( P = 0.03 ) . CONCLUSION Both groups demonstrated improvement in the rehabilitation unit . The benefits of visual biofeedback by forceplate system training suggest particular improvement of anticipation equilibrium with conventional therapy .

conventional physical therapy alone

specialised balance retraining program

physical therapy

therapy and retraining

conventional therapy

therapy

conventional therapy .

gait improvement

Gait spatiotemporal parameters

clinical scores

Gait velocity

walking pattern

stroke patients ]

post-acute hemiparetic patients

Twenty-six


Cophenylcaine spray vs. placebo in flexible nasendoscopy : a prospective double-blind randomised controlled trial . Practices vary across the UK on the use of topical preparation prior to flexible fibreoptic nasendoscopy . In this double-blind study , we randomised 98 patients to receive cophenylcaine or placebo nasal spray before flexible nasendoscopy . A visual analogue scale ( 1-100 ) was used to record pain , unpleasantness of taste and overall discomfort experienced . Overall , the procedure was associated with minimal pain and discomfort in both groups . There was no significant difference in pain or overall discomfort experienced between the two groups ; however , the sensation of bad taste was significantly worse in the cophenylcaine group . In linear regression , factors that predicted the overall unpleasantness of the experience were primarily pain experienced and secondarily unpleasantness of taste . We conclude that the routine use of cophenylcaine for nasal preparation is not justified before flexible nasendoscopy .

Cophenylcaine

placebo

cophenylcaine

placebo

cophenylcaine

cophenylcaine

pain and discomfort

pain or overall discomfort

sensation of bad taste

unpleasantness

pain

unpleasantness of taste

flexible nasendoscopy :

98 patients

flexible nasendoscopy .

flexible nasendoscopy .


Effects of Saccharomyces boulardii in children with acute diarrhoea . AIM Certain probiotic agents , e.g . Lactobacillus GG , have shown efficacy in clinical trials for the treatment of acute childhood diarrhoea , but few studies have examined the effect of Saccharomyces boulardii . We evaluated the effect of S. boulardii in children with acute diarrhoea . METHODS Two hundred children were randomized to receive S. boulardii in a granulated form in a daily dose of 250 mg ( S. boulardii group ) or placebo ( placebo group ) for 5 d. Clinical and demographic characteristics on admission were similar between the study groups . RESULTS The medians of the average stool frequency after the second day of the treatment were significantly lower in the S. boulardii group than in the placebo group ( p = 0.003 ) . The duration of diarrhoea significantly reduced in the S. boulardii group compared with the placebo group ( 4.7 vs 5.5 d , p = 0.03 ) . The effect of S. boulardii on watery diarrhoea became apparent after the second day of the treatment . The duration of hospital stay was shorter in the S. boulardii group than in the placebo group ( 2.9 vs 3.9 d , p < 0.001 ) . Four children from the placebo group versus only one child from the S. boulardii group had persisting diarrhoea . CONCLUSION The placebo-controlled study suggested that S. boulardii significantly reduced the duration of acute diarrhoea and the duration of hospital stay . S. boulardii seems to be a promising agent for the amelioration of the course of acute diarrhoea in children when used therapeutically .

Saccharomyces boulardii

Saccharomyces boulardii .

S. boulardii

S. boulardii

S. boulardii

placebo

placebo

S. boulardii

placebo

S. boulardii

placebo

S. boulardii

S. boulardii

placebo

placebo

S. boulardii

S. boulardii

S. boulardii

average stool frequency

duration of diarrhoea

duration of hospital stay

duration of acute diarrhoea

duration of hospital stay

children

acute diarrhoea

children with acute diarrhoea .

Two hundred children

acute diarrhoea in children


Interventions in the initial prodromal states of psychosis in Germany : concept and recruitment . BACKGROUND The Early Detection and Intervention Programme of the German Research Network on Schizophrenia ( GRNS ) investigates the initial prodromal phase of psychosis in a multidimensional approach . Two intervention strategies are being studied by two large-scale multicentre projects . AIMS To present the concept of the intervention studies , and to provide an interim report of the recruitment procedure . METHOD Comprehensive cognitive-behavioural therapy has been developed for patients in the " early initial prodromal state " . For patients in the " late initial prodromal state " the atypical neuroleptic amisulpride is explored . Both interventions are evaluated in randomised controlled trials using clinical management as the control condition . RESULTS Between January 2001 and March 2003 , 1212 individuals seeking help for mental health problems were screened for putative prodromal symptoms at four university centres . More than 388 individuals fulfilled criteria for both interventions and 188 ( 48.5 % ) gave informed consent to participate in the trials . CONCLUSIONS The screening procedure appears to be feasible and trial participation seems to be acceptable to a relevant proportion of people at increased risk of developing psychosis .

atypical neuroleptic amisulpride

initial prodromal states of psychosis

Germany

" early initial prodromal state "

" late initial prodromal state "


[ Effect of branch chain amino acid enriched formula on postoperative fatigue and nutritional status after digestive surgery ] . OBJECTIVE To evaluate the effect of branch chain amino acid ( BCAA ) enriched formula on nutritional status and postoperative fatigue for digestive surgery patients . METHODS Forty patients who underwent digestive surgery were randomly received parenteral nutrition with either BCAA enriched ( study group , n=20 ) or routine amino acid ( control group , n=20 ) for seven consecutive days . Nitrogen balance , serum total protein , albumin , prealbumin , transferrin , retinol binding protein and postoperative fatigue score were monitored during the postoperative period . RESULTS The cumulative postoperative fatigue scores were lower in BCAA group than that in the control group at the 4th , 5th and 7th day after operation ( P < 0.05 ) . Patients achieved positive nitrogen balance 2 days earlier in the study group than that in the control group , but there was no significant difference in cumulative nitrogen balance between the two groups . There was no significant difference in elevation of serum total protein , albumin , prealbumin , transferrin at the 7th day after operation between the two groups ( P > 0.05 ) , compared with those at the first day after operation . The serum level of retinol binding protein was higher in BCAA-enriched group than that in the control group ( P=0.004 ) . CONCLUSION TPN with BCAA enriched formula can reduce postoperative fatigue score and improve the nutritional status for digestive surgery patients .

amino acid enriched formula

BCAA enriched

routine amino acid

BCAA

BCAA-enriched

BCAA enriched formula

postoperative fatigue

nutritional status

nutritional status

postoperative fatigue

cumulative postoperative fatigue scores

nitrogen balance

cumulative nitrogen balance

serum level of retinol binding protein

postoperative fatigue score

nutritional status

after digestive surgery ]

digestive surgery patients .

Forty

digestive surgery patients .


Intervention pilot for parents of children with autistic spectrum disorder . Parents of children who receive the diagnosis of autistic spectrum disorder ( ASD ) experience a situational crisis related to receiving the diagnosis , which causes feelings of distress and urgency to access services for the affected child . This paper describes a randomized trial ( n = 31 ) that was conducted at a regional diagnostic center of a large metropolitan children 's hospital to ( a ) refine a nursing intervention designed for parents of children with ASD and ( b ) to identify methodological revisions for a larger study . A secondary purpose was to test the effects of a post-diagnosis nursing intervention on parents ' reports of stress , impact of event ( diagnosis ) , and use of services after a child is newly diagnosed with ASD . The intervention consisted of usual care plus 3 hours contact with a pediatric nurse practitioner ( PNP ) for counseling , instruction , and assistance with implementation of the recommended treatment plan . The control group received only the usual care post-diagnosis , which consisted of a 1-hour consultation session to receive the results of diagnostic tests and a written copy of the recommended treatment plan provided by a developmental pediatrician and/or PNP . Between group differences in measures of " impact of event " and " perceived stress " were not statistically significant . This was attributed to a small sample size . A larger study is feasible and recommended with an expanded nursing intervention and a significantly larger sample recruited from an additional recruitment site . Nurses working with this special population must recognize that parents have information and counseling needs that begin after they receive the diagnosis of ASD for their child and can address these needs with a standardized nursing intervention .

Intervention

nursing intervention

post-diagnosis nursing intervention

usual care

usual care

parents ' reports of stress

impact of event ( diagnosis )

use of services

" impact of event "

" perceived stress "

parents of children

autistic spectrum disorder

Parents of children

parents of children with ASD


Sleep-anticipating effects of melatonin in the human brain . Melatonin , the hormone produced nocturnally by the pineal gland , is an endogenous regulator of the sleep-wake cycle . The effects of melatonin on brain activities and their relation to induction of sleepiness were studied in a randomized , double-blind , placebo controlled functional magnetic resonance imaging ( fMRI ) study . Melatonin , but not placebo , reduced task-related activity in the rostro-medial aspect of the occipital cortex during a visual-search task and in the auditory cortex during a music task . These effects correlated with subjective measurements of fatigue . In addition , melatonin enhanced the activation in the left parahippocampus in an autobiographic memory task . Results demonstrate that melatonin modulates brain activity in a manner resembling actual sleep although subjects are fully awake . Furthermore , the fatigue inducing effect of melatonin on brain activity is essentially different from that of sleep deprivation thus revealing differences between fatigues related to the circadian sleep regulation as opposed to increased homeostatic sleep need . Our findings highlight the role of melatonin in priming sleep-associated brain activation patterns in anticipation of sleep .

melatonin

melatonin

Melatonin

placebo

melatonin

melatonin

melatonin

melatonin

effects

task-related activity

subjective measurements of fatigue .

activation in the left parahippocampus

brain activity

fatigue

human


Phase III study of two different dosing schedules of erythropoietin in anemic patients with cancer . PURPOSE To compare maintenance epoetin alfa administered once every 3 weeks with continued weekly epoetin alfa for patients with cancer-associated anemia . PATIENTS AND METHODS Eligible patients were randomly assigned at enrollment to receive three weekly doses of epoetin alfa 40,000 U subcutaneously ( SC ) , followed by either standard weekly epoetin alfa ( 40K arm ) or 120,000 U of epoetin alfa ( 120K arm ) SC every 3 weeks for 18 additional weeks . RESULTS Three hundred sixty-five patients were enrolled . One hundred eighty-three patients were assigned to the 40K arm , and 182 were assigned to the 120K arm . There was no difference in the proportion of patients requiring transfusions during the study ( 23 % in 40K arm and 18 % in 120K arm , P = .22 ) or specifically during the maintenance phase ( 13 % in 40K arm v 15 % in 120K arm , P = .58 ) . Patients randomly assigned to the 40K arm were more likely to have a > or = 2 or > or = 3 g/dL hemoglobin ( Hb ) increment , were more likely to have a drug dose held because of high Hb , and had higher mean end-of-study Hb levels . Toxicities , including thromboembolism , and overall survival were similar . Patients in the 40K arm had a higher global quality of life ( QOL ) at baseline for unclear reasons , whereas patients in the 120K arm had a greater global QOL improvement during the study , so end-of-study QOL was equivalent . CONCLUSION After three weekly doses of epoetin alfa 40,000 U , a dose of 120,000 U can be administered safely once every 3 weeks without increasing transfusion needs or sacrificing QOL . The Hb increment is somewhat greater with continued weekly epoetin alfa . Lack of blinding as a result of different treatment schedules may have confounded results .

erythropoietin

epoetin alfa

epoetin alfa

epoetin alfa

epoetin alfa

epoetin alfa

epoetin alfa

epoetin alfa .

requiring transfusions

hemoglobin ( Hb ) increment

drug dose

Hb

Hb

Toxicities

thromboembolism

overall survival

global quality of life ( QOL )

global QOL

QOL

transfusion needs

QOL

Hb increment

anemic patients with cancer .

Three hundred sixty-five patients


Local immunotherapy by inhalation of a powder extract in asthma due to house dust mite Dermatophagoides pteronyssinus : a double-blind comparison with parenteral immunotherapy . To verify the efficacy and the tolerability of local immunotherapy ( LI ) by inhalation of a powder extract of house dust mite ( HDM ) , in comparison with parenteral immunotherapy ( PI ) by injection , 10 patients with asthma due to HDM were studied in a blind fashion . 5 patients ( Group A ) underwent LI and subcutaneous injections of placebo , 5 patients ( Group B ) underwent PI and inhalation of lactose for 6 months . In both groups each inhalation was preceded by premedication with disodium cromoglycate ( DSCG ) ( 40 mg ) . In Group A a significant decrease in symptoms score and in peak expiratory flow ( PEF ) -derived parameters was observed already after 3 months of treatment , and 2 patients lost the late component of the bronchial response to the challenge with HDM . No significant variation was found in bronchial responsiveness to methacholine and ultrasonically nebulized distilled water ( UNDW ) and in immunologic humoral and cellular parameters in peripheral blood after treatment in either group . No local important adverse reactions were observed in Group A and no systemic side effects were observed in either group . We conclude that LI is as effective as PI , but more rapid in its action , in the treatment of asthma due to HDM . Moreover , LI is locally well tolerated , providing DSCG is inhaled before each therapeutic inhalation , and does not induce systemic side effects .

immunotherapy

immunotherapy

local immunotherapy

parenteral immunotherapy ( PI )

placebo

lactose

disodium cromoglycate ( DSCG )

efficacy

tolerability

symptoms score

bronchial response

bronchial responsiveness

local important adverse reactions

systemic side effects

systemic side effects .

patients with asthma due to HDM


The safety of whey protein concentrate derived from the milk of cows immunized against Clostridium difficile . A whey protein concentrate prepared from the milk of cows that have been immunized against Clostridium difficile ( C. difficile ) and its toxins , toxin A and toxin B , is produced for use as a medical food for the dietary management of patients with C. difficile-associated diarrhea ( CDAD ) to prevent a relapse of the infection . The safety of anti-C. difficile whey protein concentrate ( anti-CD WPC ) is supported by analytical data comparing the composition of raw milk from immunized cows versus that from non-immunized cows , and the composition of anti-CD WPC versus that of regular whey protein concentrate . Additionally , a prospective clinical study was conducted in 77 patients with CDAD to demonstrate the safety of consuming anti-CD WPC to prevent relapse of the infection . This study , which included adverse event monitoring , physical examinations , and extensive hematological and biochemical assessments , showed that anti-CD WPC is safe to consume by patients with CDAD . The available analytical and clinical evidence demonstrate that anti-CD WPC is safe for use by individuals with CDAD , under the described conditions of use .

whey protein concentrate

whey protein concentrate

anti-CD WPC

regular whey protein concentrate .

anti-CD WPC

anti-CD WPC

anti-CD WPC

safe

safe

patients with CDAD

patients with CDAD .

individuals with CDAD


The prophylactic effect of itraconazole capsules and fluconazole capsules for systemic fungal infections in patients with acute myeloid leukemia and myelodysplastic syndromes : a Japanese multicenter randomized , controlled study . We performed a randomized , controlled study comparing the prophylactic effects of capsule forms of fluconazole ( n = 110 ) and itraconazole ( n = 108 ) in patients with acute myeloid leukemia ( AML ) or myelodysplastic syndromes ( MDS ) during and after chemotherapy . There were 4 cases with possible systemic fungal infection in the itraconazole group , and there were 8 possible and 3 probable cases in the fluconazole group . Adverse events did not significantly differ in the 2 groups . In patients with MDS or in the remission-induction phase of chemotherapy , the numbers of cases with probable or possible infections were lower in the itraconazole group than in the fluconazole group , whereas no difference was seen in patients with AML or in the consolidation phase of therapy . In patients with neutrophil counts of > 0.1 x 10 ( 9 ) /L lasting for more than 4 weeks , the frequency of infection in the fluconazole group ( 5 of 9 patients ) was significantly higher than in the itraconazole group ( 0 of 7 patients ; P = .03 ) . Our results suggest that both drugs were well tolerated in patients with AML or MDS who received chemotherapy and that the efficacy of itraconazole for prophylaxis against systemic fungal disease is not inferior to that of fluconazole .

itraconazole

fluconazole

fluconazole

itraconazole

itraconazole

fluconazole

Adverse events

probable or possible infections

frequency of infection

Japanese


[ Intravenous treatment of postpartum anemia with trivalent ferrum preparation ] . AIM OF THE STUDY To assess the effectivity and safeness of intravenous treatment of pospartal anemia with trivalent ferrum preparation . TYPE OF THE STUDY Prospective randomized study . SETTING Department of Obstetric and Gynecology 2nd Medical Faculty Charles University and Teaching Hospital Motol , Prague , and Department of Obstetric and Gynecology 1st Medical Faculty and Teaching Hospital Bulovka , Prague . METHODS 500 mg of sacharose ferric oxide ( Venofer ) was intravenously administered in two days regimen to 50 women with clinical and lab signs of postpartal anemia . The effect of administered drug was determined by comparsion of values of red blood count recovered before the treatment , 2nd or 3rd day post administration and two weeks later . The serum values of soluble transferrin receptors and ferritin were observed as markers of iron cell saturation and body iron reserves , too . Integral part of the study was the monitoring of adverse events during the treatment . RESULTS Venofer came in sight as effective drug in the treatment of pospartal anemia and could become as the alternative to blood transfusion in mid-severe cases . It should be emphasized that we have not encountered any serious adverse event with intravenous trivalent saccharose ferric oxide treatment .

trivalent ferrum preparation ]

trivalent ferrum preparation .

sacharose ferric oxide ( Venofer )

Venofer

trivalent saccharose ferric oxide

effectivity

safeness

values of red blood count

iron cell saturation

body iron reserves

adverse events

effective

serious adverse event

postpartum

Prague

Prague

women


[ Clinical study of the efficacy of and tolerance to nimesulide in suppository formulation in pain-inflammatory pathologies of the ear , nose , and throat ] . The efficacy and tolerability of a new pharmaceutical form of the non-steroid anti-inflammatory drug . Nimesulide have been studied in a double blind study compared with flurbiprofen , in 98 patients aged between 18 and 75 suffering from pain-inflammatory pathologies of ENT nature . Both drugs , administered in a dose of one suppository twice a day for 7 days , showed marked anti-inflammatory , analgesic and antipyretic activity and produced a significant , progressive improvement in the typical symptoms of the inflammatory state up to their complete remission . Nimesulide evidenced greater speed and duration of therapeutic action . Assessment on the effectiveness and tolerability as expressed separately by the physician and patient were positive in almost all cases of both treatments .

nimesulide

Nimesulide

flurbiprofen

Nimesulide

efficacy

tolerance

efficacy

tolerability

symptoms of the inflammatory state

duration

effectiveness

tolerability

aged between 18 and 75


Salmeterol plus fluticasone propionate versus fluticasone propionate plus montelukast : a randomised controlled trial investigating the effects on airway inflammation in asthma . BACKGROUND Few studies have compared treatment strategies in patients with asthma poorly controlled on low dose inhaled corticosteroids , and little is known about the effects of different treatments on airway inflammation . In this double-blind , placebo-controlled , parallel group study , we compared the effects of salmeterol plus fluticasone propionate ( FP ) ( Seretide ; SFC ) and FP plus montelukast ( FP/M ) on sputum inflammatory markers , airway responsiveness , lung function , and symptoms in adult asthmatics . METHODS Sixty-six subjects were randomised to SFC or FP/M for 12 weeks . The primary outcome was changes in neutrophil , eosinophil , macrophage , lymphocyte , and epithelial cell levels in induced sputum . Additional outcomes included the change in other sputum markers of airway inflammation , airway responsiveness , symptom control , and lung function . RESULTS Both treatments had no significant effect on induced sputum inflammatory cells , although there was a trend for a reduction in sputum eosinophils . Both treatments significantly improved airway responsiveness , whereas SFC generally led to greater improvements in symptom control and lung function than FP/M . FP/M led to significantly greater reductions in sputum cysteinyl leukotrienes than SFC ( treatment ratio 1.80 ; 95 % CI 1.09 , 2.94 ) . CONCLUSION Both treatments led to similar control of eosinophilic airway inflammation , although PEF and symptom control were better with SFC . STUDY NUMBER : SAM40030 ( SOLTA ) .

Salmeterol

fluticasone propionate

fluticasone propionate

montelukast :

salmeterol

FP

montelukast ( FP/M )

SFC

FP/M

SFC

FP/M . FP/M

SFC

SFC .

airway inflammation

sputum inflammatory markers

airway responsiveness , lung function

symptoms

sputum inflammatory

sputum eosinophils .

airway responsiveness

symptom control and lung function

sputum cysteinyl leukotrienes

eosinophilic airway inflammation

patients with asthma

adult

asthmatics .

Sixty-six subjects