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At least 1,225 records · Page 68Linked to original sources

PubMed1982

Zopiclone to geriatric patients. A parallel double-blind dose-response clinical trial of zopiclone as a hypnotic to geriatric patients - a study in a geriatric hospital.

Zopiclone was given for 14 nights to 68 geriatric patients (mean age 81 years) with sleep problems. The patients were randomly allocated to four treatment groups: 3.75 mg, 5.0, 7.5, or 10.0 mg of zopiclone. Sleep quantity and quality, side effects, and influence on psychomotor performance (digit symbol substitution and letter cancellation test) were studied before treatment, during active treatment, and after withdrawal of the drug. All patients slept better on zopiclone compared to placebo. There were only slight differences between the different dose levels as regards quantity and quality. No influence on psychomotor performance could be shown. The side effects were mild. Zopiclone showed a good hypnotic efficacy, and 7.5 mg is probably the best dose for elderly patients.

Aged↗

PubMed1989

The incidence of myocardial ischemia during anesthesia for coronary artery bypass surgery in patients receiving pancuronium or vecuronium.

This study was performed to compare the incidence of prebypass myocardial ischemia in patients receiving fentanyl and enflurane for anesthesia along with either pancuronium or vecuronium. Ninety-eight patients with normal left ventricular function were randomly allocated to receive either pancuronium 0.15 mg.kg-1 or vecuronium 0.15 mg.kg-1 in a double-blind manner after fentanyl 40 micrograms.kg-1 for induction of anesthesia for elective coronary artery bypass grafting (CABG). Premedication included diazepam 0.15 mg.kg-1 po, morphine 0.10 mg.kg-1, and scopolamine 0.005 mg.kg-1 im. Two lead Holter monitor recordings (leads V6 and V9) from the time of arrival in the operating suite to institution of cardiopulmonary bypass were analyzed for ischemia by a cardiologist blinded to the choice of muscle relaxant. Intraoperatively, heart rates greater than 90 beats.min-1 and systolic blood pressure +/- 20% of ward values were treated with propranolol, enflurane, or phenylephrine. Nitroglycerin was infused for ECG signs of ischemia or pulmonary hypertension. After induction of anesthesia the heart rate and cardiac index were consistently decreased in patients receiving vecuronium and also lower in these patients compared with those receiving pancuronium. Thirty-two per cent of patients receiving pancuronium received propranolol for heart rates greater than 90 beats.min-1 versus 7% of those who received vecuronium (P approximately 0.01). Eight patients developed 13 episodes of ischemia after administration of the muscle relaxant: four who received pancuronium (n = 44; 9%) and four receiving vecuronium (n = 54; 7%). Four episodes occurred at induction or tracheal intubation, two in each group. There were four perioperative myocardial infarctions as determined by ECG and CPK-MB levels, two in each group.(ABSTRACT TRUNCATED AT 250 WORDS)

Anesthesia, Inhalation↗

PubMed1989

Trial of antihypertensive interventions and management. Design, methods, and selected baseline results.

The Trial of Antihypertensive Interventions and Management was a multicenter randomized, placebo-controlled trial designed to assess the effectiveness of various combinations of pharmacologic and dietary interventions in the treatment of mild hypertension (diastolic blood pressure 90-100 mmHg). The primary outcome was blood pressure change between baseline and 6 months. The study consisted of a 3 X 3 factorial design wherein participants were randomly allocated to nine drug-diet treatment groups. Drugs included placebo, diuretic, and beta-blocker. Diets were usual, weight loss, and low sodium/high potassium. The basic strategy was to address clinical questions of interest by comparing mean blood pressure changes of selected drug-diet combinations. This paper describes the study including experimental design, sample size considerations, statistical analysis, organizational structure, and baseline findings.

Adult↗

PubMed1987

Comparative trial of azapropazone and indomethacin plus allopurinol in acute gout and hyperuricaemia.

This study compared the effects of azapropazone and indomethacin plus allopurinol in the management of acute gout and hyperuricaemia. A group of 93 patients predominantly based in general practice were randomly allocated to the two treatment regimens (azapropazone (days 1-225) or indomethacin (1-28) followed by allopurinol (29-225)) on a double-blind double dummy basis. Azapropazone produced a substantial reduction in serum uric acid levels by day 4 compared with day 1 (P<0.002) and was superior to indomethacin with regard to recorded levels of serum uric acid at day 4 (P<0.01) and day 28 (P<0.05). From day 28 onwards allopurinol produced and azapropazone maintained similar reductions in serum uric acid. Both treatments rapidly controlled the initial acute attacks of gout and both produced side effects similar in frequency and nature. Fewer breakthrough attacks of gout occurred in the azapropazone group (12) than the indomethacin/allopurinol group (21).Although the results achieved in both treatment groups were similar it has been shown that azapropazone is effective monotherapy for controlling both acute attacks of gout and hyperuricaemia.

Adult↗

PubMed1988

Outcome after general anaesthesia for repair of fractured neck of femur. A randomized trial of spontaneous v. controlled ventilation.

One hundred and fifty-two patients undergoing surgery for fractured neck of femur were randomly allocated to receive either general anesthesia with spontaneous ventilation with nitrous oxide and halothane in oxygen or general anaesthesia with controlled ventilation with fentanyl, nitrous oxide and halothane in oxygen. Atracurium was used to provide muscle paralysis in 65% of the latter group, the remainder receiving no neuromuscular blocking agent other than suxamethonium for intubation. Patients were followed up for 6 months. Mortality and outcome were not significantly different between the groups. Overall mortality at 4 weeks was 5.2%, and at 6 months was 15.1%--figures which are considerably lower than in some other comparable studies. This study does not support the suggestion that general anaesthesia with controlled ventilation is associated with increased postoperative mortality.

Aged↗

PubMedDate not supplied

Nadolol can prevent the first gastrointestinal bleeding in cirrhotics: a prospective, randomized study.

Propranolol has been reported to prevent the risk of hemorrhage in patients who survived episodes of variceal rupture. Since the first bleeding episode can be lethal, we did a prospective, randomized trial to see whether beta-blockers could also prevent the first hemorrhage. Seventy-nine consecutive cirrhotics with large esophageal varices by endoscopy and who had never bled were randomly allocated to one of the following treatments: placebo; ranitidine (300 mg per day), or nadolol (40 to 120 mg per day)--which is not cardio-selective, reduces portal hypertension and does not interfere with renal flow. Since no significant differences between ranitidine and placebo treatment were observed, the two groups were combined as the control group and compared with the nadolol group. After a mean follow-up of 24 months, only 1 of the 30 patients in the nadolol group had bled, while 11 of the 49 patients in the control group had bled. The percentages of patients who had not bled 1 and 2 years after the inclusion were 100 and 94.4% for the nadolol group and 81.2 and 70.2% for the control group (p less than 0.02), respectively. There were no differences in the mortality rate. In conclusion, nadolol significantly protects against the first gastrointestinal bleeding episode in cirrhotics.

Clinical Trials as Topic↗

PubMed1988

Chlorthalidone reduces calcium oxalate calculous recurrence but magnesium hydroxide does not.

We examined the effectiveness of chlorthalidone or magnesium hydroxide in the prevention of recurrent calcium oxalate kidney calculi. In a double-blind random allocation design daily dosages of 25 or 50 mg. chlorthalidone, 650 or 1,300 mg. magnesium hydroxide, or an identical placebo were administered. All groups showed significantly decreased calculous events compared to the pretreatment rates. During the trial 56.1 per cent fewer calculi than predicted developed in the placebo group (p less than 0.01), whereas the groups receiving low and high dosage magnesium hydroxide showed 73.9 and 62.3 per cent fewer calculi, respectively (p less than 0.001 and less than 0.01, respectively). Chlorthalidone treatment resulted in a 90.1 per cent decrease from predicted rates and both dosages yielded similar results. When the treatments were compared chlorthalidone was significantly better than the placebo or magnesium hydroxide (p less than 0.01). The large decreases in calculous events seen when placebo or ineffective therapy was given underscore the positive treatment bias that occurs when historical controls are used and they demonstrate the need for proper experimental design.

Calcium Oxalate↗

PubMed1999

A study of client-focused case management and consumer advocacy: the Community and Consumer Service Project.

OBJECTIVE: The study investigated the provision of client-focused services to community-based clients with schizophrenia and bipolar disorder. It hypothesised that the delivery of more client-focused services would improve client outcome in terms of functioning, disability and satisfaction with services. Client-focused services were developed using an empowerment model of case management and by the addition of consumer advocates. METHOD: Clients referred for case management were randomly allocated to one of three groups: standard case management (n = 35), client-focused case management (n = 39), or client-focused case management plus consumer advocacy (n = 45). Measures of functioning, disability, quality of life, burden of care and service satisfaction were measured at baseline and 12 months. Outcome data were collected concerning number and duration of hospital readmission, crisis intervention and compliance with treatment and services. RESULTS: While there were no differences between the groups on quantitative measures of functioning, disability, quality of life, service satisfaction and burden of care, there were significant between-group differences on qualitative measures of satisfaction with services. CONCLUSIONS: Several methodological difficulties hampered interpretation of the findings. Although clients did not differ on outcome measures of functioning and disability, the group receiving client-focused case management reported greater satisfaction with service delivery.

Adolescent↗

PubMedDate not supplied

Oral immunisation with killed Haemophilus influenzae for protection against acute bronchitis in chronic obstructive lung disease.

Fifty patients with chronic obstructive lung disease were randomly allocated to three groups, to assess whether an oral vaccine containing non-typable Haemophilus influenzae protected against acute bronchitis. The double-blind prospective study over a three-month winter period included two placebo groups and one test group. Oral immunisation with H influenzae induced a tenfold reduction in the incidence of infection (p less than 0.001). During the subsequent winter, without further immunisation, protection by the vaccine was no longer statistically significant. There was no clear correlation between clinical protection and either carriage of H influenzae or the level of antibody to H influenzae antigen in saliva.

Acute Disease↗

PubMed1985

Potassium supplementation fails to lower blood pressure in hypertensive patients receiving a potassium losing diuretic.

Thirty-three patients with hypertension receiving drug treatment that included a potassium losing diuretic were randomly allocated to 64 mmol of potassium (14 patients) or to no additional potassium supplementation (19 patients). Potassium was administered as slow release potassium chloride. After 3 months, blood pressure fell by 5/1 mm Hg in the patients who received the supplements and by 7/4 mm Hg in those who did not receive them. The falls in pressure were not significantly different and the 90% confidence limits for the effect of supplementation on diastolic pressure were: a fall of 2 mm Hg and a rise of 11 mm Hg, thus excluding an important hypotensive effect in these patients. Conversely, plasma creatinine fell by 11% in the supplement group compared with a 6% rise in the control group (P less than 0.05). Potassium supplementation, either by pharmacological preparations or by dietary manipulation, may prove to be desirable in patients on a potassium losing diuretic but should not be expected to lower blood pressure in such patients.

Benzothiadiazines↗

PubMed1989

Amoxicillin in the treatment of asymptomatic bacteriuria in pregnancy: a single dose of 3 g amoxicillin versus a 4-day course of 3 doses 750 mg amoxicillin.

A prospective, randomized, controlled comparative clinical trial was carried out with the aim of investigating the efficacy and tolerance of two different dosage regimens of amoxicillin in the treatment of asymptomatic bacteriuria during pregnancy. Patients in group A received a single dose of 3 g amoxicillin, which was compared to a 4-day course of 3 X 750 mg amoxicillin tablets taken every 8 h (group B). Significant bacteriuria (CFU greater than or equal to 10(5)/ml clean catch midstream urine and CFU greater than or equal to 10(4)/ml urine obtained by bladder catheterization) was diagnosed using the dip-slide method (Uricult). 91 pregnant women with a mean gestational age of 25 weeks (14-38) were randomly allocated to the two treatment groups. 53 patients were assigned to group A and 38 patients to group B. The treatment groups were comparable in terms of age and duration of pregnancy. Urine culture tests were performed 1 and 4 weeks after completion of therapy. The predominant species was Escherichia coli, which was isolated in 60-65% of the cases. Bacteriological cure rates at 1 and 4 weeks, respectively, were 77 and 74% in group A, and 62 and 62% in group B. These differences were statistically not significant. The incidence of side effects was 4% in group A and 13% in group B. The results obtained in the present study suggest that in the treatment of asymptomatic bacteriuria in pregnancy, a single dose of 3 g amoxicillin is as effective and acceptable as a 4-day course. In addition, the single-dose regimen offers the advantage of a reduction in total dose, lower costs and better patient compliance.

Adolescent↗

PubMed1990

Long-term treatment of chronic bronchitis with positive expiratory pressure mask and chest physiotherapy.

Long-term treatment of chronic bronchitis with chest physiotherapy with or without positive expiratory pressure (PEP) by mask was studied in 43 patients randomly allocated to PEP treatment (PEP group, 20 patients) and conventional chest physiotherapy (control group, 23 patients). After instruction, the treatments were self-administered twice daily for 12 months (34 patients) and 5 months (9 patients). Twice weekly, patients filled in a diary concerning symptoms. The PEP group had significantly less cough and less mucus production. The number of acute exacerbations were calculated from the diaries and were lower in the PEP group compared to the control group, and 85 percent of the patients in the PEP group were free from acute exacerbations versus 48 percent in the control group. The PEP group also used less antibiotics and mucolytics. The PEP group had a small increase in FEV1 of mean 62 ml compared to a small decrease of 43 ml for the control group. Treatment with a simple PEP device can reduce morbidity in patients with chronic bronchitis and may preserve lung function from a more rapid decline.

Breathing Exercises↗

PubMedDate not supplied

A randomized double-blind investigation of cefroxadine (CGP 9000) versus cephalexin in urinary tract infection.

A total of 64 out-patients with significant urinary tract infection were randomly allocated to treatment with cefroxadine 250 mg q.i.d. or cephalexin 500 mg q.i.d. for ten days. Urine cultures were performed before allocation to the treatment groups and on Days 0, 1, 3, 7 and 21. Twenty patients discontinued treatment prematurely because of insignificant bacteriuria on Day 0. Both drug regimes--the cefroxadine dose was half that of cephalexin--showed good activity during treatment, and no statistically significant differences were found between the two drugs. At follow-up, several relapses were found in both treatment groups. Adverse drug reactions were only reported by three patients in the cefroxadine group, and by none in the cephalexin group.

Adult↗

PubMed1986

A prospective randomised trial comparing spinal anaesthesia using hyperbaric cinchocaine with general anaesthesia for lower limb vascular surgery.

One hundred and one patients were randomly allocated to have their peripheral vascular surgery performed under general anaesthesia (51 patients) or spinal anaesthesia (50 patients). Intraoperative haemodynamic changes were markedly different between the two groups with a higher incidence of hypotension in the spinal group (72% vs 31%) and a higher incidence of hypertension in the general anaesthesia group (22% vs 0%). Blood loss was significantly less in the spinal group (560, SD 340, ml vs 792, SD 440, ml). Postoperatively three patients from the general anaesthesia group died from causes unrelated to the anaesthesia, and one had a myocardial infarct. Two patients in the spinal group had myocardial infarcts, both had been treated for bradycardia and hypotension intraoperatively, and one died. There was a significantly higher incidence of postoperative chest infection in the general anaesthesia group (33% vs 16%). There was no significant difference between the groups in the incidence of postoperative confusion, or lower limb amputation rate or need for further surgery prior to hospital discharge.

Aged↗

PubMedDate not supplied

A randomized trial of aspirin and sulfinpyrazone in patients with TIA.

In a double-blind multicenter study, 124 patients with transient ischemic attacks were randomly allocated to one of two groups treated with aspirin (ASA) or sulfinpyrazone respectively. Patients were followed up to assess the relative efficacy of the two treatments in the prevention of the outcomes of stroke, myocardial infarction, vascular death, and worsening or no improvement of TIAs. No significant difference was observed between the two treatments at the end of the follow-up period. Statistical analysis revealed a significant interaction of sex, treatment, and occurrence of events. Analysis of the results according to sex showed that male patients treated with ASA had a highly significant benefit (p less than 0.001) with a 53% risk reduction for further events. In female patients, sulfinpyrazone showed a favorable trend which was not statistically significant.

Adult↗

PubMed1984

Randomised comparative study of mefloquine, qinghaosu, and pyrimethamine-sulfadoxine in patients with falciparum malaria.

A prospective trial in 80 patients randomly allocated to four antimalarial treatment regimens--mefloquine plus pyrimethamine-sulfadoxine ('Fansidar'); mefloquine plus qinghaosu; mefloquine, fansidar, and qinghaosu; and qinghaosu alone--was carried out on Hainan Island, China, in patients with chloroquine-resistant falciparum malaria. A radical cure with slight side-effects was obtained with mefloquine plus fansidar; the addition of qinghaosu greatly increased the rate of parasite clearance with no additional side-effects. Qinghaosu alone had a rapid rate of parasite clearance, no side-effects, but a high recrudescence rate. These antimalarial drugs seem to act at different stages of the asexual parasite cycle and their most efficient use may depend on when in the course of the disease they are given. Because of the continuing appearance of drug-resistant strains of Plasmodium falciparum combination drug therapy is now indicated, but which drugs and how best they should be used remains to be decided.

Adolescent↗

PubMed1987

Treatment of bacterial infections of the female urinary tract by immunization of the patients.

In an open comparative study 400 patients with urinary tract infections were randomly allocated to two treatment groups. In 202 patients an immune stimulation against uropathogenic bacteria was produced with a new preparation, SolcoUrovac, and only in exceptional cases with pronounced symptomatology was antibiotic therapy given, while in the control group (n = 198) all patients were treated with nitrofurantoin or with another appropriate antibiotic, according to the antibiogram. In the subsequent 12-month observation period 28 infections occurred in 23 patients of the immune-stimulated group and 84 in 47 patients of the control group. This difference is statistically significant (p less than or equal to 0.001). The preventive effect of the SolcoUrovac therapy was particularly impressive in patients with recurrent urinary tract infections. Thirty-two patients from each group with similar case histories, as matched pairs, were evaluated separately. The relapse rate in the 12-month observation period amounted to 2 re-infections in the group treated with immunotherapy and to 29 in the control group. All side-effects were recorded. No adverse effects were observed in pregnant women or in their offspring.

Bacterial Infections↗

PubMedDate not supplied

Influence of drape permeability on wound contamination during mastectomy.

Sixty-one patients undergoing mastectomy at three hospitals were randomly allocated to receive one of three types of drape: permeable linen sealed to the skin with self-adhesive nonwoven tape, and impermeable nonwoven with self-adhesive edges. Bacteriological contamination was assessed both in the wound and in the wound surroundings. The air counts at the centres differed but were generally low, mean approximately 10(1) colony-forming units (CFU)/m3 but higher at the beginning of the operation. Patients whose skin counts were high before disinfection had the highest skin counts after disinfection and operation and gave the highest counts on the gloves of the surgeon. The use of impermeable drapes instead of permeable linen drapes resulted in significantly fewer bacteria in the operative field (393 CFU/50 cm2 compared with 664, p less than 0.002) and also in the wound itself (12 compared with 164 CFU/sample, p less than 0.01). As a result of correlations between counts, we are also able to show how bacteria transfer from the patient's skin to the surgical wound.

Air Microbiology↗