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PubMed1987

Coagulation and fibrinolysis in post-menopausal women treated with Org OD 14.

The effects of a new synthetic steroid Org OD 14 on the haemostatic mechanism were investigated in 60 post-menopausal women, randomly allocated to 12 weeks of treatment with either 2.5 mg/day of Org OD 14 or a placebo in a double-blind, group-comparative study. Assessments were made 2 weeks before and just prior to the start of treatment, at weeks 6 and 12 during treatment, and 2 weeks after its cessation. No significant differences between the two groups were found with regard to prothrombin time, kaolin cephalin clotting time (KCCT), clotting factors VII, VIII and X, white blood count (WBC) or transaminases (ASAT, ALAT). The following statistically significant differences were seen in the Org OD 14 group: higher plasminogen, antithrombin III, haemoglobin, haematocrit and platelet count, and increased fibrinolytic activity on fibrin plates, as well as lower fibrinogen and alkaline phosphatase values. These findings indicate that Org OD 14 displays no adverse effects on coagulation, while changes in fibrinolysis seem to be beneficial for post-menopausal women.

Blood Coagulation↗

PubMed1988

Arterial oxygen saturation during upper gastrointestinal endoscopy: influence of sedation and operator experience.

In order to compare the effects of Diazemuls and midazolam on arterial oxygen saturation during upper gastrointestinal endoscopy, 120 patients were randomly allocated to receive Diazemuls, midazolam, or normal saline. Endoscopy was performed by one consultant or one of four residents. Arterial oxygen saturation was monitored continuously during endoscopy by means of a Biox III pulse oximeter and ear probe. Oxygen saturation fell during endoscopy in all three groups, but no significant differences between the groups were detected at any stage of the procedure. When all groups were combined, there was significantly less desaturation when the consultant performed the endoscopy, and he was also significantly faster in carrying out endoscopy than the residents in each group. When an inexperienced resident was compared with one with at least 6 months of experience, there were significant differences in degree of desaturation, lowest value during endoscopy and tolerance score. It is suggested that the patient at risk of hypoxemia should, if possible, be endoscoped by an experienced endoscopist.

Clinical Competence↗

PubMed1988

Antagonism of midazolam sedation by flumazenil: a placebo-controlled study in patients recovering from intravenous anaesthesia with high doses of midazolam.

Twenty adult surgical patients were anaesthetized with high-dose midazolam and alfentanil by infusion, vecuronium, and intubated and ventilated with 50% N2O in O2. The midazolam and alfentanil infusions were stopped at the end of surgery. Residual neuromuscular blockade and ventilatory depression were antagonized and the patients extubated. In the recovery room, patients were randomly allocated to receive either flumazenil 1 mg of placebo i.v. Before, and until 2 h after injection, patients were asked to perform psychomotor tests. In addition, sedation, comprehension and orientation were scored. The flumazenil (n = 10) and the placebo (n = 10) groups were comparable. Prior to injection all patients were heavily sedated. After flumazenil all were awake within 2-3 min, but fell asleep again 15-60 min later. The improvement in test scores was sustained for a longer time. After placebo, patients awoke in 1-2 h. At 60 and 120 min, test scores in the two groups were similar. Heart rate, blood pressure and respiration rate did not change. No side-effects were observed or reported. It is concluded that flumazenil is an effective and safe antagonist of high dose midazolam, with a rapid onset but a short duration of action.

Adult↗

PubMedDate not supplied

The Northwick Park electroconvulsive therapy trial.

70 patients with endogenous depression, defined by strict criteria, who fulfilled the Newcastle indications for electroconvulsive therapy (ECT) were randomly allocated either to a course of eight simulated ECTs or to a course of eight real ECTs. The improvement in terms of psychiatrists' ratings in the group of patients given real ECT was significantly greater (p < 0.01) than that in those given simulated ECT, but the difference between the two groups was small in relation to the considerable improvement of both groups over the 4-week treatment period. No differences were found between the two groups at one-month and six-month follow-up. The therapeutic benefits of electrically induced convulsions in depression were of lesser magnitude and were more transient than has sometimes been claimed. In the real-ECT group memory was impaired during treatment but memory tests revealed no difference between the groups at six-month follow-up.

Adult↗

PubMed1988

Combination treatment with cholestyramine and bezafibrate for heterozygous familial hypercholesterolaemia.

Cholestyramine and bezafibrate were compared individually and in combination in the treatment of 18 patients with heterozygous familial hypercholesterolaemia. The study used a double blind, placebo controlled block design with a placebo run in period of two months followed by three phases of active treatment, each of two months' duration. Patients were randomly allocated to one of the six possible sequences of medication so that three patients would be treated with each sequence. Two patients withdrew from the study before completion. The median concentration of total cholesterol decreased from 9.65 mmol/l (interquartile range 8.62 to 8.72) to 7.24 mmol/l (6.70 to 7.52) with cholestyramine, to 8.09 mmol/l (7.18 to 8.68) with bezafibrate, and to 6.31 mmol/l (5.84 to 7.27) with the combination. This fall was due almost entirely to a decrease in the low density lipoprotein cholesterol concentration, and the combination was significantly more effective than either drug alone. The 98% confidence intervals for the median differences between the combination and cholestyramine and the combination and bezafibrate were 0.04 to 1.49 mmol/l and 0.51 to 2.18 mmol/l respectively. These results suggest that this combination is an effective and useful treatment in heterozygous familial hypercholesterolaemia.

Adult↗

PubMed1984

Effectiveness of speech therapy for aphasic stroke patients. A randomised controlled trial.

Aphasic stroke patients were randomly allocated to either a speech therapy group receiving treatment twice a week for 24 weeks or a no-treatment control group. Patients in both groups improved and there were no significant differences in language recovery between the 104 patients allocated to the treatment group and the 87 allocated to the no-treatment group. This treatment regimen, which is representative of clinical practice, is ineffective for most aphasic stroke patients.

Acute Disease↗

PubMed1991

Adenosine provokes myocardial ischaemia in patients with ischaemic heart disease without increasing cardiac work.

Intravenous infusion of adenosine in patients with ischaemic heart disease (IHD) has been shown to induce chest pain and ST-depression. The aim of this study was to determine whether such myocardial ischaemia could be due to an increase in myocardial work. Thus patients with stable angina pectoris (n = 8) were randomly allocated to exercise or adenosine infusion, with a 1-h rest period before the second test. The maximal tolerable work load was 120 +/- 13 W, where all patients but one experienced typical angina pectoris. ECG revealed ST-depressions in all patients. The maximal tolerable dose of adenosine was 108 +/- 6 micrograms kg-1 min-1. All patients experienced chest pain typical of habitual angina pectoris, and all but one developed ST-depressions. During exercise there was a gradual and marked increase in the rate pressure product (RPP), in parallel with the development of ST-depression. By contrast, during infusion of adenosine there was only a minor increase in RPP (P = 0.0001). In conclusion, infusion of adenosine provokes signs and symptoms of myocardial ischaemia in patients with IHD with only a minor increase in cardiac work compared to exercise. These results are consistent with the hypothesis of a myocardial steal.

Adenosine↗

PubMed1987

Ipratropium bromide: bronchodilator action and effect on methacholine-induced bronchoconstriction.

The effects of ipratropium bromide (80 and 200 micrograms) and placebo on the basal bronchial tone and on methacholine-induced bronchoconstriction were investigated in 10 asthmatic patients in a placebo-controlled double-blind manner. Bronchial hyperreactivity to methacholine was confirmed at a pretrial bronchial challenge. The patients were randomly allocated to two groups in which the drug was inhaled from either metered-dose inhalers (MDI) or powder capsules. With the high dosage, the bronchodilation resulting from powder capsules was somewhat more pronounced than that achieved with the MDI. Otherwise the bronchodilator effect of ipratropium bromide and the protection afforded by the drug against methacholine-induced bronchoconstriction were similar in the two groups. In five patients the bronchodilator effect was better and in four patients the tolerance to methacholine was greater after the higher ipratropium dosage than after the lower one. In two patients ipratropium bromide had no bronchodilator effect but gave good protection against methacholine-induced bronchoconstriction. It is concluded that some patients benefit from a dosage of ipratropium bromide higher than that usually recommended and that an anticholinergic effect on the bronchi is possible even in the absence of the bronchodilator effect in the basal state.

Administration, Inhalation↗

PubMed1987

Efficacy and influence on quality of life of enalapril as a first step treatment of hypertension.

205 patients with mild to moderate uncomplicated hypertension participated in a six-month double-blind parallel study performed in a unique center. After a two-week single-blind placebo period, the patients were randomly allocated to receive either Enalapril 20 mg once-a-day or placebo as the first step treatment. They were then followed-up every two weeks and successive doses of hydrochlorothiazide, oxprenolol, and dihydralazine were added until the diastolic pressure was lower than 90 mmHg. After six months, the systolic and diastolic blood pressures were lower in the Enalapril than in the control group (129/82 +/- 12/6 mmHg versus 136/86 +/- 10/5 mmHg; p less than 0.001). Drug withdrawal was necessary for 8 patients in the Enalapril group and for 16 patients in the control group (p less than 0.05). The number of daily tablets was 2.7 +/- 1.8 in the Enalapril group and 4.4 +/- 2.4 in the control group (p less than 0.01). Therefore, a stepped-care program based on Enalapril appears significantly more effective than a stepped-care program based on a diuretic.

Adult↗

PubMed1985

Fine bore jejunostomy feeding following major abdominal surgery: a controlled randomized clinical trial.

A randomized controlled prospective clinical trial has been undertaken to examine the efficacy of the technique of early postoperative feeding using a fine bore catheter jejunostomy. Fifty patients undergoing surgery for gastrointestinal malignancy were randomly allocated into treatment and control groups. A low residue liquidized diet (Isocal) was administered to the patients in the treatment group. Control patients received routine intravenous therapy. Nutritional parameters (serum albumin, serum transferrin, serum prealbumin, weight, body fat and fat free mass) were measured pre-operatively and on the tenth postoperative day. Postoperative surgical complications were similar in both groups. There were 20 catheter complications and one death directly attributable to the jejunal catheter feeding. Postoperative stay was significantly longer (P less than 0.01) in the treatment group patients. Evaluation of the nutritional parameters showed no advantage for either the treatment group or a selected complication-free, 'successful treatment', subgroup. It is concluded that no significant clinical or nutritional advantage for jejunal catheter feeding has been demonstrated and because of the related complications, its routine use cannot be recommended.

Aged↗

PubMed1988

A double-blind randomized controlled trial on the use of prophylactic antibiotics in patients undergoing elective caesarean section.

In a double-blind randomized controlled study 232 patients undergoing elective lower segment caesarean section were randomly allocated to receive a pre-operative prophylactic dose of a combination of crystalline penicillin and chloramphenicol or a placebo. The two groups were comparable in terms of patient characteristics and operation variables. The group receiving antibiotics had significantly fewer febrile and infectious morbid events and thus spent fewer days in hospital than the group receiving the placebo.

Adult↗

PubMed1989

Effect of intravenous diltiazem on myocardial ischemia occurring during percutaneous transluminal coronary angioplasty.

To investigate the antiischemic efficacy of intravenously administered diltiazem, 42 patients were randomly allocated to receive placebo or active treatment before 1-vessel percutaneous transluminal coronary angioplasty (PTCA). The development of myocardial ischemia was studied using subjective (pain) and objective (electrocardiography) parameters. Pretreatment with intravenous diltiazem resulted in a significantly delayed onset of ischemic pain and ST-segment elevation; these variables also returned to baseline earlier after balloon deflation. Thus, intravenous diltiazem prevents or delays the onset of myocardial ischemia during repetitive transient coronary occlusions; improvement of the myocardial blood flow distal to the coronary occlusion or impedance of calcium entry into the ischemic cell are considered as possible mechanisms. Because PTCA is increasingly used in patients with poor left ventricular function and more extensive disease, and because recent evidence suggests that better PTCA results could be obtained by the use of longer inflation times, the addition of diltiazem to the classic armamentarium could be beneficial.

Angina Pectoris↗

PubMed1983

Perivascular axillary block II: influence of injected volume of local anaesthetic on neural blockade.

Perivascular axillary blockade was performed on 150 patients with the aid of a catheter technique. Blockade failure due to injection outside the neurovascular sheath was found in 5.7% of the subject material. The patients were randomly allocated to three groups. The amount of local anaesthetic was constant in each group: 400 mg mepivacaine with adrenaline. However, the injected volume was a variable factor, namely 20, 40 or 80 ml. Sensory and motor blockade was tested 30 min after each injection. The following results were obtained: 1) Apart from the axillary, musculocutaneous and radial nerves, a high frequency of analgesia was found in all cutaneous areas (over 85%). 2) In the axillary area, improvements were found with increasing volume. 3) Analgesia in the musculocutaneous area occurred in 52% of the patients in group 1 (20 ml) and improved to 75% in group 2 (40 ml). However, no difference was found between group 2 and group 3 (80 ml). 4) Volume had no influence on analgesia in the radial area. 5) Motor blockade was intensified with decreasing volume, i.e. with an increase of concentration of local anaesthetic solution.

Adult↗

PubMed1984

Oral ketoconazole and amphotericin B for the prevention of yeast colonization in patients with acute leukaemia.

Forty-eight neutropenic patients with acute leukaemia were randomly allocated to receive, as antifungal prophylaxis, either ketoconazole, 400 mg once daily (K), or amphotericin B tablets and lozenges (A), or both ketoconazole and amphotericin B together (K + A). Antifungal prophylaxis was considered to have failed if (1) there was evidence of increasing colonization of the oropharynx or faeces with Candida spp. or other yeasts, or (2) if systemic antifungal therapy was begun empirically. Prophylaxis failed in nine of 17 patients given K, in four of 19 given A, and in four of 12 given K + A. The differences between the three regimens were not statistically significant, neither was there any significant difference in the mean duration of neutropenia before prophylaxis failed. The absorption of ketoconazole was impaired when patients were neutropenic. We conclude that ketoconazole was neither more nor less effective than amphotericin B in the prevention of yeast colonization in neutropenic patients.

Adolescent↗

PubMed2005

Utilization of ensiled sweet potato (Ipomoea batatas (L.) Lam.) leaves as a protein supplement in diets for growing pigs.

Four diets were formulated with protein from fishmeal (FM), groundnut cake (GC), ensiled sweet potato (Ipomoea batatas L. (Lam.)) leaves (SP) or ensiled sweet potato leaves with lysine (SPL). In experiment 1, 24 crossbred (Large White x Mong Cai) growing pigs were allocated randomly by sex into four groups of six pigs and given one of four diets. Experiment 2 was conducted using 16 crossbred pigs (Large White x Mong Cai) at four farms. On each farm, pigs were allocated to two experimental groups. One group was fed the FM diet and the other group the SPL diet. In experiment 1, the daily live weight gains (DLWG) were significantly higher (p < 0.05) for the FM and SPL treatments (542 and 536 g/day, respectively) than for the GC and SP treatments (464 and 482 g/day, respectively). Feed intake was highest (2.0 kg/day) for the SPL and lowest (1.7 kg/day) for the GC treatment (p < 0.05) and feed conversion ratio (FCR) was highest (3.8 kg/kg gain) for SP and lowest (3.5 kg/kg gain) for FM (p < 0.05). There were no significant differences for carcase measurements among diets (p > 0.05). The feed cost per kg live weight gain was lowest for the SP and SPL diets compared to the FM and GC diets. The results of experiment 2 show that there were no significant differences in feed intake, DLWG and FCR between the two diets (p > 0.05). In conclusion, sweet potato leaves can replace fishmeal and groundnut cake in traditional Vietnamese diets for growing pigs.

Animal Feed↗

PubMed1987

The St. Thomas's Hospital maternity case notes study: a randomised controlled trial to assess the effects of giving expectant mothers their own maternity case notes.

At an antenatal clinic in St. Thomas's Hospital, London, 246 expectant mothers were randomly allocated to hold either their own maternity case notes or the standard co-operation card. Information was collected on three occasions during their care on attitudes and health behaviour. Clinical outcomes were recorded and the effects of the two systems on clinic administration were observed. More of the notes group expressed satisfaction with most aspects of their care and delivery and significantly more of the notes group felt well informed and satisfied with their companion during labour. There were no differences in clinical outcomes between the two groups except that, for no identifiable systematic reason, there were more assisted deliveries among the notes group. A number of administrative advantages resulted from mothers holding their own notes and although initial reservations were found amongst professional staff interviewed at the start of the study, the results proved persuasive and the practice of giving mothers their own notes is now to be extended throughout the department.

Adult↗

PubMed1991

Online access to MEDLINE in clinical settings: impact of user fees.

The effect of introducing user fees on the frequency and quality of MEDLINE searching with GRATEFUL MED by physicians in clinical settings was tested. After training and free use (prior study), consenting participants were randomly allocated to pay searching costs (pay group) or continue without fees (no pay group). Fifty-nine physicians participated. Among the prior study's frequent searchers, the pay group searched at less than one third of the rate of those assigned to no pay. For less frequent searchers in the prior study, only 48% of those assigned to pay did any searches, compared with 85% for the no pay group (P = 0.006), and for those who did search, their frequency was almost half. However, there was no significant difference in the quality of searches; both groups demonstrated about equivalent recall (P = 0.77), but significantly lower precision (P = 0.03) than for the librarian's independent searches. Similarly, there was no difference in the proportion of searches affecting clinical decisions for the two groups. Thus, imposing user charges for online searching in clinical settings after a period of free use adversely affects searching quantity, but not quality. MEDLINE providers should consider whether user fees will undermine its benefits.

Fees and Charges↗

PubMed1989

Guar gum and gemfibrozil--an effective combination in the treatment of hypercholesterolaemia.

Twenty-nine hypercholesterolaemic patients, treated for one year with gemfibrozil but being still hypercholesterolaemic (serum total cholesterol greater than or equal to 6.25 mmol/l) were included in a double-blind trial to evaluate the hypocholesterolaemic effects of gemfibrozil-guar gum combination (GE + GU) vs. gemfibrozil-placebo combination (GE + PL) using a cross-over study design. The patients were treated with gemfibrozil on a constant dosage (range 900-1200 mg/day) during the entire trial. After a 4-week run-in period on GE + PL treatment the patients were randomly allocated to 2 groups: one received GE + GU 15 g/day, and the other GE + PL for 3 months and after that groups were crossed over. Guar gum and placebo were administered as granules taken 3 times a day during meals. Serum total cholesterol was 8.61 +/- 0.17 mmol/l before gemfibrozil therapy, and 7.29 +/- 0.15 mmol/l at the end of the run-in period on GE + PL (P less than 0.01). During the double-blind phase serum total cholesterol values were 6.28 +/- 0.19 mmol/l at the end of the GE + GU treatment period and 7.21 +/- 0.16 mmol/l at the end of the GE + PL treatment period (P less than 0.01). At the end of the GE + GU treatment period serum total cholesterol was 27% lower and LDL-cholesterol 39% lower than before gemfibrozil treatment. A marked improvement (23%) was found in HDL/LDL ratio during GE + GU treatment compared with GE + PL treatment.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗