摘要:

An open, randomised study was carried out to compare the efficacy and tolerability of pefloxacin plus metronidazole with gentamicin plus metronidazole in the coadjuvant treatment of generalised purulent peritonitis. The study was conducted on 100 patients of both sexes aged 18 to 93 years who had a diagnosis of diffuse purulent peritoneal infection. The antibiotics were administered up to a period of 4 days after all clinical or microbiological signs of infection had disappeared, with total treatment not exceeding 4 weeks. At the end of treatment, 6 of the 48 patients (12.5%) receiving pefloxacin plus metronidazole (PM group) and 21 of the 52 patients (40.4%) receiving gentamicin plus metronidazole (GM group) had localised infections. When the clinical efficacy of treatment was evaluated 15 days after discharge from the hospital, 39 patients in the PM group were found to be cured (81.2%), and there were 3 deaths (6.25%). In the GM group, 29 patients were found to be cured (55.7%), and there were 8 deaths (15.4%). Thus, the cure rate was significantly higher in the PM group than in the GM group (X2= 6.323; p < 0.05). We conclude that both antibiotic regimens utilised were effective as coadjuvants in the surgical treatment of diffuse purulent peritonitis, although the pefloxacin/metronidazole combination led to a better cure rate.

ISSN:0114-2402    

出版商:ADIS    

年代:1994

数据来源: ADIS

摘要:

Having shown in a 20-week placebo-controlled double-blind crossover trial that ‘global’ antioxidant supplementation - including selenium, &bgr;-carotene, vitamin C (ascorbic acid), vitamin E (tocopherol) and methionine - curbs symptoms while correcting oxidative stress in patients with recurrent nongallstone pancreatitis, we have investigated through two further trials the relative importance of methionine versus that of the other antioxidants in effecting this good outcome. 30 consecutive patients were entered into the second study in which therapeutic intervention involved only the active metabolite of methionine,S-adenosylmethionine (SAMe), 2.4g per day in divided doses. Blood analysis showed that subnormal baseline levels of selenium, &bgr;-carotene and vitamins E and C were unchanged throughout and that drug treatment resulted in supranormal levels of SAMe in plasma. SAMe proved to be ineffective clinically as judged by attack rate and background pain, as well as biochemically as gauged by the percentages of oxidatively altered vitamin C and linoleic acid. The coadministration of selenium and &bgr;-carotene with SAMe was tested in the third study. This was abandoned when 3 patients had a clearcut attack of pancreatitis while on subsequent ‘open’ treatment. Analysis of clinical and biochemical information from 14 patients who had completed the 20-week trial confirmed the inefficacy of the combination, although active treatment normalised serum selenium and &bgr;-carotene concentrations while SAMe levels were again pushed into the supranormal range. The results show that SAMe on its own, or with additional selenium and &bgr;-carotene, is ineffective in patients with recurrent nongallstone pancreatitis. By a process of elimination with reference to biochemical measurements during the 3 trials, and considering experimental evidence of the importance of methionine for pancreatic integrity, we cautiously suggest that an effective antioxidant prescription should include SAMe (or methionine) as well as vitamin C, with additional compounds as indicated by blood measurements.

ISSN:0114-2402    

出版商:ADIS    

年代:1994

数据来源: ADIS

摘要:

The single-dose and steady-state pharmacokinetic and pharmacodynamic profiles of the nisoldipine coat-core tablet were determined in an open multiple dose nonrandomised study. 20 healthy young male volunteers, 21 healthy elderly volunteers, and 11 elderly hypertensive volunteers completed the study. One nisoldipine coat-core tablet (20mg) was administered as a single daily dose on days 1, 3, 4, 5, 6 and 7. Days 1 and 2 (after a single dose) and days 7 and 8 (after multiple doses) were pharmacokinetic and pharmacodynamic profile days.After both single and multiple doses, the plasma nisoldipine concentrations in the healthy elderly and elderly hypertensive volunteers were higher than in healthy young male volunteers. There was no accumulation of nisoldipine in the young males, but there was accumulation in the elderly. The degree of accumulation was similar for the healthy elderly and the elderly hypertensive volunteers.After multiple dose administration of nisoldipine (5 days), the supine diastolic blood pressure in the healthy young males remained unchanged, but a moderate decrease in the healthy elderly volunteers and a significant decrease in the elderly hypertensive volunteers could be seen. Substantial decreases in supine systolic blood pressure for both the healthy elderly volunteers and the elderly hypertensive volunteers were recorded. A small decrease in supine systolic blood pressure was recorded in the healthy young male volunteers.The results of this study indicate that once-daily administration of nisoldipine 20mg coat-core tablets is both safe and effective in elderly hypertensive volunteers.

ISSN:0114-2402    

出版商:ADIS    

年代:1994

数据来源: ADIS

摘要:

The efficacy and safety of cefetamet pivoxil in the treatment of community-acquired pneumonia in children were assessed in an open, randomised, comparative multicentre study in which 260 children (in- and outpatients) with either bacterial pneumonia (n = 170) or bronchopneumonia (n = 90) were enrolled. Cefetamet pivoxil, an oral third generation cephalosporin, was administered to 85 children at a dosage of 10 mg/kg twice daily, the recommended therapeutic dosage, and to 94 children at a dosage of 20 mg/kg twice daily. Cefaclor was administered to 81 children at a dosage of 10 mg/kg three times daily. The duration of treatment was 7 days. Assessments were performed on days 0, 3, 7 and 14 after initiation of treatment. Clinical signs and symptoms began to improve soon after the start of treatment, and continued to improve in all 3 treatment groups. The therapeutic outcome was considered successful in 80 of the 81 assessable patients receiving cefetamet pivoxil 10 mg/kg twice daily (98.8%), in 79 of the 81 assessable patients receiving cefetamet pivoxil 20 mg/kg twice daily (97.6%), and in 71 of the 75 assessable patients receiving cefaclor 10 mg/kg three times daily (94.7%). The differences in outcome between the 3 groups were not statistically significant. Adverse events were of gastrointestinal origin (mainly diarrhoea, nausea, and/or vomiting), and occurred with similar frequencies in the groups treated with cefetamet pivoxil 10 mg/kg twice daily and cefaclor 10 mg/kg three times daily.Cefetamet pivoxil administered at the standard dosage of 10 mg/kg twice daily was effective and well tolerated in children with bacterial pneumonia or bronchopneumonia. The twice-daily cefetamet pivoxil dose schedule compares favourably with the well-established cefaclor 3-times-daily regimen and may result in improved compliance.

ISSN:0114-2402    

出版商:ADIS    

年代:1994

数据来源: ADIS

摘要:

The effects of quinapril (an angiotensin converting enzyme inhibitor) on cardiac hypertrophy were evaluated in a noncomparative study of 98 patients with mild to moderate hypertension over 4 months. Left ventricular hypertrophy (LVH) was diagnosed using echocardiography in 60% of patients at baseline. Combination therapy with hydrochlorothiazide (HCTZ) was initiated after 1 month in patients with inadequate blood pressure control to achieve a target diastolic pressure reduction from baseline (≥ 10mm Hg) and/or reduction to < 90mm Hg. Left ventricular mass index (LVMI) was significantly reduced for patients of either sex with a baseline diagnosis of LVH, but not for those in whom LVH was not detected at enrolment. Systolic and diastolic blood pressures were also significantly reduced. The response rate was 83%, while 28% of patients required combination therapy with HCTZ. There was no correlation between the hypotensive effects of quinapril and change in LVMI. Furthermore, the addition of a diuretic did not appear to affect the LVMI response. Thus, the amelioration of LVH noted in this investigation appears to be attributable to quinapril.

ISSN:0114-2402    

出版商:ADIS    

年代:1994

数据来源: ADIS

摘要:

The efficacy of the modes of inhalation of 2 inhaled steroids (IS) were compared: beclomethasone dipropionate (BDP) delivered by pressurised metered dose inhaler (p MDI) and budesonide delivered by the inspiratory driven powder inhaler Turbuhaler®.146 asthmatic patients (mean age ± SD: 49 ± 13 years) treated for at least 6 months with constant doses of BDP (1000 to 2000μg per day) entered into an open, parallel group trial. After a 4-week run-in period, they were randomised to receive either BDP or budesonide at supposedly equivalent doses (BDP 1 puff 250μg ≡ budesonide 1 dose 200μg) for 12 weeks. Every 4 weeks the daily dose of IS was adjusted for control of disease as assessed by a 4-graded asthma score.Both treatment groups were comparable: puffs/doses (mean ± SD) of IS per day at randomisation were 5.6 ± 1.5 for the budesonide group versus 5.8 ± 1.4 for the BDP group (p = NS). 18 patients (10 in the budesonide group, 8 in the BDP group) did not complete the trial. At the end of the study, symptoms of asthma, morning and evening peak expiratory flow, puffs of &bgr;2-agonists per 24 hours, and short courses of oral steroids were comparable, but puffs/doses of IS per day (primary efficacy variable) were significantly lower in the budesonide than in the BDP group (4.5 ± 2.1vs5.4 ± 2.0; p = 0.009).The results of this trial show that budesonide administered via Turbuhaler®is more effective per μg than BDP delivered by p MDI.

ISSN:0114-2402    

出版商:ADIS    

年代:1994

数据来源: ADIS

摘要:

The purpose of this study was to evaluate the bioavailability of diclofenac sodium following stomal or rectal administration in patients after rectal surgery, and to compare it with that following rectal administration in healthy volunteers. Research into the efficacy of different routes of administration of a single dose of a nonsteroidal analgesic suppository (Voltaren®suppository) was carried out in order to investigate the degree of efficacy in patients after rectal surgery, i.e. in patients following rectal amputation (Miles group, n = 5), in patients after sphincter- and anus-preserved colorectal resection (LAR group, n = 5) and in a control group (n = 5). The Miles group demonstrated half the maximum plasma drug concentration (Cmax) and area under the plasma concentration-time curve (AUC) values found in the control group. However, the LAR group showed a plasma concentration curve similar to that of the control group. With regard to absorption of the suppository after rectal surgery, preservation of the proctal canal is a key factor in obtaining normal absorption. In the present study, none of the participating patients complained of discomfort at the application site. As one form of administration for nonsteroidal analgesics, the suppository was found to be effective and useful in patients of both the Miles and LAR groups after rectal surgery in whom oral administration was not possible.

ISSN:0114-2402    

出版商:ADIS    

年代:1994

数据来源: ADIS

ISSN:0114-2402    

出版商:ADIS    

年代:1994

数据来源: ADIS