A meta-analysis comparing the efficacy of omeprazole with H2-receptor antagonists for acute treatment of duodenal ulcer in Asian patients.

A meta-analysis was performed on pooled data from five large double-blind studies (a total of 1057 patients), which were conducted in Asia to compare the effects of omeprazole with H2-receptor antagonists (H2-RA) in duodenal ulcer. As each study followed the same protocol and data evaluation procedures, a detailed analysis of ulcer healing, symptom relief and influence of prognostic factors across the data was possible. Patients received omeprazole 20 mg om or standard doses of H2-RA for a minimum of 2 and a maximum of 4 weeks, depending on healing (as verified by endoscopy). All efficacy analyses were based on per protocol data. The mean healing rates at 2 weeks were 72% for omeprazole and 42% for H2-RA (difference 30%; 95% CI: 24-36%; P < 0.0001) and at 4 weeks were 96% for omeprazole and 83% for H2-RA (difference 13%; 95% CI: 10-17%; P < 0.0001). In addition to treatment, ulcer size had a significant influence on healing, with large ulcers (diameter > 10 mm) taking longer to heal than small ulcers. There was no significant influence of smoking and alcohol drinking on ulcer healing. Patients on omeprazole experienced significantly less epigastric pain after 2 weeks than those on H2-RA, 79% of them being completely symptom-free on omeprazole compared with 65% on H2-RA. The incidence of adverse events was approximately 5% on each treatment and profiles were similar for each drug. It is concluded that omeprazole, even in the presence of adverse prognostic influences, results in significantly better healing of duodenal ulcer and relief from symptoms than H2-RA.

[Comparative multicentric study of omeprazole versus ranitidine in the treatment of duodenal ulcer]. / Estudio comparativo multicéntrico de omeprazol frente a ranitidina en el tratamiento de la úlcera duodenal.

A total of 158 patients, aged 19-78 years and with endoscopically verified duodenal ulcer of at least 5 mm in maximum diameter were recruited. 79 patients were randomised to treatment with omeprazole, a proton-pump inhibitor of the parietal cell, and 79 patients were treated with ranitidine. This double blind study is the first clinical trial with omeprazole in Spain. Using "intention to treat" analysis there was no difference in healing rates at 2 weeks between the omeprazole group (70%) and the ranitidine group (59%) with p = 0.13. At four weeks, however, omeprazole healed significantly more patients (92%) than ranitidine (76%) with p = 0.005. Using per protocol analysis a similar result was obtained with no significant difference between omeprazole (71%) and ranitidine (63%) at two weeks (p = 0.3) but significantly greater healing on omeprazole at 4 weeks (97%) compared with ranitidine (83%) with p = 0.008. The influence of additional prognostic factors was assessed using a multivariate analysis. At two and four weeks, there was a significant effect of ulcer size on healing rate. At four weeks there was also a significant effect of treatment. Symptom relief was rapid in both treatments but the omeprazole group had significantly fewer days of pain and better patient's overall evaluation than ranitidine group. No serious adverse events were reported. In conclusion omeprazole healed significantly more duodenal ulcers than ranitidine and symptom relief was more rapid during omeprazole therapy.

Intravenous enprofylline in the treatment of patients with acute asthma.

The safety and efficacy of enprofylline were studied in 55 moderately severe asthmatic patients [forced expiratory volume in 1 s (FEV1) and peak expiratory flow rate (PEFR) no more than 50% of predicted values] presenting with an acute attack. A bolus injection of 1.5 mg/kg enprofylline was given over 20 min and then maintenance infusion of 0.4 mg/kg.h enprofylline for up to 24 h. On admission, 200 mg hydrocortisone was administered intravenously and additional oxygen and/or inhaled beta 2-agonist therapy was permitted after 1 h; this additional therapy was given to 39 patients. The bolus injection increased the PEFR from 121 +/- 44 l/min to 164 +/- 49 l/min at 20 min, with a further improvement during the maintenance infusion to 200 +/- 79 l/min at 24 h. Heart rate and blood pressure decreased towards normal in parallel with the improvement in lung function. The mean steady-state enprofylline plasma concentration was slightly higher than predicted. The mean renal clearance and recovery of enprofylline from urine were in good agreement with results previously obtained from healthy Caucasian subjects.

Comparison of inhaled budesonide with oral prednisolone at two dose-levels commonly used for the treatment of moderate asthma.

The purpose of the study was to compare the anti-asthmatic efficacy of two doses of inhaled budesonide with two doses of oral prednisolone commonly used in clinical practice. The patients studied had not been taking regular inhaled glucocorticosteroids and so there was minimal interference from previous medication. The study was conducted as two double-blind crossovers with a washout period between them - firstly, comparing 400 micrograms budesonide with 5 mg prednisolone per day and secondly, 800 micrograms budesonide with 10 mg prednisolone per day. Lung function and symptoms were improved significantly from run-in by all treatments and improvement on both drugs was dose-dependent. When low-dose treatments were compared, mean morning peak expiratory flow rate was higher during budesonide treatment and, as a result, diurnal variation was significantly less than that during prednisolone treatment. At the higher doses, differences between the drugs were not observed, but this may have been due to the fact that a "ceiling effect" had been reached.

Single dose oral norfloxacin or intramuscular spectinomycin to treat gonorrhoea (PPNG and non-PPNG infections): analysis of efficacy and patient preference.

Norfloxacin, a new oral quinolone, was compared with intramuscular spectinomycin for treating culture proved gonorrhoea (caused by penicillinase producing strains of Neisseria gonorrhoeae (PPNG) and non-PPNG strains. A total of 547 infected men and women were randomly allocated to treatment with either single dose norfloxacin (800 mg by mouth) or spectinomycin (2 g intramuscularly). Patient preference for tablets or injections was noted at this visit. Patients returned four to eight days later for assessment of efficacy, safety, and preference. Of the 482 patients who attended follow up, all those treated with norfloxacin (94 infected with PPNG strains, 145 with non-PPNG strains) and all 82 infected with PPNG strains and treated with spectinomycin were cured. Of 161 infected with non-PPNG strains and treated with spectinomycin, 159 (99%) were cured. Side effects (headache, nausea, and sleepiness) occurred in three patients receiving norfloxacin and in 17 (16 pain at injection site, 1 giddiness) receiving spectinomycin. Most patients preferred tablets to injection both on day 1 (313 v 200) and at follow up (373 v 104). This study showed that norfloxacin was a highly effective alternative to spectinomycin, produced fewer side effects, and was the preferred mode of administration.

Concentrations of sulphadiazine and trimethoprim in nasal secretion after co-trimazine administration.

Co-trimazine (1 g) was given once daily to 20 healthy volunteers during four days. Serum and nasal secretion concentrations were measured after the fourth dose. Secretion levels exceeded those in serum by a factor of 1.36 (sulphadiazine) and 2.96 (trimethoprim) (as expressed by the ratio of the AUC of secretion and serum concentrations). The average ratios of the concentrations of sulphadiazine to trimethoprim were 11.6-15.3 and 4.8-10.3 in serum and secretion respectively. During the dosage interval of 24 h, sulphadiazine and trimethoprim concentrations exceeded the MIC values of the common respiratory pathogens in serum and secretion.

Sulphadiazine/trimethoprim once daily in maxillary sinusitis: a randomized double-blind comparison with sulphamethoxazole/trimethoprim B.I.D.

In a randomized double-blind study fifty-four patients suffering from acute maxillary sinusitis were treated for 10 days with daily doses of sulphadiazine/trimethoprim (1 g) and sulphamethoxazole/trimethoprim (1.92 g), respectively. The efficacy was evaluated clinically at two follow-up visits. X-ray investigations were performed at admission and after the therapy. Of thirty-nine patients finally evaluated, thirty-seven showed a favourable result. After 6-8 days of therapy there was significant difference in cure rates in favour of sulphadiazine/trimethoprim (p less than 0.05) while the outcome as evaluated after treatment was similar for both drugs.

The use of co-trimazine once daily in acute otitis media and maxillary sinusitis in children.

Fifty-eight children, 1 to 12 years old, with either acute otitis media or acute maxillary sinusitis were treated with co-trimazine once daily over a period of 10 days. All of the children with otitis and all but two with sinusitis were cured. The drug was excellently tolerated and well accepted.