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Biomedical subjects

K Gibinski

Publications and source records attributed to K Gibinski.

15 recordsLinked to original sources

An evaluation of arbaprostil at multiple doses for the treatment of acute duodenal ulcer: a randomized double-blind placebo-controlled international trial.

Six hundred and thirty patients were enrolled in a randomized double-blind placebo-controlled trial evaluating two arbaprostil dosages (25 micrograms and 50 micrograms) qid for 4 wk for the treatment of acute duodenal ulcers. The healing rates in the placebo, 25-micrograms, and 50-micrograms treatment groups were 39%, 51%, and 60%, respectively. Smoking was found to adversely affect the healing rates in all the treatment groups. Pain severity was less with either arbaprostil treatment. The only side effect found was diarrhea: 10%, 14%, and 32% in the placebo, 25-micrograms, and 50-micrograms treatment groups, respectively. Severe diarrhea occurred in 1% of those patients who received the 50-micrograms dosage regimen, but in none of the other two groups. Arbaprostil at these two dosage levels, when given for 4 wk, appears to be a safe and efficacious agent for the treatment of acute duodenal ulcers.

Acute Disease

The treatment of duodenal and gastric ulcer with ranitidine--a controlled, multicentre clinical trial.

One hundred and seventy seven duodenal ulcer and eighty-one gastric ulcer patients were treated with either ranitidine or placebo in a prospective double-blind study. Groups treated with active drug and placebo were comparable and ulcer healing was assessed by weekly endoscopic examinations. Ranitidine was shown to accelerate the rate of spontaneous ulcer healing in both duodenal and gastric ulcer. This acceleration is significant after one week of treatment in duodenal ulcer and from three weeks onwards in gastric ulcer. The ulcer healing rate after three weeks treatment with ranitidine was 85.5% in duodenal ulcer, and 72.5% in gastric ulcer which was significantly higher than in the placebo group where it was 51.7% and 41.5% respectively (P less than 0.005 and P less than 0.01). Treatment with ranitidine for a maximum of six weeks healed 97.1% of duodenal ulcer patients (172 out of 177) and 96.5% of gastric ulcer patients (77 out of 81). Out of total of 258 patients only 9 failed to heal. No adverse events were seen with ranitidine and it would appear free of the side effects that have been seen with cimetidine. In addition there were no significant changes in blood haematology or clinical chemistry parameters. Ranitidine is also given in a more convenient regimen, 150 mg daily as compared to 200 mg three times daily and 400 mg nocte with cimetidine.

Adult

Some problems in modern anti-ulcer drug evaluation: a comparison of four gastric acid suppressors.

Some of the problems involved in the treatment and evaluation of drug therapy in peptic ulceration are discussed. The results of four multi-centre, double-blind, placebo-controlled clinical trials in 520 patients are reviewed. It has been shown that the potent suppressors of gastric acid secretion, histamine H2-blockers ranitidine and cimetidine, and 16,16-dimethyl prostaglandin E2, significantly accelerated the healing of peptic ulcers but that trithiozine had no beneficial effect.

Anti-Ulcer Agents

Multicentre double blind clinical trial on ranitidine for gastroduodenal ulcer.

The study was carried out in 168 patients treated in 5 Departments of Gastroenterology according to a standardized design. All were diagnosed and followed-up by panendoscopy: they were give similar diet and antacids ad libitum, and were urged not to smoke. Such basic therapy in our studies resulted in 30-40% of gastric, and about 50% of duodenal ulcers coded packages of the tested drug. Tablets contained wither 150 mg of Ranitidine or placebo They were taken twice a day. Spontaneous healing under such conditions occurred in the present study in 37% of gastric, and 45% of duodenal, ulcers, while in patients taking Ranitidine 62% of gastric (P less than 0.05) and 82% of duodenal ulcers (p less than 0.01) were cicatrized after 3 weeks. There were no drop-outs, and no undesired effects were observed.

Adult