[Multi-center double-blind clinical trial of ranitidine in the treatment of stomach and duodenal ulcers].
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Biomedical subjects
Publications and source records attributed to J Hasik.
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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.
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.
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On the basis of newer literature and of own experiences the author describes the present state of dietetics in diseases of the extrahepatic biliary ducts. The details of the basic diet in these diseases are discussed (nutrition of patients with limited fat and raw fibre supply). In acute cases the parenteral nutrition is to be recommended. In subacute cases, as well as before and after surgical interventions more frequently ballast-free, fully balanced peroral nutrition (cosmonautes' diet) is used. Finally the importance of the plant raw fibre for the prophylaxis of cholelithiasis is demonstrated.
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In 26 patients with the classical clinical picture of an ulcerous colitis and in 8 healthy control persons in the course of a rectoscopy in about 15 cm depth tissue was taken bioptically and underwent an electron-microscopic investigation. Moreover, enzyme-histological examinations were performed. Summarizingly, clear references to immune-pathological processes for development and course of ulcerous colitis are the result.
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