Barbara L, Corinaldesi R, Adamo S, Comin V, Dobrilla G, Giacosa A, Ghidini O, Huscher C, Panza E
Int J Clin Pharmacol Ther Toxicol. 1986 Feb;24(2):104-7.
A multi-center study was carried out to compare the healing rates of ranitidine 300 mg nocte and 150 mg b.i.d. in the short-term treatment of gastric ulcers and to assess the side-effect liability of ranitidine 300 mg given in a single daily dose. Forty-five outpatients suffering from endoscopically and bioptically proven uncomplicated benign gastric ulcer were selected for the study. The patients were treated, for 4 weeks, on the basis of a double-blind randomized design. An endoscopic examination was repeated within 4 days after the end of the treatments. The patients who did not demonstrate complete healing were treated for an additional 4-week period. Clinical controls were performed to evaluate symptoms, antacid consumption, compliance with trial tablet consumption; hematological and biochemical tests were also carried out at the end of the 4 and 8-week periods. No differences were observed between the healing rate induced by 300 mg nocte and 150 mg b.i.d., after 4 weeks of treatment (76% and 79% respectively) and after 8 weeks (100% in both groups). Similar results were obtained as far as symptoms, antacid consumption and compliance are concerned. Neither treatment regimen induced appreciable side-effects.
开展了一项多中心研究,以比较雷尼替丁300毫克每晚一次与150毫克每日两次在胃溃疡短期治疗中的愈合率,并评估每日单次服用300毫克雷尼替丁的副作用发生率。选择45例经内镜和活检证实为无并发症的良性胃溃疡门诊患者进行研究。患者基于双盲随机设计接受4周治疗。治疗结束后4天内重复进行内镜检查。未显示完全愈合的患者再接受4周治疗。进行临床对照以评估症状、抗酸剂消耗量、试验片剂服用依从性;在4周和8周结束时还进行了血液学和生化检查。治疗4周后(分别为76%和79%)以及8周后(两组均为100%),300毫克每晚一次和150毫克每日两次诱导的愈合率之间未观察到差异。就症状、抗酸剂消耗量和依从性而言,获得了相似的结果。两种治疗方案均未引起明显副作用。