Hepatogastroenterology. 1991 Oct;38(5):400-3.
The primary aim of this double-blind, randomized Italian multicenter trial was to compare the healing rates in patients with benign gastric ulcers after 4-8 weeks treatment with either omeprazole 20 mg uid or ranitidine 150 mg bid. Secondary aims were to compare the healing rates in a subgroup of patients after two weeks and to study symptom relief and frequency of adverse events. One hundred and sixty-seven (167) patients were randomized to treatment with either omeprazole (84) or ranitidine (83). Four and three patients in the omeprazole and ranitidine groups, respectively, were found to have malignant gastric ulcers, and were therefore excluded from the analysis. Protocol healing rates were significantly higher in the omeprazole group (35%, 74% and 96%) than in the ranitidine group (9%, 53% and 85%) after two (p = 0.004), four (p = 0.015) and eight weeks (p = 0.04) of treatment (chi 2 test). Relief of both daytime and nocturnal epigastric pain, as reported on clinic visits, was more rapid in the omeprazole group than in the ranitidine group. Diary card reports of nocturnal and day pain during the first two weeks showed a similar pattern, with somewhat faster relief of pain in the omeprazole group. Both omeprazole and ranitidine were well tolerated, and only few adverse events were reported. No changes in the laboratory tests were considered to be clinically important.
这项双盲、随机的意大利多中心试验的主要目的是比较用20毫克每日一次的奥美拉唑或150毫克每日两次的雷尼替丁治疗4至8周后良性胃溃疡患者的愈合率。次要目的是比较两周后一组患者的愈合率，并研究症状缓解情况和不良事件的发生频率。167名患者被随机分为接受奥美拉唑（84例）或雷尼替丁（83例）治疗。奥美拉唑组和雷尼替丁组分别有4例和3例患者被发现患有恶性胃溃疡，因此被排除在分析之外。在治疗两周（p = 0.004）、四周（p = 0.015）和八周（p = 0.04）后，奥美拉唑组的方案愈合率（分别为35%、74%和96%）显著高于雷尼替丁组（分别为9%、53%和85%）（卡方检验）。根据临床就诊报告，奥美拉唑组白天和夜间上腹部疼痛的缓解比雷尼替丁组更快。前两周夜间和白天疼痛的日记卡报告显示出类似的模式，奥美拉唑组疼痛缓解稍快。奥美拉唑和雷尼替丁的耐受性都很好，报告的不良事件很少。实验室检查的变化均未被认为具有临床重要性。
