摘要

我们在一项多中心试验中研究了奥美拉唑和雷尼替丁促进十二指肠溃疡愈合的作用，比较治疗2周、4周和8周后溃疡愈合的比例。总共有194名患者(143名男性)根据预先安排的治疗计划被随机分配到两种药物中，并进行双盲治疗。每个人早上接受40毫克奥美拉唑，早晚服用雷尼替丁安慰剂，或者早上接受150毫克雷尼替丁，早晚服用奥美拉唑安慰剂。共有188例患者(94例服用奥美拉唑，94例服用雷尼替丁)完成了试验。奥美拉唑治疗组64例(68%)和雷尼替丁治疗组45例(48%)溃疡在2周内愈合，奥美拉唑治疗组91例(99%)和雷尼替丁治疗组79例(88%)溃疡在4周内愈合，奥美拉唑治疗组91例(100%)和雷尼替丁治疗组86例(97%)溃疡在8周内愈合。愈合率的总体差异具有显著性(p = 0.0008, Mantel-Haenszel检验)。在两周(20%，95%置信区间5.6至34.4,p < 0.01)和四周(11%，95%置信区间3.7至17.3,p < 0.01)时差异也显著，但在八周(3%，95%置信区间-0.5至+ 7.3,p = 0.25)时差异不显著，使用chi 2统计数据，该研究在90%的情况下具有检测20%差异的能力。治疗两周后，70例(74%)奥美拉唑患者和58例(62%)雷尼替丁患者症状完全缓解。日记卡显示，奥美拉唑治疗组疼痛天数的百分比显著降低(7.4% vs 21.4%， p < 0.02)，无论是在治疗的前两周还是在治疗的第3周和第4周。144例十二指肠溃疡愈合患者随访6个月，未进行任何治疗。 At the end of this period 19 (26%) of 74 patients healed with omeprazole and 17 (24%) of 70 patients healed with ranitidine were still in remission. A similar protocol was used for 46 patients (25 men) with gastric ulcer who were randomly allocated to treatment with omeprazole or ranitidine as described above. Forty patients (16 omeprazole, 24 ranitidine) completed trial. Thirteen (81%) omeprazole treated and 14 (58%) ranitidine treated patients had healed ulcers at four weeks; at eight weeks 14 (93%) omeprazole treated and 20 (87%) ranitidine treated patients had healed ulcers. These differences were not significant at four weeks (p = 0.25) or eight weeks (p = 0.96). Twenty seven gastric ulcer patients were followed up for six months and seven (58%) of the 12 omeprazole healed and five (33%) of the 15 ranitidine healed patients were in remission at six months. Unwanted adverse events were trivial except for one fatality in a 67 year old women, who died from bronchopneumonia and myocardial ischaemia while receiving treatment with omeprazole, which was judged to be unrelated to her death.