摘要

本研究的目的是比较奥美拉唑20mg每日1次和雷尼替丁150mg每日2次对十二指肠溃疡愈合的影响，这些溃疡是由西咪替丁≥0.8 g或雷尼替丁≥0.3 g每日治疗至少6周而未愈合的。在一项双盲多中心试验中，151名患者被随机分配服用奥美拉唑或雷尼替丁。在2周和4周时进行临床评估和内窥镜检查。两组患者特征相似。统计学分析(chi 2检验)显示，无论采用何种计算方法，治愈率均无显著差异(p大于0.20)。在“意向治疗”分析(n = 151)中，愈合为:奥美拉唑46.6%，雷尼替丁43.3%在第15天，奥美拉唑70.7%，雷尼替丁68.4%在第29天;在完成治疗的患者中，奥美拉唑治愈率为48.3%，雷尼替丁治愈率为46.3% (n = 125;差异的95%置信区间—17 ~ 21)和奥美拉唑79.6%，雷尼替丁75.4%在第29天(n = 115;差值的95%置信区间—13 ~ 21)。在进一步使用奥美拉唑治疗四周后，16/20(80%)在29天仍有活动性疾病的患者出现愈合。 Patients on omeprazole and on ranitidine experienced similar decrease in day time and night time epigastric pain and in heartburn. Multivariate analysis (logistic regression) did not indicate any influence on age, sex, smoking and alcohol habits, previous drug administered, duodenitis and duodenal erosions on the healing rate. In this model, healing rate was not significantly influenced by previous treatment duration (p = 0.09 at day 15 and p greater than 0.2 at day 29) but was significantly influenced by ulcer size (p = 0.04 at day 15 and p = 0.02 at day 29). Forty one patients complained of adverse events: 19 on omeprazole (four trial withdrawals), 22 on ranitidine (three trial withdrawals).