McIsaac R L, McCanless I, Summers K, Wood J R
Department of Gastroenterology, Glaxo Group Research Ltd, Greenford, UK.
Aliment Pharmacol Ther. 1987 Oct;1(5):369-81. doi: 10.1111/j.1365-2036.1987.tb00637.x.
All available ranitidine and cimetidine comparative trials in acute duodenal ulcer disease were examined: of the 44 trials, 36 favoured ranitidine, and there was an overall difference in ulcer healing of 7%. Further stratification enabled examination of trials with common attributes: the most frequent endoscopic assessment was at 4 weeks to compare ranitidine 150 mg twice daily with cimetidine 1 g day-1 or 400 mg b.d. Twenty of these trials had sufficient data to permit pooling. Ranitidine was favoured in 18/20 trials and in three the differences achieved statistical significance. Results of the trials were combined using meta-analysis to calculate differences in ulcer healing. Most studies had sample sizes that were insufficient to detect clinically-important differences; the power to detect a 20% difference was less than 80% in 15/20 trials, and for a 10% difference was less than 80% in all but one trial. Fifteen trials compared ranitidine 150 mg b.d. with cimetidine 1 g day-1: healing after 4 weeks therapy was overall 6% greater for ranitidine. This was statistically significant (P less than 0.05) and the combined total number of patients had a power of 83% to detect this difference. In five trials the dose of cimetidine used was 400 mg b.d.: the 12% difference in healing in favour of ranitidine 150 mg b.d. was statistically significant, and the combined trials had a power of 95% to detect this difference. Ranitidine 150 mg twice daily heals significantly more duodenal ulcers after 4 weeks of therapy than either cimetidine 400 mg b.d. or cimetidine 1 g day-1.
在44项试验中,36项试验表明雷尼替丁更具优势,溃疡愈合的总体差异为7%。进一步分层后能够对具有共同特征的试验进行审查:最常见的内镜评估时间是在4周时,以比较每日两次服用150毫克雷尼替丁与每日服用1克西咪替丁或每日两次服用400毫克西咪替丁的效果。其中20项试验有足够的数据可用于汇总分析。在这20项试验中,18项试验表明雷尼替丁更具优势,其中3项试验的差异具有统计学意义。使用荟萃分析合并试验结果以计算溃疡愈合的差异。大多数研究的样本量不足以检测出具有临床重要意义的差异;在20项试验中的15项试验中,检测出20%差异的效能低于80%,除一项试验外,在所有试验中检测出10%差异的效能均低于80%。15项试验比较了每日两次服用150毫克雷尼替丁与每日服用1克西咪替丁的效果:经过4周治疗后,雷尼替丁的愈合率总体比西咪替丁高6%。这具有统计学意义(P小于0.05),合并的患者总数检测出这种差异的效能为83%。在5项试验中,使用的西咪替丁剂量为每日两次400毫克:每日两次服用150毫克雷尼替丁在愈合方面比其高12%,这具有统计学意义,合并试验检测出这种差异的效能为95%。经过4周治疗后,每日两次服用150毫克雷尼替丁治愈十二指肠溃疡的效果明显优于每日两次服用400毫克西咪替丁或每日服用1克西咪替丁。