Kerrigan D D, Taylor M E, Read N W, Johnson A G
University Surgical Unit, Royal Hallamshire Hospital, Sheffield.
Gut. 1993 Aug;34(8):1042-6. doi: 10.1136/gut.34.8.1042.
In a single centre double blind study of 66 patients, the value of cisapride (10 mg twice daily) was compared with placebo in the prevention of duodenal ulcer relapse. Patients who remained ulcer free attended for clinical review every two months and had a mandatory endoscopy at 0, 4, 8, and 12 months or if symptoms suggestive of ulcer recurrence developed. The 12 month crude relapse rates (that underestimate the probability of ulcer recurrence) showed that cisapride was superior to placebo (34% (11/32) relapsed on cisapride v 68% (23/34) on placebo, p = 0.007). This finding was confirmed using lifetable analysis, with a 35% reduction (95% confidence intervals 10-59%, p < 0.05) in the proportion of ulcer relapses in patients who had received cisapride compared with those treated with placebo. These results are similar to those reported in maintenance trials of H2 receptor antagonists analysed by the same method. Drug related adverse clinical events were mainly trivial, but led to three patients on cisapride and one on placebo withdrawing from the trial.
在一项针对66例患者的单中心双盲研究中，比较了西沙必利（每日两次，每次10毫克）与安慰剂预防十二指肠溃疡复发的效果。溃疡未复发的患者每两个月接受一次临床检查，并在0、4、8和12个月时或出现提示溃疡复发的症状时进行强制内镜检查。12个月的粗复发率（低估了溃疡复发的概率）显示，西沙必利优于安慰剂（西沙必利组34%（11/32）复发，安慰剂组68%（23/34）复发，p = 0.007）。使用生命表分析证实了这一发现，与接受安慰剂治疗的患者相比，接受西沙必利治疗的患者溃疡复发比例降低了35%（95%置信区间10 - 59%，p < 0.05）。这些结果与采用相同方法分析的H2受体拮抗剂维持试验报告的结果相似。与药物相关的不良临床事件大多轻微，但导致3例服用西沙必利的患者和1例服用安慰剂的患者退出试验。
