Barr G D, Kang J Y, Canalese J, Piper D W
Gastroenterology. 1983 Jul;85(1):100-4.
The aim of the study was to determine the effectiveness of cimetidine in a dose of 400 mg twice daily in the prevention of gastric ulcer recurrence over a 2-yr period. The trial was double-blind and placebo-controlled; 24 patients received cimetidine and 25 received placebo. All had had a gastric ulcer within the prior 6 wk, and healing was demonstrated by endoscopy or by barium meal. The patients were contacted at monthly intervals, and if symptoms were present, investigations were performed. Annual barium meal examinations or endoscopy were also performed in all except 7 patients. In the placebo group, there was rapid recurrence within the first 12 mo; 12 of the 13 recurrences that occurred in this group over the 2-yr period took place within the first 12 mo. In the cimetidine-treated group, there were eight recurrences over the 2-yr period, five of which occurred in the first year. Log rank comparison showed a significant benefit due to cimetidine at 1 yr, but not over the 2-yr period.
本研究的目的是确定每日两次服用400毫克西咪替丁在预防胃溃疡复发方面的有效性,观察期为两年。该试验为双盲、安慰剂对照试验;24名患者接受西咪替丁治疗,25名患者接受安慰剂治疗。所有患者在之前6周内均患有胃溃疡,且通过内镜检查或钡餐检查证实溃疡已愈合。每月对患者进行随访,如有症状则进行检查。除7名患者外,所有患者均每年进行钡餐检查或内镜检查。在安慰剂组中,在前12个月内溃疡迅速复发;该组在两年期间发生的13次复发中有12次发生在前12个月内。在西咪替丁治疗组中,两年期间有8次复发,其中5次发生在第一年。对数秩检验比较显示,西咪替丁在1年时有显著疗效,但在两年期间无显著疗效。