罗沙替丁(roxatidine)是目前用于美国和西欧的一种H_2受体拮抗剂。本文采用多中心、双盲、随机、安慰剂对照法,对比了本品与安慰剂治疗活动性十二指肠溃疡病(ADUD)的疗效与安全性。患者与方法美国27个医疗中心经内窥镜诊断为ADUD的患者进入本研究。356例患者中,男性262例(73.6％)、女性94例(26.4％)。患者随机接受本品75mg或安慰剂,于睡前服。用药2周后再行内窥镜检查。结果 356例患者中,341例可用于用药安全性分析(本品组170例,安慰剂组171例),329例可用于疗效评价(本品组166例, Roxatidine is an H 2 receptor antagonist currently used in the United States and Western Europe. In this paper, a multicenter, double-blind, randomized, placebo-controlled study comparing the efficacy and safety of this product with placebo in the treatment of active duodenal ulcer disease (ADUD) was performed. Patients and Methods Patients with endoscopic diagnosis of ADUD in 27 medical centers in the United States entered the study. Of the 356 patients, 262 were male (73.6%) and 94 (26.4%) were female. Patients randomized to receive 75mg of this product or placebo at bedtime. After 2 weeks medication endoscopy. Results Among the 356 patients, 341 cases were used for drug safety analysis (170 cases in the product group and 171 cases in the placebo group) and 329 cases could be used for evaluating the curative effect (166 cases in this product group,