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[米索前列醇治疗十二指肠溃疡的多中心双盲对照临床试验]

[A multiclinic double-blind, comparative clinical trial on misoprostol in the treatment of duodenal ulcer].

作者信息

Wang B E, Pei Y, Pan G Z

机构信息

Beijing Friendship Hospital.

出版信息

Zhonghua Nei Ke Za Zhi. 1991 Apr;30(4):226-9, 254-5.

PMID:1908372
Abstract

A clinical trial of misoprostol, an analog of PGE1 produced by G.D. Searle & Co., on treatment of duodenal ulcer was carried out in five hospitals in Beijing, Shanghai, and Guangzhou. Totally 94 cases were treated with misoprostol 200 micrograms q.i.d. for 4 weeks. A parallel comparison was made, using cimetidine 200 mg q.i.d. A double-blind, double-dummy study was conducted. The result showed that the therapeutic efficacy of misoprostol in duodenal ulcer is similar to that of cimetidine. The ulcer healing rate in four weeks being 60.7% and 67.9% respectively, while the overall effectiveness rate being 77.7% and 80.2%. There was no statistically significant difference between the two medication groups. The side effect of misoprostol is mainly mild diarrhea (6.4%), but it disappears despite the continued use of medication. To our impression, misoprostol represents a new therapeutic approach for treatment of peptic ulcer in addition to acid controlling H2 blockers.

摘要

由G.D. Searle公司生产的前列腺素E1类似物米索前列醇治疗十二指肠溃疡的一项临床试验在北京、上海和广州的五家医院开展。共94例患者接受米索前列醇200微克每日4次治疗,疗程4周。采用西咪替丁200毫克每日4次进行平行对照。开展了双盲、双模拟研究。结果显示,米索前列醇治疗十二指肠溃疡的疗效与西咪替丁相似。四周时溃疡愈合率分别为60.7%和67.9%,而总有效率分别为77.7%和80.2%。两组用药之间无统计学显著差异。米索前列醇的副作用主要为轻度腹泻(6.4%),但继续用药时腹泻会消失。在我们看来,除了控制胃酸的H2阻滞剂外,米索前列醇为消化性溃疡的治疗提供了一种新的治疗方法。

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