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西咪替丁与安慰剂-西咪替丁治疗慢性胃溃疡患者的疗效观察(一项多中心随机双盲对照研究)

Cimetidine and placebo-cimetidine in the treatment of patients with chronic gastric ulcer (a multiclinical randomized double-blind comparative study).

作者信息

Patty I, Tárnok F, Deák G, Mózsik G

机构信息

First Department of Medicine, University Medical School, Pécs, Hungary.

出版信息

Acta Med Hung. 1988;45(1):83-95.

PMID:3045746
Abstract

The efficacy of a 4-week cimetidine treatment was examined by a double-blind randomized study in 37 outpatients with endoscopically verified chronic gastric ulcer. The patients received a daily dose of 3 times 1 tablet and, at night before going to bed 2 more tablet, thus a total amount of 1 g cimetidine, or cimetidine-placebo, but in case of complaints they could take in addition a mixed alkaline powder. Patients not recovering in response to a 4-week treatment, were then administered daily 5 tablets of cimetidine up to their complete recovery. Endoscopic, laboratory and clinical examinations were carried out every other week. As a result of a 4-week treatment, 56% of the cimetidine group recovered. The difference was not significant (P less than 0.2). The size of the ulcer and the intensity of the complaints were reduced significantly in both groups. The decrease in the size of the ulcer was significantly greater in the first two weeks of cimetidine treatment than in the cimetidine-placebo group (P less than 0.05). This favourable dynamics of ulcer healing was not felt in the second two weeks of treatment, and after four weeks there was no difference in the size of the residual ulcer to between the two groups. Cimetidine seemed to be a suitable drug for treating chronic gastric ulcer, since its healing rate proved to be better than that of placebo, the gain in weight also was favourable and there were no side-effects.

摘要

通过一项双盲随机研究,对37例经内镜检查证实为慢性胃溃疡的门诊患者进行了为期4周的西咪替丁治疗效果研究。患者每日服用3次,每次1片,并在睡前再加服2片,每日总量为1克西咪替丁,或服用西咪替丁安慰剂,但如有不适可额外服用混合碱性粉剂。对4周治疗无反应的患者,随后每日服用5片西咪替丁直至完全康复。每隔一周进行内镜、实验室和临床检查。经过4周治疗,西咪替丁组56%的患者康复。差异无统计学意义(P<0.2)。两组患者的溃疡大小和不适程度均显著降低。西咪替丁治疗的前两周,溃疡大小的减小明显大于西咪替丁安慰剂组(P<0.05)。治疗的后两周未观察到这种有利于溃疡愈合的动态变化,4周后两组残余溃疡大小无差异。西咪替丁似乎是治疗慢性胃溃疡的合适药物,因为其治愈率高于安慰剂,体重增加也有利,且无副作用。

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