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西沙必利与安慰剂治疗慢性便秘

Treatment of chronic constipation with cisapride and placebo.

作者信息

Müller-Lissner S A

机构信息

Medizinische Klinik Innenstadt, University of Munich, FR Germany.

出版信息

Gut. 1987 Aug;28(8):1033-8. doi: 10.1136/gut.28.8.1033.

Abstract

The effect of cisapride (20 mg bid), a new prokinetic drug, on bowel habits and laxative consumption was studied in patients with idiopathic painless constipation and chronic laxative intake. After a four week base line period, spontaneous defection (frequency without laxative intake) and total defecation (total frequency) were measured. Patients with a spontaneous defecation of less than three stools per week entered the treatment period and were randomly assigned to double blind treatment with either cisapride (n = 64) or placebo (n = 62). After eight weeks of treatment, a four week run out phase on single blind placebo medication was conducted. Cisapride and placebo increased spontaneous stool frequency from 1.1 +/- 0.2 SEM to 3.0 +/- 0.2 per week (p less than 0.001) and from 1.2 +/- 0.1 to 1.5 +/- 0.2 (p greater than 0.05), respectively. Laxative consumption was decreased from 3.6 +/- 0.3 to 1.8 +/- 0.2 doses/week by cisapride (p less than 0.001) and from 3.3 +/- 0.3 to 2.8 +/- 0.3 by placebo (p less than 0.05). Both drugs improved constipation as assessed by the patient by means of a visual analogue scale, but cisapride did so to a larger extent than placebo. The effects of cisapride partly outlasted active medication by at least four weeks. It is concluded that cisapride improves bowel habits in patients with idiopathic constipation and reduces laxative consumption.

摘要

研究了新型促动力药物西沙必利(20毫克,每日两次)对特发性无痛性便秘及长期服用泻药患者排便习惯和泻药服用量的影响。在为期四周的基线期后,测量了自然排便(不服泻药时的排便频率)和总排便次数(总频率)。自然排便频率低于每周三次的患者进入治疗期,并随机分为两组,分别接受西沙必利(n = 64)或安慰剂(n = 62)的双盲治疗。治疗八周后,进行了为期四周的单盲安慰剂药物洗脱期。西沙必利和安慰剂分别使自然排便频率从1.1±0.2标准误增加到每周3.0±0.2次(p<0.001)和从1.2±0.1增加到1.5±0.2次(p>0.05)。西沙必利使泻药服用量从3.6±0.3剂/周降至1.8±0.2剂/周(p<0.001),安慰剂使其从3.3±0.3剂/周降至2.8±0.3剂/周(p<0.05)。通过视觉模拟量表评估,两种药物均改善了便秘情况,但西沙必利的改善程度大于安慰剂。西沙必利的作用在停用活性药物后至少持续四周。结论是西沙必利改善了特发性便秘患者的排便习惯并减少了泻药服用量。

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