西沙必利治疗功能性消化不良的多中心临床疗效观察

A CONTROLLED MULIT-CENTRE CLINICAL TRIAL ON CISAPRIDE IN TREATMENT OF FUNC-TIONAL DYSPEPSIA

本项多中心临床试验旨在对西沙必利（ｃｉｓａｐｒｉｄｅ）治疗功能性消化不良的疗效和安全性进行评估。其中治疗组４１４例，对照组１６９例。西沙必利的服药方法为每次５ｍｇ，每日３次，共服４周。结果显示西沙必利能使早饱、腹胀、上腹痛、恶心等多种消化道症状有明显改善，总有效率为９２．９９％，明显优于对照组的４１．４２％，且两组病人间差异有显著性。西沙必利的副作用主要为腹痛、腹泻，多数病人对其可以耐受。以上研究结果表明西沙必利为一种安全、有效的促动力药物。

controlled multi-centre clinical trial was conducted for evaluating the efficacy and safety of cisapride in the treatment of 414 cases of functional dyspepsia with 169 cases as control.Cisapride were given 5mg three times daily for 4 weeks. The results showed that cisapride could significantly improve the symptoms including early satiety,abdominal distention,epigastric pain and nausea. Total efficacy rate of cisapride and placebo were 92.99% and 41.42% respectively.There were statistically signifieant difference between the two groups.Side-effects are abdominal pain and diarrhoea but most of the patients can endure.The above results indicated that the cisapride was safe and effective in treatment of functional dyspepsia.