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本研究是一个以安慰剂做对照的随机双盲多中心临床研究，目的在于观察西沙必利治疗功能性消化不良的效果及其安全性。１１９例符合功能性消化不良的病人，随机分成西沙必利组（６９例）和安慰剂组（５０例），分别接受西沙必利（５ｍｇ，３次／ｄ）和安慰剂组（用法同西沙必利）治疗。早饱和上腹饱胀的缓解率，西沙必利组为７７．６％和７５．４％；对照组为３６．６％和４１．７％（Ｐ＜０．０５）；对疗效的总评价，西沙必利２周的显效率和总有效率分别为５０．７％和８８．４％，４ｗｋ为６６．７％和９１．３％，对照组２周为１８．６％和４４．０％；４周为２４．０％和５０．２％，（Ｐ＜０．０５）。在治疗中未发现严重不良反应和实验室检查的异常。本研究显示西沙必利是一个治疗功能性消化不良的安全有效药物。
This is a randomized, double-blind multicenter, placebo-controlled clinical trial aimed at observing the efficacy and safety of cisapride in the treatment of functional dyspepsia. 119 patients with functional dyspepsia were randomized into cisapride (69) and placebo (50) to receive cisapride (5 mg, 3 times daily) and placebo Will benefit) treatment. Early satiety and upper abdominal fullness of the remission rate, cisapride group was 77.6% and 75.4%; control group was 36.6% and 41.7% (P <0.05); the overall evaluation of the efficacy , 2 weeks of cisapride markedly effective and total effective rate was 50.7% and 88.4%, 4wk 66.7% and 91.3%, 2 weeks in the control group was 18.6% and 44.0 %; 4 weeks was 24.0% and 50.2% (P <0.05). No serious adverse reactions and laboratory tests were found during treatment. This study shows cisapride is a safe and effective drug for the treatment of functional dyspepsia.