伊托必利治疗功能性消化不良的随机双盲对照试验104例

目的:观察国产伊托必利片治疗功能性消化不良的疗效和药物安全性。方法:将209例功能性消化不良病人,采用随机双盲、阳性药物对照试验方法,随机分为2组,伊托必利(受试)组给伊托必利50mg,餐前口服,每日3次;多潘立酮(对照)组给多潘立酮10mg,餐前口服,每日3次。疗程均为2或4wk。结果:伊托必利组治疗功能性消化不良总有效率为89%,与对照组多潘立酮(89%)相比无差异(P>0.05);明显改善病人消化不良临床症状和体征,显著改善胃排空功能(P<0.01),与对照组相比无差异。伊托必利组不良反应发生率为4%,与多潘立酮组(5.9%)比较无统计学差异。结论:伊托必利治疗功能性消化不良是安全、有效。

Itopride in treatment of 104 patients with functional dyspepsia: a randomized, double-blind controlled clinical trial

AIM: To evaluate the efficacy and safety of itopride in the treatme nt for functional dyspepsia. METHODS: Two hundred and nine patients with function al dyspepsia were divided into two groups randomly based on the randomized doubl e-blind method. The itopride group were received itopride 50 mg,ante c ibum po, tid.The domperidone group were received domperidone 10 mg,ante c ibum po, tid.The course of treatment was 2 wk or 4 wk. RESULTS: The total efficacy rates of itopride group and domperidone group were equally as 89 %. Itopride group could significantly improve the alimentary tract symptoms with disappearing rates of early satiety, abdominal distention and epigastric pa in higher than those of domperidone group (P<(0.01).) The gastric emptying rate with itopride group was significantly improved (P<0.01), similar to th at of the domperidone group (P>0.05).No significant difference in incidence of side effectts between the itopride group ((4.0 %)) and domperidone group (5 .9 %). CONCLUSION: Itopride is safe and effective in the treatment of func tional dyspepsia.