伊托必利治疗功能性消化不良多中心、随机、双盲、双模拟临床研究

A double blind, double dummy, randomized, controlled trial of itopride hydrochloride capsule in treatment of functional dyspepsia

目的 观察伊托必利治疗功能性消化不良的疗效及其安全性。方法 采用多中心、随机、双盲、双模拟平行对照临床试验。治疗组 :伊托必利 15 0mg/d ,每日 3次 ,餐前 3 0min口服 ;对照组 :多潘立酮 (吗丁啉 )10mg ,每日 3次 ,餐前 3 0min口服。疗程均为 2周。 结果 伊托必利治疗餐后饱胀、早饱及上腹不适的有效率分别为 5 0 .43 %、64 .42 %和 3 9.82 % ,多潘立酮治疗的有效率分别为 5 2 .99%、5 3 .5 5 %和 45 .13 % ,两组间差异无显著性。治疗组对胃排空的改善率为 62 .16% ,对照组为 5 6.67% ,两组间差异无显著性。两组不良事件发生率的差异也无显著性。结论 伊托必利治疗功能性消化不良有效。

Objective To compare the efficacies of itopride hydrochloride capsule and domperidone tablet in the treatment of functional dyspepsia. Methods 230 patients with functional dyspepsia were randomly divided into two groups: the study group received itopride hydrochloride 50 mg pill tid orally before meal, the controlled group was given domperidone 10 mg tablet tid before meal. Two weeks later, gastric emptying rates were studied and compared. Results The effective rates of abolishing postprandial fullness, early satiety and epigastric discomfort in the study group were 50.43%, 64.42% and 39.82%, respectively, and 52.99%, 53.55% and 45.13% for the controlled group. There were no statistical difference between the two groups. The frequency of side effects in the two groups had also no statistically difference. Conclusion Itopride hydrochloride capsule is effective and safety in the treatment of functional dyspepsia.