伊托必利治疗功能性消化不良的随机双盲对照试验104例  

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

作　　者：李艳红[1,2] 龚培力[1] 侯晓华[3] 陈婕[3] 刘南植[4] 田德安[4] 唐芙爱[5] 冯常炜[5] 杨玉秀[6] 李怀斌[6] 

机构地区：[1]华中科技大学同济医学院临床药理研究所 [2]广州中医药大学临床药理研究所,广东广州510405 [3]华中科技大学同济医学院附属协和医院 [4]华中科技大学同济医学院附属同济医院 [5]郑州大学附属第二医院 [6]河南省人民医院

出　　处：《中国新药与临床杂志》2005年第7期524-528,共5页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：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。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.

关 键 词：多潘立酮 消化不良 多中心研究 随机对照试验 双盲法 伊托必利 

分 类 号：R975[医药卫生—药品] R573.9[医药卫生—药学]