胃舒安颗粒治疗功能性消化不良的有效性和安全性多中心临床评价

中国临床药理学与治疗学 ›› 2006, Vol. 11 ›› Issue (10): 1177-1180.

胃舒安颗粒治疗功能性消化不良的有效性和安全性多中心临床评价

张琼, 李保双¹, 李振华¹

中国中医研究院西苑医院国家药品临床研究基地, 北京 100091;
¹中国中医研究院西苑医院消化科, 北京 100091

收稿日期:2006-06-07 修回日期:2006-08-11 出版日期:2006-10-26 发布日期:2020-11-05
作者简介:张琼, 女, 副主任医师, 主要从事中药新药临床研究。Tel:010-62875599-6486 E-mail:zhangq810@263.net

Efficacy and safety of Weishuan pellets in treatment of patients with functional dyspepsia

ZHANG Qiong, LI Bao-shuang, LI Zhen-hua

National Drug Clinical Reasearch Base Centre , Xiyuan Hospital , Chinese Academy of Traditional Chinese Medicine , Beijing 100091 , China

Received:2006-06-07 Revised:2006-08-11 Online:2006-10-26 Published:2020-11-05

摘要/Abstract

摘要： 目的评价胃舒安颗粒治疗功能性消化不良的临床疗效和安全性。方法试验采用分层区组、随机、双盲双模拟、阳性药平行对照、多中心临床研究方法, 以西沙必利片作为对照药对比观察。共观察409 例(3 ∶1), 其中试验组308 例, 对照组101 例, 其中脱落4 例, 剔除5 例。结果中医证候疗效:胃舒安颗粒组愈显率63.03%, 总有效率95.70%;西沙必利片组愈显率62.38%, 总有效率94.06%。痞满证候疗效:胃舒安颗粒组愈显率62.04%, 总有效率92.07%;西沙必利片组愈显率54.45%, 总有效率87.12%。胃排空试验胃舒安颗粒组愈显率60.78%, 总有效率73.85%;西沙必利片组愈显率59.26%, 总有效率70.37%。两组比较无统计学意义(P>0.05)。结论胃舒安颗粒治疗功能性消化不良疗效确切, 未发现毒副作用。

关键词: 胃舒安颗粒, 痞满证, 功能性消化不良, 随机双盲双模拟多中心对照试验

Abstract: AIM: To evaluate the clinical efficacy and safety of the Weishuan pellets in treatment of patients with functional dyspepsia.METHODS: 409 subjects were involved in a multi-center randomized , doubleblinded, double-simulation , and positive drug parallelcontrolled clinical trail.308 patients were enrolled in the Weishuan-pellets grouP, while 101 cases were enrolled in the control group.RESULTS: The total effective rate and recovery and excellence rate in Weishuan pellets were 95.70% and 63.03%, respectively ;In the control grouP, the total effective rate and recovery and excellence rate were 94.06% and 62.38%, respectively.For the effects on Piman synodrome , the total effective rate and recovery and excellence rate were 92.07% and 62.04%,respectively ;In the control grouP, the total effective rate and recovery and excellence rate were 87.12% and 54.45%, respectively.For effects on gastric emptying function , in the treatment grouP, the total effective rate and recovery and excellence rate were 73.85% and 60.78%, respectively ;In the control grouP, the total effective rate and recovery and excellence rate were 70.37% and 59.26%, respectively.There was no significant difference between the two groups (P>0.05).CONCLUSION: Weishuan pellet is an effective and safe drug in treatment of patients with functional dyspepsia.

Key words: weishuan pellet, functional dyspepsia, clinical trial

中图分类号:

R969

张琼, 李保双, 李振华. 胃舒安颗粒治疗功能性消化不良的有效性和安全性多中心临床评价[J]. 中国临床药理学与治疗学, 2006, 11(10): 1177-1180.

ZHANG Qiong, LI Bao-shuang, LI Zhen-hua. Efficacy and safety of Weishuan pellets in treatment of patients with functional dyspepsia[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2006, 11(10): 1177-1180.

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