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妇炎泰颗粒治疗慢性盆腔炎有效性和安全性的多中心临床评价
引用本文:张琼,薛赛琴,姜坤. 妇炎泰颗粒治疗慢性盆腔炎有效性和安全性的多中心临床评价[J]. 中国临床药理学与治疗学, 2005, 10(4): 451-455
作者姓名:张琼  薛赛琴  姜坤
作者单位: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
2. 中国中医研究院西苑医院,妇科,北京,100091
摘    要:目的:对妇炎泰颗粒治疗慢性盆腔炎(湿热瘀毒蕴结证)的临床疗效和安全性做出评价。方法:采用分层区组、随机、双盲、阳性药平行对照、多中心临床研究方法,以盆炎净颗粒为对照药。共观察2 2 2例(1 1) ,其中妇炎泰组113例,盆炎净组10 9例,脱落7例,剔除11例。结果:妇炎泰组中医症状疗效、局部体征疗效明显优于盆炎净盆炎净组(P <0 .0 5 ) ,改善慢性盆腔炎患者下腹胀痛、刺痛,腰骶胀痛,带下色黄等症状(P <0 .0 1) ,明显优于盆炎净组(P <0 .0 5 ) ,其局部体征积分高于盆炎净组(P <0 .0 1)。结论:妇炎泰颗粒治疗慢性盆腔炎(湿热瘀毒蕴结证)疗效确切,未发现有明显的副反应。

关 键 词:妇炎泰颗粒  慢性盆腔炎  湿热瘀毒蕴结证  中药疗法  临床试验
文章编号:1009-2501(2005)04-0451-05
修稿时间:2004-11-15

Efficacy and safety of fuyantai pellets in treatment of patients with chronic pelvic inflammation
ZHANG Qiong,XUN Cai-qin,JIANG Kun. Efficacy and safety of fuyantai pellets in treatment of patients with chronic pelvic inflammation[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2005, 10(4): 451-455
Authors:ZHANG Qiong  XUN Cai-qin  JIANG Kun
Abstract:AIM: To evaluate the clinical efficacy and safety of the fuyantai pellets in treatment of patients with chronic pelvic inflammation. METHODS: 222 subjects were involved in a multi-center, randomized, double-blinded, double-simulation, and positive drug parallel-controlled clinical trail.113 patients were enrolled in the fuyantai-pellets group, while 109 cases were enrolled in the control group. RESULTS: The total effective rate in fuyantai pellet group was better than that in the control group (P< 0.05 ). CONCLUSION: Fuyantai pellets is an effective and safe drug in treatment of patients with chronic pelvic inflammation.
Keywords:fuyantai pellet  chronic pelvic inflammation  TCM therapy  clinical trial
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