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  

Efficacy and safety of fuyantai pellets in treatment of patients with chronic pelvic inflammation

作　　者：张琼[1] 薛赛琴[2] 姜坤[2] 

机构地区：[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

出　　处：《中国临床药理学与治疗学》2005年第4期451-455,共5页Chinese Journal of Clinical Pharmacology and Therapeutics

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。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.

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 

分 类 号：R969.4[医药卫生—药理学]