桂枝茯苓胶囊治疗乳腺增生病（瘀血阻络证）临床研究.doc

桂枝茯苓胶囊治疗乳腺增生病(瘀血阻络证)临床研究
作者:汪朝晖,杜彦萍,黄习文,杨忠奇,杨海燕,柳于介,冼绍祥
【摘要】【目的】评价桂枝茯苓胶囊治疗乳腺增生病(瘀血阻络证)的有效性和安全性。【方法】240例乳腺增生病(瘀血阻络证)患者采用随机、双盲、阳性药平行对照、多中心临床试验设计方法分为试验组和对照组2组。试验组口服桂枝茯苓胶囊,5粒/次(含桂枝茯苓模拟剂胶囊2粒),每天3次;对照组口服乳癖消胶囊,5粒/次,每天3次。两组疗程均为3个月。观察两组临床疗效和主要症状体征积分的变化情况,并作安全性评价。【结果】两组治疗后总有效率试验组为8407%,对照组为7143%,两组比较差异有显著性意义(P<005),说明试验组疗效优于对照组。治疗3个月后两组中医主症积分下降比较,试验组下降值大于对照组(P<005)。治疗期间,两组均未出现明显不良反应。【结论】桂枝茯苓胶囊治疗乳腺增生病(瘀血阻络证)有良好的疗效,而且具有较高的安全性。
【关键词】桂枝茯苓胶囊/治疗应用;乳腺增生病/中药疗法;瘀血阻络证;临床试验,Ⅱ期
Abstract:ObjectiveTo evaluate the clinical efficacy and safety of Guizhi Fuling Capsules (GFC) for hyperplasia of mammary glands with bloodstasis blocking randomized double
blind positivecontrolled parallel multicenter clinical trial was carried out in 240 patients with mammary gland patients were randomized into two groups:GFC group received oral use of GFC,5 capsules (including 2 capsules of GFC simulator) each day,tid,and the control group received oral use of Rupixiao Capsules,5 capsules, two groups received the corresponding treatment for 3 continuous treatment,the therapeutic effect and the changes of main symptom score were ,the safety was also total effective rate was 8407% in GFC group and 7143% in the control group(P<005).The decrease of main symptom score in GFC group was superior to that in the control group(P<005).No obvious adverse reaction was found during treatment in the two Guizhi Fuling Capsules is effective and safe for the treatment of hyperplasia of mammary glands with bloodstasis blocking collaterals.
Key words:GUIZHI FULING CAPSULES/therapeutic use;
桂枝茯苓胶囊处方来源于张仲景《金匮要略》所载之桂枝茯苓丸,属古典经方。该方由桂枝、茯苓、牡丹皮、桃仁、芍药等药物组成,具有活血化瘀、缓消癥块的功能,可用于妇女血瘀所致的乳腺增生病。按照国家药品临床试验管理规范(GCP)对药物临床的相关要求[1-2],由广州中医药大学第一附属医院等7家单位对其进行了Ⅱ期临床试验,观察其疗效及安全性,现将临床研究结果报道如下。
1研究对象与方法
11研究对象
111诊断标准参照《中药新药临床研究指导原则》[3]中有关乳腺囊性增生病诊断标准和2002年中华中医外科学会乳腺病专业委员会第八次会议通过的《乳腺增生病诊断标准》[4]中有关内容制定。
112纳入病