【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8407%，对照组为7143%，两组比较差异有显著性意义（P＜005）,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＜005）。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
Therapeutic Effect of Guizhi Fuling Capsules for Hyperplasia of Mammary Glands with Bloodstasis Blocking Collaterals
WANG Zhaohui,DU Yanping,HUANG Xiwen,YANG Zhongqi,YANG Haiyan,LIU Yujie,XIAN Shaoxiang
1.The First Affiliated Hospital,Guangzhou University of TCM,Guangzhou 510405 Guangdong,China;
2.Kangyuan Pharmaceutical Industry Limited Company of Jiangsu,Lianyungang 222001 Jiangsu,China
Abstract:ObjectiveTo evaluate the clinical efficacy and safety of Guizhi Fuling Capsules (GFC) for hyperplasia of mammary glands with bloodstasis blocking collaterals.MethodsA randomized doubleblind positivecontrolled parallel multicenter clinical trial was carried out in 240 patients with mammary gland hyperplasia.The 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,tid.The two groups received the corresponding treatment for 3 continuous months.After treatment,the therapeutic effect and the changes of main symptom score were observed.Meanwhile,the safety was also evaluated.ResultsThe total effective rate was 8407% in GFC group and 7143% in the control group(P＜005).The decrease of main symptom score in GFC group was superior to that in the control group(P＜005).No obvious adverse reaction was found during treatment in the two groups.Conclusion Guizhi Fuling Capsules is effective an
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