| 桂枝茯苓胶囊治疗乳腺增生病(瘀血阻络证)临床研究 |
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| 引用本文： | 汪朝晖,杜彦萍,黄习文,杨忠奇,杨海燕,柳于介,冼绍祥.桂枝茯苓胶囊治疗乳腺增生病(瘀血阻络证)临床研究[J].广州中医药大学学报,2009,26(2). |
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| 作者姓名： | 汪朝晖 杜彦萍 黄习文 杨忠奇 杨海燕 柳于介 冼绍祥 |
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| 作者单位： | 1. 广州中医药大学第一附属医院,广东,广州,510405
2. 江苏康缘药业股份有限公司,江苏连云港,222001 |
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| 基金项目： | 国家食品药品监督管理局新药临床观察项目 |
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| 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(JP<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.
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| 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 Blood-stasis Blocking Collaterals |
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| WANG Zhaohui,DU Yanping,HUANG Xiwen,YANG Zhongqi,YANG Haiyan,LIU Yujie,XIAN Shaoxiang.Therapeutic Effect of Guizhi Fuling Capsules for Hyperplasia of Mammary Glands with Blood-stasis Blocking Collaterals[J].Journal of Guangzhou University of Traditional Chinese Medicine,2009,26(2). |
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| Authors: | WANG Zhaohui DU Yanping HUANG Xiwen YANG Zhongqi YANG Haiyan LIU Yujie XIAN Shaoxiang |
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| Institution: | 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 |
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| Abstract: | Objective To evaluate the clinical efficacy and safety of Guizhi Fuling Capsules(GFC) for hyperplasia of mammary glands with blood-stasis blocking collaterals.Methods A randomized double-blind positive-controlled parallel multi-center 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 Caps... |
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