| 欣可静和丁螺环酮治疗广泛性焦虑(心肝火旺证)的多中心随机双盲对照试验 |
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| 引用本文： | 刘松山,何成诗,孙鸿辉,刘福友,吉海旺,孟翠霞,张震中,杨晓航,杨志宏.欣可静和丁螺环酮治疗广泛性焦虑(心肝火旺证)的多中心随机双盲对照试验[J].中国新药与临床杂志,2011(5). |
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| 作者姓名： | 刘松山 何成诗 孙鸿辉 刘福友 吉海旺 孟翠霞 张震中 杨晓航 杨志宏 |
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| 作者单位： | 成都中医药大学附属医院;陕西省人民医院;湖南中医药大学第一附属医院;新疆维吾尔自治区中医医院;陕西中医学院附属医院; |
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| 摘 要： | 目的评价欣可静治疗广泛性焦虑(心肝火旺证)的有效性和安全性。方法采用随机、双盲、双模拟、丁螺环酮平行对照多中心试验。入选474例,随机分为试验组(口服欣可静1.26g·次~(-1)、tid)和对照组(口服丁螺环酮5mg·次~(-1),tid),观察4wk。采用汉密尔顿焦虑量表(HAMA)、疗效指数、中医证候评价有效性,以不良反应、实验室检查评价安全性。结果纳入全分析集467例(试验组349例,对照组118例),安全性分析集473例(试验组355例,对照组118例)。治疗4wk末,试验组和对照组的HAMA减分值分别为(11±6)和(9±6),与基线相比或组间相比均有非常显著差异(P<0.01)。试验组疗效指数显著高于对照组(2.9±1.1)vs.(2.3±1.3),P<0.01]。试验组中医证候的愈显率、总有效率分别为53.6%、84.5%,对照组分别为39.8%、71.2%,试验组优于对照组(P<0.01)。试验组不良反应发生率低于对照组(2.8%vs.39.0%,P<0.01),且严重程度较轻。结论欣可静治疗广泛性焦虑(心肝火旺证)有效、安全,不良反应发生率低、程度轻。
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| 关 键 词： | 欣可静 丁螺环酮 焦虑 心肝火旺证 双盲法 随机对照试验 临床试验 |
Xinkejing and buspirone in treatment of generalized anxiety disorder with syndrome of heart-liver fire flourwashing:a multicenter,randomized,and double-blind controlled clinical trial |
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| Institution: | LIU Song-shan~1,HE Cheng-shi~1,SUN Hong-hui~1,LIU Fu-you~1,JI Hai-wang~2,MENG Cui-xia~3,ZHANG Zhen-zhong~4,YANG Xiao-hang~5,YANG Zhi-hong~5 (1.The Affiliated Hospital of Chengdu Traditional Chinese Medicine University,Chengdu SICHUAN 610072,China,2.Shaanxi Provincial People's Hospital,Xi-an SHAANXI 710068,3.The First Affiliated Hospital of Hu-nan Traditional Chinese Medicine University,Changsha HU-NAN 410007,4.The Hospital of Xinjiang Uygur Autonomous Region of Traditional Chinese Medicine,Uru... |
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| Abstract: | AIM To evaluate the clinical efficacy and safety of Xinkejing in treatment of generalized anxiety disorder with syndrome of heart-liver fire flourwashing.METHODS A randomized,double-blind, double-dummy,and buspirone-parallel controlled multicenter trial was conducted.Total 474 patients were randomized into two groups for 4 weeks:the Xinkejing group(trial group) and buspirone group(control group).The trial group were treated with Xinkejing 1.26 g,po,tid,and the control group were treated with buspirone 5 mg,... |
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| Keywords: | Xinkejing buspirone anxiety syndrome of heart-liver fire flourwashing double-blind method randomized controlled trials clinical trials |
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