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  

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

作　　者：刘松山[1] 何成诗[1] 孙鸿辉[1] 刘福友[1] 吉海旺[2] 孟翠霞[3] 张震中 杨晓航[5] 杨志宏[5] 

机构地区：[1]成都中医药大学附属医院,四川成都610072 [2]陕西省人民医院,陕西西安710068 [3]湖南中医药大学第一附属医院,湖南长沙410007 [4]新疆维吾尔自治区中医医院,新疆乌鲁木齐830000 [5]陕西中医学院附属医院,陕西咸阳712000

出　　处：《中国新药与临床杂志》2011年第5期334-338,共5页Chinese Journal of New Drugs and Clinical Remedies

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。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, rid, and the control group were treated with buspirone 5 mg, po, tid. Hamilton Anxiety Scale （HAMA）, efficacy index, and traditional Chinese medicine （TCM） syndrome were employed to assess the effectiveness, and adverse reaction observation and laboratory examination indexes were employed to assess the safety. RESULTS There were 467 patients in Full Analysis Set （349 in the trial group, 118 in the control group） and 473 patients in Safe Set （355 in the trial group, 118 in the control group）. At the end of treatment, the HAMA decreased score was 11± 6 in the trial group and 9 ＋- 6 in the control group with significant difference between the two groups （P 〈 0.01 ）, and the HAMA scores in both group reduced significantly compared with their baseline （P 〈 0.01 ）. The efficacy index in the trial group was higher than that in the control group （（2.9 ± 1.1） vs. （2.3 ±1.3）, P 〈 0.01）. The curative-markedly effective rate and total effective rate of TCM syndrome in the trial group （53.6% and 84.5% ） were better than those in the control group （39.8% and 71.2%）, P 〈 0.01. The trial group showed lower incidence of adverse reactions compared with the control group （2.8% vs. 39.0%, P 〈 0.01） with lighter severity degree. CONCLUSION Xinkejing shows effective and safe in treatment of generalized anxiety disorder with syndrome of heart-liver fire flourwashing and has less adverse reaction incidence with lighter severity degree.

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 

分 类 号：R749[医药卫生—神经病学与精神病学]