温胆宁心颗粒联合心理疗法治疗心胆气虚型广泛性焦虑症的随机对照临床研究  

The combination of Wendan Ningxin Granule and psychotherapy in the treatment of generalized anxiety disorder (Qi deficiencies of the heart and gallbladder) : a randomized,controlled clinical trial

作　　者：史华伟[1] 郭蓉娟[1] 耿东[1] 朱晓晨[1] 王嘉麟[1] 李麒豫[1] 熊航[1] 汪卫东[2] 林颖娜[2] 黄艳影[2] 

机构地区：[1]北京中医药大学东方医院脑病二科,博士研究生100078 [2]中国中医科学院广安门医院心理科

出　　处：《环球中医药》2013年第10期728-732,共5页Global Traditional Chinese Medicine

基　　金：国家"十一五"科技支撑计划项目(2009BA177B09);北京中医药大学创新团队项目(2011-CXTD-23);高等学校博士学科点专项科研基金(20110013110008)

摘　　要：目的探讨温胆宁心颗粒联合心理疗法治疗心胆气虚型广泛性焦虑症的临床疗效。方法以心胆气虚型广泛性焦虑症患者为研究对象,根据随机、双盲、对照原则,将200例患者分为中药组、安慰剂组、中药+心理组、安慰剂+心理组,每组50例,疗程6周。以汉密尔顿焦虑量表评分、减分率作为疗效评价指标。结果符合方案集175例患者,其中中药组43例、安慰剂组42例、中药+心理组46例、安慰剂+心理组44例。四组临床疗效经CMHχ2检验,治疗4周、6周后,四组疗效差异存在显著的统计学意义(P<0.05),其中中药+心理组、中药组及安慰剂+心理组疗效均优于安慰剂组(P值均<0.05);中药+心理组疗效优于中药组、安慰剂+心理组(P值均<0.05)。结论温胆宁心颗粒联合心理疗法治疗心胆气虚型广泛性焦虑症患者安全有效,心身并调是治疗情志疾病的较好方案。Objective To explore the treatment efficacy on the combination of Wendan Ningxin Granule and psychotherapy in the treatment of generalized anxiety disorder （ Qi deficiency of the heart and gall）. Methods In this study, 200 GAD patients with Qi deficiency of the heart and gall were divided into Chinese medicine group, placebo group, Chinese medicine ＋ psychotherapy group and placebo ＋ psychotherapy group. They were observed for 6 weeks in a randomized controlled clinical trail with Wendan Ningx- in Granule. HAMA was used to assess the measure of the treatment. Results 175 cases were analyzed in per-protocol set. The efficacy was analyzed by Cochran-Mantel-Haensel statistics. Statistically significant differences in efficacy among groups were observed in 4th-6th week, （P 〈0. 05）. The efficacy in the Chi- nese medicine ＋ psychotherapy, Chinese medicine and placebo ＋ psychotherapy groups was superior to those in placebo group （ P 〈 0. 05 ）. The efficacy in the Chinese medicine ＋ psychotherapy group was superior to those in Chinese medicine ＋ psychotherapy, and Chinese medicine group （P 〈 0. 05 ）. Conclusion The combination of Wendan Ningxin Granule and psychotherapy has a remarkable efficacy with higher safety on generalized anxiety disorder （Qi deficiencies of the heart and gall）, therefore it is an advantageous option in treating diseases due to emotional disorders.

关 键 词：温胆宁心颗粒 心理疗法 广泛性焦虑症 心胆气虚 

分 类 号：R277.7[医药卫生—中医学]