加味逍遥胶囊治疗轻中度抑郁症的随机对照临床研究  

Randomized controlled trial of Jiawei Xiaoyao Capsule in the treatment of mild to moderate depression

作　　者：周杰[1] 苏芮[2] 李涛[3] 曹欣冬[4] 韩振蕴[5] 林彬[5] 郭荣娟[5] 范吉平[2] 

机构地区：[1]中国中医科学院望京医院,北京100102 [2]中国中医科学院,北京100700 [3]中国中医科学院广安门医院,北京100053 [4]首都医科大学安定医院,北京100088 [5]北京中医药大学东方医院,北京100078

出　　处：《中华中医药杂志》2013年第9期2804-2806,共3页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：中国中医科学院自主选题项目(No.ZZ040808)~~

摘　　要：目的:评价加味逍遥胶囊治疗轻中度抑郁症的疗效及安全性。方法:采用多中心随机双盲安慰剂对照的研究方法。共入组127例轻中度抑郁症患者,中药组(加味逍遥胶囊+舍曲林安慰剂)65例,西药组(舍曲林+加味逍遥胶囊安慰剂)62例,疗程8周。以汉密尔顿抑郁量表(HAMD)和中医证候量表评分作为疗效评价指标,副反应量表评定不良反应。结果:基于汉密尔顿抑郁量表评估,两组临床疗效比较无显著性差异;两组治疗后HAMD积分均明显低于治疗前(P<0.05),两组间比较无显著性差异;两组中医证候总分差值组间比较无显著性差异;中药组不良反应发生率低于西药组(P<0.05)。结论:加味逍遥胶囊治疗轻中度抑郁症与舍曲林相当,不良反应明显少于舍曲林。Objective： To evaluate the effect and safety of Jiawei Xiaoyao （JWXY） Capsule in the treatment of mild to moderate depression. Methods： The research was conducted by a multicenter randomized, double-blind and placebo controlled trial of 127 patients with mild to moderate depression, who received JWXY Capsule and Sertraline placebo （65 patients） or Sertraline and JWXY Capsule placebo （62 patients）, each of them got different treatment for 8 weeks. The efficacy was evaluated by Hamilton Depression Scale （HAMD） and the scale for Traditional Chinese Medicine （TCM） syndrome, adverse reactions were evaluated by Treatment Emergent Symptom Scale （TESS）. Results： There was no significant difference between the two groups in scores of HAMD. The scores of HAMD of both groups were remarkably lowered after therapy （P〈0.05）, showed no significance between them. There was no statistically significant difference between the two groups of TCM syndrome score. The incidence of adverse reactions in Chinese medicine group was lower than that in western medicine group （P〈0.05）. Conclusion： JWXY Capsule shows the effect equivalent to that of Sertraline in the treatment of mild to moderate depression with obviously less adverse reactions.

关 键 词：加味逍遥胶囊 抑郁症 中医证候 多中心 随机对照研究 

分 类 号：R277.7[医药卫生—中医学]