安佳欣胶囊治疗抑郁症(肝郁脾虚证)的临床研究  

Clinical trials for Anjiaxin Capsule to treat depression (stagnation of liver-qi with deficiency of the spleen syndrome)

作　　者：白燕[1] 姜红燕[1] 许秀峰[1] 罗珊珊[1] 

机构地区：[1]昆明医学院第一附属医院,云南昆明650032

出　　处：《中成药》2011年第1期17-21,共5页Chinese Traditional Patent Medicine

基　　金：成都大西南制药股份有限公司提供资助

摘　　要：目的:评价安佳欣胶囊(贯叶金丝桃、刺五加)治疗抑郁症(肝郁脾虚证)的疗效和安全性。方法:对符合《CCMD-Ⅲ》抑郁发作诊断标准的45例抑郁症患者进行安佳欣胶囊和安慰剂胶囊的随机双盲对照研究,其中安佳欣胶囊组30例,安慰剂胶囊组15例,共治疗6周。采用汉密尔顿抑郁量表(HAMD17项),中医症候评分、汉密尔顿焦虑量表(HA-MA)评定临床疗效,采用实验室检查和临床观察评定不良反应。结果:在治疗4周时、6周时两组间HAMD、中医症候评分、HAMA评分有显著性差异(P<0.05)。不良反应分析,两组不良反应的发生率无显著性差异(P>0.05),常见的不良反应为恶心、食欲减退、头昏等。结论:安佳欣胶囊治疗抑郁症(肝郁脾虚证)疗效好,不良反应少而轻,适合临床应用。AIM：To determine the efficacy and safety of Anjiaxin Capsule（St.John’s wort,Radix et Rhizoma Seu Caulis acanthopanacis senticosi） to treat the depressive patients（stagnation of liver-qi with deficiency of the spleen syndrome）.METHODS：A random double-blind controlled study was carried out in 45 patients who met the CCMD-Ⅲ diagnostic criteria of depressed episode.Thirty cases of total patients were treated with Anjiaxin Capsules and the others were treated with placebo capsule without active constituent for six weeks.The clinical efficacy was assessed with Hamilton Depression Rating Scale（HAMD）,Symptom Rating Scale of Traditional Chinese Medicine and Hamilton Anxiety Rating Scale（HAMA）,the safety was assessed with laboratory tests and clinical obser-vation.RESULTS：The scores of HAMD,Symptom Rating Scale of Traditional Chinese Medicine and HAMA had significant statistical difference between two groups after four weeks and six weeks treatment（P 〈 0.05）.There was significant difference in incidence of adverse events between two groups（P 〉0.05）.The main adverse events of Anjiaxin Capsules group were nausea,anorexia and dizziness,etc.CONCLUSION：Anjiaxin Capsules to treat depression（stagnation of liver-qi with deficiency of the spleen syndrome） is an effective antidepressants with less side effects,safety,to fit in clinical use.

关 键 词：抑郁症 肝郁脾虚证 安佳欣胶囊 安慰剂 双盲对照研究 

分 类 号：R287[医药卫生—中药学]