解郁除烦胶囊治疗抑郁症334例多中心随机双盲对照试验  

Multicenter Randomized Double-blind Controlled Trial of Jieyu Chufan Capsule (解郁除烦胶囊) Treating 334 Cases with Depression

作　　者：谷春华[1] 任君霞[1] 杨立波[1] 高学东[1] 颜红[2] 胡思源[2] 汪卫东[3] 艾长山[4] 海英[5] 殷晓莉 郭连澍[7] 张怀亮[8] 孟毅[9] 邢艳丽[10] 

机构地区：[1]石家庄以岭药业股份有限公司 [2]天津中医药大学第一附属医院 [3]中国中医科学院广安门医院 [4]吉林省中医药科学院第一临床医院 [5]辽宁中医药大学附属医院 [6]辽宁中医药大学附属第二医院 [7]河北省人民医院 [8]河南中医药大学第一附属医院 [9]河南省中医院 [10]黑龙江中医药大学附属第二医院

出　　处：《中医杂志》2016年第15期1297-1302,共6页Journal of Traditional Chinese Medicine

基　　金：国家科技重大专项重大新药创制(2014ZX09301307-001)

摘　　要：目的评价解郁除烦胶囊治疗抑郁症的临床疗效与安全性。方法采用随机双盲双模拟多中心临床试验设计,入组560例受试者,随机分为治疗组336例、对照组112例和安慰剂组112例,治疗组口服解郁除烦胶囊和盐酸氟西汀片模拟片,对照组口服解郁除烦胶囊模拟胶囊和盐酸氟西汀片,安慰剂组口服解郁除烦胶囊模拟胶囊和盐酸氟西汀片模拟片,疗程42天。治疗前后进行汉密尔顿抑郁量表(HAMD)评分、汉密尔顿焦虑量表(HAMA)评分、中医证候积分,治疗后评价疾病疗效、中医证候疗效和临床总体印象量表的疗效总评(CGI-GI)及安全性。结果各组治疗后HAMD、HAMA评分及中医证候积分均较治疗前明显降低(P<0.01),治疗组及对照组治疗后HAMD评分、HAMA评分及中医证候积分均低于安慰剂组(P<0.01),且治疗组HAMA评分及中医证候积分均低于对照组(P<0.01)。治疗组、对照组、安慰剂组疾病疗效总有效率分别为90.1%、84.5%、38.7%;中医证候疗效总有效率分别为88.6%、75.5%、34.2%;CGI-GI的总进步分别为90.4%、85.3%、45.0%,治疗组与对照组各疗效指标均优于安慰剂组(P<0.01),治疗组中医证候疗效优于对照组(P<0.01)。治疗组出现1例与药物有关的不良事件,显示了较好的临床安全性。结论解郁除烦胶囊治疗抑郁症具有较好的临床疗效与安全性。Objective To evaluate the clinical effect and safety of Jieyu Chufan Capsule（解郁除烦胶囊） in treating depression. Methods The researchers used randomized double-blind double-dummy multicenter clinical trial design to select 560 subjects randomly into treatment group（ 336 cases）,control group（ 112 cases） and placebo group（112 cases）. The treatment group took Jieyu Chufan Capsules and placebo tablets with fluoxetine hydrochloride. The control group took placebo capsules with Jieyu Chufan Capsules and fluoxetine hydrochloride tablets. The placebo group took placebo capsules with Jieyu Chufan Capsules and placebo tablets with fluoxetine hydrochloride. All courses of treatment were 42 days. Before and after treatment,the researchers gave a mark with Hamilton＇s depression scale（ HAMD）,Hamilton＇ s anxiety scale（ HAMA） and Chinese medical syndrome scores. After treatment,the researchers evaluated curative effects of diseases and Chinese medical syndromes,general comment of curative effects about clinical general impression scale（ CGI-GI） and safety. Results After treatment,HAMD,HAMA scores and Chinese medical syndrome scores of each group were significantly lower than those before treatment（ P〈0. 01）. After treatment,HAMD,HAMA scores and Chinese medical syndrome scores of the treatment group and the control group were lower than those of the placebo group（ P〈0. 01）. And HAMA scores and Chinese medical syndrome scores of the treatment group were lower than those of the control group（ P〈0. 01）. Total effective rates about curative effects of diseases in the treatment group,the control group and the placebo group respectively were 90. 1%,84. 5% and38. 7%; The total effective rates about curative effects of Chinese medical syndromes were respectively 88. 6%,75. 5% and 34. 2%; The total progress of CGI-GI were respectively 90. 4%,85. 3% and 45. 0%. The therapeutic effect indexes of the treatment group and the control group were better than those of the placebo group（

关 键 词：抑郁症 解郁除烦胶囊 氟西汀 随机对照试验 

分 类 号：R277.7[医药卫生—中医学]