金玉康胶囊治疗轻中度抑郁症的多中心随机双盲对照临床试验  

Randomized,multicenter,double blind comparative trial of Jin-yu-kang capsule in the treatment of mild and moderate depression

作　　者：刘琦[1] 张鸿燕[1] 刘平兰[2] 李占江[3] 谢世平[4] 高成阁[5] 许秀峰[6] 杜波[7] 唐茂芹[8] 沈鑑清[9] 李鸣[10] 张晓斌 张燕[2] 舒良[1] 

机构地区：[1]北京大学第六医院,北京100083 [2]北京北大维信生物科技有限公司,北京100080 [3]北京安定医院,北京100088 [4]南京脑科医院,南京210029 [5]西安交通大学第一医院心理卫生中心,西安710061 [6]昆明医学院第一附属医院,昆明650032 [7]河北省精神卫生中心,河北保定071000 [8]山东省精神卫生中心,济南250014 [9]杭州市第七人民医院,杭州310013 [10]苏州市广济医院,江苏苏州215008 [11]扬州五台山医院,江苏扬州225003

出　　处：《中国临床药理学杂志》2007年第4期251-254,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的评价不同剂量金玉康胶囊(抗抑郁药)治疗轻中度抑郁症的有效性和安全性。方法用多中心、随机、双盲双模拟、活性药物平行对照设计。538例轻中度抑郁症患者,随机分为2个剂量(600,750mg.d-1)试验组和对照组,疗程6周。观察基线以及治疗不同时段的17项汉密尔顿抑郁量表(HAMD17)、汉密尔顿焦虑量表、临床总体印象量表评分。以HAMD17作为主要疗效指标。结果治疗结束时,3组的HAMD17总分与基线相比均明显降低(P<0.001),3组比较差异无统计学意义;3组HAMD减分率、有效率和痊愈率接近,低、高剂量试验组的疗效非劣于对照组。3组药物不良反应发生率分别为14.69%,20.00%和15.03%。不良反应主要为胃肠不适、口干、恶心、厌食、头晕等。结论金玉康胶囊600～750mg.d-1治疗轻中度抑郁症安全、有效。Objective To investigate the efficacy and safety of Jin - yu -kang capsule compared with fluoxetine in patients with mild and moderate depression. Methods This is a multi - center, randomized, doub- le - blind double - dummy, active - controlled study. A total of 538 patients with mild and moderate depression were enrolled. Subjects were randomized to 600 mg · d ^- 1 and 750 mg ·d ^-1 Jin - yu - kang capsule or 20 mg fluoxetine for six weeks. Primary outcome measures changes in scores on 17 - items Hamilton rating scale for depression （ HAMD17 ） from baseline to week 6. Secondary measures were the rate of respond and recovery according on the scores of HAMD17, total scores in Hamilton rating scale for anxiety （HAMA） and clinical global impressions scale （CGI）. Results At the endpoint, the scores of HAMD17 decreased by mean of 12.37, 11.89 and 12.67 points in the low ,high dosage trial group and the control group, respectively. The intention to treat analysis （lower one sided 95% confidence limit 3 points for the difference trial group minus control group） showed non -inferiority of Jin- yu -kang capsule over fluoxetine. The incidence of adverse events of the three groups were 14.69%, 20.00% and 15.03% respectively. The common adverse reaction symptoms were as upset, dry mouth, nausea, loss of appetite, dizziness. Conclusion A novel antidepressant agent Jin -yu -kang capsule is as effective asfluoxetine and better tolerated in the treatment of mild and moderate depression.

关 键 词：金玉康胶囊 抑郁症 氟西汀片 

分 类 号：R971.43[医药卫生—药品] R794.41[医药卫生—药学]