金玉康胶囊治疗轻中度抑郁症的疗效和安全性  

Efficacy and safety of Jinyukang capsules in the treatment of mild and moderate depression

作　　者：张鸿燕[1] 刘琦[1] 刘平兰[2] 李占江[3] 谢世平[4] 高成阁 许秀峰[6] 张燕[2] 舒良[1] 

机构地区：[1]北京大学第六医院,北京100083 [2]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]西安精神卫生中心,西安710061 [6]昆明医学院附属医院精神科,昆明650032

出　　处：《中国新药杂志》2006年第11期903-907,共5页Chinese Journal of New Drugs

摘　　要：目的:评价金玉康胶囊治疗轻中度抑郁症的有效性和安全性。方法:采用多中心、随机、双盲、双模拟、活性药物平行对照设计。入选293例轻中度抑郁症患者,随机分为试验组145例和对照组148例,分别口服金玉康胶囊600 mg·d-1或盐酸氟西汀片20 mg·d-1,疗程均为6周。疗效观察指标包括基线以及治疗不同阶段的17项汉密尔顿抑郁量表(Hamilton rating scale for depression,HAMD17)、汉密尔顿焦虑量表(Hamilton rating scale for anxiety,HAMA)、临床总体印象量表(Clinical Global Impression scale,CGI)评分,以HAMD17作为主要疗效指标。结果:治疗结束时,两组的HAMD17总分与基线相比均明显降低,但两组间差异无显著性;两组的HAMD减分率接近,分别为55．77％和59．95％;以HAMD17减分率判断有效率,两组间差异也无显著性。两组的不良反应发生频率相当;体重在治疗结束时金玉康组较基线有所增加而氟西汀组没有明显变化,组间比较差异有统计学意义(F=5．014,P=0．026)。结论:金玉康胶囊治疗轻中度抑郁症安全、有效。Objective： To assess the efficacy and safety of Jinyukang capsules versus fluoxetine in patients with mild and moderate major depression. Methods： A muhicenter, randomized double blind, double dummy, positive-control clinical study recruited 293 subjects with mild and moderate depression. Subjects were randomized to receive 600 mg. d^-1 Jinyukang capsules made from Hypericum extract （ n = 145 ） or 20 mg fluoxetine （ n = 148 ） for six weeks. The primary endpoint was to measure improvements of Hamilton rating scale for depression （HAMD17）. The secondary endpoints included Hamilton rating scale for anxiety （HAMA） and clinical global impression scale （CGI）. Results： At the end of therapy, subjects treated with Hypericum extract and fluoxetine all experienced significant decreases of HAMD 17 from the baseline, scoring 55.77% and 59. 95% , respectively （P〉 0. 05）. The major adverse event for Hypericum-treated subjects was weight gain; the P value for such weight gain showed statistical difference （P = 0. 026）. Conclusion： The Jinyukang capsules provided a therapeutic option for subjects with mild and moderate depression.

关 键 词：金玉康胶囊 抑郁症 氟西汀 

分 类 号：R971.4[医药卫生—药品] R969.4[医药卫生—药学]