金玉康胶囊治疗轻、中度抑郁症的Ⅱ期临床研究  

The second phase clinical trials of Jinyukang in the treatment of mild to moderate depressive disorders

作　　者：王继才[1] 熊鹏[1] 许秀峰[1] 李文昱[1] 

机构地区：[1]昆明医学院第一附属医院精神科,昆明650032

出　　处：《精神医学杂志》2007年第5期267-270,共4页Journal of Psychiatry

摘　　要：目的评价金玉康胶囊治疗轻中度抑郁症的临床疗效和安全性。方法对符合CCMD-3抑郁症诊断标准的59例抑郁症患者进行金玉康胶囊和氟西汀治疗的对照研究,其中金玉康胶囊组30例(600mg/d),氟西汀组29例(20mg/d),共治疗6周。采用汉密顿抑郁量表(HAMD),汉密顿焦虑量表(HAMA),临床总体评定量表(CGI)评定临床疗效,不良事件量表评定安全性。结果经6周治疗后,金玉康胶囊组总有效率为73.33%,氟西汀组为75.86%,两组比较差异无显著性(P>0.05)。两组的HAMD,HAMA评分治疗前后比较差异有极显著性(P<0.001)。两组药物不良反应的发生率无显著性差异(P>0.05)。结论金玉康胶囊治疗轻中度抑郁症疗效好,不良反应少而轻,适合临床应用。Objective To determine the efficacy and safety of Jinyukang for the patients with mild to moderate depressive disorders. Methods A total of 30 patients were treated with Jinyukang（600mg/d）and 29 patients were treated with fluoxetine （20mg/d）for 6 weeks. The efficacy were assessed by Hamilton Depressi＇on Rating Scale（HAMD）, Hamilton Anxiety Scale（HAMA）, Clinical Global Impression （CGI） and the safety was assessed by Adverse Event Scale. Results After six weeks treatment, the improvement rates of Jinyukang group and fluoxetine group were 73.33% and 75.86% ,there was no difference between two groups （P〉0.05）. The scores of HAMD and HAMA in two groups significantly decreased after treatment （P〈0. 001）. The main adverse events of two groups were nausea, dry mouth, insomnia , et al. There was no significant difference in incidence of adverse events between Jinyukang group and fluoxetine group. Conclusion Jinyukang is an effective antidepressant with less side effects and better safety.

关 键 词：抑郁症 金玉康 氟西汀 贯叶连翘 

分 类 号：R971.4[医药卫生—药品] R749.4[医药卫生—药学]