金玉康胶囊治疗轻、中度抑郁症的Ⅲ期临床研究

The Third Phase Clinical Trials of Jinyukang for the Treatment of Mild to Moderate Depressive Disorders

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90例抑郁症患者进行金玉康胶囊和氟西汀的对照研究,其中金玉康低剂量组30例(600mg/d),金玉康高剂量组30例(750mg/d),氟西汀组30例(20mg/d),共治疗6周.采用汉密尔顿抑郁量表(HAMD),汉密尔顿焦虑量表(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,金玉康低剂量组有效率为80.00%,金玉康高剂量组为76.67%,氟西汀组为76.67%,两两比较,差异无统计学意义(P>0.05).3组的HAMD,HAMA评分治疗前后相比较差异有高度统计学意义(P<0.01).不良反应分析,3组药物不良反应的发生率无统计学意义(P>0.05),常见的不良反应有恶心、口干、失眠等.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 safely of Jinyukang to the patients with mild to moderate depressive disorders. Methods A controlled study was carried out among 90 patients who met the CCMD-3 criteria of depression and depressed episode. All the patients were divided into three groups： the low-dose Jinyukang （600 mg/d）, the high-dose Jinyukang （750 mg/d） and the fluoxetine （20 mg/d）, and were treated for 6 weeks. The efficacy was assessed by Hamilton Depression Rating Scale （HAMD） , Hamilton Anxiety Scale （HAMA）, and Clinical Global Impression （CGI） and the safety was assessed by Adverse Event. Results After six-week treatment, the improvement rate of the low-dose Jinyukang, the high-dose Jinyukang and the fluoxetine were 80.00% ,76.67%, 76.67%, respectively （P 〉 0.05） .The scores of HAMD and HAMA in three groups were statistically different before and after treatment （P 〈 0.01） The main adverse events of three groups were nausea, dry mouth, insomnia, et al. there were no significant differences in incidence of adverse events among them. Conclusions Jinyukang is an effective antidepressants, with less side effects, better safety, suiting for clinical use.