太子神悦胶囊治疗轻中度抑郁症的疗效和安全性

Efficacy and safety of Taizi Shenyue Capsules in the treatment of mild to moderate depression

目的:评价太子神悦胶囊治疗轻中度抑郁症的疗效和安全性。方法:将研究对象随机分为试验组、阳性药组和安慰剂组,疗程为8周。以治疗终点的汉密尔顿抑郁17项(Hamilton Depression Scale-17 items,HAMD-17)量表减分值作为主要疗效评价指标,在基线、给药后1,2,4,8周末进行评价;安全性评价指标包括实验室检查、心电图检查、生命体征及不良事件发生率。结果:纳入符合标准的抑郁症患者601例。治疗终点3组间减分值比较差异有统计学意义(P<0.0001),试验组优于安慰剂组(P<0.0001),试验组非劣于阳性药组(P=0.7354>0.05),尚不能认为试验组优于阳性药组。治疗期不良事件发生率分别为9.27%,15.97%,10.83%,组间差异无统计学意义(P>0.05)。结论:太子神悦胶囊治疗轻中度抑郁症安全有效。

Objective:To evaluate the efficacy and safety of Taizi Shenyue Capsules in the treatment of mild to moderate depression.Methods:The study subjects were randomly divided into experimental group,positive drug group,and placebo group,with a treatment period of 8 weeks.Evaluation was conducted after 0,1,2,4,8 weeks of treatment with the Hamilton Depression Scale-17 items(HAMD-17)scale score reduction as the main efficacy evaluation indicators,and the safety evaluation indicators included laboratory examination,electrocardiogram examination,vital signs,and incidence of adverse events.Results:Totally 601 depression patients met the inclusion criteria.At the treatment endpoint,there was a statistically significant difference in the reduction score between the three groups(P<0.0001).The experimental group was superior to the placebo group(P<0.0001),while the experimental group was not inferior to the positive drug group(P=0.7354>0.05).It cannot be considered that the experimental group was superior to the positive drug group.The incidences of adverse events during the treatment period were 9.27%,15.97%,and 10.83%,respectively(P>0.05).Conclusion:Taizi Shenyue Capsules is safe and effective in treating mild to moderate depression.