解郁胶囊治疗轻、中度抑郁症双盲双模拟随机对照多中心临床研究

A randomized,double-blind,double simulation-controlled,and multi centre trial of Jieyu capsule in the treatment of mild and moderate depression

目的:评价解郁胶囊治疗轻、中度抑郁症的疗效和安全性,探索适宜治疗剂量。方法:采用多中心、随机、双盲双模拟、阳性药和安慰剂平行对照的研究方法。共入组轻、中度抑郁症患者433例,高剂量组108例,低剂量组109例,安慰剂对照组107例,阳性药对照组109例,疗程均为6周。用汉密尔顿抑郁量表17项(HAMD17)、中医症候量化评分作为疗效评价指标。结果:治疗6周后,4组患者HAMD17项总分的减分值分别为(8.95±4.97),(8.06±4.78),(6.09±6.02)和(7.38±4.58)(P=0.000 7)。基于中医症候量化评分,高剂量组疗效最好(P=0.036)。4组不良事件发生率无显著性差异。结论:解郁胶囊治疗轻中度抑郁症安全有效。

Objective： To evaluate the efficacy and safety of Jieyu capsule in the treatment of mild and moderate depression,and explore the suitable dose. Methods： In a randomized,double-blind,double simulationcontrolled and multicenter trial,433 patients with mild or moderate depression were recruited. They were treated with Jieyu capsules in high dose group（ n = 108） and low dose group（ n = 109）,placebo group（ n = 107）,or positive drug control group（ n = 109） for 6 weeks. The efficacy was evaluated by Hamilton Depression Scale 17item（ HAMD17） and symptom of traditional Chinese medicine（ STCM）. Results： Compared with baseline,the decreases of HAMD 17 were 8. 95 ± 4. 97（ high dose of Jieyu capsule）,8. 06 ± 4. 78（ low dose of Jieyu capsule）,6. 09 ± 6. 02（ placebo capsules） and 7. 38 ± 4. 58（ positive drug control group）,respectively（ P = 0. 000 7）. The efficacy of high dose Jieyu capsule was the best based on STCM（ P = 0. 036）. The incidences of adverse events were not significantly different among the 4 groups. Conclusion： Jieyu capsule is an effective and safe antidepressant.