丹栀宁神胶囊治疗轻中度抑郁症的随机双盲安慰剂对照研究

Randomized,double-blind,placebo-controlled trial of Danzhiningshen capsules in the treatment of mild and moderate depression

目的:评价丹栀宁神胶囊治疗轻中度抑郁症的疗效和安全性。探索适宜剂量。方法:采用随机双盲多中心安慰剂对照的研究方法,共入组患者236例。安慰剂组76例,低剂量组80例,高剂量组80例。疗程为6周,以汉密尔顿抑郁量表、中医症候量表评分作为疗效评价指标。结果:基于汉密尔顿抑郁量表评估,安慰剂组有效率22.22%,低剂量组47.37%、高剂量组69.89%(组间比较P<0.001)。基于中医症候量化评分,3组比较高剂量组疗效最好(组间比较P<0.001)。3组均无严重不良事件发生。结论:丹栀宁神胶囊治疗轻中度抑郁症安全有效。

Objective： To evaluate the efficacy and safety of Danzhiningshen capsules in the treatment of mild and moderate depression and explore the suitable dose. Methods： A randomized,double-blind,placebo-controlled,multi-center trial recruited 236 patients with mild or moderate depression. They were treated with placebo capsules（ n = 76） or Danzhiningshen capsules of low dose（ n = 80） or high dose（ n = 80） for 6 weeks. The efficacy was evaluated by Hamilton Depression Scale（ HAMD） and Symptom of Traditional Chinese Medicine（ STCM）.Results： The effective rates of placebo capsules,low and high dose Danzhiningshen capsules based on HAMD were22. 22%,47. 37% and 69. 89%,respectively（ P〈0. 001）. High dose Danzhiningshen capsules had the best efficacy based on STCM（ P〈0. 001）. The incidences of adverse reaction and adverse events were not significantly different among placebo capsules,low dose Danzhiningshen capsules,and high dose Danzhiningshen capsules.Conclusion： Danzhiningshen capsules are an effective and safe antidepressant.