百乐眠胶囊治疗失眠症肝郁阴虚证的临床研究

目的:评价百乐眠胶囊对失眠症肝郁阴虚证的改善作用。方法:采用随机、双盲双模拟、平行对照、多中心临床研究方法纳入10家医院454例失眠症肝郁阴虚证患者。治疗组342例服用试验药百乐眠胶囊和天王补心丸模拟剂,对照组112例服用对照药天王补心丸和百乐眠胶囊模拟剂。连续4周为1个疗程,观察时间为5周。结果:匹兹堡睡眠质量指数积分的变化及中医证候疗效治疗组均优于对照组,组间差异具有统计学意义。结论:百乐眠胶囊治疗失眠症肝郁阴虚证具有较好的疗效及安全性。

Clinical Study on Bailemian Capsule in Treating Insomnia with Liver Qi Stagnation and Yin Deficiency Syndrome

Objective： To evaluate effect of Bailemian capsule in improving insomnia with liver qi stagnation and yin deficiency syn- drome. Methods： A randomized, double-blind, parallel-group, multi-center clinical research was conducted involving 10 hospitals and 454 cases of insomnia patients with liver qi stagnation and yin deficiency. The 342 patients in experimental group received Bailemian capsule and Tianwangbuxin pills simulant. The 112 cases in control group were given Tianwangbuxin pills and Bailemian capsules simu- lation agent. 4 weeks were one course of treatment, and 5 weeks were observation duration. Results： The Pittsburgh Sleep Quality Index score and the efficacy of TCM symptoms in the experimental group were better than that of the control group, and there was a statistically significant difference between two groups. Conclusion： Bailemian has good clinical efficacy and safety in treating insomnia with liver qi stagnation and yin deficiency.