摘要
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。
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.
出处
《世界中医药》
CAS
2014年第4期460-462,共3页
World Chinese Medicine
基金
国家科技部重大新药创制项目中药新药临床评价研究技术平台(南京)建设(编号:2012ZX09303009-002)
江苏省人力资源和社会保障厅333高层次人才培养工程及六大人才高峰行动计划
关键词
百乐眠胶囊
失眠症
肝郁阴虚证
Bailemian Capsules
Insomnia
Liver qi stagnation and yin deficiency
