蝉夜安神胶囊与安慰剂对照治疗失眠症的临床试验  

Placebo controlled clinical trial of Chanyeanshen capsules in insomnia patients

作　　者：连凤梅[1] 徐贵成[2] 刘坤[2] 刘宗莲[2] 王秋风 邱萍[2] 于春岩[2] 尹倚艰[2] 李宁[2] 高琳[2] 

机构地区：[1]中国中医科学院广安门医院药物临床试验机构办公室,北京100053 [2]中国中医科学院广安门医院综合科,北京100053

出　　处：《中国新药杂志》2009年第21期2056-2060,共5页Chinese Journal of New Drugs

摘　　要：目的:评价蝉夜安神胶囊治疗痰热内扰型失眠症的临床疗效和不良反应。方法:采用随机、双盲、安慰剂对照、多中心临床研究方法。患者108例,试验组(n=72)口服蝉夜安神胶囊5粒;对照组(n=36)口服安慰剂5粒;qd,临睡前1 h服。疗程3周,以睡眠评分、改良的匹兹堡睡眠质量指数(PSQI)、入睡时间、睡眠时间、中医证候、临床症状为疗效评价指标,分别评价患者服药1周、3周及随访1周的疗效。以不良事件、实验室检查和心电图检查等评价安全性。结果:试验组服药后患者的睡眠评分、PSQI下降,入睡时间缩短,睡眠时间延长,可改善患者入睡困难、睡而易醒、睡眠时间短、口苦等症状,各指标改善幅度明显大于安慰剂。结论:蝉夜安神胶囊是一种有效、安全的治疗失眠症的药物。Objective： To evaluate the efficacy and safety of Chanyeanshen capsule in the treatment of insomnia with internal disturbance of phlegm heat syndrome. Methods： A randomized, double-blind, placebo controlled multi-center clinical trial recruited 108 patients with insomnia, who received a 3-week treatment of Chanyeanshen capsule （n =72） or placebo （n =36） at lh before sleep. The efficacy was evaluated after 1 week and 3 weeks of administration and 1 week after trial by sleep-score, PSQI, fall-sleep time, sleeping-time, syndrome,and symptoms. The safety was evaluated based on the incidences of adverse events, laboratory and electrocardiography examination. Results： The sleep-score and PSQI were reduced after treatment in the trial group. Chanyeanshen capsule shortened fall-sleep time, prolonged sleeping-time, relieved the symptoms. The trail drug showed more stronge efficacy to treat insomnia than placebo. Conclusion： Chanyeanshen capsule provides an effective and safe therapeutic option for insomnia patients.

关 键 词：失眠症 安慰剂 中医药疗法 蝉夜安神胶囊 

分 类 号：R971.3[医药卫生—药品]