三七颗粒治疗失眠心虚瘀热内扰证随机双盲对照临床研究  

Sanqi Granule the Treatment of Insomnia of Deficiency Heart Blood and Stagnant Heat Type Randomized Double-blind Clinical Curative Effect Observation

作　　者：王之通[1] 贺敏[1] 蒋健[1] 

机构地区：[1]上海中医药大学附属曙光医院中医内科,上海200021

出　　处：《辽宁中医杂志》2010年第12期2289-2292,共4页Liaoning Journal of Traditional Chinese Medicine

基　　金：国家"重大新药创制"科技重大专项新药临床评价研究技术平台(GCP);中医肝肾疾病病证教育部重点实验室(上海中医药大学附属曙光医院);上海市教委重点学科中药临床药理学(J50303);上海市申康医院发展中心临床药理学科研共享平台(SHDC12007202);上海市浦东新区科技局新药临床试验研究平台(PDPT2005-03)

摘　　要：目的:评价三七颗粒对于失眠心虚瘀热内扰证的临床疗效。方法:将80例符合《中国精神障碍分类与诊断标准》(CCMD-3,Chinese Classification of Mental Disorders and Diagnostic Criteria for 3rd Edition)失眠诊断标准及自拟心虚瘀热内扰证的辨证标准的失眠患者通过随机双盲法分成三七颗粒组(41例)和安慰剂组(39例),于临睡前30min分别以开水冲服1剂三七颗粒或安慰剂,2周为1个疗程,共治疗2个疗程,观察治疗前、治疗2周、4周的匹兹堡睡眠质量指数(PSQI,Pittsburgh Sleep Quality Index)及中医证候积分,以评价三七颗粒对失眠心虚瘀热内扰证的临床疗效。结果:与安慰剂组比较,三七颗粒组的睡眠效率明显提高,睡眠时间明显延长,且PSQI的睡眠质量、睡眠时间、睡眠效率、睡眠障碍积分及PSQI总积分显著降低;在改善中医证候积分方面,三七颗粒组也明显优于和安慰剂组。结论:三七颗粒对于心虚瘀热内扰型失眠具有一定的治疗作用且服用安全。Objective ： To evaluate Sanqi Granule＇ s curative effect in treatment of insomnia of deficiency heart blood and stagnant heat type. Methods：By Randomized Double-blind Clinical Trial,80 insomnia cases corresponding to《Chinese Classification of Mental Disorders and Diagnostic Criteria for 3rd edition》 （ CCMD - 3 ） and the serf - drafted diagnosis standard of insomnia of deficiency heart blood and stagnant heat type were randonmly divided into treatment group （41cases） and control group （39cases） ,which received the treatment of Sanqi Granule and placebo respectively for two weeks as a course. The patients in treatment group took one bag of Sanqi Granule infused with boiled water and the control group took one bag of placebo infused with boiled water both 30min before sleeping. The curative cffects were evaluated with Pittsburgh Sleep Quality index（PSQI） and the self-drafted T. C. M synptom integral before and after the 2th and 4th week. Results：Comparing to the control group, Sanqi Granule can significantly improve the sleep efficiency, prolong the sleep time and reduce the integral of sleep quality, sleep time, sleep efficiency,sleep disturbance and the total integral of PSQI. Comparing to the control group ,the treatment group can also de- crease the self-drafted T. C. M synptom integral. Conclusim~：Sanqi Granule has effect on treating insomnia of deficiency heart blood and stagnant heat type without dependence and adverse effect.

关 键 词：三七颗粒 失眠症 心虚瘀热内扰证 匹兹堡睡眠质量指数 

分 类 号：R256.23[医药卫生—中医内科学]