参芪五味子颗粒治疗慢性失眠症的效果及安全性观察  

Clinical observation of efficacy and safety of Shenqiwuweizikeli for chronic insomnia

作　　者：宋日新[1] 姜国红[2] 常宝忠[1] 吴芳芳[1] 崔立莹[1] 刘聪[1] 刘静静[1] 

机构地区：[1]大庆油田总医院中医科,163001 [2]大庆油田总医院肾内科,163001

出　　处：《中国综合临床》2015年第10期931-933,共3页Clinical Medicine of China

摘　　要：目的观察参芪五味子颗粒治疗慢性失眠症的有效性及安全性。方法将196例受试者应用随机数字表分组，参芪五味子颗粒组98例、艾司唑仑组98例。采用匹兹堡睡眠质量指数（PSQI）评定临床疗效，对研究期间的不良反应进行记录，并进行实验室常规检测（血常规、尿常规、肝肾功能、心电图等）来评价安全性。结果参芪五味子颗粒和艾司唑仑对慢性失眠症疗效相当，治疗总有效率分别为92．86％（91／98）、93．88％（92／98），差异无统计学意义（χ2=0．082，P〉0．05）。安全性观察：两组患者各项常规检查指标均未见异常；停药后艾司唑仑组反跳性失眠60例，用药期间日间困倦、嗜睡55例，头晕乏力45例，轻度头痛23例，均明显高于参芪五味子颗粒组（分别为0、11、3、0例），不良反应的发生率两组比较差异均有统计学意义（P均〈0．001）。结论参芪五味子颗粒治疗慢性失眠症安全有效，无停药反跳及依赖性。Objective To observe the efficacy and safety of Shenqiwuweizikeli for treating chronic insomnia. Methods One hundred and ninety-six cases of subjects were randomly divided into Shenqiwuweizikeli group（ n= 98） and Estazolam tablets group （n = 98）. The pittsburg sleep quality index （PSQI） was adopted to evaluate the clinical effects and records of adverse reactions during the study period. Also the lab routine inspection（ blood routine ,urine routine, liver and kidney function, electrocardiogram were conducted to evaluate safety. Results The Shenqiwuweizikeli and Estazolam tablets all had significant effects for chronic insomnia. The total effective rate of. Shenqiwuweizikeli group was 92. 86% （ 91/98）, of Estazolam tablets group was 931 88% （92/98）, and there was no significant difference （P〉0. 05）. There were no abnormalities in terms of each routine inspection index. After stopping take the medicine, The adverse reactions including bounce sex insomnia（ 60 cases ）, daytime sleepiness/drowsiness （55 cases ）, dizziness with lacking of power and light headedness（23 cases） in Estazolam tablets group were all more than Shenqiwuweizikeli group with significant difference（P〈0. 01 ）. Conclusion The Shenqiwuweizikeli has definite efficacy and safety for treated with chronic insomnia without withdrawal of recoil and dependence.

关 键 词：参芪五味子颗粒 慢性失眠症 艾司唑仑 

分 类 号：R512.5[医药卫生—内科学]