摘要
目的评价心仁神安胶囊治疗失眠阴虚火旺挟痰证的有效性与安全性。方法采用多中心随机、双盲、安慰剂平行对照方法,115例患者分为治疗组57例,对照组58例,两组均在进行睡眠卫生教育的基础上,治疗组加服心仁神安胶囊,对照组加服安慰剂,均每次3粒,每日3次,连续28天。治疗前后观察两组患者匹兹堡睡眠质量指数(PSQI)总分及7因子积分、中医症状积分,并于治疗后评价两组患者疾病疗效、中医证候疗效及安全性。结果治疗组疾病疗效总有效率、中医证候疗效总有效率分别为70.18%、49.12%,均显著高于对照组的20.69%、5.17%(P<0.01)。两组治疗后PSQI总分均较治疗前显著下降(P<0.01),且治疗组改善优于对照组(P<0.01);除因子Ⅵ催眠药物外,两组患者治疗后PSQI其他各因子得分分布与治疗前比较差异均有统计学意义(P<0.01),且治疗组治疗后因子Ⅰ主观睡眠质量、因子Ⅱ入睡时间、因子Ⅲ睡眠时间、因子Ⅳ睡眠效率、因子Ⅶ日间功能障碍改善均优于对照组(P<0.01)。除对照组的胸脘痞闷症状外,对照组与治疗组各中医症状治疗前后比较,差异均有统计学意义(P<0.05或P<0.01,且治疗组除口苦、耳鸣、盗汗、腰膝酸软外各中医症状积分改善均优于对照组(P<0.05或P<0.01)。两组治疗期间均未发生明显不良反应。结论心仁神安胶囊治疗失眠阴虚火旺挟痰证疗效确切,能显著改善患者症状。
Objective To evaluate the efficacy and safety of Xinren Shen＇an Capsule（ 心仁神安胶囊） in treating insomnia of fire excess due to Yin-deficiency with phlegm syndrome. Methods Using multi-center,randomized,double-blind,placebo parallel controlled method,the researchers divided 115 patients into the treatment group（ 57cases） and the control group（ 58 cases）. Sleep health education was conducted in both groups. In addition,the treatment group was given Xinren Shen＇ an Capsule,and the control group was given placebo,with 3 capsules each time,3 times per day,for 28 days. The researchers observed the total score of Pittsburgh Sleep Quality Index（ PSQI） and the score of 7 factors,Chinese medicine symptom score in the two groups before and after treatment,and evaluated the curative effect,Chinese medicine syndrome efficacy and safety after treatment. Results In the treatment group,the total effective rate and the Chinese medicine syndrome curative effect were 70. 18% and 49. 12% respectively,which were significantly higher than 20. 69% and 5. 17% in the control group（ P〈0. 01）. After treatment,the total score of PSQI in the two groups were significantly lower than that before treatment（ P〈0. 01）,and the improvement of the treatment group was superior to that of the control group（ P〈0. 01）. Except factor hypnotic drugs,PSQI factors score distribution after treatment in the two groups had significant difference with those before treatment（ P〈0. 01）. The improvement of subjective sleep quality,time of falling asleep,sleep time,sleep efficiency,daytime dysfunction after treatment in the treatment group was all better than that in the control group（ P〈0. 01）. Except chest and epigastric fullness and distress in the control group,the Chinese medicine symptoms in the two groups were significantly improved after treatment（ P〈0. 05 or P〈0. 01）. Except mouth bitterness,tinnitus,night sweat,soreness and weakness of waist and knees,the score improvement of other Chinese
作者
刘芳
姜亚军
常诚
邹建东
熊宁宁
LIU Fang JIANG Yajun CHANG Cheng ZOU Jiandong XIONG Ningning(Chinese Medicine Hospital of Jiangsu Province, Nanjing, 210029)
出处
《中医杂志》
CSCD
北大核心
2016年第22期1934-1938,共5页
Journal of Traditional Chinese Medicine
关键词
失眠
心仁神安胶囊
阴虚火旺挟痰证
匹兹堡睡眠质量指数
insomnia
Xinren Shen＇an Capsule
fire excess due to Yin-deficiency with phlegm syndrome
Pittsburgh sleep quality index（PSQI）
