健延龄胶囊治疗肾阴虚型原发性失眠症:多中心随机双盲双模拟对照研究

Jian- yan- ling Capsules for Primary Insomnia with Kidney Yin Deficiency: A Multi- centered Randomized Double- blind and Dummy Controlled Trial

目的:观察健延龄胶囊治疗原发性失眠症(肾阴虚证)的有效性及安全性。方法:采用多中心随机对照试验的方法,分为试验组(FAS集269例;PPS集266例)和对照组(FAS集89例;PPS集87例),试验组口服健延龄胶囊,对照组口服乌灵胶囊,连续治疗28天,观察治疗前后PSQI指数及中医证候积分的变化,进行疗效评定;并且通过生命体征及实验室检查进行安全性评定。结果:FAS集试验组PSQI愈显率为44.98%(121/269),对照组42.70%(38/89),组间比较无显著性差异(P>0.05);试验组中医证候积分愈显率为18.22%(49/269),对照组的17.98%(16/89),组间比较无显著性差异(P>0.05),FAS集结果与PPS集一致;两组间生命体征治疗前后无统计学差异(P>0.05),实验室检查疗后均未见有意义的异常结果。结论:健延龄胶囊治疗原发性失眠症(肾阴虚证)疗效确定,并且其疗效及安全性与乌灵胶囊相当。

Objective：To observe the therapeutic effect and safe reliability of Jian-yan-ling capsules for the treatment of primary insomnia with kidney Yin deficiency.Methods：A multi-centered randomized controlled trial was conducted and the enrolled participants were divided into a treatment group（ FAS 269 cases;PPS 266 cases） and a control group （ FAS 89 cases;PPS 87 cases） .The Jian-yan-ling capsules were applied in the treatment group and the Wu-ling capsules were used in the control group.The treatment session was 28 days.The therapeutic effects were systematically evaluated with the scores of PSQI and TCM syndrome, meanwhile we performed the safety assessment according to vital sign and laboratory examination.Results：In the FAS, the cure and markedly effective rates of PSQI in the treatment group and control group were 44.98%（121/269） and 42.70%（38/89）;the cure and markedly effective rates of TCM syndrome in the treatment group and control group were 18.22%（49/269） and 17.98%（16/89）,and the differences were no sta-tistically significant（P〉0.05）.PPS was in agreement with FAS.There was no significant difference in the vital sign be-tween two groups before and after the treatment（P〉0.05）and there were no meaningful abnormal laboratory indices af-ter the treatment.Conclusion：The Jian-yan-ling capsules are an effective medicine for treating primary insomnia with kidney Yin deficiency and its security and effect are similar to the Wu-ling capsules.