益脑吾斯提库都斯糖浆改善原发性失眠患者睡眠质量的临床研究

Clinical study of Yinao Wusiti Kudousi Syrup on the improvement of sleep quality of patients with primary insomnia

目的:评价益脑吾斯提库都斯糖浆改善(异常赛吾达型)原发性失眠患者睡眠质量的临床有效性和安全性。方法:通过随机、单盲、安慰剂平行对照及单中心试验设计,将符合标准的108例患者随机分为试验组和对照组各54例,对照组予安慰剂,试验组予益脑吾斯提库都斯糖浆,疗程4周,观察匹兹堡睡眠指数量表(PSQI)、维吾尔医症状评分量表及安全性指标。结果:试验组总有效率、各等级有效率明显优于对照组(P<0.01),异常赛吾达性失眠症状、PSQI积分较对照组显著降低(P<0.01),入睡困难、睡眠不足、易醒、多梦、困倦神疲、健忘、思索紊乱症状明显缓解(P<0.01),安全性较好。结论:益脑吾斯提库都斯糖浆改善失眠患者睡眠质量具有良好的有效性和安全性。

Objective:To evaluate the clinical efficacy and safety of Yinao Wusiti Kudousi Syrup in the improvement of sleep quality of the patients with abnormal Sawda primary insomnia.Methods:Through randomized,single blind,placebo parallel contrasted and single-center trial design,108 patients meeting the standard were randomly divided into treatment group and the control group,54 cases in each group.Patients in control group were treated with placebo,and patients in treatment group were treated with Yinao Wusiti Kudousi Syrup.Four weeks later,PSQI scale,uyghur medical symptoms rating scale and safety indicators were observed.Results:Total effective rate and each grade efficient in treatment group were higher than the control group(P<0.01).Compared with control group,the scores of abnormal Sawda insomnia and PSQI in treatment group were decreased(P<0.01).The symptomes of difficulty falling asleep,lack of sleep,festless sleep,dreaminess,sleepy spiritlessness,amnesia and disorder of thought were obviously alleviated(P<0.01),and Yinao Wusiti Kudousi Syrup has good safety.Conclusion:Yinao Wusiti Kudousi Syrup is effective and safe for sleep quality of insomnia patients.