安寐丹治疗成人慢性失眠的多中心随机对照临床试验  

Anmeidan in treating chronic insomnia in adults:A multicenter randomized controlled clinical trial

作　　者：纪可 王平[3] 谭云霞 刘玲 李莉 刘福贵 徐福平[4] 卢玉俊 金海涛[6] JI Ke;WANG Ping;TAN Yunxia;LIU Ling;LI Li;LIU Fugui;XU Fuping;LU Yujun;JIN Haitao(The First Clinical College of Hubei University of Chinese Medicine,Wuhan 430061,China;Hubei Hospital of Traditional Chinese Medicine,Hubei Shizhen Laboratory,Affiliated Hospital of Hubei University of Chinese Medicine,Wuhan 430074,China;Engineering Research Center of TCM Protection Technology and New Product Development for the Elderly Brain Health,Ministry of Education,Hubei University of Chinese Medicine,Wuhan 430065,China;Guangdong Provincial Hospital of Chinese Medicine,Guangzhou 510120,China;Affiliated Hospital of Gansu University of Chinese Medicine,Lanzhou 730000,China;Wuhan Hospital of Traditional Chinese Medicine,Wuhan 430010,China)

机构地区：[1]湖北中医药大学第一临床学院,武汉430061 [2]湖北省中医院/湖北时珍实验室/湖北中医药大学附属医院,武汉430074 [3]湖北中医药大学老年脑健康中医药防护技术与新产品研发教育部工程研究中心,武汉430065 [4]广东省中医院,广州510120 [5]甘肃中医药大学附属医院,兰州730000 [6]武汉市中医医院,武汉430010

出　　处：《中华中医药杂志》2024年第12期6890-6893,共4页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：国家重点研发计划(No.2018YFC1705600);湖北省自然科学基金创新发展联合基金项目(No.2022CFD138)。

摘　　要：目的:评价安寐丹治疗成人慢性失眠的临床疗效及安全性。方法:采用多中心、随机双盲、安慰剂平行对照试验设计,将2020年11月—2021年9月在湖北、广东、甘肃的4家医院就诊的480例慢性失眠患者以1∶1比例分为试验组和对照组。试验组予安寐丹颗粒剂,对照组予安寐丹颗粒模拟剂,疗程均为4周。比较两组治疗前后匹兹堡睡眠指数(PSQI)评分,多导睡眠监测(PSG)中非快速动眼睡眠1期(N1期)、N2期、N3期、快速动眼睡眠期(REM期)、总睡眠时间(TST)、睡眠效率(SE)、夜间觉醒时间(AT)、睡眠潜伏期(SL)等参数指标以及安全性指标。结果:试验组、对照组治疗总有效率分别为69.0%(147/213)、37.1%(75/202),试验组显著优于对照组(P<0.01);与治疗前比较,治疗后试验组TST显著延长、SE显著提高、AT显著缩短、N2期占比显著增加(P<0.01),N1期占比显著减少(P<0.05),对照组治疗后仅AT显著缩短(P<0.05);试验组与对照组发生不良事件比例差异无统计学意义。结论:安寐丹治疗成人慢性失眠疗效确切,且具有较好的安全性。Objective:To evaluate the clinical efficacy and safety of Anmeidan in the treatment of adult chronic insomnia.Methods:This study was designed as a multicenter,randomized,double-blind,placebo-controlled trial.A total of 480 chronic insomnia patients treated in 4 hospitals in Hubei,Guangdong and Gansu from November 2020 to September 2021 were divided into treatment group and control group at 1∶1 ratio.The treatment group was given Anmeidan granules and the control group was given Anmeidan granules simulant.The treatment course was 4 weeks.Pittsburgh sleep quality index(PSQI)scores,parameters of non-rapid eye movement sleep 1(N1),N2,N3,rapid eye movement sleep(REM),total sleep time(TST),sleep efficiency(SE),awakening time(AT),sleep latency(SL)and safety indexes in polysomnography(PSG)were compared between the two groups before and after treatment.Results:The total effective rate of treatment group and control group were 69.0%(147/213)and 37.1%(75/202),respectively.The therapeutic effect of treatment group was better than that of control group(P<0.01).Compared with before treatment,TST was significantly prolonged,SE was significantly increased,AT was significantly shortened and the proportion of N2 stage was significantly increased in treatment group after treatment(P<0.01),and the proportion of N1 stage was decreased(P<0.05),while AT was only shortened in control group after treatment(P<0.05).There was no significant difference in the proportion of adverse events between the treatment group and the control group.Conclusion:Anmeidan is effective and safe in treating adult chronic insomnia.

关 键 词：安寐丹 成人 慢性失眠 双盲 多中心随机对照临床研究 匹兹堡睡眠指数 睡眠进程参数 睡眠结构参数 

分 类 号：R74[医药卫生—神经病学与精神病学]