基于前瞻性队列研究分析中医药治疗慢性失眠的临床安全性  

Clinical safety analysis of traditional Chinese medicine treatment for chronic insomnia based on prospective cohort study

作　　者：徐文华[1] 徐心然 仲瑾 刘晋 冷秀梅[1] 吴婷[1] 李勇[1] 孙丽霞[2] 戴恒 陈炯华[3] 张群[1] 钦佩 李婉婷 杨思雨[1] 袁勇贵[4] 汪秀琴[1] XU Wenhua;XU Xinran;ZHONG Jin;LIU Jin;LENG Xiumei;WU Ting;LI Yong;SUN Lixia;DAI Heng;CHEN Jionghua;ZHANG Qun;QIN Pei;LI Wanting;YANG Siyu;YUAN Yonggui;WANG Xiuqin(The First Affiliated Hospital of Nanjing Medical University,Jiangsu Province Hospital,Nanjing 210029,China;Affiliated Hospital of Nanjing University of Chinese Medicine,Nanjing 210029,China;Jiangsu Province Hospital of Integrative Chinese and Western Medicine,Nanjing 210028,China;Zhongda Hospital Southeast University,Nanjing 210009,China)

机构地区：[1]江苏省人民医院(南京医科大学第一附属医院),南京210029 [2]南京中医药大学附属医院,南京210029 [3]江苏省中西医结合医院,南京210028 [4]东南大学附属中大医院,南京2100091

出　　处：《中华中医药杂志》2023年第12期6139-6143,共5页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：江苏省中医药科技发展专项(No.2020ZX19);江苏省人民医院(南京医科大学第一附属医院)临床能力提升工程项目(No.JSPH-MA-2022-7);江苏省药学会-正大天晴医院药学科研基金项目(No.Q202207)。

摘　　要：目的:观察中医药治疗慢性失眠的临床安全性。方法:本研究采用前瞻性队列研究设计,选取2021年3月至2022年1月在研究者门诊治疗失眠的连续病例,符合慢性失眠诊断与入组标准者130例作为研究对象,其中64例中医药组患者辨证施治,66例西医药组患者按照西医诊疗常规方案治疗,两组治疗周期均为1个月,观察两组治疗前后肝肾功能、血常规以及不良反应发生情况。结果:中医药组患者共发生不良反应3例(4.69%,3/64),包括胃肠道不适2例及肝功能异常1例;西医药组共发生不良反应13例(19.70%,13/66),包括胃肠道不适3例、头晕2例、嗜睡3例、乏力4例以及肝功能异常1例,两组差异有统计学意义(P=0.009)。结论:中医药辨证论治慢性失眠未发现明显安全性问题,安全性优于西医药。Objective:To observe the clinical safety of traditional Chinese medicine(TCM)treatment for chronic insomnia.Methods:This study used a prospective cohort study design.From March 2021 to January 2022,130 consecutive cases of insomnia treated in the researcher's clinic were selected as the study population if they met the diagnostic and inclusion criteria for chronic insomnia.Of these cases,64 were treated with TCM based on syndrome differentiation,and 66 were treated with Western medicine according to routine Western medical diagnosis and treatment protocols,the treatment cycle was one month.The hepatic and renal function,blood routine examination,and incidence of adverse reactions in the two groups was observed.Results:Three cases(4.69%,3/64)of adverse reactions occurred in the TCM group,including two cases of gastrointestinal discomfort and one case of abnormal liver function.Thirteen cases(19.70%,13/66)of adverse reactions occurred in the Western medicine group,including three case of gastrointestinal discomfort,two cases of dizziness,three cases of drowsiness,four cases of fatigue and one case of abnormal liver function.There was statistically significant difference between the two groups(P=0.009).Conclusion:The differentiation and treatment of chronic insomnia in TCM has not shown any significant safety issues and has greater safety compared to Western medicine.

关 键 词：中医药 西医药 慢性失眠 临床 安全性 前瞻性队列研究 

分 类 号：R256.23[医药卫生—中医内科学]