中医药治疗艾滋病随机对照试验的结局指标分析  

Analysis of outcome indicators in randomized controlled trials of traditional Chinese medicine treatment for AIDS

作　　者：张欣欣[1,2] 胡新宁 罗琳琳 张悦 许前磊 金艳涛[1,3] 郭会军 ZHANG Xinxin;HU Xinning;LUO Linlin;ZHANG Yue;XU Qianlei;JIN Yantao;GUO Huijun(The First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou 450000,Henan,China;The First Clinical Medical College,Henan University of Chinese Medicine,Zhengzhou 450046,Henan,China;Henan Key Laboratory of Viral Diseases Control and Treatment with Traditional Chinese Medicine,Zhengzhou 450008,Henan,China)

机构地区：[1]河南中医药大学第一附属医院,郑州450000 [2]河南中医药大学第一临床医学院,郑州450046 [3]河南省病毒性疾病中医药防治重点实验室,郑州450008

出　　处：《中国艾滋病性病》2024年第6期584-590,共7页Chinese Journal of Aids & STD

基　　金：“中原英才计划(育才系列)”中原青年拔尖人才(ZYYCYU202012153);河南省自然科学基金项目(222300420059);河南省科技研发计划联合基金(优势学科培育类)(232301420089);河南省中医药科学研究专项课题(20-21ZY1047,2022ZY1032)。

摘　　要：目的 分析中医药治疗艾滋病随机对照试验(RCT)结局指标的应用情况,讨论存在的问题,为构建基于中医药核心指标集的艾滋病中医临床疗效评价规范提供基础。方法 分别检索中国知网(CNKI)、维普数据库(VIP)、万方数据库、中国生物医学文献服务系统、PubMed、Cochrane Library和EMbase 7个数据库中中医药治疗艾滋病所有RCT,检索时间为各数据库建库至2023年9月14日,完成文献筛选后进行数据提取,对纳入的结局指标进行统计分析,并根据结局指标功能属性划分指标域。结果 共纳入99篇文献,样本量9 203例,观察周期1~60个月,共得到70种结局指标,总使用频次787次,结局指标可分为6大类,使用频次从高到低分别是理化检测(90.91%)、中医病证(76.77%)、安全性事件(66.67%)、生活质量(43.43%)、症状体征(30.30%)、远期预后(14.14%)。使用频次排名前10位的指标依次为CD4细胞、中医证候体征总积分、病毒载量、肝功能、血常规、肾功能、CD8细胞、尿常规、中医症状总疗效、卡氏积分。结论 中医药治疗艾滋病相关RCT的结局指标选用存在主要、次要结局指标不明确、缺少卫生经济学评价指标、远期预后指标使用较少、结局指标使用差异大等问题,未来应进一步构建中医药治疗艾滋病核心指标集,为中医药治疗艾滋病临床疗效的认可提供更加可靠的循证医学证据。Objective To analyze the application of outcome indicators in randomized controlled trials(RCTs)of traditional Chinese medicine(TCM)treatment for AIDS,and discuss existing issues,so as to provide a basis for establishing a clinical efficacy evaluation criteria of TCM for AIDS based on a core indicator set.Methods RCTs of TCM treatment for AIDS were retrieved from seven databases including China National Knowledge Internet(CNKI),VIP Chinese Journal Service Platform,Wanfang Data Knowledge Service Platform,China Biomedical Literature Service System,PubMed,Cochrane Library,and EMbase,from the inception of each database to September 14,2023.After literature screening and data extraction,statistical analysis was carried out on the included outcome indicators,and indicator domains were classified according to the functional attributes of the outcome indicators.Results A total of 99 studies were included,with a sample size of 9203 cases and an observation period ranging from 1 to 60 months.A total of 70 outcome indicators were obtained,with a total frequency of 787 times.The outcome indicators could be divided into 6 categories,with the highest to lowest frequency of use being physiological and biochemical tests(90.91%),TCM syndrome differentiation(76.77%),safety events(66.67%),quality of life(43.43%),symptoms and signs(30.30%),and long-term prognosis(14.14%).The top 10 outcome indicators in terms of frequency of use were CD4 cells,total score of TCM syndromes and signs,viral load,liver function,blood routine,kidney function,CD8 cells,urine routine,total efficacy of TCM symptoms,and Karnovsky score.Conclusions There are issues with the selection of outcome indicators in RCTs of TCM treatment for AIDS,including unclear primary and secondary outcome indicators,lack of health economic evaluation indicators,limited use of long-term prognostic indicators,and significant differences in the use of outcome indicators.In the future,it is necessary to further establish a core indicator set for TCM treatment of AIDS,providing more

关 键 词：中医药 艾滋病 随机对照试验 结局指标 核心指标集 

分 类 号：R512.91[医药卫生—内科学]