中医药治疗急性心肌梗死随机对照试验结局指标的现状分析  

Analysis of Outcomes Used in Randomized Controlled Trials on Traditional Chinese Medicine for Treatment of Acute Myocardial Infarction

作　　者：李慧敏 熊兴江[2] 胡瑞学 于丹丹[1] 赵晖[3] 廖星[1] 杨伟[1] 商洪才 LI Huimin;XIONG Xingjiang;HU Ruixue;YU Dandan;ZHAO Hui;LIAO Xing;YANG Wei;SHANG Hongcai(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing,100700;Guang'anmen Hospital,China Academy of Chinese Medical Sciences;China Academy of Chinese Medical Sciences;Dongzhimen Hospital,Beijing University of Chinese Medicine)

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京市100700 [2]中国中医科学院广安门医院 [3]中国中医科学院 [4]北京中医药大学东直门医院

出　　处：《中医杂志》2021年第5期405-413,共9页Journal of Traditional Chinese Medicine

基　　金：国家重点研发计划(2017YFC1700406-2)。

摘　　要：目的评价目前中医药治疗急性心肌梗死(AMI)随机对照试验(RCT)中结局指标的选择现状。方法检索4个中文数据库(中国知网、重庆维普中文科技期刊数据库、万方数据知识服务平台、中国生物医学文献服务系统)、3个英文数据库(Cochrane Library,Embase,Medline),按照预先制定的遴选标准筛选出中医药治疗AMI的RCT,根据Cochrane风险偏倚评估工具对纳入研究进行质量评价,并且按照结局指标分类方法进行频次统计。结果初步检索出11277篇相关文献,最终纳入39篇文献。纳入的39篇RCT均报告了有效性结局指标和安全性结局指标。围绕偏倚风险评估工具评价:1)随机序列的生成:17篇低偏倚风险、18篇偏倚风险不确定、4篇高偏倚风险;2)分配隐藏:3篇低偏倚风险、36篇偏倚风险不确定;3)对患者、试验人员实施盲法:3篇低偏倚风险、36篇偏倚风险不确定;4)对结局评估者实施盲法:4篇低偏倚风险、35篇偏倚风险不确定;5)结局数据不完整:39篇低偏倚风险;6)选择报告偏倚:39篇偏倚风险不确定;7)其他偏倚(包括利益冲突和样本量计算):39篇偏倚风险不确定。39篇RCT的结局指标主要概括为8类,心脏指标出现的频次为107次,其次为血生化指标60次,临床重要结局指标57次、安全性指标13次、心电图疗效指标10次、生活质量量表5次、心绞痛疗效指标4次、其他项指标16次。纳入的RCT采用的结局指标共计118个,单篇RCT结局指标数量最少为1个,最多达14个,平均为6个。结论中医药治疗AMI的RCT总体偏倚风险不明确,结局指标遴选存在结局指标主次轻重不分,重视替代指标、轻视终点结局指标,指标数量差异性大等问题。Objective To evaluate the outcomes selected in the randomized controlled trials(RCTs)on traditional Chinese medicine(TCM)for acute myocardial infarction(AMI).Methods Four Chinese databases(CNKI,VIP,Wanfang,and Sinomed)and three English databases(Cochrane Library,Embase and Medline)were searched for RCTs on TCM for treatment of AMI.The predefined inclusion and exclusion criteria were followed for literature screening and selection.Cochrane risk of bias tool was used for methodological evaluation.The outcomes in RCTs were categorized and calculated for frequency.Results Thirty-nine out of 11,277 papers were included.All the papers reported on both effectiveness and safety outcomes.The low/unclear/high risk ratio of each bias item was as follows:random sequence generation(17/18/4),allocation concealment(3/36/0),blinding of patients and personnel(3/36/0),blinding of outcome assessors(4/35/0),incomplete outcome data(39/0/0),selective reporting(0/39/0),and other bias(including interest conflict and sample size calculation)(0/39/0).The outcomes in 39 RCTs were mainly categorized into 8 groups,with highest frequency of cardiac indexes(107 times),followed by comprehensive metabolic panel indicators(60 times),clinically important outcomes(57 times),safety outcomes(13 times),electrocardiogram measurements(10 times),quality of life(5 times),and angina indicators(4 times),and others(16 times).A total of 118 outcomes were reported,and the average number was six per RCT,ranging from 1 to 14.Conclusion The overall risk of bias is unclear for RCTs on TCM in the treatment of AMI.And there are problems in setting outcomes,including unclear definition of primary and secondary outcomes,overuse of surrogate outcomes,lack of endpoint outcomes,and unbalanced allocation of different outcomes,all of which need to be solved in future researches.

关 键 词：中医药疗法 急性心肌梗死 随机对照试验 结局指标 核心指标集 

分 类 号：R259[医药卫生—中西医结合]