中医药治疗高脂血症临床研究中复合结局指标应用情况分析  

Analysis on Application of Composite Outcomes in Clinical Trials of Chinese Medicine for Hyperlipidemia

作　　者：李庚 曹文聪 谭俊 温泽淮 LI Geng;CAO Wencong;TAN Jun;WEN Zehuai(The Second Affiliated Hospital of Guangzhou University of Chinese Medicine/Guangdong Provincial Hospital of Traditional Chinese Medical,Guangzhou,510120;The Second Clinical Medical College of Guangzhou University of Chinese Medicine;Science and Technology Innovation Center,Guangzhou University of Chinese Medicine)

机构地区：[1]广州中医药大学第二附属医院/广东省中医院,广东省广州市510120 [2]广州中医药大学第二临床医学院 [3]广州中医药大学科技创新中心

出　　处：《中医杂志》2022年第11期1037-1042,共6页Journal of Traditional Chinese Medicine

摘　　要：目的总结中医药治疗高脂血症临床研究中复合结局指标的应用情况,分析其存在的问题并提出解决思路。方法计算机检索中国学术期刊网络出版总库、万方数据知识服务平台、中国生物医学文献数据库、PubMed、EMbase和Cochrane Library,检索时间范围为2017年11月1日至2020年11月24日。提取纳入研究的相关信息,对其复合结局指标相关信息、研究的基本数据(受试者数量、脱落数量、年龄、高脂血症类型、中医辨证、干预措施等)进行分析。结果共纳入91篇文献,使用的复合结局指标均为有效率/控制率,其中采用3个等级和4个等级进行有效率/控制率分类的研究分别有50和40篇文献,具体报告了有效率/控制率各等级定义的研究有88篇(96.7%),70篇(76.9%)文献报告了疗效判定标准参考的相关标准、指南或教材,其中2002年出版的《中药新药临床研究指导原则(试行)》是参考最多的标准(44篇,48.4%)。复合指标的内容主要包括颈动脉粥样硬化斑块情况、血脂检测指标、中医证候积分、疾病症状和体征四个方面,且不同研究之间复合结局指标包含的内容异质性较大。97.8%的研究未报告有效率/控制率是否为主要结局指标。结论目前中医药治疗高脂血的临床研究中,采用的复合结局指标以有效率/控制率为主,存在定义、组成成分不统一等问题,建议此类临床研究选择公认的、构建流程规范的、并经验证的复合结局指标,以利于同类研究数据的合并分析和比较。Objective medicine(CM)for hyperlipidemia,summarize problems and propose solutions.MethodsElectronic databases including PubMed,Embase,Cochrane Library,WanFang Data,Sinomed and CNKI were searched to find clinical trials of CM for hyperlipidemia from November 1,2017 to November 24,2020.The data of the included studies were extracted,and the composite outcomes as well as the basic characteristics including number of participants,number of dropouts,age,type of hyperlipidemia,CM syndrome,and interventions were analyzed.ResultsA total of 91 articles were included,all of which used effective rate or control rate as a composite outcome.The effective rate/control rate was classified using 3-level(50 articles)and 4-level(40 articles)grading method.There were 88(96.7%)articles clarified the grading definitions,70(76.9%)articles additionally reported the referred standards,guidelines,or textbooks,and the Guidance for Clinical Research of New Drugs of Chinese Medicine published in 2002 was the most frequently referred standard(44 articles,48.4%).The content of the composite outcomes mainly included four aspects,including carotid atherosclerotic plaque,blood lipids test indicators,CM syndrome scores,and disease symptoms and signs.There was substantial heterogeneity of the contents of the composite outcomes across the included studies.Morover,97.8%of the studies did not report whether the effective rate or control rate was the primary outcome.Conclusion or control rate,which currently has the problems such as inconsistent definitions and content.We therefore recommend that recognized,standardized and verified composite outcomes be used to facilitate the synthesis and comparison of data from similar studies.

关 键 词：高脂血症 中医药疗法 复合结局指标 有效率 

分 类 号：R259[医药卫生—中西医结合]