中医药治疗急性缺血性脑卒中RCT结局指标的现状分析  

Analysis of status quo of RCT outcome indexes in treatment of acute ischemic stroke with traditional Chinese medicine

作　　者：李慧敏 廖星[1] 胡瑞学 于丹丹[1] 顾浩[1] 王乐[2] 赵晖 张允岭 LI Hui-min;LIAO Xing;HU Rui-xue;YU Dan-dan;GU Hao;WANG Le;ZHAO Hui;ZHANG Yun-ling(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;Graduate School of China Academy of Chinese Medical Sciences,Beijing 100700,China;China Center for Evidence Based Traditional Chinese Medicine,Beijing 100700,China;Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China)

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700 [2]中国中医科学院研究生院,北京100700 [3]中国中医药循证医学中心,北京100700 [4]中国中医科学院西苑医院,北京100091

出　　处：《中国中药杂志》2020年第9期2210-2220,共11页China Journal of Chinese Materia Medica

基　　金：国家自然科学基金面上项目(81774159);中国中医科学院基本科研业务费优秀青年科技人才(创新类)培养专项(ZZ13-YQ-075);中国中医科学院中央级公益性科研院所基本科研业务费自主选题(第十三批)(Z0650)。

摘　　要：为评价中医药治疗急性缺血性脑卒中随机对照试验中结局指标的选择现状,给未来相关研究提供建议。该研究系统全面检索了4大中文数据库、3大英文数据库,检索时间为2017年1月至2019年6月,按照预先制定的遴选标准筛选出中医药治疗急性缺血性脑卒中的随机对照试验。并根据Cochrane偏倚风险评估工具对纳入研究进行质量评价。初步检索出20 651篇相关文献,剔除重复后剩余11 662篇,最终纳入42篇文献,其中中文36篇,英文6篇;40篇随机对照试验,2篇为随机对照试验的注册方案。结果显示,42个随机对照试验的结局指标主要分为7大类,即临床结局指标,血生化指标,评价精神状态指标,脑血流动力学指标,评价颈动脉狭窄程度的指标,安全性指标和其他指标。血生化指标为出现频次最高的指标,临床结局指标次之。在17个研究中使用了中医证候积分作为疗效结局指标。分析后发现,中医药治疗急性缺血性脑卒中随机对照试验中结局指标遴选存在着较多问题,如主要结局指标极少选择终点指标和硬指标,绝大多数为中间替代指标,不能获得较为公认的疗效;关注的结局指标种类过多,异质性过大,阻碍中医药优势治疗措施在临床实践中的推广。为此应该借鉴国际核心指标结局指标集的创建方法,构建中医药治疗急性缺血性脑卒中的核心指标结局指标集,研制符合中医药治疗措施疗效特色的结局指标集,可以有效解决相关问题。The purpose of this study was to evaluate the selection situation of outcome indexes in randomized controlled trials of traditional Chinese medicine(TCM)in the treatment of acute ischemic stroke and to provide suggestions for future research.In this study,four Chinese databases and three English databases were searched from January 2017 to June 2019.The randomized controlled trials of traditional Chinese medicine in the treatment of ischemic stroke were selected according to the pre-established selection criteria.Cochrane bias risk assessment tool was used to evaluate the quality of the included studies.A total of 20651 related articles were searched,and 11662 ones were left after eliminating the repetitions.Finally,42 articles were included,including 36 articles in Chinese and 6 articles in English,40 randomized controlled trials and 2 registration schemes of randomized controlled trials.The results showed that the outcome indexes of 42 randomized controlled trials were mainly divided into seven categories,that is clinical outcome index,blood biochemical index,mental state evaluation index,cerebral hemodynamics index,index of evaluating the degree of carotid artery stenosis,safety indicators and other indicators.The blood biochemical index was the one with highest frequency,followed by the clinical outcome index.TCM syndrome score was used as an indicator of curative outcome in 17 studies.After the analysis,it was found that there were many problems in selecting the outcome indexes for the randomized controlled trials of traditional Chinese medicine in the treatment of cerebral apoplexy.For example,the end point index and hard index were rarely selected as the main outcome indicators,and the vast majority of them were intermediate alternative indexes;recognized curative effect could not be obtained;there were too many kinds of outcome indicators and excessive heterogeneity,hindering the promotion of superior treatment measures of traditional Chinese medicine in clinical practice.Therefore,we should draw lessons

关 键 词：中医药 急性缺血性脑卒中 随机对照试验 结局指标 

分 类 号：R277.7[医药卫生—中医学]