基于ROB和CONSORT-CHM Formulas 2017的近5年中药注射液治疗急性脑梗死随机对照试验质量评价  

Quality Evaluation of the Randomized Controlled Trials of Chinese Medicine Injection for Acute Cerebral Infarction in Last Five Years Based on ROB and CONSORT-CHM Formulas 2017

作　　者：胡紫腾 车前子 梁宁 张钰菁 陈雅馨 张福强 王巍力 张海力 曹文杰 杨一玖 宋填 王丁熠 宗星煜 程翠翠 蒋寅 王燕平[1] 史楠楠[1] HU Ziteng;CHE Qianzi;LIANG Ning;ZHANG Yujing;CHEN Yaxin;ZHANG Fuqiang;WANG Weili;ZHANG Haili;CAO Wenjie;YANG Yijiu;SONG Tian;WANG Dingyi;ZONG Xingyu;CHENG Cuicui;JIANG Yin;WANG Yanping;SHI Nannan(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,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

出　　处：《中国中医药信息杂志》2024年第7期32-37,共6页Chinese Journal of Information on Traditional Chinese Medicine

基　　金：中国中医科学院科技创新工程项目(CI2021A00702-3);国家自然科学基金(82174532);国家中医药管理局2022年青年岐黄学者项目(Z0841)。

摘　　要：目的评价近5年中药注射液治疗急性脑梗死随机对照试验(RCTs)的偏倚风险和报告质量。方法系统检索中国知识资源总库(CNKI)、万方数据知识服务平台(万方数据)、维普资讯中文期刊服务平台(维普网)、中国生物医学文献数据库(CBM)、PubMed、Embase和Cochrane Library于2018年4月20日-2023年4月20日公开发表的中药注射液治疗急性脑梗死的RCTs文献。使用Cochrane偏倚风险评估工具(ROB 1.0)和CONSORT-CHM Formulas 2017分别评价纳入RCTs的偏倚风险和报告质量。结果共检索4301篇文献,根据纳排标准最终纳入408篇RCTs。ROB评价结果显示,由于分配隐藏、盲法、试验注册信息、基金资助等内容报告的缺失,大部分研究偏倚风险评定为不清楚。CONSORT-CHM Formulas 2017评价结果显示,17个条目的文献报告篇数≥50%,25个条目的文献报告篇数<10%,大多数文献未凸显中医药辨证论治特色。结论中药注射液治疗急性脑梗死RCTs的质量普遍偏低,建议研究者参考RCTs的方法学设计和国际报告标准,完善试验设计,规范试验报告,同时突出中医药辨证论治的特色。Objective To evaluate the risk of bias and reporting quality in randomized controlled trials(RCTs)of the Chinese medicine injection for acute cerebral infarction in the last five years.Methods RCTs literature on Chinese medicine injection in the treatment of acute cerebral infarction was systematically searched in CNKI,Wanfang Data,VIP,China Biology Medicine Database(CBM),PubMed,Embase and Cochrane Library from April 20,2018 to April 20,2023.The risk of bias and reporting quality of included RCTs were evaluated using the Cochrane Risk of Bias Tool(ROB 1.0)and CONSORT-CHM Formulas 2017,respectively.Results A total of 4301 articles were retrieved,and 408 RCTs were included according to inclusion and exclusion criteria.The ROB evaluation results showed that the the majority of studies were rated as having an unclear risk of bias due to the lack of reporting on allocation concealment,blind method,trial registration information,and funding sources.The evaluation results of CONSORT-CHM Formulas 2017 showed that the number of reported papers of 17 items was greater than or equal to 50%,and the number of reported papers of 25 items was less than 10%,and most of the RCTs did not show the characteristics of TCM syndrome differentiation and treatment.Conclusion The quality of Chinese medicine injection in the treatment of acute cerebral infarction RCTs is generally low.It is recommended that researchers refer to the methodology design of RCTs and international reporting standards,improve the trial design,standardize the trial report,and highlight the characteristics of TCM syndrome differentiation and treatment.

关 键 词：中药注射液 急性脑梗死 随机对照试验 质量评价 

分 类 号：R277.733[医药卫生—中医学]