中国中医药信息杂志2024，Vol.31Issue(7)：32-37,6.DOI:10.19879/j.cnki.1005-5304.202306246
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
摘要
Abstract
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 4 301 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Key words
Chinese medicine injection/acute cerebral infarction/randomized controlled trial/quality evaluation分类
医药卫生引用本文复制引用
胡紫腾,杨一玖,宋填,王丁熠,宗星煜,程翠翠,蒋寅,王燕平,史楠楠,车前子,梁宁,张钰菁,陈雅馨,张福强,王巍力,张海力,曹文杰..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[J].中国中医药信息杂志,2024,31(7):32-37,6.基金项目
中国中医科学院科技创新工程项目(CI2021A00702-3) （CI2021A00702-3）
国家自然科学基金(82174532) （82174532）
国家中医药管理局2022年青年岐黄学者项目(Z0841) （Z0841）
