基于ROB和CONSORT-CHM Formulas 2017的中药复方治疗慢性萎缩性胃炎随机对照试验质量评价  

Evaluations of RCTs for the Treatment of Chronic Atrophic Gastritis with TCM Compounds Based on the ROB and CONSORT-CHM Formulas 2017

作　　者：赵冉 张雯[2] 王斌 ZHAO Ran;ZHANG Wen;WANG Bin(Institute of Information on Traditional Chinese Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;National Data Center of TCM,China Academy of Chinese Medical Sciences,Beijing 100700,China)

机构地区：[1]中国中医科学院中医药信息研究所,北京100700 [2]中国中医科学院中医临床基础医学研究所,北京100700 [3]中国中医科学院中医药数据中心,北京100700

出　　处：《中国中医药信息杂志》2023年第3期43-50,共8页Chinese Journal of Information on Traditional Chinese Medicine

基　　金：中国中医科学院科技创新工程重大攻关面上项目(CI2021A01009)。

摘　　要：目的评价中药复方治疗慢性萎缩性胃炎随机对照试验(RCT)的偏倚风险和报告质量。方法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)、中文科技期刊数据库(维普网)、中国生物医学文献数据库(CBM)、Cochrane Library、PubMed、Web of Science建库至2021年12月24日的中药复方治疗慢性萎缩性胃炎RCT文献,基于The Cochrane Collaboration’s tool for assessing risk of bias(ROB)和CONSORT-CHM Formulas 2017分别评价纳入文献的偏倚风险和报告质量。进行单因素分析以确定CONSORT-CHM Formulas 2017的发布与报告质量的相关性。结果最终纳入文献215篇。ROB评价结果显示,大多数纳入文献各方面偏倚存在不确定风险。CONSORT-CHM Formulas 2017评价结果显示,19项条目的报告率达到60%,18项条目的报告率低于10%,一些重要条目的报告率较低。CONSORT-CHM Formulas 2017的发布对总体报告质量的提升无显著影响。结论中药复方治疗慢性萎缩性胃炎RCT的质量普遍较低,建议研究者学习RCT的方法学及其报告规范,以提高临床研究质量。Objective To evaluate the bias risks and report quality of randomized controlled trials(RCTs)for the treatment of chronic atrophic gastritis(CAG)with TCM compounds.Methods RCTs for the treatment of CAG with TCM compounds were retrieved from CNKI,Wanfang Data,VIP,CBM,Cochrane Library,PubMed and Web of Science from the establishment to December 24,2021.The bias risks and report quality of included RCTs were assessed based on the Cochrane Collaboration’s tool for assessing risk of bias(ROB)and CONSORT-CHM Formulas 2017 respectively.A univariate analysis was conducted to define the correlation between the release of CONSORT-CHM Formulas 2017 and report quality.Results Totally 215 articles were included.The evaluation results of ROB showed that there was an uncertain risk of bias in all aspects of most of the included literature.The evaluation results of CONSORT-CHM Formulas 2017 showed that the reporting rate of 19 items reached 60%,the reporting rate of 18 items was less than 10%,and the reporting rate of some important items was extremely low.The release of CONSORT-CHM Formulas 2017 had no significant impact on the improvement of report quality.Conclusion The quality of RCTs for the treatment of CAG with TCM compounds is generally low.Therefore,it is suggested that researchers learn the methodology of RCT and its reporting norms to improve the quality of clinical research.

关 键 词：慢性萎缩性胃炎 胃癌前病变 随机对照试验 中药复方 ROB CONSORT-CHM Formulas 2017 

分 类 号：R2-05[医药卫生—中医学] R259.733.2