玉屏风制剂治疗慢性阻塞性肺疾病随机对照试验的质量评价

Quality evaluation of randomized controlled trial of Yupingfeng preparation in treatment of chronic obstructive pulmonary disease(COPD)

目的评价玉屏风制剂治疗慢性阻塞性肺疾病(Chronic obstructive pulmonary disease,COPD)随机对照试验(Randomized controlled trial,RCT)的方法学质量和报告质量,以期为研究者临床决策和报告书写提供参考。方法检索中国知网总库(China-latin america lecture series,CNKI)、万方数据平台(WANFANG DATA)、维普中文期刊数据库(China science and technology journal database,VIP)、中国生物医学文献服务系统(SinoMed)、PubMed、Web of Science、The Cochrane Library数据库从建库到2022年12月31日收录的玉屏风治疗COPD的随机对照试验。对筛选纳入的文献进行资料提取,并参照Cochrane协作网的偏倚风险评估工具(RoB2版)进行方法学评价,结合中医药的特殊性参照CONSORT拓展声明清单进行质量评价。结果共纳入30篇文献,包含29篇中文,1篇英文。方法学质量评价显示21篇文献因使用了主观结局指标,且未使用盲法被评为高偏倚风险;质量评价显示所有条目的平均报告率为37.37%,纳入的文献均未对适当的关键词(1c)、试验开始后对试验方法做出改变(3b)、解释中期分析试验中止原则(7b)、附加分析方法(12b)、试验中断和停止原因(14b)5项条目进行报告。结论纳入研究的玉屏风治疗COPD的随机对照试验方法学质量和报告质量普遍较低。为提高玉屏风制剂治疗COPD的疗效,建议研究者参照CONSORT声明拓展清单对临床随机对照试验进行设计、注册、实施和结果报告。

Objective To evaluate the methodological and reporting quality of a randomized controlled trial of Yupingfeng preparation in the treatment of chronic obstructive pulmonary disease(COPD).MethodsComprehensive search from China-Latin America Lecture Series(CNKI),WANFANG DATA,VIP Chinese Journal Database(VIP),SinoMed,PubMed,Web of Science and The Cochrane Library.From the establishment of the database to the inclusion of a randomized controlled trial of Yupingfeng preparation in the treatment of COPD on December 31,2022.The data were extracted from the selected literatures,and methodological evaluation was carried out with reference to RoB2,a bias risk assessment tool of the Cochrane Collaboration.Quality evaluation was carried out with reference to CONSORT extended list of Chinese patent medicines based on the particularity of traditional Chinese medicine(TCM).ResultsA total of 30 articles were included in this study,including 29 in Chinese and 1 in English.Methodological quality evaluation showed that 21 articles were rated as having a high risk of bias because the articles used subjective outcome measures and did not use blind methods.The quality evaluation showed that the average reporting rate of 37.37%for all articles,and the included articles did not report on five items:appropriate keywords(1c),changes in test methods after the start of the trial(3b),explanation of the principle of trial discontinuation in the interim analysis(7b),additional analysis methods(12b)and reasons for trial discontinuation and cessation(14b).ConclusionThe included randomized controlled trials of Yupingfeng preparation for COPD were generally of low methodological and reporting quality.In order to improve the efficacy of Yupingfeng preparation in the treatment of COPD,it is recommended that researchers design,register,conduct and report the results of randomized controlled clinical trials according to the extended list of CONSORT claims.