2018-2023年中药复方治疗非酒精性脂肪性肝炎的随机对照试验质量评价
Quality assessment of randomized controlled trials of compound traditional Chinese medicine prescriptions in treatment of nonalcoholic steatohepatitis in 2018-2023
姚伟伟 1焦睿珉 1刘可佳 1徐帅 1李丽 2尤红 3赵静洁4
作者信息
- 1. 首都医科大学附属北京友谊医院中医科,北京 100050
- 2. 首都医科大学附属北京中医医院肝病科,北京 100050
- 3. 首都医科大学中西医结合代谢相关脂肪性肝病临床诊疗与研究中心,北京 100050
- 4. 首都医科大学附属北京友谊医院中医科,北京 100050;首都医科大学中西医结合代谢相关脂肪性肝病临床诊疗与研究中心,北京 100050
- 折叠
摘要
目的 评价中药复方治疗非酒精性脂肪性肝炎(NASH)随机对照试验(RCT)的研究质量,为规范该领域RCT的研究设计和报告提出建议.方法 系统检索2018年1月1日—2023年12月31日PubMed、Web of Science、Embase、Cochrane Library、中国知网、维普和万方等数据库发表的中药复方干预NASH的RCT相关文献,参照Cochrane偏倚风险评估工具(RoB 2.0)和临床试验报告统一标准CONSORT 2010及针对中药复方CONSORT-CHM Formulas 2017扩展版分别对文献进行筛选评价及分析讨论.结果 本研究最终纳入文献45篇,大部分研究被RoB 2.0评为高风险偏倚.根据CONSORT对照检查清单发现大部分关于RCT研究质量的关键条目报告率较低.结论 近6年中药复方治疗NASH的临床研究偏倚风险较大,报告质量较差,从而可能造成证据质量不高,提示在挖掘中医药优势的同时更应注重临床研究的顶层设计,提高研究质量.
Abstract
Objective To assess the quality of randomized controlled trials(RCTs)of compound traditional Chinese medicine(TCM)prescriptions in the treatment of nonalcoholic steatohepatitis(NASH),and to provide recommendations for standardizing the design and reporting of RCTs in this field.Methods Databases such as PubMed,Web of Science,Embase,the Cochrane Library,CNKI,VIP,and Wanfang Data were searched for RCTs of compound TCM prescriptions in the treatment of NASH published from January 1,2018 to December 31,2023,and the articles were screened and assessed based on the Cochrane risk-of-bias assessment tool(RoB 2),the unified standard for clinical trial reporting(CONSORT 2010),and CONSORT-CHM Formulas 2017 for compound TCM prescriptions.Results A total of 45 articles were finally included,and most of these studies were rated as high-risk bias by RoB 2.0.The analysis based on the CONSORT control checklist showed a relatively low reporting rate for most of the key items regarding the quality of RCT studies.Conclusion A relatively large risk of bias is observed in the clinical studies on compound TCM prescriptions in the treatment of NASH published in the past six years,which may lead to the poor quality of reporting and evidence.It is suggested that the top-level design of clinical studies should be taken seriously in addition to investigating the advantages of TCM,so as to improve the quality of clinical studies.
关键词
非酒精性脂肪性肝病/中草药/复方/随机对照试验(主题)Key words
Non-alcoholic Fatty Liver Disease/Drugs,Chinese Herbal/Compounds/Randomized Controlled Trials as Topic引用本文复制引用
出版年
2024
国家科技期刊平台
NSTL
万方数据