基于3种评分工具的国内中药复方随机对照试验报告质量评价研究
Study on evaluating the quality of reports of randomized controlled trials of traditional Chinese medicine compounds in China based on three scoring tools
李德众 1庞立健 2王琳琳 2王天娇 3王梅 2王佳然 1邹吉宇 1于睿智 1臧凝子 3吕晓东1
作者信息
- 1. 辽宁中医药大学,沈阳 110847
- 2. 辽宁中医药大学附属医院,沈阳 110032
- 3. 辽宁中医药大学,沈阳 110847;辽宁中医药大学附属医院,沈阳 110032
- 折叠
摘要
目的:评价近20年的中药复方随机对照试验(RCT)报告的质量.方法:对中国知网(CNKI)、万方(WangFang COJ)、维普(VIP-CSTJ)、中国生物医学文献数据库(CBM)等中文数据库进行检索,纳入文献采用改良Jadad量表、Cochrane风险偏倚评估工具2.0评价;用CONSORT-CHM formulas进行质量分析.结果:共纳入413篇文献,经改良Jadad量表评价:低质量文献共404篇(97.8％),高质量文献仅9篇(2.2％);经Cochrane风险偏倚评估工具2.0评价:高风险文献有406篇(98.3％),7篇(1.7％)被判定为不确定,无低风险文献;经CONSORT-CHM formulas评价:纳入文献平均得分为28.8分,得分在28.8分以下的文献共255篇(61.7％),得分在28.8分以上共158篇(38.3％).结论:目前国内中药复方RCT报告质量偏低,偏倚风险过大.
Abstract
Objective:To evaluate the quality of Chinese medicine compounds randomized controlled trial(RCT)reports in the past 20 years.Methods:Chinese databases such as China Knowledge Network(CNKI),Wanfang(WangFang COJ),Vipu(VIPCSTJ),and China Biomedical Literature Database(CBM)were searched,the included literature was evaluated by the modified Jadad scale and the Cochrang Risk of Bias Assessment Tool 2.0;quality analyses were performed by CONSORTCHM formulas.Results:A total of 413 papers were included,evaluated by the modified Jadad scale:404 papers(97.8％)with low quality,and only 9 papers(2.2％)with high quality;evaluated by the Cochrane Risk of Bias Assessment Tool 2.0:there were 406 papers(98.3％)at high risk,and 7 papers(1.7％)were judged to be indeterminate,with no low-risk papers;evaluated by the CONRORTCHM formulas:the average score of the included literature was 28.8,with a total of 255(61.7％)literature scoring below 28.8,158(38.3％)scoring above 28.8.Conclusion:At present,the reporting quality of RCT of Chinese medicine compounds in China is low and the risk of bias is too high.
关键词
中药复方/随机对照试验/CONSORT-CHM/formulas/改良Jadad量表/Cochrane风险偏倚评估工具2.0/质量评价Key words
Traditional Chinese medicine compounds/Randomized controlled trial(RCT)/CONSORT-CHM formulas/Modified Jadad scale/Cochrane Risk of Bias Assessment Tool 2.0/Quality evaluation引用本文复制引用
基金项目
国家自然科学基金面上项目(82274440)
国家自然科学基金青年科学基金(82004294)
国家自然科学基金青年科学基金(82104804)
吕晓东辽宁省名中医传承工作室建设项目(辽中医药函[2021]1号)
出版年
2024
NETL
NSTL
万方数据