《中医杂志》2018年发表的中医药随机对照试验质量评价

Quality Assessment of Randomized Controlled Trials Related to Traditional Chinese Medicine Published in Journal of Traditional Chinese Medicine in 2018

目的评价《中医杂志》2018年发表的中医药随机对照试验(RCT)报告的质量。方法检索中国知网全文数据库(CNKI)收录的《中医杂志》2018年刊载全部文章,筛选出RCT文章,采用CONSORT标准修订版、Jadad评分量表、中医药特色及补充指标对其进行质量评价。结果2018年《中医杂志》共发表临床研究类文章75篇,其中RCT类文章60篇,占80.0%。CONSORT标准:入选标准、排除标准、随机化方法、干预措施、统计方法等项占100.0%;不良事件处理、研究局限性超50%,分配隐藏、盲法、样本量估算、病例脱落等项占比较低。中医药特色和补充指标:知情同意、中医证型占比较高,伦理审批、经典引用近50%,中医证候疗效评估占35.0%,多中心试验、模拟剂、干预措施质控标准、临床试验注册等项占比较低。Jadad量表评分:0~2分文章45篇,3~5分文章15篇。结论《中医杂志》2018年间发表临床研究类文章中RCT占比较高。进一步引导作者重视研究方法学,更加符合CONSORT标准、提高Jadad评分、彰显中医药特色,是杂志社面临的重要任务。

Objective To evaluate quality of randomized controlled trials(RCT)related to traditional Chinese medicine published in Journal of Traditional Chinese Medicine in 2018.Methods All papers published in Journal of Traditional Chinese Medicine in 2018 were included.Full text Database of Chinese academic journals(CNKI)were retrieved,and the RCT papers were screened out.The quality of the articles was evaluated by the revised version of CONSORT,Jadad scale score,and traditional Chinese medicine supplementary indicators.Results In 2018 there were of 75 clinical research papers published in Journal of Traditional Chinese Medicine,of which RCT accounted for 75%.CONSORT:inclusion criteria,exclusion criteria,randomization methods,intervention measures,and statistical methods all were met for consont;aderse event management and research limitations were accounted for more than 50%,while allocation concealment,blind method,sample size estimation and case shedding accounted for a relatively low proportion.Characteristics and supplementary indicators of traditional Chinese medicine:informed consent and traditional Chinese medicine syndrome type accounted for a relatively high proportion,ethical approval and classical citation were accounted for nearly 50%,traditional Chinese medicine syndrome efficacy evaluation were accounted for 35%,multi-center trials,simulators,quality control standards of intervention measures,clinical trial registration and other items wrere accounted for a relatively low proportion.Jadad scale score:45 studies with 0~2 score and 14 studies with 3~5 score.Conclusion The clinical research papers published in Journal of Traditional Chinese Medicine in 2018 were an important task for the editorial department to further guide the authors to attach importance to the research methodology,more conform the CONSORT standard,improve the Jadad scale score,and to highlight the characteristics of traditional Chinese medicine.