中医药随机对照试验质量评价文献再评价  

Re-evaluation of quality evaluation literature of randomized controlled trials of traditional Chinese medicine

作　　者：龙德怀 尚菊菊[1] 刘红旭[1] 周明学[1,2] LONG De-huai;SHANG Juju;LIU Hong-xu;ZHOU Ming-xue(Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,Beijing 100010,China;Beijing Institute of Traditional Chinese Medicine,Beijing 100010,China)

机构地区：[1]首都医科大学附属北京中医医院,北京100010 [2]北京市中医研究所,北京100010

出　　处：《中华中医药杂志》2022年第9期5318-5322,共5页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：国家中医药管理局中医药循证能力建设项目(No.2019XZZX-XXG001);北京市医院管理局重点医学专业发展计划(No.ZYLX201817)。

摘　　要：目的:对中医药随机对照试验(RCT)质量评价文献进行再评价,以期为中医药RCT质量水平及其评价类研究水平的提高提供文献信息参考。方法:系统检索中国生物医学文献数据库(CBMdisc)、万方数据库、中国知网(CNKI)、维普数据库(VIP)收录的国内中医药RCT质量评价文献,由两名研究者独立筛选文献,并提取文献的年份、类型、来源、机构、质量评价工具等资料。结果:CNKI(260篇),万方数据库(291篇),VIP(317篇),CBMdisc(173篇),筛选后,最终纳入文献220篇;中医药RCT质量评价类研究从21世纪初开始出现,2014年数量达顶峰,随后主要波动于10~20篇之间;《中国循证医学杂志》发文量最多(14篇),其次是辽宁中医杂志和中医杂志;文献报告质量评价工具主要有6类:CONSORT2010(64次),CONSORT修订版(43次),CONSORT for TCM(11次),CONSORT-CHM Formulas 2017(4次),STRICTA(57次;其中53次与CONSORT联用),自拟指标(65次);文献方法学质量评价工具主要有3类,Jadad评分量表(37次),改良Jadad评分量表(21次),Cochrane偏倚风险评估量表(26次,与Jadad或改良Jadad联用5次)。结论:中医药RCT质量水平已有较大幅度提升,评价工具趋于完善、统一,方法学、中医药特色方面尚有较大提升空间,更加符合中医药特色的质量评价工具有待探索。Objective: Re-evaluate the quality evaluation literature of randomized controlled trials(RCT) of Chinese medicine in order to provide references for the improvement of the quality level of Chinese medicine RCT and its evaluation research level. Methods: The system searches the domestic Chinese medicine RCT quality evaluation documents included in China Biology Medicine disc(CBMdisc), Wan Fang Data, CNKI, and VIP databases. Two researchers independently screen the documents and extract the year, type, source, institution, and quality of the documents Evaluation tools and other materials.Results: CNKI(260 papers), Wan Fang Data(291 papers), VIP(317 papers), CBMdisc(173 papers). After screening, 220papers were finally included;Chinese medicine RCT quality evaluation literature began to appear in the early 21st century, 2014The annual literature volume reached its peak, after which the number of literature fluctuated between 10 and 20;the Chinese Evidence-Based Medicine Journal published the most, with 14 articles, followed by the Liaoning Journal of Traditional Chinese Medicine and the Journal of Traditional Chinese Medicine;There are mainly 6 types of literature report quality evaluation tools:CONSORT2010(64 times), CONSORT revised edition(43 times), CONSORT for TCM(11 times), CONSORT–CHM Formulas 2017(4 times), STRICTA(57 times;of which 53 times were used in conjunction with CONSORT), self-developed indicators(65 times);there are mainly 3 types of literature methodological quality evaluation tools, Jadad score scale(37 times), improved Jadad Scoring scale(21 times), Cochrane Risk of Bias Scale(26 times, 5 times in combination with Jadad or modified Jadad).Conclusion: The quality of Chinese medicine RCT has been greatly improved, and the evaluation tools tend to be perfect and unified. There is still room for improvement in methodology and Chinese medicine characteristics. Quality evaluation tools that are more in line with the characteristics of Chinese medicine need to be explored.

关 键 词：中医药 随机对照试验 质量评价 再评价 评价工具 方法学 报告质量 

分 类 号：R2-03[医药卫生—中医学]