中医药临床应用N-of-1试验报告质量评价的研究  

Studies on the Quality Evaluation of N-of-1 Trials Report for Clinical Application of Traditional Chinese Medicine

作　　者：刘雪莹 司雨琦 潘治森 沈创鹏[2] 吴浩祥[2] LIU Xue-Ying;SI Yu-Qi;PAN Zhi-Sen;SHEN Chuang-Peng;WU Hao-Xiang(The First Clinical Medical School of Guangzhou University of Chinese Medicine,Guangzhou 510405 Guangdong,China;The First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510405 Guangdong,China)

机构地区：[1]广州中医药大学第一临床医学院,广东广州510405 [2]广州中医药大学第一附属医院,广东广州510405

出　　处：《广州中医药大学学报》2020年第12期2466-2471,共6页Journal of Guangzhou University of Traditional Chinese Medicine

基　　金：2018年广东省教育厅项目(编号:2018KTSCX039)。

摘　　要：【目的】参照中医药单病例随机对照研究(N-of-1)试验指南(TCM-CENT)中的条目,对中医药领域应用N-of-1的试验报告质量进行评估。【方法】检索中国知网(CNKI)、中国生物医学文献数据库(CBM)、中文期刊数据库(维普)、万方数据库(万方)、超星期刊、PubMed、Web of Science等主要中英文文献数据库中的中医药N-of-1试验报告。由两名研究人员筛选合格的文章,并独立提取数据。参照TCM-CENT条目对纳入的文献进行计分并评估其报告质量。【结果】共纳入24篇(中文20篇,英文4篇)中医药N-of-1试验报告,其中单一N-of-1试验3篇,系列N-of-1试验21篇。两名评审员评价的一致性较高,Kappa值平均值为93%,有27个条目判断一致,最低值为65%,对应第16和第21条条目。条目平均报告率为61%,其中报告率为100%的有9个,未进行报告的有4个。讨论部分平均报告率最高(92%),其他信息部分平均报告率最低(25%)。单篇的报告率平均值为62%。【结论】中医药临床应用N-of-1试验尚处于起步状态,发展缓慢,试验报告的总体质量一般,在随机方法设计、样本量估算、不良反应报告及分析、试验方案的注册等方面,有待进一步完善和提高。Objective With reference to the CONSORT extension for reporting N-of-1 trails(CENT)for traditional Chinese medicine(TCM),we made the evaluation of report quality of the single case randomized controlled trails(N-of-1 trials)applied in the field of TCM.Methods By searching the main Chinese and English literature electronic databases of CNKI,CBM,VIP,Wanfang,Chaoxing,PubMed,and Web of Science,we identified the reports of N-of-1 trials applied in the clinical TCM research.The reports were screened out by two researchers and the data was extracted data independently.Quality assessment was scored by using CENT for TCM(TCMCENT).Results A total of 24 TCM N-of-1 trials reports were included,and 20 trial reports were in Chinese and4 trial reports were in English.Of the 24 trial reports,3 trial reports were for single N-of-1 trial and 21 for series of N-of-1 trials.The consistency of the evaluation results from the two reviewers was relatively high.The mean Kappa value was 93%.The judgment for 27 items was consistent,and the minimum Kappa value was 65%that corresponding to item 16 and item 21.The average report rate of the item was 61%,9 items had the report rate of100%,and 4 items were not reported.The discussion section had the highest average reporting rate of 92%,and the other information section had the lowest reporting rate of 25%.The average report rate of the single trial was62%.Conclusion The clinical application of N-of-1 trial in the field of TCM is still in the initial stage and with slow development,and the quality of the trial report is at the generally average level.Therefore,it is needed to further improve the trial design of random methods,sample size estimation,adverse reaction reporting and analysis,as well as the registration of trial schemes,etc.

关 键 词：单病例随机对照试验(N-of-1) 中医药N-of-1试验指南(TCM-CENT) 报告质量评估 

分 类 号：R2-03[医药卫生—中医学]