国内肿瘤坏死因子α抑制剂治疗类风湿关节炎随机对照试验方法学及报告质量评价

Reporting and methodological quality assessment of randomized controlled trials involving tumor necrosis factor alpha blockers for rheumatoid arthritis in china

目的:评价国内肿瘤坏死因子α抑制剂治疗类风湿关节炎(RA)随机对照试验(RCT)的方法学质量和报告质量,以期揭示现存问题,规范未来研究。方法:计算机检索中国生物医学文献数据库、中国期刊全文数据库、数字化期刊全文数据库等资源,收集目前我国发表的有关肿瘤坏死因子α抑制剂治疗RA的RCT,文献检索时间为建库至2014年1月。采用Jadad等设计的文献质量评价方法对纳入RCT的方法学质量进行评价,采用CONSORT声明(2010修订版)对纳入RCT的报告质量进行评价。结果:最终纳入45个RCT。方法学质量评价结果显示,84.44%的文献为低质量研究;报告质量评价结果显示,主要存在的问题有文题缺乏识别标识、引言阐述不充分、方法报告不确切、缺乏局限性讨论、结论推导缺乏科学性、注册工作不完善等。结论:目前该领域RCT的方法学质量普遍存在问题,报告亦不充分,文献质量整体处于较低水平。未来急需开展多方面工作,致力于我国RCT方法学水平的提高和报告规范。

[Abstract] Objective：The purpose of this study was to evaluate reporting and methodological quality of randomized controlled trials （RCTs） involving tumor necrosis factor alpha blockers for rheumatoid arthritis （RA） in China. Methods：A systematic search of the China academic journals full-text databases, the Chinese Biomedical Literature Database, and the Chinese digital journals full-text databases was carried out. RCT examining the effects of tumor necrosis factor alpha blockers in Rheumatoid Arthritis （RA） were included. The methodological quality of the literatures was evaluated according to a quality-scoring instrument developed by Jadad et al, and the reporting quality was assessed by means of the CONSORT checklist. Results：Finally, 45studies were included, and 84.44 percent of them were poor quality. The deficiencies of reporting characteristics were reflected on incomplete reporting of title, introduction, methods, discussion, conclusion and register. Conclusions：The overall quality of RCTs in this field was unsatisfactory. The included RCTs have more or less laws with regard to the quality of reporting and methodology, which has influences on the realevaluation of the effect of tumor necrosis factor alpha blockers. Focusing on the improvement of reporting and methodological quality of RCT in China is urgently needed in order to increase the value of these studies