临床试验中类风湿关节炎的放射学进展：行业开展试验的系统性文献复习。
Radiographic progression in clinical trials in rheumatoid arthritis: a systemic literature review of trials performed by industry.
机构信息
Internal Medicine, The Catholic University of Korea, Seoul, Korea (the Republic of).
Rheumatology, St. Vincent's Hospital, The Catholic University of Korea, Suwon, Korea (the Republic of).
出版信息
RMD Open. 2020 Jul;6(2). doi: 10.1136/rmdopen-2020-001277.
OBJECTIVES
To summarise radiographic data in randomised controlled trials (RCTs) as part of the radiographic inhibition claim of disease-modifying antirheumatic drugs (DMARDs) approved for patients with rheumatoid arthritis (RA).
METHODS
A systemic literature review was performed using the Medline database from 1994 to February 2020. The results were grouped based on the scoring methods (Sharp, Genant modification, van der Heijde modification) and RA patient populations.
RESULTS
One hundred sixty-eight publications were selected. After detailed assessment, 52 RCTs (7 methotrexate (MTX)-naive, 23 MTX inadequate response (IR), 9 DMARDs IR and 3 tumour necrosis factor-alpha inhibitors (TNFi) IR studies) were finally included. Information on patient population, scoring method used, reader reliability, statistical analyses and detailed radiographic data on baseline and change scores over multiple follow-up periods are presented.
CONCLUSION
The data gathered in this review serve as a repository for the design of future trials with radiographic damage as an outcome.
目的
总结随机对照试验（RCT）中的影像学数据，作为获批用于类风湿关节炎（RA）患者的改善病情抗风湿药物（DMARDs）影像学抑制疗效主张的一部分。
方法
从 1994 年至 2020 年 2 月，使用 Medline 数据库进行系统文献回顾。根据评分方法（Sharp、Genant 改良、van der Heijde 改良）和 RA 患者人群对结果进行分组。
结果
共选择了 168 篇出版物。经过详细评估，最终纳入 52 项 RCT（7 项甲氨蝶呤（MTX）初治、23 项 MTX 应答不足（IR）、9 项 DMARDs IR 和 3 项肿瘤坏死因子-α抑制剂（TNFi）IR 研究）。介绍了患者人群、使用的评分方法、观察者可靠性、统计分析以及基线和多次随访期间变化评分的详细影像学数据。
结论
本综述中收集的数据为未来以影像学损伤为结局的试验设计提供了依据。
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