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MRI开启RA临床试验新纪元

作者:admin 发布时间:2017.11.21 浏览:

Peterfy C et al

Ann Rheum Dis. 2013 Jun;72(6):794-6.

摘要

风湿性关节炎(RA)治疗方法和治疗策略的成功需要在对照试验中延长安慰剂的使用时间,这就可能导致一些伦理上的欠妥。因此现代临床试验会增加阳性药物设计并结合一些先进检测技术用于鉴别那些传统放射学难于检测到的结构破坏。在探查骨损伤方面,磁共振成像(MRI)已被证实比X线敏感, 出国看病 ,但MRI更重要的作用是可以检测到骨侵蚀和软骨丢失的上游阶段——骨水肿和滑膜炎。最近越来越多的用过RAMRIS评分系统随机对照试验证实了MRI在鉴别骨侵蚀进展和药物疗效中的作用。这些试验大多数都以观察骨侵蚀进展为研究目标。多数研究,在短期(12周)就可以见到MRI下滑膜炎的改善和骨水肿的减少,MRI的检测结果可以预知以后放射学结局。这些试验往往只要求少数人行MRI下的观察,临床试验监察机构是时候要求RA临床试验中增加MRI检测数据了,这些数据可用于证实药物抑制结构损伤进展。

 

原文:

MRI comes of age in RA clinical trials.

Peterfy C, et al.

Abstract

The success of modern rheumatoid arthritis (RA) therapies and treatment strategies has led to extended placebo phases being unethical in RA randomised controlled trials (RCTs). Modern trials therefore increasingly involve active comparator designs, and this together with some technical issues has meant difficulties in differentiating structural progression using traditional radiographic outcome measures. Magnetic resonance imaging (MRI) has been demonstrated to assess damage more sensitively than radiographs, but importantly it can measure the upstream drivers of erosions and cartilage loss, synovitis and osteitis. An increasing number of recent RCTs using the RA MRI scoring system (RAMRIS) have demonstrated the ability of MRI to discriminate progression and treatment effect. Consistency of erosion progression determination was seen across the majority of these studies. In most studies, MRI demonstrated reduction in synovitis and osteitis at early (12 week) timepoints, and MRI predicted subsequent radiographic findings. Often small numbers of patients were required to demonstrate such changes. The time is right for regulatory authorities to include MRI as an alternative to radiographic data in support of claims of inhibition of progression of structural damage in RA trials.

 

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