Martinelli V, Dalla Costa G, Messina M J, Di Maggio G, Sangalli F, Moiola L, Rodegher M, Colombo B, Furlan R, Leocani L, Falini A, Comi G
Department of Neurology, San Raffaele Hospital, Milan, Italy.
Department of Neurology, San Donato Hospital, Milan, Italy.
Acta Neurol Scand. 2017 Nov;136(5):454-461. doi: 10.1111/ane.12761. Epub 2017 Apr 9.
Since its introduction, MRI had a major impact on the early and more precise diagnosis of multiple sclerosis (MS), and the 2010 diagnostic criteria even allow a diagnosis to be made just after a single attack if stringent MRI criteria are met. Several other clinical and paraclinical markers have been reported to be associated with an increased risk of MS independently of MRI in patients with clinically isolated syndromes (CIS), but the incremental usefulness of adding them to the current criteria has not been evaluated. In this study, we determined whether multiple biomarkers improved the prediction of MS in patients with CIS in a real-world clinical practice.
This was a retrospective study involving patients with CIS admitted to our department between 2000 and 2013. We evaluated baseline clinical, MRI, neurophysiological, and cerebrospinal fluid (CSF) data.
During follow-up (median, 7.2 years), 127 of 243 participants (mean age, 31.6 years) developed MS. Cox proportional-hazards models adjusted for established MRI criteria, age at onset, number of T1 lesions, and presence of CSF oligoclonal bands significantly predicted the risk of developing MS at 2 and 5 years. The use of multiple biomarkers led to 29% net reclassification improvement at 2 years (P<.001) and 30% at 5 years (P<.001).
The simultaneous addition of several biomarkers significantly improved the risk stratification for MS in patients with CIS beyond that of a model based only on established MRI criteria.
自引入以来，磁共振成像（MRI）对多发性硬化症（MS）的早期及更精确诊断产生了重大影响，2010年的诊断标准甚至允许在单次发作后，若满足严格的MRI标准即可做出诊断。据报道，在临床孤立综合征（CIS）患者中，其他一些临床和辅助临床标志物与MS风险增加独立相关，而不依赖于MRI，但将它们添加到当前标准中的额外效用尚未得到评估。在本研究中，我们确定了多种生物标志物是否能在真实世界临床实践中改善CIS患者MS的预测。
这是一项回顾性研究，纳入了2000年至2013年间入住我科的CIS患者。我们评估了基线临床、MRI、神经生理学和脑脊液（CSF）数据。
在随访期间（中位时间为7.2年），243名参与者（平均年龄31.6岁）中有127人发展为MS。针对既定的MRI标准、发病年龄、T1病变数量和CSF寡克隆带的存在进行调整的Cox比例风险模型显著预测了2年和5年时发展为MS的风险。使用多种生物标志物在2年时导致净重新分类改善29%（P<0.001），在5年时为30%（P<0.001）。
同时添加多种生物标志物显著改善了CIS患者MS的风险分层，超过了仅基于既定MRI标准的模型。
