Stangel Martin, Penner Iris Katharina, Kallmann Boris A, Lukas Carsten, Kieseier Bernd C
Clinical Neuroimmunology and Neurochemistry, Department of Neurology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.
Cognitive Psychology and Methodology, University of Basel, Basel, Switzerland.
Ther Adv Neurol Disord. 2015 Jan;8(1):3-13. doi: 10.1177/1756285614560733.
The introduction of new and potent therapies for the treatment of relapsing remitting multiple sclerosis (MS) has increased the desire for therapeutic success. There is growing doubt that the mere reduction of relapse rate, Expanded Disability Status Scale (EDSS) progression and magnetic resonance imaging (MRI) markers are exclusive and appropriate factors to monitor the new aim of 'no evidence of disease activity' (NEDA). However, there is no generally accepted definition so far.
To achieve the therapeutic aim of NEDA, a panel of MS experts searched the available literature on clinical and paraclinical outcomes to propose a test battery that is sensitive to detect disease activity in an everyday clinical setting.
The panel proposed to include, besides relapse rate, disability progression and MRI, neuropsychological outcome measures such as cognitive status, fatigue, depression and quality of life. To standardize the examinations in an economic and schematic way, a multifactorial model [multiple sclerosis decision model (MSDM)] that includes the domains 'relapse', 'disability progression', 'MRI', and 'neuropsychology' is proposed. The scheme reflects the complexity of the disease even in the early stages when scales such as the EDSS are not able to distinguish low levels of progression.
The MSDM aims to support early treatment decisions and uncover timely treatment failure. Prospective investigations are required to prove that such a disease-monitoring concept leads to an early and effective silencing of disease activity.
用于治疗复发缓解型多发性硬化症（MS）的新型强效疗法的引入增加了对治疗成功的渴望。人们越来越怀疑，仅仅降低复发率、扩展残疾状态量表（EDSS）进展以及磁共振成像（MRI）指标是否是监测“无疾病活动证据”（NEDA）这一新目标的唯一且合适的因素。然而，目前尚无普遍接受的定义。
为实现NEDA的治疗目标，一组MS专家检索了有关临床和临床旁结局的现有文献，以提出一套在日常临床环境中对检测疾病活动敏感的测试组合。
该小组建议，除了复发率、残疾进展和MRI外，还应纳入神经心理学结局指标，如认知状态、疲劳、抑郁和生活质量。为了以经济且模式化的方式规范检查，提出了一个多因素模型[多发性硬化决策模型（MSDM）]，该模型包括“复发”“残疾进展”“MRI”和“神经心理学”等领域。该方案反映了疾病的复杂性，即使在早期阶段，当EDSS等量表无法区分低水平进展时也是如此。
MSDM旨在支持早期治疗决策并及时发现治疗失败。需要进行前瞻性研究以证明这样一种疾病监测概念能够导致疾病活动的早期有效抑制。
