Benešová Yvonne, Tvaroh Aleš
Department of Neurology, University Hospital Brno and Faculty of Medicine, Masaryk University, Jihlavská 20, Brno 625 00, Czech Republic.
Merck spol. s r.o., Prague, Czech Republic.
Ther Adv Neurol Disord. 2017 Jan;10(1):18-32. doi: 10.1177/1756285616671882. Epub 2016 Oct 21.
Multiple sclerosis (MS) is a chronic autoimmune disease of the central nervous system, which often causes progressive neurological disability. In addition to motor and sensory dysfunction, cognitive decline and fatigue are frequent manifestations of the disease. Fatigue is probably the most common symptom, with up to 90% of MS individuals reporting fatigue at some point. Cognitive impairment affects about 50% of patients and may be present at all MS stages. The aim of this observational study was to evaluate changes in cognition, fatigue, and disability status in 300 relapsing-remitting MS (RRMS) patients, treated with subcutaneous (sc) interferon (IFN) β-1a over 2 years.
The study was designed as an observational, multicentre, prospective, single-arm, phase IV study carried out in 13 MS centres in the Czech Republic. Cognition status was assessed using the Paced Auditory Serial Addition Task (PASAT), fatigue using the Fatigue Descriptive Scale (FDS), and disability using the Expanded Disability Status Scale (EDSS), at baseline, and after 6, 12 and 24 months. The percentage of patients with changed stable cognition, fatigue status and disability was calculated at each time point and the changes in these scores were evaluated.
The proportion of patients with cognitive improvement was higher compared with those with a stable or decreased PASAT scores at all time points, and the average cognitive performance improved during the follow-up period. Also the proportion of patients with stable or improved fatigue and EDSS scores was higher compared with those in which FDS or EDSS scores declined, this was found at all time points of the analysed sample. However, the direct effect of IFN β-1a on cognition and fatigue cannot be concluded from this study.
The results of this observational study have demonstrated a stable or improved cognitive performance, fatigue status, and disability level in the majority of RRMS patients treated with sc IFN β-1a over a two-year follow-up period, in a real life setting, in the Czech Republic.
多发性硬化症（MS）是一种中枢神经系统的慢性自身免疫性疾病，常导致进行性神经功能障碍。除运动和感觉功能障碍外，认知衰退和疲劳是该疾病的常见表现。疲劳可能是最常见的症状，高达90%的MS患者在某些时候会出现疲劳。认知障碍影响约50%的患者，且可能在MS的所有阶段出现。这项观察性研究的目的是评估300例复发缓解型MS（RRMS）患者在接受皮下注射（sc）干扰素（IFN）β-1a治疗2年期间认知、疲劳和残疾状态的变化。
该研究设计为一项在捷克共和国13个MS中心进行的观察性、多中心、前瞻性、单臂IV期研究。在基线以及6、12和24个月后，使用听觉连续加法任务（PASAT）评估认知状态，使用疲劳描述量表（FDS）评估疲劳，使用扩展残疾状态量表（EDSS）评估残疾。计算每个时间点认知、疲劳状态和残疾发生改变或稳定的患者百分比，并评估这些评分的变化。
在所有时间点，认知改善的患者比例高于PASAT评分稳定或降低的患者，且随访期间平均认知表现有所改善。同样，疲劳和EDSS评分稳定或改善的患者比例高于FDS或EDSS评分下降的患者，在分析样本的所有时间点均如此。然而，本研究无法得出IFNβ-1a对认知和疲劳的直接影响。
这项观察性研究的结果表明，在捷克共和国的现实生活环境中，大多数接受sc IFNβ-1a治疗的RRMS患者在两年随访期内认知表现、疲劳状态和残疾水平保持稳定或有所改善。
