Department of Neurology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.
J Neurol Sci. 2009 Oct 15;285(1-2):109-13. doi: 10.1016/j.jns.2009.06.004. Epub 2009 Jun 26.
To assess multiple sclerosis (MS) associated fatigue after the first 6 months of natalizumab treatment.
Prospective, open-label, uncontrolled study. Fatigue was measured before treatment initiation and at month 6 with the Modified Fatigue Impact Scale (MFIS) and the Fatigue Severity Scale (FSS) in 42 patients. Subjective impression of well-being was assessed with a visual analogue scale (1-10).
42 patients were followed (mean age 35.1 years, 60% female, mean EDSS 3.7). The mean total MFIS were 45.8 (17.5) at baseline and decreased to 40.1 (18.0) (p<0.01) at month 6. Mean scores on the VAS for subjective impression of well-being increased from 5.5 (1.9) to 6.1 (2.1) at month 6 (p<0.01). Pre-treatment annual relapse rate decreased from 2.2 to 0.2, gadolinium enhancing lesions were reduced by 96% with natalizumab. There was no correlation of gadolineum enhancing lesions and fatigue scores.
Fatigue and well-being improved after treatment initiation with natalizumab. A randomized controlled trial is necessary to come to definite conclusions as to a potential effect of natalizumab on fatigue in MS.
评估那他珠单抗治疗后前 6 个月多发性硬化症（MS）相关疲劳。
前瞻性、开放标签、非对照研究。在 42 例患者中，在治疗开始前和第 6 个月使用改良疲劳影响量表（MFIS）和疲劳严重程度量表（FSS）测量疲劳，并使用视觉模拟量表（1-10）评估主观幸福感。
42 例患者得到随访（平均年龄 35.1 岁，60%为女性，平均 EDSS 为 3.7）。基线时 MFIS 总分为 45.8（17.5），第 6 个月降至 40.1（18.0）（p<0.01）。第 6 个月主观幸福感的 VAS 评分从 5.5（1.9）增加到 6.1（2.1）（p<0.01）。治疗前每年复发率从 2.2 下降到 0.2，那他珠单抗使钆增强病变减少了 96%。钆增强病变与疲劳评分之间无相关性。
那他珠单抗治疗后疲劳和幸福感得到改善。需要进行随机对照试验，以明确那他珠单抗对 MS 疲劳的潜在影响。
