Rodriguez-Leal Francisco Alejandro, Haase Rocco, Akgün Katja, Eisele Judith, Proschmann Undine, Schultheiss Thorsten, Kern Raimar, Ziemssen Tjalf
Center of Clinical Neuroscience, University Hospital, Carl Gustav Carus, TU Dresden, Germany.
Center of Clinical Neuroscience, Department of Neurology, University Hospital Carl Gustav Carus, Fetscherstr. 74, Dresden, 01307, Germany.
Ther Adv Chronic Dis. 2019 Apr 19;10:2040622319835136. doi: 10.1177/2040622319835136. eCollection 2019.
Mobility impairments constitute a long-term burden in patients with multiple sclerosis (MS). Currently there is evidence that the drug fampridine may improve nonwalking symptoms in MS patients. The main objective of this study is to analyze whether participants showing a beneficial walking response to fampridine, also show a positive response in nonwalking assessments in a real-world clinical setting.
Subjects enrolled were part of a study analyzing gait parameters, for which response to treatment with fampridine was monitored after a period of 2 weeks. Neurologists then decided whether patients were responders to fampridine (RF) according to their global impression of patients' gait improvement. As nonwalking outcomes, we included the nine-hole peg test (9-HPT), the EuroQoL five dimensions questionnaire (EQ-5D) for quality of life, The Würzburger Fatigue Inventory for MS (WEIMuS), the Center for Epidemiologic Studies depression scale (CES-D), and the Paced Auditory Serial Addition Test (PASAT). Minimal clinically important difference (MCID) was evaluated for each test.
A total of 189 participants were included: 122 were women (64.55%), with a mean age of 53.55 (±10.83). RFs showed significant improvement in all of the nonwalking outcomes ( < 0.05), except for a nonsignificant improvement in nondominant upper limb function and PASAT; the largest score improvement was seen in the physical and cognitive sections of the WEIMuS (25.69% and 29.81%, respectively, < 0.001).
We provide evidence that physician's global judgement of walking improvement is a reliable measure for determining response to fampridine in nonwalking parameters, with fatigue showing the greatest score improvement after 2 weeks.
行动障碍是多发性硬化症（MS）患者的长期负担。目前有证据表明，药物氨吡啶可能改善MS患者的非步行症状。本研究的主要目的是分析在现实临床环境中，对氨吡啶有有益步行反应的参与者在非步行评估中是否也有积极反应。
纳入的受试者是一项分析步态参数研究的一部分，在2周的治疗期后监测他们对氨吡啶治疗的反应。然后神经科医生根据对患者步态改善的总体印象来判定患者是否为氨吡啶反应者（RF）。作为非步行结果，我们纳入了九孔插板试验（9-HPT）、用于评估生活质量的欧洲五维健康量表（EQ-5D）、MS的维尔茨堡疲劳量表（WEIMuS）、流行病学研究中心抑郁量表（CES-D）以及听觉连续加法测验（PASAT）。对每个测试评估最小临床重要差异（MCID）。
共纳入189名参与者：122名女性（64.55%），平均年龄53.55岁（±10.83）。除了非优势上肢功能和PASAT改善不显著外，RF在所有非步行结果方面均有显著改善（<0.05）；WEIMuS的身体和认知部分得分改善最大（分别为25.69%和29.81%，<0.001）。
我们提供的证据表明，医生对步行改善的总体判断是确定对氨吡啶在非步行参数反应的可靠指标，疲劳在2周后得分改善最大。
