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Drugs. 2017 Sep;77(14):1593-1602. doi: 10.1007/s40265-017-0808-z.
Oral fampridine prolonged release (PR) [Fampyra] is a lipid-soluble selective potassium channel blocker that is approved in the EU for the improvement of walking in adult multiple sclerosis (MS) patients with walking disability (expanded disability status scale score of 4-7). In clinical trials (MS-F203 and MS-F204) using an objective measure of walking improvement [the timed 25-foot walk (T25FW)], more than one-third of patients receiving fampridine PR achieved a consistent on-treatment improvement in walking speed (i.e. became TW responders) over 9-14 weeks of treatment. Fampridine PR recipients who fulfilled the definition of TW responder had mean improvements of ≈25% from baseline in T25FW walking speed. In a clinical trial (ENHANCE) that used a patient-rated measure of walking improvement [12-item MS walking scale (MSWS-12)], a significantly greater proportion of fampridine PR recipients than placebo recipients achieved a ≥8-point improvement on the MSWS-12 with 24 weeks of treatment. Where reported, adverse events were mostly mild or moderate in severity, and generally consistent with the underlying disease or mechanism of action of fampridine PR. Fampridine PR is a useful treatment option to consider in adult MS patients with walking disability.
口服苯丁胺缓释片（Fampyra）是一种脂溶性、选择性钾通道阻滞剂，在欧盟被批准用于改善行走障碍的成年多发性硬化症（MS）患者的步行能力（扩展残疾状态量表评分为 4-7 分）。在使用客观步行改善测量指标的临床试验（MS-F203 和 MS-F204）中，超过三分之一接受苯丁胺 PR 治疗的患者在 9-14 周的治疗中持续改善步行速度（即成为 TW 应答者）。符合 TW 应答者定义的苯丁胺 PR 治疗者在 T25FW 步行速度方面的平均改善约为 25%。在一项使用患者自评步行改善测量指标的临床试验（ENHANCE）中，接受苯丁胺 PR 治疗的患者与安慰剂治疗者相比，有更大比例的患者在 24 周的治疗后在 12 项 MS 步行量表（MSWS-12）上获得了≥8 分的改善。在报告的不良事件中，大多数为轻度或中度严重程度，且通常与苯丁胺 PR 的基础疾病或作用机制一致。苯丁胺 PR 是治疗有行走障碍的成年 MS 患者的一种有效治疗选择。
