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Fampridine Prolonged Release: A Review in Multiple Sclerosis Patients with Walking Disability

机译:Fampridine延长的释放:多发性硬化症患者的行走残疾患者综述

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摘要

Oral fampridine prolonged release (PR) [Fampyra (R)] 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 approximate to 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.
机译:口服孢粉延长释放(PR)[Fampyra]是一种脂质可溶性选择性钾通道阻滞剂,可在欧盟批准,用于改善成人多发性硬化(MS)行走残疾患者(扩展残疾状态规模得分4-7)。在临床试验(MS-F203和MS-F204)使用客观度量的行走改善[定时25英尺的步行(T25FW)],超过16岁的患者接受Fampridine PR的患者在步行方面取得了一致的治疗改善治疗超过9-14周的速度(即响应者)。符合TW响应者定义的Fampridine PR接收者的意味着从T25FW步行速度的基线提高到25%的近似。在使用患者级步行改进的患者额定衡量的临床试验中[12项MS行走量表(MSWS-12)],比安慰剂接受者显着更大比例,而不是安慰剂获得A> = 8点改善在MSWS-12上有24周的治疗。在报告的情况下,不良事件严重程度大多是轻微或中度,并且通常与法普利汀公关的潜在疾病或作用机制一致。法普利汀公关是在成人MS患者中考虑的有用的治疗选择,患有行动残疾。

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