在多发性硬化症中持续释放的口服fampridine:一个随机,双盲,受控试验
Andrew D Goodman1, Theodore R Brown, Lauren B Krupp
1University of Rochester, Rochester, NY, USA.
Lancet (London, England)
|March 3, 2009
概括
在多发性硬化症患者中,Fampridine显著改善了行走能力,并减少了门诊残疾. 这种临床上有意义的益处是在III期试验中观察到的,证实了fampridine.
科学领域:
- 神经学 神经学
- 临床药理学 临床药理学
- 康复医学 康复医学 康复医学
背景情况:
- 临床研究表明,fampridine (4-aminopyridine) 增强了多发性硬化症 (MS) 的运动功能.
- 这项III期研究研究了持续释放的fampridine用于MS相关的门诊缺陷.
研究的目的:
- 在患有多发性硬化症和行走障碍的人群中评估口服持续释放的fampridine的疗效和安全性.
- 根据定时步行测试,确定对fampridine治疗有反应的患者比例.
主要方法:
- 一个随机的,多中心的,双盲的,安慰剂控制的III期试验.
- 301名患有多发性硬化症的患者被随机分配给14周的fampridine (10毫克每天两次) 或安慰剂.
- 响应以定时25英尺步行的持续改善来定义;主要结果是响应者的比例.
主要成果:
- 与安慰剂 (8%;p<0.0001) 相比,治疗famppridine的患者中,有显著更高的比例是定时步行反应者 (35%),而不是安慰剂 (8%;p<0.0001).
- 普利丁的响应者表现出25.2%的步行速度改善,在整个治疗过程中保持.
- 与非响应者相比,受访者在12项多发性硬化症步行量表上表现出显著更大的改善.
结论:
- 口服,持续释放的fampridine有效地改善了一些患有多发性硬化症的人的行走能力.
- 观察到的步行改善与患者报告的门诊残疾减少有关,这代表了临床上有意义的治疗益处.
- 福普利丁的安全性概况与先前的调查结果一致.
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