Oral fingolimod (FTY720) for relapsing multiple sclerosis
Oral fingolimod (FTY720) for relapsing multiple sclerosis
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DOI：
10.1056/nejmoa052643
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发表时间：
2006-09-14
影响因子：
158.5
通讯作者：
Radue, Ernst W.
中科院分区：
文献类型：
--
作者：
Kappos, Ludwig;Antel, Jack;Radue, Ernst W.
背景：Fingolimod（FTY 720）是一种新的口服免疫调节剂，正在评估其治疗复发性多发性sclerosis.METHODS：我们将281例患者随机分为两组，一组口服Fingolimod 1.25 mg或5.0 mg，另一组口服安慰剂，每日1次，我们对这些患者进行了6个月的磁共振成像（MRI）和临床评估（核心研究，0 ~ 6个月）。主要终点是在6个月内每月一次的T（sub 1）加权MRI上记录的钆增强病变的总数。在一项扩展研究中，研究人员和患者仍然不知道剂量分配（第7至12个月），接受安慰剂的患者再次随机分配到其中一个fingolimod doses.RESULTS：共有255例患者完成了核心研究。1.25 mg芬戈莫德组MRI上钆增强病灶的中位总数较低（1个病灶，P
BACKGROUND:Fingolimod (FTY720) is a new oral immunomodulating agent under evaluation for the treatment of relapsing multiple sclerosis.METHODS:We randomly assigned 281 patients to receive oral fingolimod, at a dose of 1.25 mg or 5.0 mg, or a placebo once daily, and we followed these patients for 6 months with magnetic resonance imaging (MRI) and clinical evaluations (core study, months 0 to 6). The primary end point was the total number of gadolinium-enhanced lesions recorded on T(sub 1)-weighted MRI at monthly intervals for 6 months. In an extension study in which the investigators and patients remained unaware of the dose assignments (months 7 to 12), patients who received placebo underwent randomization again to one of the fingolimod doses.RESULTS:A total of 255 patients completed the core study. The median total number of gadolinium-enhanced lesions on MRI was lower with 1.25 mg of fingolimod (1 lesion, P