A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis
A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis
复制标题
DOI：
10.1056/nejmoa044397
复制
发表时间：
2006-03-02
影响因子：
158.5
通讯作者：
Sandrock, AW
中科院分区：
文献类型：
--
作者：
Polman, CH;O'Connor, PW;Sandrock, AW
背景：Natalizumab是一类新的选择性粘附分子抑制剂中第一个（α）（亚4）整合素拮抗剂。我们报告了一项为期两年的natalizumab治疗复发性多发性硬化症的3期临床试验的结果。方法：在总共942例患者中，627例随机分配接受natalizumab（剂量为300 mg）， 315例接受安慰剂，每四周静脉输注一次，持续两年以上。主要终点是1年的临床复发率和2年的残疾持续进展率（用扩展残疾状态量表测量）。结果：Natalizumab在两年内将残疾持续进展的风险降低了42%(风险比，0.58；95%置信区间，0.43至0.77；P
Background: Natalizumab is the first (alpha)(sub 4) integrin antagonist in a new class of selective adhesion-molecule inhibitors. We report the results of a two-year phase 3 trial of natalizumab in patients with relapsing multiple sclerosis.Methods: Of a total of 942 patients, 627 were randomly assigned to receive natalizumab (at a dose of 300 mg) and 315 to receive placebo by intravenous infusion every four weeks for more than two years. The primary end points were the rate of clinical relapse at one year and the rate of sustained progression of disability, as measured by the Expanded Disability Status Scale, at two years.Results: Natalizumab reduced the risk of sustained progression of disability by 42 percent over two years (hazard ratio, 0.58; 95 percent confidence interval, 0.43 to 0.77; P