Comi G, Barkhof F, Durelli L, Edan G, Fernandez O, Filippi M, Hartung H P, Hommes O R, Seeldrayers P, Soelberg-Sorensen P
Centro Sclerosi Multipla, Instituto Scientifico San Raffaele, Milan, Italy.
Mult Scler. 1995;1 Suppl 1:S24-7.
Two recent properly controlled trials performed in patients with relapsing-remitting MS have demonstrated that interferon beta substantially improves the evolution of the disease. The results of the Optic Neuritis Treatment Trials suggest that early treatment of patients with isolated optic neuritis may delay the conversion to clinically definite MS (CDMS). Moreover, clinical trials in MS and in immune-mediated diseases indicate that better results are obtained in patients in the early phases of the disease. We present the design of a multicentre, randomized, double-blind, placebo-controlled study of recombinant interferon beta (Rebif-Serono) in patients with a first attack suggestive of MS. The primary objective of the study is to investigate the efficacy of Rebif, administered subcutaneously at the dose of 8 million international units (MIU) once a week for 2 years, on the risk of developing CDMS.
最近在复发缓解型多发性硬化症患者中进行的两项严格对照试验表明，β-干扰素可显著改善疾病的进展。视神经炎治疗试验的结果表明，对孤立性视神经炎患者进行早期治疗可能会延迟向临床确诊的多发性硬化症（CDMS）的转化。此外，针对多发性硬化症和免疫介导疾病的临床试验表明，疾病早期阶段的患者能取得更好的疗效。我们介绍了一项针对首次发作疑似多发性硬化症患者的重组β-干扰素（Rebif-赛诺菲）多中心、随机、双盲、安慰剂对照研究的设计。该研究的主要目的是调查每周皮下注射一次剂量为800万国际单位（MIU）、持续2年的Rebif对发展为CDMS风险的疗效。
