Prescrire Int. 2000 Aug;9(48):110-1.
(1) Interferon beta-1b is now licensed to treat patients with secondary progressive multiple sclerosis. (2) The clinical file that we compiled on this indication, includes a double-blind placebo-controlled trial in which 718 patients were treated for 2-3 years. The trial is methodologically sound. (3) In this trial, interferon beta-1b, at the only dose tested (8 MIU every two days by the subcutaneous route), significantly reduced the progression of the disability linked to the disease. After 2-3 years of treatment the percentage of patients confined to a wheelchair was, in absolute values, 16.7% in the interferon beta-1b group and 24.6% in the placebo group. (4) In this trial the adverse effects linked to interferon beta-1b were already known, i.e. mainly a 'flu-like syndrome at the outset of treatment, and reactions at the injection site. (5) More than a quarter of patients on interferon beta-1b had neutralising antibodies against interferon beta-1b. More follow-up is needed to determine the possible impact of these antibodies on treatment efficacy and on the possible risk of autoimmune diseases. (6) Treatment with interferon beta-1b is still costly.
（1）干扰素β-1b现已获批用于治疗继发进展型多发性硬化症患者。（2）我们就该适应症汇编的临床档案包括一项双盲安慰剂对照试验，其中718名患者接受了2至3年的治疗。该试验在方法学上是合理的。（3）在该试验中，干扰素β-1b以唯一测试的剂量（每两天皮下注射8百万国际单位）显著降低了与疾病相关的残疾进展。经过2至3年的治疗，绝对数值上，使用干扰素β-1b组中需要依靠轮椅行动的患者百分比为16.7%，而安慰剂组为24.6%。（4）在该试验中，与干扰素β-1b相关的不良反应是已知的，即主要是治疗开始时的“流感样综合征”以及注射部位的反应。（5）超过四分之一使用干扰素β-1b的患者产生了针对干扰素β-1b的中和抗体。需要更多的随访来确定这些抗体对治疗效果以及自身免疫性疾病潜在风险的可能影响。（6）使用干扰素β-1b进行治疗仍然成本高昂。
