Comi G, Filippi M, Barkhof F, Durelli L, Edan G, Fernández O, Hartung H, Seeldrayers P, Sørensen P S, Rovaris M, Martinelli V, Hommes O R
Multiple Sclerosis Centre, Department of Neuroscience, IRCCS Ospedale S Raffaele, via Olgettina 60, 20132, Milan, Italy.
Lancet. 2001 May 19;357(9268):1576-82. doi: 10.1016/s0140-6736(00)04725-5.
Interferon beta reduces activity in multiple sclerosis as measured clinically and by magnetic resonance imaging (MRI). We assessed the effect of interferon beta-1a on the occurrence of relapses in patients after first presentation with neurological events, who are at high risk of conversion to clinically definite multiple sclerosis.
Eligible patients had had a first episode of neurological dysfunction suggesting multiple sclerosis within the previous 3 months and had strongly suggestive brain MRI findings. Patients were randomly assigned interferon beta-1a 22 microg or placebo subcutaneously once weekly for 2 years. Neurological and clinical assessments were done every 6 months and brain MRI every 12 months. Analyses excluded one patient assigned placebo who received no study injections.
241 (78%) of 308 randomised patients received study treatment for 2 years; 278 (90%) remained in the study until termination. 57 (85%) of 67 who stopped therapy did so after conversion to clinically definite multiple sclerosis. Fewer patients developed clinically definite multiple sclerosis in the interferon group than in the placebo group (52/154 [34%] vs 69/154 [45%]; p=0.047). The time at which 30% of patients had converted to clinically definite multiple sclerosis was 569 days in the interferon group and 252 in the placebo group (p=0.034). The annual relapse rates were 0.33 and 0.43 (p=0.045). The number of new T2-weighted MRI lesions and the increase in lesion burden were significantly lower with active treatment.
Interferon beta-1a treatment at an early stage of multiple sclerosis had significant positive effects on clinical and MRI outcomes.
干扰素β可降低多发性硬化症患者的临床活动度，并通过磁共振成像（MRI）得到证实。我们评估了干扰素β-1a对首次出现神经事件后有转化为临床确诊多发性硬化症高风险患者复发情况的影响。
符合条件的患者在过去3个月内首次出现提示多发性硬化症的神经功能障碍发作，且脑部MRI表现强烈提示该病。患者被随机分配接受皮下注射22微克干扰素β-1a或安慰剂，每周一次，共2年。每6个月进行一次神经和临床评估，每12个月进行一次脑部MRI检查。分析排除了一名被分配接受安慰剂但未接受任何研究注射的患者。
308名随机分组患者中的241名（78%）接受了2年的研究治疗；278名（90%）留在研究中直至结束。67名停止治疗的患者中有57名（85%）是在转化为临床确诊多发性硬化症后停止的。干扰素组中发展为临床确诊多发性硬化症的患者少于安慰剂组（52/154 [34%] 对69/154 [45%]；p=0.047）。30%的患者转化为临床确诊多发性硬化症的时间在干扰素组为569天，在安慰剂组为252天（p=0.034）。年复发率分别为0.33和0.43（p=0.045）。积极治疗组新的T2加权MRI病灶数量和病灶负荷增加明显更低。
在多发性硬化症早期使用干扰素β-1a治疗对临床和MRI结果有显著的积极影响。
