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首页> 外文期刊>The Lancet >Placebo-controlled multicentre randomised trial of interferon beta-1b in treatment of secondary progressive multiple sclerosis. European Study Group on interferon beta-1b in secondary progressive MS (see comments)
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Placebo-controlled multicentre randomised trial of interferon beta-1b in treatment of secondary progressive multiple sclerosis. European Study Group on interferon beta-1b in secondary progressive MS (see comments)

机译：安慰剂对照多中心干扰素β-1b治疗继发性进行性多发性硬化症的随机试验。欧洲研究小组关于继发性进行性MS中干扰素β-1b的研究（请参阅评论）

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BACKGROUND: The beneficial effects of interferon beta have only been shown for patients in the relapsing-remitting phase of multiple sclerosis (MS). The role of interferon beta in the treatment of patients who are in the secondary progressive phase of the disease (SP-MS), and for whom no effective drug treatment is available, has not been assessed. METHODS: In this multicentre, double-masked, randomised, placebo-controlled trial, outpatients with SP-MS having scores of 3.0-6.5 on the Expanded Disability Status Scale (EDSS) received either 8 million IU interferon beta-1b every other day subcutaneously, or placebo, for up to 3 years. The primary outcome was the time to confirmed progression in disability as measured by a 1.0 point increase on the EDSS, sustained for at least 3 months, or a 0.5 point increase if the baseline EDSS was 6.0 or 6.5. A prospectively planned interim analysis of safety and efficacy of the intention-to-treat population was done after all patients had been in the study for at least 2 years. FINDINGS: 358 patients with SP-MS were allocated placebo and 360 were allocated interferon beta-1b; 57 patients (31 placebo, 26 interferon beta-1b) were lost to follow-up. There was a highly significant difference in time to confirmed progression of disability in favour of interferon beta-1b (p=0.0008). Interferon beta-1b delayed progression for 9-12 months in a study period of 2-3 years. The odds ratio for confirmed progression was 0.65 (95% CI 0.52-0.83). This beneficial effect was seen in patients with superimposed relapses and in patients who had only progressive deterioration without relapses. Positive results were also obtained regarding time to becoming wheelchair-bound, relapse rate and severity, number of steroid treatments and hospital admissions, as well as on magnetic resonance imaging variables. The drug was safe and side effects were in line with previous experience with interferon beta-1b. The study was stopped after the interim results gave clear evidence of efficacy. INTERPRETATION: Treatment with interferon beta-1b delays sustained neurological deterioration in patients with SP-MS. Interferon beta-1b is the first treatment to show a therapeutic effect in patients with SP-MS.
机译：背景：干扰素β的有益作用仅在多发性硬化症（MS）复发-缓解期的患者中显示。尚未评估干扰素β在该疾病的继发性进展期（SP-MS）患者的治疗中的作用，并且尚无有效的药物治疗方法。方法：在这项多中心，双掩蔽，随机，安慰剂对照试验中，SP-MS门诊患者在扩展残疾状态量表（EDSS）上得分为3.0-6.5，每隔一天皮下接受800万IU干扰素beta-1b或安慰剂，最多3年。主要结果是确认残疾进展的时间，方法是EDSS增加1.0点，持续至少3个月，如果基线EDSS为6.0或6.5，则增加0.5点。在所有患者接受研究至少2年后，对预期治疗人群的安全性和有效性进行了前瞻性计划中期分析。结果：358名SP-MS患者被分配了安慰剂，360名被分配了干扰素beta-1b。失访57例患者（31例安慰剂，26例干扰素β-1b）。确认残疾进展支持干扰素β-1b的时间存在高度显着差异（p = 0.0008）。干扰素beta-1b在2-3年的研究期内延迟了9-12个月的进展。确诊进展的优势比为0.65（95％CI 0.52-0.83）。在具有重叠复发的患者和仅进行性恶化而没有复发的患者中看到了这种有益效果。在坐轮椅的时间，复发率和严重程度，类固醇治疗的次数和住院次数以及磁共振成像变量方面也获得了积极的结果。该药物是安全的，且副作用与干扰素β-1b以前的经验一致。中期结果明确表明疗效后，停止研究。解释：干扰素β-1b的治疗延迟了SP-MS患者持续的神经功能恶化。干扰素beta-1b是第一种对SP-MS患者显示出治疗效果的治疗方法。

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