Beck Roy W, Chandler Danielle L, Cole Stephen R, Simon Jack H, Jacobs Lawrence D, Kinkel R Philip, Selhorst John B, Rose John W, Cooper Joanna A, Rice George, Murray Thomas J, Sandrock Alfred W
CHAMPS Analysis Center, Jaeb Center for Health Research, Tampa, FL 33613, USA.
Ann Neurol. 2002 Apr;51(4):481-90. doi: 10.1002/ana.10148.
The objective of this work was to assess the effect of interferon beta-1a (Avonex) on the rate of development of clinically definite multiple sclerosis and brain magnetic resonance imaging changes in subgroups based on type of presenting event, baseline brain magnetic resonance imaging parameters, and demographic factors in the Controlled High-Risk Subjects Avonex Multiple Sclerosis Prevention Study (CHAMPS) trial. After the onset of a first demyelinating event, 383 patients with brain magnetic resonance imaging evidence of subclinical demyelination were treated with corticosteroids and randomly assigned to receive weekly intramuscular injections of 30 microg interferon beta-1a or placebo. The treatment effect within subgroups was assessed in proportional hazards models both for the development of clinically definite multiple sclerosis and for a combined outcome of development of clinically definite multiple sclerosis or >1 new or enlarging T2 lesions on brain magnetic resonance imaging. A beneficial effect of treatment was noted in all subgroups evaluated. Adjusted rate ratios for the development of clinically definite multiple sclerosis in the optic neuritis, brainstem-cerebellar, and spinal cord syndrome subgroups were 0.58 (p = 0.05), 0.40 (p = 0.03), and 0.30 (p = 0.01) and for the development of the combined clinically definite multiple sclerosis/magnetic resonance imaging outcome were 0.50 (p < 0.001), 0.41 (p = 0.001), and 0.40 (p = 0.004), respectively. A treatment benefit on both outcome measures also was seen in subgroups based on baseline brain magnetic resonance imaging parameters, gender, and age. Interferon beta-1a is beneficial when initiated at the first clinical demyelinating event in patients with brain magnetic resonance imaging evidence of subclinical demyelination. The beneficial effect is present for optic neuritis, brainstem-cerebellar syndromes, and spinal cord syndromes.
本研究的目的是在控制高风险受试者阿沃尼单抗多发性硬化预防研究（CHAMPS）试验中，基于首发事件类型、基线脑磁共振成像参数和人口统计学因素，评估β-1a干扰素（阿沃尼单抗）对临床确诊多发性硬化症的发展速率以及亚组脑磁共振成像变化的影响。在首次脱髓鞘事件发生后，383例有亚临床脱髓鞘脑磁共振成像证据的患者接受了皮质类固醇治疗，并随机分配接受每周一次30微克β-1a干扰素肌肉注射或安慰剂。在比例风险模型中评估了亚组内治疗效果，包括临床确诊多发性硬化症的发展以及临床确诊多发性硬化症或脑磁共振成像上出现>1个新的或扩大的T2病变的综合结果。在所有评估的亚组中均观察到治疗的有益效果。视神经炎、脑干小脑和脊髓综合征亚组中临床确诊多发性硬化症发展的调整率比分别为0.58（p = 0.05）、0.40（p = 0.03）和0.30（p = 0.01），临床确诊多发性硬化症/磁共振成像综合结果发展的调整率比分别为0.50（p < 0.001）、0.41（p = 0.001）和0.40（p = 0.004）。基于基线脑磁共振成像参数、性别和年龄的亚组中，在两种结局指标上均观察到治疗益处。对于有亚临床脱髓鞘脑磁共振成像证据的患者，在首次临床脱髓鞘事件时开始使用β-1a干扰素是有益的。对视神经炎、脑干小脑综合征和脊髓综合征均有有益效果。
