Kinkel R Philip, Dontchev Mariya, Kollman Craig, Skaramagas Thomai T, O'Connor Paul W, Simon Jack H
Multiple Sclerosis Center, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Ave, KS 211, Boston, MA 02215, USA.
Arch Neurol. 2012 Feb;69(2):183-90. doi: 10.1001/archneurol.2011.1426. Epub 2011 Oct 10.
To determine whether immediate initiation of treatment at the time of a clinically isolated syndrome in patients at high risk for clinically definite multiple sclerosis alters disease course over 10 years.
Prospective follow-up study.
Twenty-four Controlled High-Risk Subjects Avonex Multiple Sclerosis Prevention Study (CHAMPS) sites in the United States and Canada.
A total of 81 patients originally randomly assigned to receive intramuscular interferon beta-1a (the immediate-treatment group) and 74 patients originally randomly assigned to receive placebo (the delayed-treatment group). All patients were from CHAMPS.
For the immediate-treatment group, treatment was initiated within a month after the onset of a clinically isolated syndrome, and for the delayed-treatment group, treatment was initiated a median of 30 months (interquartile range, 24-35 months) after CHAMPS randomization.
Rate of developing clinically definite multiple sclerosis, annualized relapse rate, disease course classification, disability measures, and magnetic resonance imaging measures.
The immediate-treatment group showed a lower 10-year rate of clinically definite multiple sclerosis (unadjusted hazard ratio, 0.64 [95% CI, 0.48-0.87]; P = .004) and a lower annualized relapse rate between years 5 and 10 (P = .03). There was no differential effect on disability, magnetic resonance imaging T2-weighted lesions, or the proportion of patients developing progressive disease at 10 years. Few patients reached the Expanded Disability Status Scale milestone scores of 4.0 or greater (9% of patients) or 6.0 or greater (6% of patients).
Immediate initiation of intramuscular interferon beta-1a at the time of a clinically isolated syndrome in high-risk patients reduces relapse rates over 10 years but does not improve disability outcomes compared with a control group that also initiated therapy relatively early in the disease course.
clinicaltrials.gov Identifier: NCT00179478.
确定临床孤立综合征高危患者在出现该综合征时立即开始治疗是否会在10年内改变疾病进程。
前瞻性随访研究。
美国和加拿大的24个控制高危受试者阿沃尼单抗多发性硬化预防研究（CHAMPS）站点。
共有81名最初随机分配接受肌肉注射β-1a干扰素的患者（立即治疗组）和74名最初随机分配接受安慰剂的患者（延迟治疗组）。所有患者均来自CHAMPS。
立即治疗组在临床孤立综合征发作后1个月内开始治疗，延迟治疗组在CHAMPS随机分组后中位30个月（四分位间距，24 - 35个月）开始治疗。
临床确诊多发性硬化的发生率、年化复发率、疾病进程分类、残疾测量指标以及磁共振成像测量指标。
立即治疗组临床确诊多发性硬化的10年发生率较低（未调整风险比，0.64 [95% CI，0.48 - 0.87]；P = 0.004），且在第5年至第10年的年化复发率较低（P = 0.03）。在残疾、磁共振成像T2加权病变或10年时出现进展性疾病的患者比例方面没有差异效应。很少有患者达到扩展残疾状态量表里程碑分数4.0或更高（9%的患者）或6.0或更高（6%的患者）。
高危患者在临床孤立综合征发作时立即开始肌肉注射β-1a干扰素可降低10年复发率，但与在疾病进程中相对较早开始治疗的对照组相比，并未改善残疾结局。
clinicaltrials.gov标识符：NCT00179478。
