Trojano Maria, Pellegrini Fabio, Fuiani Aurora, Paolicelli Damiano, Zipoli Valentina, Zimatore Giovanni B, Di Monte Elisabetta, Portaccio Emilio, Lepore Vito, Livrea Paolo, Amato Maria Pia
Department of Neurological and Psychiatric Sciences, University of Bari, Bari, Italy.
Ann Neurol. 2007 Apr;61(4):300-6. doi: 10.1002/ana.21102.
To investigate the impact of interferon-beta (IFNbeta) on disease progression in relapsing-remitting multiple sclerosis patients.
A cohort of 1,504 relapsing-remitting multiple sclerosis (1,103 IFNbeta-treated and 401 untreated) patients was followed for up to 7 years. Cox proportional hazards regression adjusted for propensity score inverse weighting was used to assess the differences between the two groups for three different clinical end points: secondary progression (SP) and irreversible Expanded Disability Status Scale (EDSS) scores 4 and 6. Times from first visit and from date of birth were used as survival time variables.
The IFNbeta-treated group showed a highly significant reduction in the incidence of SP (hazard ratio [HR], 0.38, 95% confidence interval [CI], 0.24-0.58 for time from 1st visit; HR, 0.36, 95% CI, 0.23-0.56 for time from date of birth; p < 0.0001), EDSS score of 4 (HR, 0.70, 95% CI, 0.53-0.94 for time from first visit; HR, 0.69, 95% CI, 0.52-0.93 for time from date of birth; p < 0.02), and EDSS score of 6 (HR, 0.60, 95% CI, 0.38-0.95 for time from first visit; HR, 0.54, 95% CI, 0.34-0.86 for time from date of birth; p < or = 0.03) when compared with untreated patients. SP and EDSS scores of 4 and 6 were reached with significant delays estimated by times from first visit (3.8, 1.7, and 2.2 years) and from date of birth (8.7, 4.6, and 11.7 years) in favor of treated patients. Sensitivity analysis confirmed findings.
IFN-beta slows progression in relapsing-remitting multiple sclerosis patients.
研究β-干扰素（IFNβ）对复发缓解型多发性硬化症患者疾病进展的影响。
对1504例复发缓解型多发性硬化症患者（1103例接受IFNβ治疗，401例未治疗）进行了长达7年的随访。采用倾向评分逆加权调整的Cox比例风险回归，评估两组在三个不同临床终点的差异：继发进展（SP）以及不可逆扩展残疾状态量表（EDSS）评分为4分和6分。首次就诊时间和出生日期作为生存时间变量。
与未治疗患者相比，接受IFNβ治疗的组在SP发生率（首次就诊时间的风险比[HR]为0.38，95%置信区间[CI]为0.24 - 0.58；出生日期的HR为0.36，95% CI为0.23 - 0.56；p < 0.0001）、EDSS评分为4分（首次就诊时间的HR为0.70，95% CI为0.53 - 0.94；出生日期的HR为0.69，95% CI为0.52 - 0.93；p < 0.02）和EDSS评分为6分（首次就诊时间的HR为0.60，95% CI为0.38 - 0.95；出生日期的HR为0.54，95% CI为0.34 - 0.86；p ≤ 0.03）方面均有显著降低。从首次就诊时间（3.8、1.7和2.2年）和出生日期（8.7、4.6和11.7年）估计，接受治疗的患者达到SP以及EDSS评分为4分和6分的时间显著延迟。敏感性分析证实了研究结果。
IFN-β可减缓复发缓解型多发性硬化症患者的疾病进展。
