Frank J A, Richert N, Bash C, Stone L, Calabresi P A, Lewis B, Stone R, Howard T, McFarland H F
Experimental Neuroimaging Section, Lab of Diagnostic Radiology Research, NINDS, NIH, Uniformed Services University of Health Sciences, Bethesda, USA.
Neurology. 2004 Mar 9;62(5):719-25. doi: 10.1212/01.wnl.0000113765.75855.19.
To determine the effect of interferon-beta-1b (IFNbeta-1b) treatment on total contrast-enhancing lesions (CEL), white matter lesion load (WMLL), and cerebral atrophy (CA) in patients with relapsing-remitting multiple sclerosis (RRMS) using serial monthly MRI.
An open-label baseline-vs-treatment crossover trial was conducted with 30 RRMS patients monitored during a 6-month baseline and up to 36 months on treatment with IFNbeta-1b. Monthly MRI exams and neurologic exams using the Expanded Disability Status Scale (EDSS) were performed.
The percentage changes from baseline for years 1, 2, and 3 on IFNbeta-1b were as follows: brain volume (BV) = -1.35, -1.48, and -1.68%; CEL = -76.5, -60.1, and -54.7%; WMLL = -12.2, -9.8, and -10.4%. There was no difference in the BV, CEL, or WMLL for between-year comparisons, and the decrease in BV from year 1 to years 2 and 3 was less than the change from baseline to year 1. EDSS did increase (p < 0.001) when comparing the last 3 months of baseline (2.8 +/- 2.1) and the last 3 months on IFNbeta-1b (3.6 +/- 2.1). Eleven patients developed neutralizing antibody (NAb) during the study. The effect of IFNbeta-1b on CEL and WMLL was significantly reduced in NAb+ patients compared with NAb- patients (p < 0.003).
IFNbeta-1b decreases contrast-enhancing lesions and white matter lesion load over 3 years on therapy and slows the progression in cerebral atrophy during years 2 and 3.
采用每月一次的系列磁共振成像（MRI），确定β-1b干扰素（IFNβ-1b）治疗对复发缓解型多发性硬化症（RRMS）患者总的强化病灶（CEL）、白质病变负荷（WMLL）和脑萎缩（CA）的影响。
进行了一项开放标签的基线与治疗交叉试验，对30例RRMS患者在6个月的基线期进行监测，并在接受IFNβ-1b治疗长达36个月期间进行监测。每月进行MRI检查，并使用扩展残疾状态量表（EDSS）进行神经学检查。
接受IFNβ-1b治疗的第1、2和3年相对于基线的百分比变化如下：脑体积（BV）=-1.35%、-1.48%和-1.68%；CEL=-76.5%、-60.1%和-54.7%；WMLL=-12.2%、-9.8%和-10.4%。各年份之间的BV、CEL或WMLL比较无差异，且从第1年到第2年和第3年BV的下降小于从基线到第1年的变化。比较基线期最后3个月（2.8±2.1）和接受IFNβ-1b治疗的最后3个月（3.6±2.1）时，EDSS确实有所增加（p<0.001）。11例患者在研究期间产生了中和抗体（NAb）。与无NAb的患者相比，有NAb的患者中IFNβ-1b对CEL和WMLL的作用显著降低（p<0.003）。
IFNβ-1b在治疗3年内可减少强化病灶和白质病变负荷，并在第2年和第3年减缓脑萎缩的进展。
