MS/MRI Research Group, Department of Medicine, University of British Columbia, Vancouver, Canada.
Mult Scler. 2010 Apr;16(4):434-42. doi: 10.1177/1352458509359726. Epub 2010 Feb 18.
The rate of new contrast-enhancing lesions (CELs) on monthly magnetic resonance imaging (MRI) scans has been shown to decrease over a 9-month period in placebo-treated patients with relapsing-remitting (RR) multiple sclerosis (RRMS).
We examined this phenomenon in placebo-treated secondary progressive MS (SPMS) patients.
Patients were chosen from two clinical trials. Monthly scans were taken at screening, baseline and months 1-9 for Cohort-1 and months 1-6 for Cohort-2. We examined the monthly new CEL rates according to initial CEL level: 0, 1-3, >3 CELs at screening, and presence and absence of pre-study relapses.
Respectively, 59, 21 and 14 of the 94 Cohort-1 patients, and 36, 17 and 9 of the 62 Cohort-2 patients had 0, 1-3 and >3 initial CELs. For Cohort-1, the monthly new CEL rates did not change during follow-up, regardless of initial CEL level. For Cohort-2, the monthly rate was unchanged in the 0 initial CEL subgroup, but decreased 33% (95% confidence interval: 8%, 52%) from months 1-3 to months 4-6 in the other two subgroups. For the combined cohorts, a decreasing rate was observed in the 12 patients with >3 initial CELs and pre-study relapses.
The short-term trend of new CEL activity in placebo-treated SPMS patients may vary across cohorts.
在安慰剂治疗的复发缓解型多发性硬化症(RRMS)患者中,每月磁共振成像(MRI)扫描的新增强病变(CEL)率已显示在 9 个月期间下降。
我们检查了安慰剂治疗的继发进展型多发性硬化症(SPMS)患者中的这种现象。
从两项临床试验中选择患者。每月进行扫描,在筛选、基线和第 1-9 个月进行队列 1,在第 1-6 个月进行队列 2。我们根据初始 CEL 水平检查每月新 CEL 率:筛选时为 0、1-3、>3 个 CEL,以及存在和不存在研究前复发。
分别在队列 1 的 94 名患者中,59、21 和 14 名患者和队列 2 的 62 名患者中,有 0、1-3 和>3 个初始 CEL。对于队列 1,无论初始 CEL 水平如何,在随访期间每月新 CEL 率均未改变。对于队列 2,在初始 CEL 为 0 的亚组中,每月的发生率保持不变,但在其他两个亚组中,从第 1-3 个月到第 4-6 个月,每月的发生率下降了 33%(95%置信区间:8%,52%)。对于联合队列,在有>3 个初始 CEL 和研究前复发的 12 名患者中观察到新 CEL 活性的下降趋势。
安慰剂治疗的 SPMS 患者中新 CEL 活动的短期趋势可能因队列而异。