Lublin Fred D, Baier Monika, Cutter Gary
Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Mount Sinai Medical Center, New York, NY 10029, USA.
Neurology. 2003 Dec 9;61(11):1528-32. doi: 10.1212/01.wnl.0000096175.39831.21.
To determine the percentage of patients with residual deficits following multiple sclerosis (MS) exacerbations and the magnitude of those deficits using a database of pooled placebo patients from clinical trials.
A database of patients assigned to the placebo group in several randomized clinical trials was queried to determine those patients with Expanded Disability Status Scale (EDSS) and Scripps Neurologic Rating Scale assessments prior to, at the time of, and after an acute exacerbation of MS. The extent of deficit present at these time points was compared to determine the acute effect of exacerbations and the degree of persistent disability.
Forty-two percent of patients had residual deficit of at least 0.5 and 28% had residual of >or=1.0 EDSS units, at an average of 64 days after an exacerbation. The results were reproduced across subsequent exacerbations and were sustained over time. The subgroup of patients with measurable change in EDSS during the exacerbation had more extensive residual impairment on the follow-up visits. Similar results were seen when the Scripps score was examined.
MS exacerbations produce a measurable and sustained effect on disability.
利用临床试验中合并的安慰剂组患者数据库,确定多发性硬化症(MS)病情加重后存在残留缺陷的患者百分比以及这些缺陷的严重程度。
查询几个随机临床试验中分配到安慰剂组的患者数据库,以确定那些在MS急性加重之前、之时和之后进行了扩展残疾状态量表(EDSS)和斯克里普斯神经学评定量表评估的患者。比较这些时间点存在的缺陷程度,以确定病情加重的急性影响和持续性残疾的程度。
在病情加重后平均64天时,42%的患者存在至少0.5的残留缺陷,28%的患者残留缺陷≥1.0个EDSS单位。这些结果在随后的病情加重中得到重现,并随时间持续存在。在病情加重期间EDSS有可测量变化的患者亚组在随访时残留损伤更广泛。检查斯克里普斯评分时也看到了类似结果。
MS病情加重对残疾产生可测量且持续的影响。