Sellebjerg F, Frederiksen J L, Nielsen P M, Olesen J
Department of Neurology, Glostrup Hospital, University of Copenhagen, Glostrup Copenhagen, Denmark.
Neurology. 1998 Aug;51(2):529-34. doi: 10.1212/wnl.51.2.529.
There is only limited evidence from adequately controlled clinical trials to support high-dose methylprednisolone therapy for attacks of multiple sclerosis (MS) and none supporting oral administration. We assessed the effect of oral high-dose methylprednisolone therapy in attacks of MS.
Twenty-five patients with an attack of MS lasting less than 4 weeks were randomized to placebo treatment. Twenty-six patients received oral methylprednisolone (500 mg once a day for 5 days with a 10-day tapering period). The patients received scores on the Scripps Neurological Rating Scale (NRS) and Kurtzke Expanded Disability Status Scale. The symptoms were scored on a visual analog scale (VAS) before treatment and after 1, 3, and 8 weeks of treatment. Primary efficacy measures were NRS and VAS scores in the first 3 weeks and changes in NRS score and answers to an efficacy questionnaire administered after 8 weeks of treatment.
Changes in NRS scores among methylprednisolone- and placebo-treated patients differed significantly in the first 3 weeks and after 8 weeks (p = 0.005 and p = 0.0007). VAS scores the first 3 weeks and treatment efficacy after 8 weeks also favored a beneficial effect of methylprednisolone treatment (p = 0.02 and p = 0.05). After 1, 3, and 8 weeks, 4%, 24%, and 32% in the placebo group and 31%, 54%, and 65% in the methylprednisolone group had improved one point on the Expanded Disability Status Scale score (all p < 0.05). No serious adverse events were seen.
Oral high-dose methylprednisolone is recommended for managing attacks of MS.
仅有来自充分对照临床试验的有限证据支持大剂量甲基强的松龙治疗多发性硬化症（MS）发作，且无证据支持口服给药。我们评估了口服大剂量甲基强的松龙治疗MS发作的效果。
25例MS发作持续时间少于4周的患者被随机分配接受安慰剂治疗。26例患者接受口服甲基强的松龙（每日500 mg，共5天，随后10天逐渐减量）。患者接受斯克里普斯神经学评定量表（NRS）和库尔特克扩展残疾状态量表评分。在治疗前以及治疗1、3和8周后，根据视觉模拟量表（VAS）对症状进行评分。主要疗效指标为前3周的NRS和VAS评分，以及治疗8周后NRS评分的变化和一份疗效问卷的答案。
在治疗的前3周和8周后，甲基强的松龙治疗组和安慰剂治疗组患者的NRS评分变化有显著差异（p = 0.005和p = 0.0007）。前3周的VAS评分和8周后的治疗疗效也显示甲基强的松龙治疗有有益效果（p = 0.02和p = 0.05）。在治疗1、3和8周后，安慰剂组分别有4%、24%和32%的患者，甲基强的松龙组分别有31%、54%和65%的患者在扩展残疾状态量表评分上提高了1分（所有p < 0.05）。未观察到严重不良事件。
推荐口服大剂量甲基强的松龙治疗MS发作。
