静脉注射甲基强的松龙治疗继发进展型多发性硬化症的II期研究。
A phase II study of i.v. methylprednisolone in secondary-progressive multiple sclerosis.
作者信息
Goodkin D E, Kinkel R P, Weinstock-Guttman B, VanderBrug-Medendorp S, Secic M, Gogol D, Perryman J E, Uccelli M M, Neilley L
机构信息
UCSF/Mt. Zion Multiple Sclerosis Center, San Francisco, CA 94115, USA.
出版信息
Neurology. 1998 Jul;51(1):239-45. doi: 10.1212/wnl.51.1.239.
OBJECTIVE
To compare the tolerability and efficacy of two doses of i.v. methylprednisolone in patients with secondary-progressive MS.
METHODS
I.v. methylprednisolone administered in high or low dose every other month for up to 2 years to 108 patients with secondary-progressive MS.
RESULTS
No significant difference in efficacy with the primary outcome, a comparison of the proportions of patients in each treatment group who experienced sustained progression of disability. A relative treatment effect was detected with the high-dose regimen as measured by the preplanned secondary analysis, a comparison of time to onset of sustained progression of disability. Drug-related adverse events were observed more frequently in high-dose recipients but serious drug-related adverse events were uncommon, and cessation of study drug was only required in one patient.
CONCLUSION
The results of the secondary analysis of this study suggest that a phase III trial of corticosteroids for secondary-progressive MS is warranted.
目的
比较两种剂量静脉注射甲泼尼龙对继发进展型多发性硬化症（MS）患者的耐受性和疗效。
方法
对108例继发进展型MS患者每隔一个月给予高剂量或低剂量静脉注射甲泼尼龙，持续2年。
结果
在主要结局方面，即比较各治疗组中出现持续性残疾进展的患者比例，疗效无显著差异。通过预先计划的二次分析检测到高剂量方案有相对治疗效果，即比较持续性残疾进展开始的时间。高剂量接受者中药物相关不良事件的观察频率更高，但严重的药物相关不良事件并不常见，仅1例患者需要停用研究药物。
结论
本研究的二次分析结果表明，有必要对继发进展型MS进行皮质类固醇的III期试验。
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