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低剂量FK506治疗重症肌无力的疗效——一项随机试验研究

Efficacy of low-dose FK506 in the treatment of Myasthenia gravis--a randomized pilot study.

作者信息

Nagane Yuriko, Utsugisawa Kimiaki, Obara Daiji, Kondoh Ryushi, Terayama Yasuo

机构信息

Department of Neurology, Iwate Medical University, Morioka, Japan.

出版信息

Eur Neurol. 2005;53(3):146-50. doi: 10.1159/000085833. Epub 2005 May 17.

DOI:10.1159/000085833
PMID:15900097
Abstract

To determine the efficacy of low-dose FK506 in the treatment of myasthenia gravis (MG), untreated de novo patients were randomly selected to receive treatment with (n = 18) or without (n = 16) FK506, and were evaluated for 1 year after treatment with limitation of daily dose of prednisolone. Low-dose FK506 reduced the duration of early-phase therapy in hospital (p < 0.05) and the need for combined therapy with plasmapheresis and high-dose intravenous methylprednisolone or high-dose intravenous methylprednisolone alone (p < 0.05). It also reduced the daily dose of prednisolone (p < 0.05) required to maintain minimal manifestations of MGFA postintervention status. None of the patients exhibited significant side effects up to 1 year after treatment. These findings suggest that low-dose FK506 is safe and efficacious for the treatment of de novo MG patients.

摘要

为确定低剂量他克莫司(FK506)治疗重症肌无力(MG)的疗效,随机选取未经治疗的初发患者,分为接受FK506治疗组(n = 18)和未接受FK506治疗组(n = 16),在泼尼松龙每日剂量受限的情况下治疗1年后进行评估。低剂量FK506缩短了早期住院治疗时间(p < 0.05),并减少了联合血浆置换及大剂量静脉注射甲泼尼龙或仅使用大剂量静脉注射甲泼尼龙的需求(p < 0.05)。它还降低了维持干预后MGFA最低表现所需的泼尼松龙每日剂量(p < 0.05)。治疗后长达1年,无一例患者出现明显副作用。这些发现表明,低剂量FK506治疗初发MG患者安全有效。

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