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用醋酸格拉替雷治疗后多发性硬化症患者的神经心理状态

Neuropsychologic status in multiple sclerosis after treatment with glatiramer.

作者信息

Weinstein A, Schwid S R, Schiffer R B, McDermott M P, Giang D W, Goodman A D

机构信息

Department of Neurology, University of Rochester Medical Center, NY 14642, USA.

出版信息

Arch Neurol. 1999 Mar;56(3):319-24. doi: 10.1001/archneur.56.3.319.

Abstract

BACKGROUND

Glatiramer acetate (Copaxone) therapy reduces clinical disease activity in relapsing-remitting multiple sclerosis (MS).

OBJECTIVE

To study the effect of glatiramer therapy on neuropsychologic function as part of a randomized, placebo-controlled, multicenter trial.

METHODS

Two hundred forty-eight patients with relapsing-remitting MS and mild to moderate disability (Expanded Disability Status Scale score, <5.0) were tested before and 12 and 24 months after randomization to administration of glatiramer acetate, 20 mg/d, or matching placebo. Neuropsychologic tests examined 5 cognitive domains most often disrupted in patients with MS: sustained attention, perceptual processing, verbal and visuospatial memory, and semantic retrieval.

RESULTS

Baseline neuropsychologic test performance was similar in both treatment groups and was within normal range, except for impaired semantic retrieval. Mean neuropsychologic test scores were higher at 12 and 24 months than at baseline, and no differences were detected between treatment groups over time. No significant interactions were detected between treatment and either time or baseline impairment.

CONCLUSIONS

Our 2-year longitudinal study showed no effect of glatiramer therapy on cognitive function in relapsing-remitting MS. Although it is possible that glatiramer therapy has no effect on cognitive function, the lack of measurable decline in cognitive function in both patient groups for 2 years limits the opportunity for glatiramer to demonstrate a therapeutic effect by minimizing such decline. Emerging treatments for MS should continue to be examined for their effect on cognitive impairment because it can be a critical determinant of disability. A greater understanding of the natural history of cognitive decline in MS is essential for a rational design of these drug trials.

摘要

背景

醋酸格拉替雷(考帕松)疗法可降低复发缓解型多发性硬化症(MS)的临床疾病活动度。

目的

作为一项随机、安慰剂对照、多中心试验的一部分,研究格拉替雷疗法对神经心理功能的影响。

方法

248例复发缓解型MS且轻度至中度残疾(扩展残疾状态量表评分<5.0)的患者在随机分组接受每日20mg醋酸格拉替雷或匹配安慰剂治疗前、治疗12个月和24个月后接受测试。神经心理测试检查了MS患者中最常受到干扰的5个认知领域:持续注意力、知觉加工、言语和视觉空间记忆以及语义检索。

结果

除语义检索受损外,两个治疗组的基线神经心理测试表现相似且在正常范围内。12个月和24个月时的平均神经心理测试得分高于基线,且随时间推移治疗组之间未检测到差异。治疗与时间或基线损伤之间未检测到显著相互作用。

结论

我们的2年纵向研究表明,格拉替雷疗法对复发缓解型MS的认知功能无影响。虽然格拉替雷疗法可能对认知功能无影响,但两组患者2年的认知功能均未出现可测量的下降,这限制了格拉替雷通过最小化此类下降来证明其治疗效果的机会。MS的新兴治疗方法应继续接受对认知障碍影响的检查,因为它可能是残疾的关键决定因素。更深入了解MS认知衰退的自然史对于合理设计这些药物试验至关重要。

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