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左乙拉西坦对伴有小脑体征的多发性硬化症患者上肢运动的疗效:一项多中心、双盲、安慰剂对照、交叉研究。

Efficacy of levetiracetam on upper limb movement in multiple sclerosis patients with cerebellar signs: a multicenter double-blind, placebo-controlled, crossover study.

机构信息

Rehabilitation Unit, 'Mons. L. Novarese' Hospital, Moncrivello, Italy.

Physical and Rehabilitative Medicine, Department of Health Sciences, University of Eastern Piedmont 'A. Avogadro', Novara, Italy.

出版信息

Eur J Neurol. 2020 Nov;27(11):2209-2216. doi: 10.1111/ene.14403. Epub 2020 Jul 12.

DOI:10.1111/ene.14403
PMID:32558044
Abstract

BACKGROUND AND PURPOSE

The literature provides contrasting results on the efficacy of levetiracetam (LEV) in multiple sclerosis (MS) patients with cerebellar signs. It was sought to evaluate the efficacy of LEV on upper limb movement in MS patients.

METHODS

In this multicenter double-blind placebo-controlled crossover study, MS patients with prevalently cerebellar signs were randomly allocated into two groups: LEV followed by placebo (group 1) or placebo followed by LEV (group 2). Clinical assessments were performed by a blinded physician at T0 (day 1), T1 (day 22), T2 (2-week wash-out period, day 35) and T3 (day 56). The primary outcome was dexterity in the arm with greater deficit, assessed by the nine-hole peg test (9HPT). Secondary clinical outcomes included responders on the 9HPT (∆9HPT >20%), tremor activity of the daily living questionnaire and self-defined upper limb impairment, through a numeric rating scale. Kinematic evaluation was performed using a digitizing tablet, providing data on normalized jerk, aiming error and centripetal acceleration.

RESULTS

Forty-eight subjects (45.2 ± 10.4 years) were randomly allocated into two groups (n = 24 each). 9HPT significantly improved in the LEV phase in both groups (P < 0.001). The LEV treatment phase led to a significant improvement (P < 0.01) of all clinical outcomes in group 1 and in dexterity in group 2. No significant changes were reported during both placebo phases in the two groups. Considering the kinematic analysis, only normalized jerk significantly improved after treatment with LEV (T0-T1) in group 1.

CONCLUSIONS

Levetiracetam treatment seems to be effective in improving upper limb dexterity in MS patients with cerebellar signs.

摘要

背景与目的

文献对伴有小脑体征的多发性硬化症(MS)患者使用左乙拉西坦(LEV)的疗效提供了相互矛盾的结果。本研究旨在评估 LEV 对 MS 患者上肢运动的疗效。

方法

在这项多中心、双盲、安慰剂对照交叉研究中,将以小脑体征为主的 MS 患者随机分为两组:LEV 后安慰剂(组 1)或安慰剂后 LEV(组 2)。由一位盲法医师在 T0(第 1 天)、T1(第 22 天)、T2(2 周洗脱期,第 35 天)和 T3(第 56 天)进行临床评估。主要结局是使用九孔钉测试(9HPT)评估上肢较大缺陷侧的灵巧度。次要临床结局包括 9HPT 应答者(∆9HPT >20%)、日常生活震颤活动问卷和自我定义的上肢障碍,通过数字评分量表评估。使用数字化平板进行运动学评估,提供标准化急动度、瞄准误差和向心加速度的数据。

结果

48 名受试者(45.2 ± 10.4 岁)被随机分为两组(每组 24 名)。两组 LEV 阶段 9HPT 均显著改善(P < 0.001)。LEV 治疗阶段导致组 1 所有临床结局均显著改善(P < 0.01),组 2 上肢灵巧度显著改善。两组在两个安慰剂阶段均未报告显著变化。考虑运动学分析,仅组 1 在 LEV 治疗后(T0-T1)标准化急动度显著改善。

结论

LEV 治疗似乎可有效改善伴有小脑体征的 MS 患者上肢灵巧度。

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