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一项左乙拉西坦治疗多发性硬化症中枢痛的随机、安慰剂对照试验。

A randomized, placebo-controlled trial of levetiracetam in central pain in multiple sclerosis.

机构信息

Department of Neurology, Odense University Hospital, Odense, Denmark.

出版信息

Eur J Pain. 2012 Jul;16(6):860-9. doi: 10.1002/j.1532-2149.2011.00073.x. Epub 2011 Dec 19.

Abstract

Levetiracetam is an anticonvulsant which is assumed to act by modulating neurotransmitter release via binding to the vesicle protein SV2A. This could have an impact on signalling in the pain pathway. The aim of this study was to test the analgesic effect of levetiracetam in central pain in multiple sclerosis. This was a randomized, double-blind, placebo-controlled, cross-over trial with levetiracetam 3000 mg/day versus placebo (6-week treatment periods). Patients with multiple sclerosis, symptoms and signs complying with central neuropathic pain and pain symptoms for more than 6 months, as well as pain intensity of more than 4 on a 0 to 10-point numeric rating scale were included in the study. The primary outcome measure was pain relief at the end of each treatment period as measured on a 6-point verbal scale. Eighty-nine patients were screened for participation and 30 patients entered the study. Twenty-seven patients were included in the data analysis. There were no differences in the ratings of pain relief (levetiracetam 2.4 vs. placebo 2.1, p = 0.169), total pain intensity (levetiracetam 5.3 vs. placebo 5.7, p = 0.147) or any of the other outcome measures (p = 0.086-0.715) in the total sample of patients. However, there was significant reduction of pain, increased pain relief and/or more favourable pain relief with levetiracetam than with placebo in patients with lancinating or without touch-evoked pain (p = 0.025-0.046). This study found no effect of the anticonvulsant levetiracetam in non-selected patients with central pain in multiple sclerosis, but an effect in subgroups with specific pain symptoms was indicated.

摘要

左乙拉西坦是一种抗惊厥药,据推测它通过与囊泡蛋白 SV2A 结合来调节神经递质的释放而起作用。这可能会对疼痛途径中的信号传递产生影响。本研究旨在测试左乙拉西坦在多发性硬化症中枢性疼痛中的镇痛作用。这是一项随机、双盲、安慰剂对照、交叉试验,使用左乙拉西坦 3000mg/天与安慰剂(6 周治疗期)进行比较。纳入研究的患者符合以下标准:多发性硬化症,有症状和体征符合中枢性神经病性疼痛,疼痛症状持续超过 6 个月,以及数字评分量表上的疼痛强度超过 4(0 到 10 分)。主要观察指标为每个治疗期结束时的疼痛缓解程度,采用 6 分制言语量表进行评估。对 89 名患者进行了参与筛查,有 30 名患者进入了研究。27 名患者纳入数据分析。在总样本患者中,左乙拉西坦组的疼痛缓解评分(2.4 分比安慰剂组 2.1 分,p = 0.169)、总疼痛强度(5.3 分比安慰剂组 5.7 分,p = 0.147)或其他任何结局指标(p = 0.086-0.715)均无差异。然而,在有刺痛或无触诱发痛的患者中,与安慰剂相比,左乙拉西坦可显著减轻疼痛、增加疼痛缓解程度和/或使疼痛缓解更有利(p = 0.025-0.046)。本研究未发现抗惊厥药左乙拉西坦对多发性硬化症非选择性中枢性疼痛患者有作用,但提示在具有特定疼痛症状的亚组中可能有作用。

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