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左乙拉西坦对多发性硬化症慢性疼痛的影响:一项试点随机安慰剂对照研究的结果

Effects of levetiracetam on chronic pain in multiple sclerosis: results of a pilot, randomized, placebo-controlled study.

作者信息

Rossi S, Mataluni G, Codecà C, Fiore S, Buttari F, Musella A, Castelli M, Bernardi G, Centonze D

机构信息

Dipartimento di Neuroscienze, Università Tor Vergata, Rome, Italy.

出版信息

Eur J Neurol. 2009 Mar;16(3):360-6. doi: 10.1111/j.1468-1331.2008.02496.x.

Abstract

BACKGROUND AND PURPOSE

Central neuropathic pain (CNP) is a prevalent and distressing symptom in patients with multiple sclerosis (MS). The anticonvulsant levetiracetam (LEV) has been shown to be efficacious in some types of CNP, but its efficacy in MS-related CNP has not been confirmed.

METHODS

To investigate the tolerability and potential effects of LEV against CNP in MS subjects, we performed a single-center, prospective, randomized, single-blind, placebo-controlled study in twenty patients with MS and CNP. Outcomes before and during the 3-month study were assessed using validated measures of pain, depression, disability and quality of life.

RESULTS

The medication was well tolerated and analysis revealed a significant difference between the LEV and placebo arm in all study outcomes related to pain (mean pain intensity score, mean pain difference, percentage of patients with a clinically significant pain reduction). Furthermore, the individual quality of life rating improved in treated patients, showing a significant correlation with pain reduction.

CONCLUSIONS

These findings suggest that further studies with larger samples of patients be carried out in order to confirm the efficacy of LEV in MS-related CNP population.

摘要

背景与目的

中枢神经性疼痛(CNP)是多发性硬化症(MS)患者中普遍存在且令人痛苦的症状。抗惊厥药物左乙拉西坦(LEV)已被证明在某些类型的CNP中有效,但其在MS相关性CNP中的疗效尚未得到证实。

方法

为了研究LEV对MS患者CNP的耐受性和潜在影响,我们对20例患有MS和CNP的患者进行了一项单中心、前瞻性、随机、单盲、安慰剂对照研究。使用经过验证的疼痛、抑郁、残疾和生活质量测量方法评估3个月研究期间及之前的结果。

结果

该药物耐受性良好,分析显示LEV组和安慰剂组在所有与疼痛相关的研究结果(平均疼痛强度评分、平均疼痛差异、临床疼痛显著减轻的患者百分比)上存在显著差异。此外,接受治疗患者的个人生活质量评分有所改善,且与疼痛减轻显著相关。

结论

这些发现表明,为了证实LEV在MS相关性CNP人群中的疗效,应开展更大样本量患者的进一步研究。

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