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纳比昔单抗对治疗抵抗性多发性硬化痉挛患者目标达成量表评分的影响。

Effect of nabiximols on Goal Attainment Scale scores in patients with treatment-resistant multiple sclerosis spasticity.

机构信息

Experimental & Clinical Research Center & NeuroCure Clinical Research Center, Max Delbrueck Center for Molecular Medicine & Charité-Universitätsmedizin Berlin, Berlin, Germany.

Global Medical Affairs, Almirall S.A., Barcelona, Spain.

出版信息

Neurodegener Dis Manag. 2021 Apr;11(2):143-153. doi: 10.2217/nmt-2020-0060. Epub 2021 Mar 1.

Abstract

Nabiximols oromucosal spray (Sativex) is an approved add-on treatment option for moderate-to-severe treatment-resistant multiple sclerosis (MS) spasticity. This prospective, observational, noninterventional, 3-month follow-up pilot study assessed the evolution of patient-selected goal attainment scale (GAS) item scores and of MS spasticity and associated symptoms during nabiximols treatment. In the full analysis set (n = 21), the mean (SD) overall unweighted GAS score increased from 32.1 (3.4) at baseline to 43.6 (14.6) at month 3 (p = 0.0060), constituting a clinically meaningful change. Slight improvements were observed in MS spasticity and most associated symptoms. Nabiximols improved walking ability and was well tolerated. The study provides proof-of-concept that GAS methodology can be applied to MS management in daily practice.

摘要

那比非司特口腔喷雾剂(Sativex)是一种已获批的附加治疗选择,适用于中度至重度治疗抵抗性多发性硬化症(MS)痉挛。这项前瞻性、观察性、非干预性、为期 3 个月的随访性先导研究评估了患者选择的目标实现量表(GAS)项目评分的演变,以及那比非司特治疗期间 MS 痉挛和相关症状的演变。在全分析集(n=21)中,整体未加权 GAS 评分从基线时的 32.1(3.4)平均值增加到第 3 个月时的 43.6(14.6)(p=0.0060),构成了有临床意义的变化。MS 痉挛和大多数相关症状也观察到了轻微改善。那比非司特改善了行走能力,且耐受性良好。该研究提供了概念验证,证明 GAS 方法可应用于日常实践中的 MS 管理。

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