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拉科酰胺作为老年人唯一的附加癫痫治疗药物:来自回顾性、多中心、观察性研究的真实世界数据的亚组分析。

Perampanel as only add-on epilepsy treatment in elderly: A subgroup analysis of real-world data from retrospective, multicenter, observational study.

机构信息

Department of Medical and Surgical Sciences, Magna Græcia University of Catanzaro, Italy; Regional Epilepsy Centre, Great Metropolitan "Bianchi-Melacrino-Morelli Hospital", Reggio Calabria, Italy.

Clinical Epidemiology and Physiopathology of Renal Diseases and Hypertension of Reggio Calabria, National Council of Research, Institute of Clinical Physiology, Reggio Calabria, Italy.

出版信息

J Neurol Sci. 2023 Dec 15;455:122797. doi: 10.1016/j.jns.2023.122797. Epub 2023 Nov 13.

Abstract

INTRODUCTION

Drug management of epilepsy in the elderly presents unique but data on this population are scarce. This study aimed to assess the effectiveness and tolerability of perampanel (PER) used as only add-on to a background anti-seizure medication (ASM) in the elderly in a real-world setting.

METHODS

We performed a subgroup analysis of patients aged ≥65 years included in a previous 12-month multicenter study on adults. Treatment discontinuation, seizure frequency, and adverse events were recorded at 3, 6 and 12 months after PER introduction. Sub-analyses by early (≤1 previous ASM) or late PER add-on were also conducted.

RESULTS

The sample included 65 subjects (mean age: 75.7 ± 7.2 years), with mainly focal (73.8%) epilepsy. The mean PER daily dose was ≈4 mg during all follow-up. Retention rates at 3, 6, and 12 months were 90.5%, 89.6%, and 79.4%ly. The baseline median normalized per 28-day seizure number significantly decreased at 3-, 6- and 12-month visits. One year after PER introduction, the responder rate (≥50% reduction in baseline seizure frequency) was 89.7%, with a seizure freedom rate of 72.4%. Adverse events occurred in 22 (34.9%) patients with dizziness and irritability being the most frequent. No major differences between early (41 patients, 63.1%), and late add-on groups were observed.

CONCLUSION

Adjunctive PER was effective and well-tolerated when used as only add-on treatment in elderly people with epilepsy in clinical practice, thus representing a suitable therapeutic option in this age category.

摘要

简介

老年人癫痫的药物管理具有独特性,但针对该人群的数据却很少。本研究旨在评估普瑞巴林(PER)作为背景抗癫痫药物(ASM)的附加治疗在老年人中的有效性和耐受性。

方法

我们对先前进行的一项为期 12 个月的成人多中心研究中≥65 岁的患者进行了亚组分析。在 PER 引入后 3、6 和 12 个月记录治疗停药、发作频率和不良事件。还进行了早期(≤1 种先前的 ASM)或晚期 PER 添加的亚分析。

结果

该样本包括 65 名患者(平均年龄:75.7±7.2 岁),主要为局灶性癫痫(73.8%)。整个随访期间,PER 的平均日剂量约为 4mg。3、6 和 12 个月的保留率分别为 90.5%、89.6%和 79.4%。基线期每 28 天正常化发作次数的中位数在 3、6 和 12 个月时显著降低。PER 引入后 1 年,应答率(基线发作频率降低≥50%)为 89.7%,无发作率为 72.4%。22 名(34.9%)患者出现不良事件,头晕和烦躁最常见。早期(41 名患者,63.1%)和晚期添加组之间没有明显差异。

结论

在临床实践中,作为唯一的附加治疗,辅助 PER 对老年人癫痫是有效且耐受良好的,因此代表了该年龄组的一种合适的治疗选择。

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