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长期随访中癫痫患者使用吡仑帕奈的疗效和耐受性。

Perampanel effectiveness and tolerability in patients with epilepsy at long-term follow-up.

机构信息

Epilepsy Centre, Department of Systems Medicine, University of Rome 'Tor Vergata", Rome, Italy; Neurology Unit, University Hospital of Rome "Tor Vergata", Rome, Italy.

Epilepsy Centre, Neurologic Unit, SS.Giovanni e Paolo Hospital, Venice, Italy.

出版信息

Epilepsy Behav. 2021 Aug;121(Pt A):108069. doi: 10.1016/j.yebeh.2021.108069. Epub 2021 May 30.

Abstract

INTRODUCTION

The main of the present study was to assess the effectiveness and tolerability of perampanel (PER) in association with 1 or 2 concomitant antiseizure medications (ASMs) in patients with epilepsy throughout a follow-up period of 24 months or longer in a real-world setting.

METHODS

This retrospective, observational, multi-center study collected data from both underage (<18 years old) and adult patients who had started PER in association with 1 or 2 ASMs. Only patients who had started PER and were followed up for at least 24 months were included. Response to treatment was analyzed at the 24-, 36-, and 48-month visits by considering the last visit undergone by patients. Subgroup analyses were performed according to age, gender, and epilepsy type and patients were categorized following PER treatment in concomitance with 1 or 2 ASMs to evaluate the factors affecting the achievement of seizure freedom (SF) at the 24-month FU.

RESULTS

Ninety-four patients were included (mean age 36.89 years; 51.1% female). At the 24-month follow-up visit, 90 (95.74%) patients were still receiving PER concomitantly with 1 or 2 ASMs. The mean PER dose was 6.02 mg/day and SF was achieved by 33 (35.1%) patients. A significantly higher SF rate was found in patients who had started PER with only 1 ASM when compared to those who had started PER with 2 concomitant ASMs. Effectiveness was maintained also in the subgroups of patients with a 36- or 48-month follow-up visit. Adult patients had a higher final daily dosage of PER than underage patients. Logistic regression found that the lowest number of previously failed ASMs was associated with a higher SF rate (p = 0.036).

CONCLUSION

Perampanel demonstrated a good effectiveness in association with 1 or 2 ASMs in both pediatric and adult patients, without having to use a high dose of the drug. The possibility to present SF was higher when PER was added early. Finally, the maintenance of effectiveness was observed also in the subgroups of patients with a follow-up of 36 and 48 months.

摘要

简介

本研究的主要目的是评估培米普利(PER)与 1 种或 2 种伴随抗癫痫药物(ASMs)联合使用在癫痫患者中的有效性和耐受性,在真实世界环境中进行了长达 24 个月或更长时间的随访。

方法

这项回顾性、观察性、多中心研究从未成年(<18 岁)和成年患者中收集了开始使用 PER 联合 1 种或 2 种 ASMs 的数据。仅纳入开始 PER 治疗并随访至少 24 个月的患者。通过考虑患者最后一次就诊,在 24、36 和 48 个月的就诊时分析治疗反应。根据年龄、性别、癫痫类型进行亚组分析,并根据 PER 与 1 种或 2 种 ASMs 联合治疗进行分组,以评估在 24 个月随访时达到无癫痫发作(SF)的因素。

结果

共纳入 94 例患者(平均年龄 36.89 岁,51.1%为女性)。在 24 个月的随访中,90 例(95.74%)患者仍同时接受 PER 联合 1 种或 2 种 ASMs 治疗。PER 的平均剂量为 6.02mg/天,33 例(35.1%)患者达到 SF。与开始 PER 联合 2 种 ASMs 相比,开始 PER 联合 1 种 ASMs 的患者 SF 率显著更高。在进行 36 个月或 48 个月随访的亚组中,疗效也得到了维持。成年患者的 PER 日终剂量高于未成年患者。Logistic 回归发现,先前失败的 ASMs 数量最少与更高的 SF 率相关(p=0.036)。

结论

培米普利与 1 种或 2 种 ASMs 联合使用在儿科和成人患者中均显示出良好的疗效,且无需使用高剂量药物。当 PER 早期添加时,达到 SF 的可能性更高。最后,在随访 36 个月和 48 个月的亚组中也观察到了疗效的维持。

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