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在年龄≥4 岁的癫痫儿科患者中使用吡仑帕奈的疗效、耐受性和安全性:一项真实世界观察性研究。

Efficacy, Tolerability, and Safety of Treatment With Perampanel in Pediatric Patients With Epilepsy Aged ≥4 Years: A Real-Life Observational Study.

机构信息

Department of Pharmacy, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, Xinjiang, China.

Institute of Clinical Pharmacy of Xinjiang Uygur Autonomous Region, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, Xinjiang, China.

出版信息

J Child Neurol. 2023 May;38(6-7):414-421. doi: 10.1177/08830738231182536. Epub 2023 Jun 22.

DOI:10.1177/08830738231182536
PMID:37350050
Abstract

The safety and effectiveness of perampanel in clinical settings involving Chinese pediatric patients are limited, as perampanel has only recently been approved for use in China, in September 2019. We aimed to evaluate the efficacy and tolerability of perampanel as an adjunctive therapy for pediatric patients with epilepsy aged ≥ 4 years in Xinjiang, Northwest China. Efficacy was assessed by measuring changes in seizure frequency at 3-, 6-, and 12-month follow-up compared with baseline. The baseline was 3 months before the addition of perampanel, and the seizure frequency was based on the patients' seizure diary. The safety and tolerability depended on the type and frequency of any adverse event during epilepsy treatment across all pediatric patients. Overall, 67 pediatric patients from 2 different hospitals were enrolled in the study. Among the pediatric patients with seizures during the baseline period, the effective rates for all seizure types at 3, 6, and 12 months were 59.1%, 58.7%, and 57.4%, respectively. During perampanel treatment, 34 patients (50.7%) experienced at least 1 adverse reaction. Overall, this real-world retrospective study of pediatric patients validated that perampanel is an effective treatment option as an adjunctive therapy among pediatric patients with epilepsy aged ≥4 years.

摘要

在涉及中国儿科患者的临床环境中,吡仑帕奈的安全性和有效性有限,因为吡仑帕奈仅于 2019 年 9 月在中国获得批准使用。我们旨在评估吡仑帕奈作为辅助治疗在中国新疆(中国西北部)≥4 岁癫痫儿科患者的疗效和耐受性。通过与基线相比,在 3、6 和 12 个月的随访时测量癫痫发作频率的变化来评估疗效。基线是在添加吡仑帕奈之前的 3 个月,癫痫发作频率基于患者的癫痫日记。安全性和耐受性取决于所有儿科患者癫痫治疗过程中任何不良事件的类型和频率。 总体而言,来自 2 家不同医院的 67 名儿科患者入组了该研究。在基线期有癫痫发作的儿科患者中,所有癫痫发作类型在 3、6 和 12 个月的有效率分别为 59.1%、58.7%和 57.4%。在吡仑帕奈治疗期间,34 名患者(50.7%)至少经历了 1 次不良反应。 总体而言,这项针对≥4 岁癫痫儿科患者的真实世界回顾性研究验证了吡仑帕奈作为辅助治疗是一种有效的治疗选择。

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Efficacy, Tolerability, and Safety of Treatment With Perampanel in Pediatric Patients With Epilepsy Aged ≥4 Years: A Real-Life Observational Study.在年龄≥4 岁的癫痫儿科患者中使用吡仑帕奈的疗效、耐受性和安全性:一项真实世界观察性研究。
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引用本文的文献

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Mol Neurobiol. 2024 Nov;61(11):9210-9221. doi: 10.1007/s12035-024-04136-1. Epub 2024 Apr 11.
2
Efficacy and safety of perampanel as early add-on therapy in Chinese patients with focal-onset seizures: a multicenter, open-label, single-arm study.吡仑帕奈作为中国局灶性发作患者早期添加治疗的疗效和安全性:一项多中心、开放标签、单臂研究。
Front Neurol. 2023 Aug 30;14:1236046. doi: 10.3389/fneur.2023.1236046. eCollection 2023.