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吡仑帕奈治疗儿童耐药性局灶性癫痫发作的疗效和安全性:一项回顾性研究。

Efficacy and Safety of Perampanel in Children with Drug-Resistant Focal-Onset Seizures: A Retrospective Review.

作者信息

Elmardenly Ahmed, Aljehani Zekra, Tamim Abdullah, Alyazidi Anas, Muthaffar Osama

机构信息

Department of Pediatrics, King Faisal Specialist Hospital & Research Centre, Jeddah 23431, Saudi Arabia.

Medical/Critical Pharmacy Department, Pharmaceutical Care Division, King Faisal Specialist Hospital and Research Centre, Jeddah 23431, Saudi Arabia.

出版信息

Children (Basel). 2023 Jun 17;10(6):1071. doi: 10.3390/children10061071.

Abstract

BACKGROUND

Epilepsy is one of the most common neurological disorders. Existing antiseizure medications (ASMs) are still unable to control seizures in one-third of these patients, making the discovery of antiseizure therapies with novel mechanisms of action a necessity.

AIM OF THE STUDY

This study aimed to determine the safety and efficacy of perampanel (PER) as an adjuvant treatment for children with drug-resistant focal-onset seizures with or without focal to bilateral tonic-clonic seizures.

PATIENTS AND METHODS

This is a single-center retrospective study of 38 epileptic pediatric patients, aged 2 to 14, at King Faisal Specialist Hospital and Research Center whose seizures were pharmaco-resistant to more than two antiseizure medications and followed for at least three months after PER adjuvant therapy initiation. Efficacy was assessed by the PER response rate at 3-, 6-, and 12-month follow-up evaluations, and side effects were also reported.

RESULTS

Multiple seizure types were reported. Myoclonic seizures were the predominant type of epilepsy in 17 children (44.7%). At 3 months, 6 months, and 12 months of follow-up, approximately 23.4%, 23.4%, and 18.4% of the patients were seizure-free at these time points, respectively. Adverse events were documented in 14 patients (35.7%) and led to the discontinuation of PER in 26.3%, 31.6%, and 36.8% of the studied group at the 3-, 6-, and 12-month follow-ups, respectively. The most common adverse events included dizziness or drowsiness, irritability, gait disturbance, and confusion; however, all were transient, and no serious adverse effects occurred.

CONCLUSION

Our findings confirm the therapeutic efficacy of adjunctive PER in the treatment of drug-resistant epilepsy in children. As an adjunctive treatment for epilepsy, perampanel demonstrated sufficient effectiveness and tolerability.

摘要

背景

癫痫是最常见的神经系统疾病之一。现有的抗癫痫药物(ASMs)仍无法控制三分之一此类患者的癫痫发作,因此发现具有新作用机制的抗癫痫疗法很有必要。

研究目的

本研究旨在确定吡仑帕奈(PER)作为辅助治疗药物,用于治疗伴有或不伴有局灶性至双侧强直阵挛发作的耐药性局灶性发作儿童的安全性和有效性。

患者与方法

这是一项在费萨尔国王专科医院和研究中心进行的单中心回顾性研究,研究对象为38例年龄在2至14岁的癫痫儿科患者,其癫痫发作对两种以上抗癫痫药物耐药,且在开始PER辅助治疗后至少随访三个月。通过在3个月、6个月和12个月随访评估时的PER反应率评估疗效,并报告副作用。

结果

报告了多种癫痫发作类型。肌阵挛发作是17名儿童(44.7%)中最主要的癫痫类型。在随访的3个月、6个月和12个月时,分别约有23.4%、23.4%和18.4%的患者在这些时间点无癫痫发作。14例患者(35.7%)记录到不良事件,在3个月、6个月和12个月随访时,分别导致26.3%、31.6%和36.8%的研究组患者停用PER。最常见的不良事件包括头晕或嗜睡、易怒、步态障碍和意识模糊;然而,所有这些都是短暂的,未发生严重不良反应。

结论

我们的研究结果证实了辅助使用PER治疗儿童耐药性癫痫的疗效。作为癫痫的辅助治疗药物,吡仑帕奈显示出足够的有效性和耐受性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0c84/10297347/bf357a471640/children-10-01071-g001.jpg

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