Department of Pediatrics, People's Hospital of Zhengzhou University, Henan Provincial People's Hospital, Zhengzhou 450003, Henan, China.
Department of Pediatrics, People's Hospital of Zhengzhou University, Henan Provincial People's Hospital, Zhengzhou 450003, Henan, China.
Epilepsy Behav. 2022 Dec;137(Pt A):108961. doi: 10.1016/j.yebeh.2022.108961. Epub 2022 Oct 31.
The main aim of this study was to assess the efficacy, safety, and tolerability of adjunctive perampanel (PER) in the treatment of children and adolescents with epilepsy.
Pediatric patients who visited the pediatric epilepsy clinic of Henan Provincial People's Hospital between May 2020 and December 2021 were recruited. All participants were treated with PER as adjunctive therapy and were seen routinely (minimum: a baseline and 12-week visit). The efficacy and tolerability of adjunctive PER for the treatment of epilepsy were investigated.
One hundred and fourteen patients were enrolled, among whom 7 (6.1%) were lost to follow-up. At 12 weeks, the responder rate and the seizure-free rate were 56.1% (60/107) and 32.7% (35/107), respectively. The responder rate increased with the duration of PER administration and was significantly higher when PER was used as an early add-on (after ≤2 prior antiseizure medications (ASMs)) than a late add-on (after >2 prior ASMs). However, there was no significant difference in the treatment efficacy of adjunctive PER in patients with different epilepsy etiologies or types. Adverse events, including irritability, dizziness, somnolence, ataxic gait, weight gain, and tinnitus, were reported in thirty-two patients (29.9%).
In a routine clinical setting of pediatric patients with epilepsy, good effectiveness and tolerability of adjunctive PER were demonstrated. Notably, patients initiating PER as an early add-on showed a better seizure outcome than those initiating PER as a late add-on.
本研究的主要目的是评估辅助性吡仑帕奈(PER)治疗癫痫儿童和青少年的疗效、安全性和耐受性。
招募 2020 年 5 月至 2021 年 12 月期间在河南省人民医院儿科癫痫诊所就诊的儿科患者。所有患者均接受 PER 辅助治疗,并进行常规随访(最少:基线和 12 周访视)。研究了辅助 PER 治疗癫痫的疗效和耐受性。
共纳入 114 例患者,其中 7 例(6.1%)失访。12 周时,有效率和无发作率分别为 56.1%(60/107)和 32.7%(35/107)。PER 给药时间越长,有效率越高,早期添加(<2 种抗癫痫药物)明显高于晚期添加(>2 种抗癫痫药物)。然而,PER 辅助治疗对不同病因或类型癫痫患者的疗效无显著差异。32 例患者(29.9%)报告出现不良反应,包括易激惹、头晕、嗜睡、共济失调步态、体重增加和耳鸣。
在儿科癫痫患者的常规临床环境中,辅助 PER 具有良好的疗效和耐受性。值得注意的是,早期添加 PER 的患者发作控制效果优于晚期添加 PER 的患者。