Perampanel (PER) is expanding the therapeutic scope for pediatric epilepsy owing to its efficacy and favorable safety profile. However, concerns about psychiatric and behavioral adverse events (PBAEs) in combination therapy with levetiracetam (LEV) continue to contribute to hesitation in its prescription. We investigated the risk profiles for PBAEs when adding PER to pediatric epilepsy treatment and analyzed the differences according to the presence of concomitant LEV. We retrospectively reviewed the medical records of children aged 4–18 years with epilepsy who were prescribed PER as adjunctive therapy from March 2016 to February 2023. We compared the occurrence and management of PBAEs between the PER without LEV and PER with LEV groups. The risk factors for PBAEs were also analyzed. Ninety-four patients (53 boys and 41 girls) were included in this study. The median age of total patients at the time of adding PER was 14.9 years (12.3–16.4 years), and 53 patients (56.4 %) had concomitant LEV. Forty-seven PBAEs occurred in 34 patients (36.2 %), with no significant differences depending on whether concomitant LEV is present or not. The most common PBAEs were aggression (14.9 %), irritability (9.6 %), affect lability (7.4 %), and acute psychosis (6.4 %). PBAEs occurred at a lower dosage (2–6 mg/day) in 70.6 % of the patients. In addition, 73.5 % of patients with PBAEs continued PER treatment by follow-up observation or by reducing the PER dosage. No risk factors, such as the presence of concomitant LEV or lamotrigine, any comorbid conditions, higher PER dosage (8–12 mg/day), two or more concomitant anti-seizure medications, and younger age (<13 years) at PER add-on, showed significant associations. When expanding the use of anti-seizure medications in pediatric patients, real-world evidence on safety issues is crucial for pediatric epileptologists. We confirmed that combination therapy with PER and LEV did not increase the risk profile of PBAEs.

中文翻译：

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吡仑帕奈联合左乙拉西坦治疗癫痫儿童的精神和行为问题

吡仑帕奈 (PER) 因其疗效和良好的安全性而正在扩大小儿癫痫的治疗范围。然而，对左乙拉西坦 (LEV) 联合治疗中精神和行为不良事件 (PBAE) 的担忧继续导致其处方犹豫不决。我们调查了将 PER 添加到儿科癫痫治疗中时 PBAE 的风险状况，并根据伴随 LEV 的存在分析了差异。我们回顾性回顾了 2016 年 3 月至 2023 年 2 月期间接受 PER 作为辅助治疗的 4-18 岁癫痫儿童的病历。我们比较了不加 LEV 的 PER 组和加 LEV 组的 PER 组 PBAE 的发生和处理情况。还分析了 PBAE 的危险因素。本研究包括 94 名患者（53 名男孩和 41 名女孩）。添加 PER 时所有患者的中位年龄为 14.9 岁（12.3-16.4 岁），53 名患者 (56.4%) 伴有 LEV。 34 名患者 (36.2%) 发生了 47 例 PBAE，根据是否存在 LEV，没有显着差异。最常见的 PBAE 是攻击性 (14.9%)、易怒 (9.6%)、情感不稳定性 (7.4%) 和急性精神病 (6.4%)。 70.6% 的患者在较低剂量（2-6 毫克/天）时发生 PBAE。此外，73.5%的PBAE患者通过随访观察或减少PER剂量继续进行PER治疗。无风险因素，例如同时服用 LEV 或拉莫三嗪、任何合并症、较高 PER 剂量（8-12 毫克/天）、两种或多种同时服用抗癫痫药物以及 PER 年龄较小（<13 岁） -on，显示出显着的关联。当扩大儿科患者抗癫痫药物的使用时，安全问题的现实证据对于儿科癫痫学家至关重要。我们证实 PER 和 LEV 联合治疗不会增加 PBAE 的风险状况。