Effectiveness and safety of perampanel as adjunctive therapy among Chinese patients with focal-onset epilepsy: A real-world prospective observational study
Effectiveness and safety of perampanel as adjunctive therapy among Chinese patients with focal-onset epilepsy: A real-world prospective observational study
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DOI：
10.1016/j.yebeh.2022.108937
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发表时间：
2022-10-07
影响因子：
2.6
通讯作者：
Zhu, Guoxing
中科院分区：
文献类型：
--
作者：
Wang, Qinyue;Xu, Ye;Zhu, Guoxing
目的：Perampanel（PER）先前已被证明在用作局灶性癫痫发作（FOS）患者的连续治疗时有效且可耐受。方法：在华山医院进行了一项前瞻性、单中心、为期1年的观察性研究，纳入了4岁以下和4岁以下的FOS患者。在3个月、6个月和12个月的检查点，通过分析50%应答率、无癫痫发生率和癫痫发作频率的减少来评估对PER的应答。（平均年龄：26.6岁，56.5%为男性），76例患者完成了1年随访（留存率：70.4%，平均PER剂量：4.3 mg/天）。在3、6和12个月时，癫痫发作频率相对于基线显著降低（每种癫痫发作类型p < 0.001）。12个月时，有效率为65.8%，无复发率为39.5%。局灶性至双侧强直阵挛性癫痫发作患者的应答率显著较高（p = 0.024），其中睡眠相关癫痫患者的百分比显著较高（p = 0.045）。应答者的伴随抗癫痫药物（ASM）数量低于非应答者（p = 0.009）。37%的患者报告了药物相关不良事件（AE），大多数为轻度或中度，发生AE的患者的PER日剂量高于未发生AE的患者（p = 0.026）。结论：Perampanel是一种局灶性癫痫发作的辅助治疗，在中国患者中12个月时有效且可耐受。(c)2022年由Elsevier Inc.出版
Objective: Perampanel (PER) has previously been shown to be effective and tolerable when used as an adjunctive therapy for patients with focal-onset seizures (FOS). This study aimed to evaluate the effect of PER as adjunctive therapy for patients with FOS in the Chinese population under real-world conditions for 1 year.Methods: A prospective, single-center, 1-year observational study was conducted at Huashan Hospital, enrolling both under age (>= 4 years old) and adult patients with FOS. Response to PER was assessed at 3-, 6-, and 12-month checkpoints by analyzing the 50 % responder rate, the seizure-free rate, and reduc-tion in seizure frequency.Results: One hundred and eight patients (mean age: 26.6 years, 56.5 % males) with FOS were included, with seventy-six patients finishing the 1-year follow-up (retention rate: 70.4 %, mean PER dose: 4.3 mg/day). The seizure frequency was reduced significantly at 3, 6, and 12 months relative to baseline (p < 0.001 for each seizure type). At 12 months, the responder rate was 65.8 %, and the seizure-free rate was 39.5 %. A significantly higher responder rate was found in patients with focal to bilateral tonic-clonic seizures (p = 0.024), among which the percentage of patients with sleep-related epilepsy was signifi-cantly high (p = 0.045). Responders had a lower number of concomitant anti-seizure medications (ASMs) than the non-responders (p = 0.009). Drug-related adverse events (AEs) were reported in 37 % of patients, mostly mild or moderate, and the patients who experienced AEs had a higher daily dose of PER than those who did not (p = 0.026).Conclusion: Perampanel, an add-on therapy for focal-onset seizures, was found to be effective and toler-able in Chinese patients at 12 months.(c) 2022 Published by Elsevier Inc.