Zeng Ya, Wu Xintong
Department of Pharmacy, West China Hospital, Sichuan University, Chengdu, China.
Department of Neurology, West China Hospital, Sichuan University, Chengdu, China.
Front Neurol. 2024 Jan 19;14:1286276. doi: 10.3389/fneur.2023.1286276. eCollection 2023.
To investigate whether there exists a statistically significant distinction between the effectiveness and tolerance of perampanel (PER) and the number of antiseizure medications (ASMs) that were tried prior to administering PER.
A prospective, observational study was performed at West China Hospital of Sichuan University. The study included patients diagnosed with epilepsy who were prescribed PER and were monitored for a minimum of 6 months. The efficacy of PER was evaluated at 1, 3, 6, and 12-month intervals by examining the retention rate and the 50% response rate. All statistical analyses were conducted using IBM SPSS Statistics version 25 (IBM Corporation, Armonk, New York).
A total of 1,025 patients were identified, of which 836 were included in the analysis. Seven hundred and eighty-nine patients (94.4%) were followed up for a year. The median age of the patients was 29.32 ± 14.06 years, with 45.81% of the patients being male and 17.0% being adolescents. The average duration of epilepsy was 11.22 ± 8.93 years. Overall, PER was discontinued in 49.5% of patients, with the most common reasons being inadequate therapeutic effect and treatment-emergent adverse events (TEAEs). At the 6-month follow-up, the retention rate was 54.2% (454/836), and 39.6% of patients had a 50% response. At the 12-month follow-up, the retention rate was 49.4% (340/789), and 44.5% of patients had a 50% response. Patients who received PER as monotherapy had the highest retention rates ( = 0.034) and 50% response rates ( < 0.001) at any follow-up point. TEAEs were reported in 32.0% of patients, and these led to discontinuation in 15.4% of patients. The most common TEAEs were dizziness and somnolence. There was no significant difference between subgroups ( = 0.57), but there was a significant difference between the dosage of PER and TEAEs ( < 0.001).
The study concludes that PER is effective in treating both focal and generalized tonic-clonic seizures. Patients who had fewer previous exposures to ASMs exhibited higher response rates to PER. TEAEs related to PER dosage were more prevalent during the first 3 months of treatment and tended to improve with continued use, ultimately demonstrating favorable long-term tolerability.
探讨吡仑帕奈（PER）的有效性和耐受性与在给予PER之前尝试的抗癫痫药物（ASM）数量之间是否存在统计学上的显著差异。
在四川大学华西医院进行了一项前瞻性观察性研究。该研究纳入了被诊断为癫痫并开具PER处方且至少监测6个月的患者。通过检查留存率和50%反应率，在1、3、6和12个月的时间间隔评估PER的疗效。所有统计分析均使用IBM SPSS Statistics 25版（IBM公司，纽约州阿蒙克）进行。
共确定了1025例患者，其中836例纳入分析。789例患者（94.4%）接受了一年的随访。患者的中位年龄为29.32±14.06岁，45.81%的患者为男性，17.0%为青少年。癫痫的平均病程为11.22±8.93年。总体而言，49.5%的患者停用了PER，最常见的原因是治疗效果不佳和治疗中出现的不良事件（TEAE）。在6个月的随访中，留存率为54.2%（454/836），39.6%的患者有50%的反应。在12个月的随访中，留存率为49.4%（340/789），44.5%的患者有50%的反应。在任何随访点，接受PER单药治疗的患者留存率最高（=0.034），50%反应率最高（<0.001）。32.0%的患者报告了TEAE，其中15.4%的患者因此停药。最常见的TEAE是头晕和嗜睡。亚组之间无显著差异（=0.57），但PER剂量与TEAE之间存在显著差异（<0.001）。
该研究得出结论，PER对治疗局灶性和全身性强直阵挛性发作均有效。之前接触ASM较少的患者对PER的反应率较高。与PER剂量相关的TEAE在治疗的前3个月更为普遍，并倾向于随着持续使用而改善，最终显示出良好的长期耐受性。
