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在局灶性发作性癫痫患者中单用吡仑帕奈的疗效和安全性:来自中国东部的真实世界经验。

Efficacy and safety of perampanel monotherapy in patients with focal-onset seizures:A real-world experience in eastern China.

机构信息

Department of Neurology, Epilepsy Center, the Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.

Department of Pediatrics, the Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.

出版信息

Seizure. 2023 Aug;110:231-237. doi: 10.1016/j.seizure.2023.06.024. Epub 2023 Jul 6.

Abstract

OBJECTIVE

To assess the effectiveness and tolerability of perampanel (PER) monotherapy in real-world practice for the treatment of focal-onset seizures (FOS) in eastern China.

METHOD

This is a single-center, retrospective study of patients with FOS, aged ≥ 4 years, who had been prescribed PER as monotherapy. Outcomes included retention, seizure-free, and responder rates at 3, 6 and 12 months and adverse events (AEs) throughout the follow-up period. The efficacy and AEs of PER monotherapy in patients with aged < 14 years old and ≥ 14 years old were also compared.

RESULTS

Sixty-seven patients with FOS who received PER monotherapy and completed a one-year follow-up were included in the analysis. The median maintenance dose was 4 mg. Modified intent-to-treat analysis demonstrated that the retention rates of PER monotherapy at follow-up of 3, 6 and 12months were 75%, 70% and 63%, respectively. At the same points, seizure-free rates of PER monotherapy were 69%, 63% and 52%, and responder rates were 69%, 66% and 61%, respectively. Patients with sleep-related seizures had higher seizure-free rates at 12 months of follow-up. No significant difference in seizure-free and responder rates was found between the aged < 14 years old and the aged ≥ 14 years old. Twenty-one patients (31.3%) had AEs and five patients discontinued using PER because of intolerant AEs. Common AEs were dizziness, irritability and somnolence. The AEs rate in patients < 14 years was 17.9%, significantly lower than patients ≥ 14 years.

CONCLUSIONS

Our findings revealed the real-world data of patients in eastern China with FOS using PER as monotherapy. Patients had good retention, seizure-free and responder rates, and relatively low AEs rate at a low dose of PER treatment.

摘要

目的

评估吡仑帕奈(PER)单药治疗在中国东部局灶性发作性癫痫(FOS)的有效性和耐受性。

方法

这是一项单中心、回顾性研究,纳入年龄≥4 岁、接受 PER 单药治疗的 FOS 患者。结局包括治疗 3、6 和 12 个月的保留率、无癫痫发作率和应答率以及整个随访期间的不良事件(AE)。还比较了年龄<14 岁和≥14 岁患者 PER 单药治疗的疗效和 AE。

结果

纳入 67 例接受 PER 单药治疗并完成 1 年随访的 FOS 患者。中位维持剂量为 4mg。意向治疗分析显示,PER 单药治疗的保留率在随访 3、6 和 12 个月时分别为 75%、70%和 63%。同期,PER 单药的无癫痫发作率分别为 69%、63%和 52%,应答率分别为 69%、66%和 61%。睡眠相关癫痫发作的患者在 12 个月随访时无癫痫发作率更高。年龄<14 岁和≥14 岁患者的无癫痫发作率和应答率无显著差异。21 例(31.3%)出现 AE,5 例因不耐受 AE 停用 PER。常见 AE 为头晕、易怒和嗜睡。年龄<14 岁患者的 AE 发生率为 17.9%,显著低于年龄≥14 岁患者。

结论

本研究结果揭示了中国东部 FOS 患者使用 PER 单药治疗的真实世界数据。患者在低剂量 PER 治疗时具有良好的保留率、无癫痫发作率和应答率,且 AE 发生率相对较低。

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