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WRAPPER 研究:在香港,添加用普瑞巴林治疗耐药性癫痫患者的真实世界疗效和耐受性。

WRAPPER study: Real-world effectiveness and tolerability of adjunctive perampanel for people with drug-resistant epilepsy in Hong Kong.

机构信息

Division of Neurology, Department of Medicine and Therapeutics, Prince of Wales Hospital, Hong Kong, Special Administrative Regions, China.

出版信息

Epilepsia Open. 2024 Feb;9(1):345-354. doi: 10.1002/epi4.12882. Epub 2023 Dec 26.

DOI:10.1002/epi4.12882
PMID:38101856
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10839329/
Abstract

OBJECTIVE

The Prince of Wales Hospital (PWH) Real-world Analysis of People with Drug-Resistant Epilepsy (DRE) on PERampanel (WRAPPER) study assessed effectiveness and tolerability of adjunctive perampanel in people with DRE attending PWH.

METHODS

This was a prospective single-center real-world observational study involving 70 people with DRE between July 2016 and June 2021. A post hoc analysis after the initial study period of 16 weeks assessed outcomes for an extended period up to 52 weeks.

RESULTS

After 16 weeks, median dose of perampanel was 2 mg (IQR 24 mg). 50% responder rates were 40.0%, 41.5%, and 48.7% at 16, 26, and 52 weeks. Seizure freedom was 12.9%, 20.7%, and 25.6% at 16, 26, and 52 weeks. Monthly seizure frequency reduced from 3.0 (IQR 3.0-6.6) at baseline to 2.0 (IQR 2.0-6.0, p = 0.005) at 16 weeks; 2.0 (IQR 2.0-5.0, p = 0.01) at 26 weeks; and 2.0 (IQR 0.0-4.0, p = 0.018) at 52 weeks. Older age predicted 50% responders (OR 1.08, 95% CI 1.01-1.14, p = 0.048). At 16 weeks, 51.4% (36/70) had treatment-emergent adverse effects (TEAEs). Most common was seizure exacerbation at 35.7% (25/70) followed by fatigue at 15.7% (11/70). NPI-12 and ZBI scores indicated no increase in neuropsychiatric symptoms on perampanel.

SIGNIFICANCE

Low-dose 2-4 mg adjunctive perampanel for people with DRE conferred appreciable improvements in seizure reduction without significant neuropsychiatric adverse effects in the real-world setting at a tertiary center in Hong Kong and had better antiseizure effect with advancing age.

PLAIN LANGUAGE SUMMARY

This real-world study from Hong Kong found low-dose perampanel was effective and tolerable for people with drug-resistant epilepsy. Furthermore, perampanel was also potentially more effective with advancing age.

摘要

目的

威尔斯亲王医院耐药性癫痫患者(DRE)曲拉西泮真实世界分析(WRAPPER)研究评估了 DRE 患者在威尔斯亲王医院使用添加性拉西泮的有效性和耐受性。

方法

这是一项前瞻性单中心真实世界观察性研究,涉及 2016 年 7 月至 2021 年 6 月期间的 70 名 DRE 患者。在最初的 16 周研究期后进行的事后分析评估了长达 52 周的扩展期的结果。

结果

在 16 周后,拉西泮的中位剂量为 2 毫克(24 毫克的 IQR)。在 16、26 和 52 周时,50%的应答率分别为 40.0%、41.5%和 48.7%。癫痫无发作率分别为 12.9%、20.7%和 25.6%,在 16、26 和 52 周时。每月癫痫发作频率从基线时的 3.0(IQR 3.0-6.6)降至 16 周时的 2.0(IQR 2.0-6.0,p=0.005);在 26 周时为 2.0(IQR 2.0-5.0,p=0.01);在 52 周时为 2.0(IQR 0.0-4.0,p=0.018)。年龄较大预测 50%的应答者(OR 1.08,95%CI 1.01-1.14,p=0.048)。在 16 周时,51.4%(36/70)出现治疗相关不良事件(TEAEs)。最常见的是癫痫发作恶化,占 35.7%(25/70),其次是疲劳,占 15.7%(11/70)。NPI-12 和 ZBI 评分表明拉西泮没有增加神经精神症状。

意义

在香港的一个三级中心的真实世界环境中,低剂量 2-4 毫克的辅助性拉西泮可显著减少癫痫发作,且没有明显的神经精神不良反应,在年龄较大的患者中,抗癫痫作用更好。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6e56/10839329/4757bc7fd67c/EPI4-9-345-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6e56/10839329/487025b7a108/EPI4-9-345-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6e56/10839329/4757bc7fd67c/EPI4-9-345-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6e56/10839329/487025b7a108/EPI4-9-345-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6e56/10839329/4757bc7fd67c/EPI4-9-345-g001.jpg

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Effectiveness and safety of perampanel as adjunctive therapy among Chinese patients with focal-onset epilepsy: A real-world prospective observational study.普瑞巴林辅助治疗中国局灶性癫痫患者的有效性和安全性:一项真实世界前瞻性观察研究。
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