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辅助性布瓦西坦治疗癫痫合并智力残疾患者:来自布瓦西坦附加治疗首个意大利网络研究的证据。

Adjunctive Brivaracetam in People with Epilepsy and Intellectual Disability: Evidence from the BRIVAracetam Add-On First Italian netwoRk Study.

作者信息

Lattanzi Simona, Canafoglia Laura, Canevini Maria Paola, Casciato Sara, Irelli Emanuele Cerulli, Chiesa Valentina, Dainese Filippo, De Maria Giovanni, Didato Giuseppe, Di Gennaro Giancarlo, Falcicchio Giovanni, Fanella Martina, Ferlazzo Edoardo, Gangitano Massimo, La Neve Angela, Mecarelli Oriano, Montalenti Elisa, Morano Alessandra, Piazza Federico, Pizzanelli Chiara, Pulitano Patrizia, Ranzato Federica, Rosati Eleonora, Tassi Laura, Di Bonaventura Carlo

机构信息

Neurological Clinic, Department of Experimental and Clinical Medicine, Marche Polytechnic University, Via Conca 71, 60020, Ancona, Italy.

Department of Epileptology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.

出版信息

Neurol Ther. 2025 Jun;14(3):775-786. doi: 10.1007/s40120-025-00717-x. Epub 2025 Mar 12.

Abstract

INTRODUCTION

Subjects with intellectual disability are usually excluded from clinical trials and there is limited evidence-based guidance for the choice of antiseizure medications in this vulnerable population. The study explored the effectiveness of brivaracetam (BRV) in people with epilepsy and intellectual disability.

METHODS

BRIVAracetam add-on First Italian netwoRk Study (BRIVAFIRST) was a 12-month retrospective, multicenter study including adults prescribed adjunctive BRV. Main outcomes included the rates of seizure-freedom, seizure response (≥ 50% reduction in baseline seizure frequency), and treatment discontinuation. The occurrence of adverse events (AEs) was also considered. Analyses by the presence and severity of intellectual disability were performed.

RESULTS

Subjects with intellectual disability were 253 (24.6%) out of 1029 participants. The 12-month rates of seizure freedom were 18.4% and 10.3% in participants without and with intellectual disability, respectively; the corresponding values for seizure response were 40.0% and 28.9%. Intellectual disability was not an independent predictor of seizure outcomes. The rates of treatment discontinuation were 25.8% and 26.4% in participants without and with intellectual disability. respectively. There were no statistically significant differences in the rates of any AEs, somnolence, nervousness/agitation, and aggressiveness by the presence and degree of intellectual disability.

CONCLUSION

Brivaracetam can be a suitable treatment option and offer opportunities for clinical improvement in subjects with intellectual disability and uncontrolled seizures.

摘要

引言

智障患者通常被排除在临床试验之外,对于这一弱势群体抗癫痫药物的选择,基于证据的指导有限。本研究探讨了布瓦西坦(BRV)对癫痫合并智障患者的有效性。

方法

布瓦西坦附加治疗意大利首个网络研究(BRIVAFIRST)是一项为期12个月的回顾性多中心研究,纳入了接受布瓦西坦辅助治疗的成年人。主要结局包括无癫痫发作率、癫痫发作反应(基线癫痫发作频率降低≥50%)和治疗中断率。还考虑了不良事件(AE)的发生情况。按智障的存在情况和严重程度进行了分析。

结果

1029名参与者中,有智障的受试者为253名(24.6%)。无智障和有智障的参与者12个月无癫痫发作率分别为18.4%和10.3%;癫痫发作反应的相应值分别为40.0%和28.9%。智障不是癫痫发作结局的独立预测因素。无智障和有智障的参与者治疗中断率分别为25.8%和26.4%。在任何不良事件、嗜睡、紧张/激动和攻击性的发生率方面,按智障的存在情况和程度分类均无统计学显著差异。

结论

布瓦西坦可以是一种合适的治疗选择,为智障且癫痫未得到控制的患者提供临床改善机会。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3beb/12089543/08f89cb7a45f/40120_2025_717_Fig1_HTML.jpg

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