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评论:海湾地区癫痫管理中品牌名和通用名抗癫痫药物合理使用的共识指南

Commentary: Consensus Guidelines on the Appropriate Use of Brand-Name and Generic Anti-Seizure Medication for the Management of Epilepsy in the Gulf Region.

作者信息

Alsaadi Taoufik, Almadani Abubaker, Al-Hashel Jasem, Al Salti Abdullah, Melikyan Gayane, Khan Riaz Ahmed

机构信息

Neurology Department, American Center for Psychiatry and Neurology, Abu Dhabi, UAE.

Neurology Department, Rashid Hospital, Dubai, UAE.

出版信息

Neurol Ther. 2023 Aug;12(4):1015-1031. doi: 10.1007/s40120-023-00491-8. Epub 2023 May 24.

Abstract

INTRODUCTION

The clinical, social, and economic burden of epilepsy is undeniable. Local guidance on epilepsy management is limited and needed to address the both use of anti-seizure medication (ASM) and switching practices which influence clinical outcomes.

AREAS COVERED

An expert panel composed of practicing neurologists and epileptologists from countries of the Gulf Cooperation Council (GCC) met in 2022 to discuss local challenges in the management of epilepsy and formulate recommendations for clinical practice. Published literature on the outcomes of ASM switching was reviewed along with clinical practice/gaps, international guidelines, and local treatment availabilities.

EXPERT OPINION

Improper ASM use and inappropriate brand-name-to-generic or generic-to-generic switching can contribute to worsening clinical outcomes in epilepsy. ASMs should be used for the management of epilepsy based on patient clinical profile, underlying epilepsy syndrome, and drug availability to ensure optimal and sustainable treatment. Both first-generation and newer ASMs can be considered; appropriate use is recommended from the beginning of treatment. It is critical to avoid inappropriate ASM switching to avoid breakthrough seizures. All generic ASMs should fulfill strict regulatory requirements. If needed, ASM changes should always be approved by the treating physician. ASM switching (brand-name-to-generic, generic-to-generic, generic-to-brand-name) should be avoided in epilepsy patients who have achieved control but can be considered for those uncontrolled on current medication.

摘要

引言

癫痫的临床、社会和经济负担是不可否认的。关于癫痫管理的本地指南有限,需要制定相关指南来解决抗癫痫药物(ASM)的使用以及影响临床结果的换药做法。

涵盖领域

由海湾合作委员会(GCC)国家的执业神经科医生和癫痫专家组成的专家小组于2022年召开会议,讨论癫痫管理中的本地挑战,并制定临床实践建议。对已发表的关于ASM换药结果的文献以及临床实践/差距、国际指南和本地治疗可用性进行了综述。

专家意见

ASM使用不当以及不恰当的品牌药换用仿制药或仿制药之间的换药可能会导致癫痫临床结果恶化。应根据患者的临床情况、潜在癫痫综合征和药物可用性使用ASM来管理癫痫,以确保最佳和可持续的治疗。第一代和新型ASM均可考虑;建议从治疗开始就合理使用。避免不恰当的ASM换药以防止癫痫发作突破至关重要。所有仿制药ASM都应符合严格的监管要求。如有必要,ASM的更换应始终得到主治医生的批准。对于已实现病情控制的癫痫患者,应避免ASM换药(品牌药换用仿制药、仿制药之间换药、仿制药换用品牌药),但对于目前药物治疗未能控制病情的患者可考虑换药。

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