首页|期刊导航|中国实用儿科杂志|拉考沙胺治疗儿童癫痫发作的精准用药专家共识(2026)

拉考沙胺治疗儿童癫痫发作的精准用药专家共识(2026)OA

Expert consensus on precision medication of lacosamide in the treatment of children with epilepsy

中文摘要英文摘要

癫痫是儿童时期最常见的慢性神经系统疾病之一.拉考沙胺(lacosamide,LCM)作为第3代新型抗癫痫发作药物,因其独特的作用机制和良好的安全性,为儿童癫痫治疗提供了新选择.然而,儿童处于快速生长发育期,其药物动力学(pharmacokinetics,PK)个体差异显著,亟需规范化指导.该共识由中国药理学会治疗药物监测研究专业委员会儿童治疗药物监测研究学组发起,南京医科大学附属儿童医院牵头,严格遵循《中国制订/修订临床诊疗指南的指导原则(2022版)》,并在国际实践指南注册与透明化平台完成注册(PREPARE-2026CN141).共识制订组系统检索2005-2026年中英文主流数据库证据,使用2009版牛津大学循证医学中心制订的证据分级和推荐强度标准,并采用改良德尔菲法进行专家调研与匿名投票,围绕LCM在儿童癫痫群体中的临床应用、PK特征、药物基因组学、治疗药物监测及模型引导的精准用药等核心问题,最终达成21条推荐意见.该共识首次提出中国儿童LCM治疗药物监测的初步目标浓度范围(2~10 μg/mL)及模型引导精准用药方案,旨在为临床医生与药师提供科学、规范的个体化用药指导,提升LCM治疗儿童癫痫的安全性和精准性.

Epilepsy is one of the most prevalent chronic neurological disorders in the pediatric population.As a third-generation antiseizure medication with a unique pharmacological mechanism and good safety,lacosamide(LCM)has provided a new option for pediatric epilepsy management.However,the pharmacokinetics(PK)profile of LCM in children exhibits substantial inter-individual variability because of the fact that children are at the stage of rapid growth and development,highlighting an urgent need for standardized clinical guidance.Initiated by the Division of Therapeutic Drug Monitoring,Chinese Pharmacological Society,and led by the Children's Hospital of Nanjing Medical University,this consensus has strictly followed the 2022 Edition of the Guideline for the Development and Revision of Clinical Practice Guidelines in China,and registered in the PREPARE registry(PREPARE-2026CN141).The consensus development group systematically retrieved relevant clinical evidence published from 2005 to 2026 across major Chinese and English academic databases.Based on the evidence grading and recomendation strength criteria made by Oxford Centre for Evidence-Based Medicine(2009),and after Delphi expert consultations and anonymous voting,a total of 21 recommendations were finally formulated,covering the clinical application,PK characteristics,pharmacogenomics,therapeutic drug monitoring(TDM),and model-informed precision dosing(MIPD)of LCM in children with epilepsy.This consensus establishes a preliminary TDM target concentration range of 2-10 μ g/mL for LCM in Chinese pediatric patients,and proposes a standardized MIPD workflow.The aim is to provide clinicians and pharmacists with scientific and standardized guidance for individualized medication and improve the safety and efficacy of LCM treatment for pediatric epilepsy.

中华医学会儿科学分会临床药理学组;江苏省药理学会治疗药物监测研究专业委员会;《中国实用儿科杂志》编辑委员会;陈峰;王晓玲;卢孝鹏

医药卫生

癫痫儿童拉考沙胺精准用药专家共识

epilepsychildrenlacosamideprecision medicationexpert consensus

《中国实用儿科杂志》 2026 (7)

538-553,16

国家重点研发计划(2023YFC2706100)中华医学会临床药学专项科研基金(Z-2021-46-2503Z-2021-46-2101)

10.19538/j.ek2026070602

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