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1.河北医科大学药学院,石家庄 050017
2.河北省人民医院药学部/河北省临床药学重点实验室,石家庄 050051
3.河北省人民医院神经康复科,石家庄 050051
硕士研究生。研究方向:临床药学。E-mail:2471767053@qq.com
主任药师,硕士生导师,博士。研究方向:临床药学。E-mail:wuyin82@163.com
收稿:2026-01-20,
修回:2026-05-12,
录用:2026-05-12,
纸质出版:2026-05-30
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崔赛,孟楠,吴惠珍,等.拉考沙胺群体药动学研究的系统分析 Δ[J].中国药房,2026,37(10):1302-1306. DOI: 10.6039/j.issn.1001-0408.2026.10.11.
CUI Sai,MENG Nan,WU Huizhen,et al.Systematic analysis of population pharmacokinetics of lacosamide[J].ZHONGGUO YAOFANG,2026,37(10):1302-1306.
崔赛,孟楠,吴惠珍,等.拉考沙胺群体药动学研究的系统分析 Δ[J].中国药房,2026,37(10):1302-1306. DOI: 10.6039/j.issn.1001-0408.2026.10.11. DOI:
CUI Sai,MENG Nan,WU Huizhen,et al.Systematic analysis of population pharmacokinetics of lacosamide[J].ZHONGGUO YAOFANG,2026,37(10):1302-1306. DOI: 10.6039/j.issn.1001-0408.2026.10.11.
目的
2
系统分析拉考沙胺的群体药动学(PPK)研究,并阐述其在不同人群中的药动学影响因素。
方法
2
检索Web of Science、PubMed、Embase、迈特思创、中国知网、万方数据和维普网等中英文数据库,收集拉考沙胺PPK相关研究,提取相关资料,并使用预测模型偏倚风险评估工具对纳入研究进行PPK模型质量评价。
结果
2
最终纳入的8项研究中,6项为回顾性研究,2项为前瞻性研究;5项纳入了儿童患者;7项采用一室模型,1项采用两室模型;4项的模型质量为A级,各有2项的模型质量分别为B、C级。体重、肾功能及肝药酶诱导剂是影响拉考沙胺PPK的显著协变量。
结论
2
现有拉考沙胺PPK研究以儿童人群为主,药动学变异主要受体重、肾功能及肝药酶诱导剂影响。但当前PPK研究普遍缺乏外部验证,模型的普适性有待确证。
OBJECTIVE
2
To systematically analyze the population pharmacokinetics (PPK) studies of lacosamide and expound the influential factors of its pharmacokinetics in different populations.
METHODS
2
PPK studies of lacosamide were collected by searching the databases, such as Web of Science, PubMed, Embase, Metasearch, CNKI, Wanfang Data and VIP, both in Chinese and English. Relevant data were extracted, and the Prediction Model Risk of Bias Assessment Tool was used to evaluate the quality of the PPK models in the included studies.
RESULTS
2
Among 8 studies ultimately included, 6 were retrospective studies and 2 were prospective studies; 5 studies involved pediatric patients. Seven studies adopted a one-compartment model, while 1 study utilized a two-compartment model. Four studies had a model quality rating of grade A, two of grade B and two of grade C, respectively. Body weight, renal function, and hepatic enzyme inducers were significant covariates influencing PPK of lacosamide.
CONCLUSIONS
2
The existing PPK studies of lacosamide are predominantly conducted in pediatric populations. Pharmacokinetic variability is mainly influenced by body weight, renal function, and hepatic enzyme inducers. However, most PPK studies have not conducted external validation, and the generalizability of the models remains to be confirmed.
CHEN Y S , LAI M C , CHEN T S , et al . Effectiveness and safety of lacosamide,a third-generation anti-seizure medication,for poststroke seizure and epilepsy:a literature review [J ] . Curr Neuropharmacol , 2023 , 21 ( 10 ): 2126 - 2133 .
BABAR R K , BRESNAHAN R , GILLESPIE C S , et al . Lacosamide add-on therapy for focal epilepsy [J ] . Cochrane Database Syst Rev , 2021 , 5 ( 5 ): CD008841 .
MAO F Q , CHEN S N , HU Y N , et al . Therapeutic drug monitoring for lacosamide in Chinese pediatric patients with epilepsy:focus on clinical effectiveness,tolerability and drug interactions [J ] . Int J Med Sci , 2025 , 22 ( 5 ): 1150 - 1157 .
HIEMKE C , BERGEMANN N , CLEMENT H W , et al . Consensus guidelines for therapeutic drug monitoring in neuropsychopharmacology:update 2017 [J ] . Pharmacopsychiatry , 2018 , 51 ( 1/2 ): e1 .
WOODS M , PHELPS S J , CHRISTENSEN M L , et al . Impact of age and concurrent antiseizure medication use on lacosamide dose to concentration ratio and dosing in pediatric patients [J ] . J Pediatr Pharmacol Ther , 2024 , 29 ( 5 ): 514 - 524 .
European Medicines Agency . Vimpat(lacosamide):summary of product characteristics [EB/OL ] .( 2025-05-08 )[ 2026-05-11 ] . https://www.ema.europa.eu/en/medicines/human/EPAR/vimpat https://www.ema.europa.eu/en/medicines/human/EPAR/vimpat .
ETTE E I , WILLIAMS P J . Population pharmacokinetics Ⅰ:background,concepts,and models [J ] . Ann Pharmacother , 2004 , 38 ( 10 ): 1702 - 1706 .
李莹 , 王鸣璐 , 王成彬 , 等 . 左乙拉西坦群体药动学系统分析 [J ] . 中国药学杂志 , 2023 , 58 ( 7 ): 632 - 637 .
MOONS K G M , WOLFF R F , RILEY R D , et al . PROBAST:a tool to assess risk of bias and applicability of prediction model studies:explanation and elaboration [J ] . Ann Intern Med , 2019 , 170 ( 1 ): W1 - W33 .
李芷凡 , 刘明 , 赵文硕 , 等 . PROBAST+AI:基于人工智能或回归方法的预测模型研究质量、偏倚风险及适用性评估工具解读 [J ] . 中国循证医学杂志 , 2025 , 25 ( 9 ): 1107 - 1116 .
WINKLER J , SCHOEMAKER R , STOCKIS A . Population pharmacokinetics of adjunctive lacosamide in pedia-tric patients with epilepsy [J ] . J Clin Pharmacol , 2019 , 59 ( 4 ): 541 - 547 .
WINKLER J , SCHOEMAKER R , STOCKIS A . Model-ing and simulation for the evaluation of dose adaptation rules of intravenous lacosamide in children [J ] . Epilepsy Res , 2019 , 149 : 13 - 16 .
WANG J , MEI Y , LIANG S , et al . How to handle a missed or delayed dose of lacosamide in pediatric patients with epilepsy? A mode-informed individual dosing [J ] . Epilepsy Behav , 2024 , 151 : 109601 .
LUKKA P B , WOODS M , CHHIM R , et al . Use of real-world data and pharmacometric modeling in support of lacosamide dosing in pediatric patients under 4 years of age [J ] . J Clin Pharmacol , 2021 , 61 ( 7 ): 881 - 888 .
KIM S E , GU N , KIM B H , et al . Pharmacokinetics of lacosamide in healthy Korean male volunteers [J ] . Pharmacology , 2012 , 89 ( 3/4 ): 172 - 178 .
SCHAEFER C , CAWELLO W , WAITZINGER J , et al . Effect of age and sex on lacosamide pharmacokinetics in healthy adult subjects and adults with focal epilepsy [J ] . Clin Drug Investig , 2015 , 35 ( 4 ): 255 - 265 .
WU R Y , LIU S S , ZHAO Z G , et al . Population pharmacokinetic model of lacosamide in Chinese children and adults with epilepsy [J/OL ] . Ther Drug Monit , 2025 [ 2026-01-01 ] . https://pubmed.ncbi.nlm.nih.gov/40960184/.DOI:10.1097/FTD. 0000000000001385 https://pubmed.ncbi.nlm.nih.gov/40960184/.DOI:10.1097/FTD.0000000000001385 .
YU L Y , MAO F Q , CHEN S N , et al . Development and validation of a population pharmacokinetic model for lacosamide in adult patients with epilepsy to inform precision dosing [J ] . BMC Pharmacol Toxicol , 2026 , 27 ( 1 ): 61 .
CHHUN S , JULLIEN V , REY E , et al . Population pharmacokinetics of levetiracetam and dosing recommendation in children with epilepsy [J ] . Epilepsia , 2009 , 50 ( 5 ): 1150 - 1157 .
李红健 , 孙岩 , 赵婷 , 等 . 新疆癫痫患儿拉考沙胺血药浓度的影响因素探讨 [J ] . 中国医院药学杂志 , 2021 , 41 ( 13 ): 1323 - 1326,1346 .
赵婷 , 孙岩 , 张惠兰 , 等 . 拉考沙胺在癫痫患儿中的临床疗效和血药浓度研究 [J ] . 中国药学杂志 , 2022 , 57 ( 5 ): 403 - 407 .
ROBERTI R , PALLERIA C , NESCI V , et al . Pharmacokinetic considerations about antiseizure medications in the elderly [J ] . Expert Opin Drug Metab Toxicol , 2020 , 16 ( 10 ): 983 - 995 .
FUKUSHIMA Y , YAMAMOTO Y , YAMAZAKI E , et al . Change in the pharmacokinetics of lacosamide before, during,and after pregnancy [J ] . Seizure , 2021 , 88 : 12 - 14 .
习志洁 , 孙红斌 . 女性癫痫患者围妊娠期癫痫管理的研究进展 [J ] . 四川医学 , 2017 , 38 ( 1 ): 109 - 113 .
李玥 , 郭宏丽 , 赵越桃 , 等 . 拉考沙胺在儿童癫痫中的治疗药物监测研究进展 [J ] . 中国药学杂志 , 2023 , 58 ( 19 ): 1731 - 1735 .
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