新型抗癫痫药物吡仑帕奈在新疆癫痫患儿中的血药浓度测定及影响因素分析  

Determination of Plasma Concentration and Influencing Factors of A New Antiepileptic Drug,Perampanel,in Children with Epilepsy in Xinjiang

作　　者：赵婷[1,2] 张惠兰 冯继荣 于静 于鲁海[1,2] 冯杰[1,2] 王婷婷[1,2] 孙岩 李红健[1,2] ZHAO Ting;ZHANG Huilan;FENG Jirong;YU Jing;YU Luhai;FENG Jie;WANG Tingting;SUN Yan;LI Hongjian(Department of Pharmacy,People's Hospital of Xinjiang Uygur Autonomous Region,Urumqi 830000,China;Institute of Clinical Pharmacy,People's Hospital of Xinjiang Uygur Autonomous Region,Urumqi 830000,China;Department of Pediatrics,Children's Hospital of Xinjiang Uygur Autonomous Region(Xinjiang Hospital of Beijing Pediatric patients's Hospital),Urumqi 830000,China)

机构地区：[1]新疆维吾尔自治区人民医院药学部,乌鲁木齐830000 [2]新疆维吾尔自治区人民医院临床药学研究所,乌鲁木齐830000 [3]新疆维吾尔自治区儿童医院(北京儿童医院新疆医院)神经内科,乌鲁木齐830000

出　　处：《中国药学杂志》2024年第13期1233-1237,共5页Chinese Pharmaceutical Journal

基　　金：中国抗癫痫协会AMPA机制及抗癫痫药物研究科研基金资助(CW-202-016)。

摘　　要：目的吡仑帕奈(perampanel,PER)于2019年在我国批准上市,笔者未见与PER血药浓度监测相关的研究报道。本研究旨在探讨癫痫患儿的年龄、性别、体重指数、癫痫类型、给药剂量和合并用药对PER稳态血药浓度的影响。方法收集2019年—2023年就诊于新疆维吾尔自治区人民医院和新疆维吾尔自治区儿童医院并规律服用PER的4~14岁癫痫患儿的血清样本95例,用超高效液相色谱法进行血药浓度测定,并分析患儿年龄、性别、身体质量指数(BMI)、给药剂量及合并用药等因素对其血药浓度的影响。结果患儿年龄分布为4.25~14岁,平均(7.25±3.99)岁;PER的血药浓度0.13~0.99μg·mL^(-1),平均(0.47±0.36)μg·mL^(-1)。不同年龄组、性别组患儿的PER血药浓度和浓度剂量比(ratio of concentration dose,CDR)结果均无显著性差异(P>0.05)。18.5≤BMI<24.0患儿的CDR结果显著高于BMI<18.5组患儿,差异均具有统计学意义(t=-1.207,P<0.05)。合并用药对PER的给药剂量、血药浓度和CDR结果均无显著影响(P>0.05)。PER血药浓度与给药剂量的相关性较差(r=0.113)。结论患儿临床应用PER治疗癫痫的过程中有必要进行治疗药物监测,使PER血药浓度控制在治疗剂量范围内而提高临床疗效并减少不良反应发生率。OBJECTIVE To investigate the effects of age,gender,body mass index(BMI),type of epilepsy,dosage and combined medication on the steady-state serum concentration of perampanel in children with epilepsy.METHODS A total of 95 serum samples from 4 to 14 years old children with epilepsy who were admitted to our hospital from 2019 to 2023 and took perampanel regularly were collected.The serum concentration was determined by high performance liquid chromatography.The influence of factors such as gender,BMI,dosage and combined medication on the concentration were analyzed.RESULTS The children aged 4.25-14(7.25±3.99)years.The serum concentration of perampanel was 0.13-0.99(0.47±0.36)μg·mL^(-1).There were no significant differences in the serum concentration and ratio of concentration dose(CDR)of perampanel among different age groups and gender groups(P>0.05).The CDRs of patients of 18.5≤BMI<24.0 group were significantly higher than those of BMI<18.5 group(t=-1.207,P<0.05).The combination of drug had no significant effects on the dosage,blood concentration and CDR of perampanel(P>0.05).The correlation between perampanel concentration and dose was poor(r=0.113).CONCLUSION In the course of using perampanel for the treatment of epilepsy in children,it is necessary to conduct therapeutic drug monitoring,so that the concentration can be controlled within the therapeutic range to ensure clinical efficacy and reduce the incidence of adverse reactions.

关 键 词：癫痫 吡仑帕奈 血药浓度 

分 类 号：R969.4[医药卫生—药理学]