摘要
目的分析左乙拉西坦在成人癫痫患者中血药浓度监测结果及影响因素,为临床左乙拉西坦个体化给药提供依据。方法选取2020年10月至2024年8月南昌市第一医院接受左乙拉西坦片剂治疗并进行治疗药物监测(TDM)的癫痫患者作为研究对象,测定患者血中左乙拉西坦稳态谷浓度,采用单因素分析及多重线性回归方法分析日剂量、体质量、年龄、性别、肾功能、联合用药等因素对左乙拉西坦血药浓度的影响。结果共纳入128例次左乙拉西坦血药浓度监测结果,样本来源于89例患者,左乙拉西坦血药浓度范围为0.94~62.97 mg/L,监测达标率为41.41%。89例患者左乙拉西坦剂量校正后浓度(CDR)变异系数计算为73.35%,提示药动学个体间变异显著。单因素分析显示,年龄、肌酐、肌酐清除率(Ccr)、尿素显著影响左乙拉西坦CDR;进一步多重线性回归分析表明,Ccr、联合应用丙戊酸钠是引起CDR个体间变异的独立影响因素。结论左乙拉西坦血药浓度与剂量呈正相关,但个体间药动学变异显著。对于肾功能不全或联用丙戊酸钠的癫痫患者,临床可通过TDM优化左乙拉西坦剂量,以减少个体药动学变异的影响。
Objective To analyze the serum concentration monitoring results of levetiracetam and its influencing factors in adult patients with epilepsy,thus to provide evidence for individual administration of levetiracetam.Methods Epileptic patients who received levetiracetam treatment and therapeutic drug monitoring(TDM)of levetiracetam in our hospital from October 2020 to August 2024 were selected as study subjects.The steady-state trough concentration of serum levetiracetam was measured.Univariate analysis and multiple linear regression were used to analyze the effects of daily dose,body weight,age,gender,renal function,combined medication,and other factors on levetiracetam concentration.Results A total of 128 levetiracetam blood concentration samples from 89 patients were included in this study.Levetiracetam concentration ranged from 0.94 to 62.97 mg/L,and the target attainment rate was 41.41%.The coefficient of variation of levetiracetam concentration/dose(CDR)in the 89 patients was calculated to be 73.35%,suggesting significant inter-individual pharmacokinetic variability.Univariate analysis showed that age,creatinine,creatinine clearance(Ccr)and urea significantly affected levetiracetam CDR.Further multiple linear regression analysis showed that Ccr and combined use of sodium valproate were independent factors causing inter-individual variation of CDR.Conclusion Levetiracetam concentration is positively correlated with the dosage,but there is significant pharmacokinetic variation among individuals.For patients with epilepsy who have renal insufficiency or receiving valproate,optimization of the levetiracetam dosage can be achieved through TDM to reduce the impact of pharmacokinetic variation among individuals.
作者
刘燕
肖勇
刘匡一
谢毕阳
虞佳
LIU Yan;XIAO Yong;LIU Kuangyi;XIE Biyang;YU Jia(Department of Pharmacy,Nanchang First Hospital,Nanchang 330008,China;Department of Head and Neck Surgery,the Second Affiliated Hospital of Nanchang University,Nanchang 330006,China;School of Pharmacy,Nanchang University,Nanchang 330046,China)
出处
《临床药物治疗杂志》
2025年第9期53-57,89,共6页
Clinical Medication Journal
基金
江西省药品监督管理局科研项目(2021KY17)
江西省卫生健康委科技计划(202211615)。
关键词
左乙拉西坦
血药浓度监测
影响因素
levetiracetam
therapeutic drug monitoring
influencing factor
