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左乙拉西坦在脑卒中后癫痫患者中的群体药动学研究
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| 篇名： | 左乙拉西坦在脑卒中后癫痫患者中的群体药动学研究 |
| TITLE： | Study on population pharmacokinetics of levetiracetam in post-stroke epilepsy patients |
| 摘要： | 目的 建立中国脑卒中后癫痫（PSE）患者的左乙拉西坦（Lev）群体药动学模型，为Lev在PSE患者中个体化治疗方案的制订提供参考。方法回顾性收集符合纳入标准的PSE患者的血药浓度与临床诊疗信息，根据随机数法按8∶2比例划分为模型组与验证组。基于模型组数据，采用非线性混合效应法构建群体药动学模型，通过拟合优度检验和自举法开展内部评价，并用验证组数据进行外部验证。结果共收集到70例PSE患者的75个血药浓度数据，其中55例患者的60个血药浓度数据用于建立模型，15例患者的15个血药浓度数据用于外部验证。最终模型清除率的群体典型值为2.98L/h；估算肾小球滤过率、每日给药剂量、同型半胱氨酸水平对Lev的清除率均有显著影响（P＜0.01）；拟合优度检验、自举法及外部验证结果均提示所建模型预测性能良好。结论每日给药剂量、肾小球滤过率和同型半胱氨酸水平为影响中国PSE患者Lev清除率变化的重要协变量。临床决策时应综合考虑患者的治疗反应、生理病理情况及不良反应发生情况等，以群体药动学模型结果为依据调整给药剂量。 |
| ABSTRACT： | OBJECTIVE To establish population pharmacokinetic model of levetiracetam （Lev） for Chinese patients with post- stroke epilepsy （PSE）， and provide reference for formulating individualized dosing regimens for Lev therapy in this specific population. METHODS Blood concentration data and clinical diagnosis and treatment information of PSE patients meeting the inclusion criteria were retrospectively collected and divided into model group and validation group at an 8∶2 ratio using a random number method. Based on the model group data， a population pharmacokinetic model was developed using nonlinear mixed-effects modeling. Internal evaluation was performed through goodness-of-fit tests and bootstrap analysis， while external validation was conducted using the validation group data. RESULTS A total of 75 blood concentration measurements from 70 PSE patients were collected， with 60 measurements from 55 patients used for model development and 15 measurements from 15 patients reserved for external validation. The final model estimated a population typical value of clearance at 2.98 L/h. Estimated glomerular filtration rate， daily dose， and homocysteine level significantly influenced clearance of Lev （P＜0.01）. The model demonstrated satisfactory predictive performance， as evidenced by goodness-of-fit tests， bootstrap analysis， and external validation results. CONCLUSIONS Daily dose， estimated glomerular filtration rate， and homocysteine level are identified as significant covariates influencing Lev clearance in Chinese PSE patients. When making clinical decisions， comprehensive consideration should be given to the patient’s treatment response， physiological and pathological conditions， and the occurrence of adverse reactions， etc. The dosage of Lev should be adjusted based on the results of population pharmacokinetic model. |
| 期刊： | 2025年第36卷第05期 |
| 作者： | 刘晨茜；吴茵；贾彩云；崔赛；吴惠珍；王素星 |
| AUTHORS： | LIU Chenxi，WU Yin，JIA Caiyun，CUI Sai，WU Huizhen，WANG Suxing |
| 关键字： | 左乙拉西坦；脑卒中后癫痫；群体药动学；个体化用药；清除率 |
| KEYWORDS： | levetiracetam； post-stroke epilepsy； population |
| 阅读数： | 4 次 |
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