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已发表论文
肾功能和血红蛋白可独立预测癫痫患者中左乙拉西坦的暴露量：一项多因素回归研究
Authors Jiang X , Xiong F, Lin Z, Huang X
Received 14 July 2025
Accepted for publication 12 October 2025
Published 17 October 2025 Volume 2025:19 Pages 9415—9423
DOI https://doi.org/10.2147/DDDT.S553644
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Solomon Tadesse Zeleke
Xuehui Jiang,1,* Fangfang Xiong,2,* Zhihang Lin,1 Xiaowei Huang1
1Department of Pharmacy, Quanzhou First Hospital Affiliated to Fujian Medical University, Quanzhou, 362000, People’s Republic of China; 2Department of Pharmacy, The Second Affiliated Hospital of Fujian Medical University, Quanzhou, 362000, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Zhihang Lin, Department of Pharmacy, Quanzhou First Hospital Affiliated to Fujian Medical University, No. 1028 Anji South Road, Fengze District, Quanzhou, 362000, People’s Republic of China, Tel +86 13506000324, Email fjqzpha@163.com Xiaowei Huang, Department of Pharmacy, Quanzhou First Hospital Affiliated to Fujian Medical University, No. 1028 Anji South Road, Fengze District, Quanzhou, 362000, People’s Republic of China, Tel +86 13400538528, Email qzpharmacy@163.com
Purpose: To investigate the key factors influencing the plasma concentration of levetiracetam (LEV) in patients with epilepsy and to establish a predictive model for LEV steady-state trough concentration.
Patients and Methods: Clinical data from 130 epilepsy patients (175 steady-state trough concentration blood samples) were retrospectively collected at a single center. Univariate analysis and multiple linear regression modeling were employed to systematically quantify the independent effects of demographic characteristics, biochemical indicators, and concomitant medications on the LEV C/D. The robustness of the model was validated using the Bootstrap method (1000 resamples).
Results: Creatinine clearance rate (Ccr) emerged as the strongest independent predictor (unstandardized β = − 0.168, p < 0.001), with every 1 mL/min increase in Ccr resulting in a 0.168 ng·mL− 1/(g·d− 1) decrease in C/D. Hemoglobin (HGB) exhibited a secondary negative association (unstandardized β = − 0.070, p < 0.05), where every 1 g/L decrease led to a 0.070 ng·mL− 1/(g·d− 1) increase in C/D. Bootstrap validation confirmed the stability of these coefficients (95% CI: Ccr [− 0.221, − 0.123], HGB [− 0.140, − 0.008]). The final predictive equation was: C/Dpred [ng·mL− 1/(g·d− 1)] = 37.759 − 0.168 × Ccr (mL/min) − 0.070 × HGB (g/L) (adjusted R² = 0.440, p < 0.001).
Conclusion: Routine clinical indicators Ccr and HGB are core influencing factors of LEV exposure. This model quantifies their independent effects on LEV steady-state trough concentration, providing novel insights into the interindividual variability of LEV pharmacokinetics and offering a potential tool for aiding individualized dosing strategies, especially in resource-limited settings where therapeutic drug monitoring is not readily available. However, its generalizability still needs to be demonstrated through subsequent external validation and prospective multicenter studies.
Keywords: levetiracetam, creatinine clearance, hemoglobin, multifactorial regression, epilepsy
1Department of Pharmacy, Quanzhou First Hospital Affiliated to Fujian Medical University, Quanzhou, 362000, People’s Republic of China; 2Department of Pharmacy, The Second Affiliated Hospital of Fujian Medical University, Quanzhou, 362000, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Zhihang Lin, Department of Pharmacy, Quanzhou First Hospital Affiliated to Fujian Medical University, No. 1028 Anji South Road, Fengze District, Quanzhou, 362000, People’s Republic of China, Tel +86 13506000324, Email fjqzpha@163.com Xiaowei Huang, Department of Pharmacy, Quanzhou First Hospital Affiliated to Fujian Medical University, No. 1028 Anji South Road, Fengze District, Quanzhou, 362000, People’s Republic of China, Tel +86 13400538528, Email qzpharmacy@163.com
Purpose: To investigate the key factors influencing the plasma concentration of levetiracetam (LEV) in patients with epilepsy and to establish a predictive model for LEV steady-state trough concentration.
Patients and Methods: Clinical data from 130 epilepsy patients (175 steady-state trough concentration blood samples) were retrospectively collected at a single center. Univariate analysis and multiple linear regression modeling were employed to systematically quantify the independent effects of demographic characteristics, biochemical indicators, and concomitant medications on the LEV C/D. The robustness of the model was validated using the Bootstrap method (1000 resamples).
Results: Creatinine clearance rate (Ccr) emerged as the strongest independent predictor (unstandardized β = − 0.168, p < 0.001), with every 1 mL/min increase in Ccr resulting in a 0.168 ng·mL− 1/(g·d− 1) decrease in C/D. Hemoglobin (HGB) exhibited a secondary negative association (unstandardized β = − 0.070, p < 0.05), where every 1 g/L decrease led to a 0.070 ng·mL− 1/(g·d− 1) increase in C/D. Bootstrap validation confirmed the stability of these coefficients (95% CI: Ccr [− 0.221, − 0.123], HGB [− 0.140, − 0.008]). The final predictive equation was: C/Dpred [ng·mL− 1/(g·d− 1)] = 37.759 − 0.168 × Ccr (mL/min) − 0.070 × HGB (g/L) (adjusted R² = 0.440, p < 0.001).
Conclusion: Routine clinical indicators Ccr and HGB are core influencing factors of LEV exposure. This model quantifies their independent effects on LEV steady-state trough concentration, providing novel insights into the interindividual variability of LEV pharmacokinetics and offering a potential tool for aiding individualized dosing strategies, especially in resource-limited settings where therapeutic drug monitoring is not readily available. However, its generalizability still needs to be demonstrated through subsequent external validation and prospective multicenter studies.
Keywords: levetiracetam, creatinine clearance, hemoglobin, multifactorial regression, epilepsy