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Vancomycin population pharmacokinetics analysis in Chinese paediatric patients with varying degrees of renal function
Jihui Chen1, Xiaohui Huang1, Liting Yu2
1Department of Clinical Pharmacy, Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Insights
This study established vancomycin pharmacokinetic parameters in Chinese children, developing dosing guidelines based on age, kidney function, and surgery status to improve treatment effectiveness and reduce side effects.
Area of Science:
- Pharmacokinetics and Pharmacodynamics
- Paediatric Pharmacology
- Infectious Diseases
Background:
- Vancomycin is crucial for treating serious bacterial infections in children.
- Optimizing vancomycin dosing is essential to maximize efficacy and minimize toxicity, particularly nephrotoxicity.
- Limited pharmacokinetic data exists for Chinese paediatric populations with diverse renal function.
Purpose of the Study:
- To characterize vancomycin pharmacokinetics in a large Chinese paediatric cohort.
- To develop practical, evidence-based dosing guidelines for paediatric vancomycin therapy.
- To identify factors influencing vancomycin exposure in children.
Main Methods:
- Retrospective population pharmacokinetic analysis of 673 paediatric patients.
- Utilized a one-compartment non-linear mixed-effect model.
- Employed Monte Carlo simulations to determine optimal dosing regimens targeting AUC24/MIC.
Main Results:
- Physiological maturation, renal function (eGFR), albumin, and cardiothoracic surgery (CTS) significantly impacted vancomycin pharmacokinetics.
- Established typical vancomycin clearance (7.75 L/h) and volume of distribution (36.2 L) in this cohort.
- Proposed a dosing guideline incorporating age, eGFR, and CTS status; a 20 mg/kg loading dose aids achievement of target AUC in patients with eGFR <60 mL/min/1.73 m².
Conclusions:
- Developed specific vancomycin pharmacokinetic parameters for Chinese paediatric patients.
- Introduced a novel dosing guideline integrating eGFR, age, and CTS status.
- The proposed guideline aims to enhance clinical outcomes and mitigate nephrotoxicity risks associated with vancomycin treatment in children.
Objectives:
To describe the pharmacokinetics of vancomycin in a large Chinese paediatric cohort with varying degrees of renal function and ages and to develop practical dosing guidelines.
Patients And Methods:
We conducted a retrospective population pharmacokinetic study using data from paediatric patients who received vancomycin between June 2013 and June 2022. A non-linear mixed-effect modelling approach with a one-compartment model structure was applied. Monte Carlo simulations were used to stimulate an optimal dosage regimen to achieve the target of AUC24/MIC between 400 and 650.
Results:
We analysed a total of 673 paediatric patients and 1547 vancomycin serum concentrations. Covariate analysis revealed that physiological maturation, renal function, albumin and cardiothoracic surgery (CTS) significantly affected vancomycin pharmacokinetics. The typical clearance and volume of distribution, standardized to 70 kg, were 7.75 L/h (2.3% relative standard error, RSE) and 36.2 L (1.7% RSE), respectively. Based on the model, we proposed an optimal dosing regimen that considers the patient's age and estimate glomerular filtration rate (eGFR) to achieve a target AUC24/MIC for CTS and non-CTS patients. We also found that a loading dose of 20 mg/kg can help patients with an eGFR of <60 mL/min/1.73 m2 achieve the target AUC on the first day of treatment.
Conclusions:
We established vancomycin pharmacokinetic parameters in Chinese paediatric patients and proposed a dosing guideline integrating eGFR, age and CTS status, potentially improving clinical outcomes and reducing nephrotoxicity risk.
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