Population Pharmacokinetics and AUC‐Based Dose Optimization of Vancomycin in Chinese Neonates.

Objective: The primary objective of this study revolves around the development of a population pharmacokinetic (PPK) model for vancomycin in neonatal subjects, with the objective of providing a theoretical basis for judicious therapeutic interventions. Methods: In this study, a retrospective collect...

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Published in:Journal of Clinical Pharmacy & Therapeutics Vol. 2025; no. 1; pp. 1 - 13
Main Authors: Yang, Caiyan, Wei, Shifeng, Wang, Bo, Yang, Jiayu, Zhao, Zhigang, Xu, Daqing, Mei, Shenghui, Bondareva, Irina B.
Format: equations & formulas research tables/charts Journal Article
Published: Wiley-Blackwell 3/12/2025
Online Access:View this record in EBSCOhost
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        02694727
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      dt: 3/12/2025
      vid: 2025
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      pub: Wiley-Blackwell
      place: Malden, Massachusetts
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        183690904
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        10.1155/jcpt/6935260
        183690904
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        atl: Population Pharmacokinetics and AUC‐Based Dose Optimization of Vancomycin in Chinese Neonates.
      aug:
        au:
          Yang, Caiyan
          Wei, Shifeng
          Wang, Bo
          Yang, Jiayu
          Zhao, Zhigang
          Xu, Daqing
          Mei, Shenghui
          Bondareva, Irina B.
        affil: Department of Pharmacy,, Yinchuan First People's Hospital,, 2 Liqun West Street Xingqing District, Yinchuan, 750001,, Ningxia, China
      sug:
        subj:
          Vancomycin Pharmacokinetics
          Vancomycin Blood
          Vancomycin Administration and Dosage
          Models, Statistical
          Administration, Intravenous
          Chinese Persons In Infancy and Childhood
          Human
          Retrospective Design
          Infant, Newborn
          China
          Male
          Female
          Dose-Response Relationship, Drug
          Intensive Care Units, Neonatal
          Descriptive Statistics
          Infant, Newborn: birth-1 month
          Male
          Female
      ab: Objective: The primary objective of this study revolves around the development of a population pharmacokinetic (PPK) model for vancomycin in neonatal subjects, with the objective of providing a theoretical basis for judicious therapeutic interventions. Methods: In this study, a retrospective collection encompassed 75 neonatal patients, contributing to a total of 89 vancomycin blood concentration monitoring datasets. The establishment of the PPK model is carried out utilizing the nonlinear mixed effects model methodology. The PPK model was constructed employing a one‐compartment model with proportional residual error, and the influence of covariates on pharmacokinetic parameters was systematically assessed through forward stepwise addition and backward elimination methods. The stability and predictive accuracy of the final model were assessed using goodness‐of‐fit plots, nonparametric bootstrap validation, visual predictive checks, and normalized prediction distribution errors. Furthermore, Monte Carlo simulations were employed to predict vancomycin concentrations in neonatal patients with typical characteristics. Results: The final PPK model yielded population‐typical values of 0.24 L/h for vancomycin clearance (CL). Noteworthy contributors to vancomycin CL were identified as body weight, gestational age, creatinine clearance rate (CLcr), and sex. Internal validation results of the model indicate that it possesses stability, efficacy, and demonstrates a favorable predictive capacity. Monte Carlo simulations indicate that for a male neonatal patient characterized by a gestational age of 37 weeks, a body weight of 2.5 kg, and a CLcr of 60 mL/min, the recommended dosing regimen is 25.5 to 41.5 mg every 8 h. Conclusion: This investigation has successfully formulated a PPK model for vancomycin in neonatal patients, offering the capacity to estimate individual CL. The dosing regimen for neonates should take into account factors such as body weight, gestational age, CLcr, and sex.
      pubtype: Academic Journal
      doctype:
        equations & formulas
        research
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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