万古霉素在脑膜炎患儿中的群体药代动力学模型的建立与应用。
Establishment and application of population pharmacokinetics model of vancomycin in infants with meningitis.
作者信息
Xu Jianwen, Zhu Yanting, Niu Peiguang, Liu Ying, Li Danyun, Jiang Li, Shi Daohua
机构信息
Department of Pharmacy, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, 350001, China; Department of Pharmacy, Affiliated First Hospital of Fujian Medical University, Fuzhou, Fujian, 350001, China.
Department of Pharmacy, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, 350001, China.
出版信息
Pediatr Neonatol. 2022 Jan;63(1):57-65. doi: 10.1016/j.pedneo.2021.06.018. Epub 2021 Sep 2.
BACKGROUND
To establish a population pharmacokinetics (PPK) model of vancomycin (VCM) for dose individualization in Chinese infants with meningitis.
METHODS
We collected the data of 82 children with meningitis in hospital from July 2014 to June 2016. The initial vancomycin dosage regimen for children was 10 or 15 mg/kg for q12 h, q8 h or q6 h. Serum concentrations were determined by Viva-E Analyzer before and after the fifth administration. The PPK model was developed by nonlinear mixed-effect model software, assessed by the bootstrap method and then tested in 20 infant patients.
RESULTS
The VCM clearance (CL) was increased by body weight (WT) and decreased by blood urea nitrogen (BUN). Pharmacokinetic parameters of VCM were not influenced by co-administered drugs. The trough concentrations of VCM were accurately predicted by the PPK model, with the prediction errors less than 32%.
CONCLUSION
A new individual strategy for VCM regimens was proposed and validated by the PPK model.
背景
建立万古霉素（VCM）群体药代动力学（PPK）模型，用于中国患脑膜炎婴儿的剂量个体化。
方法
收集2014年7月至2016年6月期间82例住院患脑膜炎儿童的数据。儿童初始万古霉素给药方案为每12小时、8小时或6小时10或15mg/kg。在第五次给药前后，用Viva-E分析仪测定血清浓度。用非线性混合效应模型软件建立PPK模型，采用自抽样法进行评估，然后在20例婴儿患者中进行测试。
结果
VCM清除率（CL）随体重（WT）增加而升高，随血尿素氮（BUN）升高而降低。VCM的药代动力学参数不受联合用药影响。PPK模型能准确预测VCM的谷浓度，预测误差小于32%。
结论
提出了一种新的VCM给药个体化策略，并通过PPK模型进行了验证。
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