万古霉素在韩国健康志愿者体内的药代动力学以及蒙特卡罗模拟探索肾功能正常患者的最佳剂量方案。

IF 4.3 2区 医学 Q1 INFECTIOUS DISEASES Antibiotics-Basel Pub Date : 2024-10-19 DOI:10.3390/antibiotics13100993
Yong Kyun Kim, Doee Kim, Gaeun Kang, Dae Young Zang, Dong-Hwan Lee
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引用次数: 0

摘要

背景/目的:迄今为止,尚未对健康的韩国成年人进行万古霉素的群体药代动力学(PK)研究。本研究旨在调查万古霉素在健康志愿者中的 PK 特性,并根据肾功能正常的成人患者的浓度-时间曲线下面积(AUC)确定最佳给药方案。研究方法我们进行了一项前瞻性临床研究,利用非室分析和非线性混合效应模型分析了 12 名健康参与者的 PK 样本。得出的群体 PK 参数被用于蒙特卡罗模拟,以评估当前给药方案的适当性并制定给药建议。结果:两室模型对 PK 曲线进行了最佳描述,体重和年龄是影响总清除率的重要协变量。模拟结果表明,对于肾功能正常的成人,要达到治疗目标,即 24 小时内稳态时的 AUC 为 400-600 毫克-小时/升,则每日剂量为 60-70 毫克/千克。结论:本研究强调了根据万古霉素 PK 模型积极调整剂量和给药的必要性,该模型能充分反映患者的人口统计学特征,从而同时满足安全性和有效性标准。
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Pharmacokinetics of Vancomycin in Healthy Korean Volunteers and Monte Carlo Simulations to Explore Optimal Dosage Regimens in Patients with Normal Renal Function.

Background/Objectives: To date, population pharmacokinetic (PK) studies of vancomycin on healthy Korean adults have not been conducted. This study aimed to investigate the PK properties of vancomycin in healthy volunteers and to identify optimal dosing regimens based on the area under the concentration-time curve (AUC) in adult patients with normal renal function. Methods: We conducted a prospective clinical study, analysing PK samples from 12 healthy participants using noncompartmental analysis and non-linear mixed-effects modelling. The population PK parameters derived were employed in Monte Carlo simulations to evaluate the adequacy of the current dosing regimen and to formulate dosing recommendations. Results: The PK profiles were optimally described by a two-compartment model, with body weight and age as significant covariates affecting total clearance. The simulations indicated that to achieve a therapeutic target-defined as an AUC at steady-state over 24 h of 400-600 mg·h/L-daily doses ranging from 60 to 70 mg/kg are necessary in adults with normal renal function. Conclusions: This study underscores the need to actively adjust dosage and administration based on a vancomycin PK model that adequately reflects the demographic characteristics of patients to meet both safety and efficacy standards.

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来源期刊
Antibiotics-Basel
Antibiotics-Basel Pharmacology, Toxicology and Pharmaceutics-General Pharmacology, Toxicology and Pharmaceutics
CiteScore
7.30
自引率
14.60%
发文量
1547
审稿时长
11 weeks
期刊介绍: Antibiotics (ISSN 2079-6382) is an open access, peer reviewed journal on all aspects of antibiotics. Antibiotics is a multi-disciplinary journal encompassing the general fields of biochemistry, chemistry, genetics, microbiology and pharmacology. Our aim is to encourage scientists to publish their experimental and theoretical results in as much detail as possible. Therefore, there is no restriction on the length of papers.
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