Eur J Clin Pharmacol. 2025 Dec 22;82(1):14. doi: 10.1007/s00228-025-03959-8.
ABSTRACT
PURPOSE: This systematic review aimed at consolidating evidence regarding vancomycin dosing regimens, therapeutic drug monitoring (TDM) practices, clinical efficacy, and toxicity profiles in neonates admitted to neonatal intensive care units (NICUs). The primary research question focused on identifying the most effective and safe vancomycin protocols for this vulnerable population.
METHODS: Following PRISMA guidelines, a comprehensive search was conducted in six databases: PubMed, Scopus, Embase, Web of Science, Cochrane Library, and Lilacs. Eligible studies included observational cohorts and randomized clinical trials involving neonates receiving intravenous vancomycin with reported dosing and TDM data. Data extraction encompassed study design, dosing regimens, serum concentration targets, efficacy outcomes, and toxicity reports.
RESULTS: Thirty-two studies met inclusion criteria, revealing substantial heterogeneity in vancomycin dosing strategies, target trough concentrations, and evaluation methods for efficacy and toxicity. Target serum concentrations varied widely (5-30 mg/L), and dosing regimens ranged from 10 to 61 mg/kg/day. Only three studies assessed clinical efficacy, and eleven evaluated nephrotoxicity risk, with reported nephrotoxicity rates between 1.1% and 14%. Variability in methods limited the comparability across studies.
CONCLUSIONS: Vancomycin use in neonates lacks standardized dosing and monitoring practices, making it challenging to define an optimal therapeutic protocol. Greater consistency in clinical approaches and further high-quality studies are urgently needed to establish safe and effective vancomycin management strategies for neonatal patients.
PMID:41428193 | DOI:10.1007/s00228-025-03959-8
