Fuxiang He, Ya Yang, Bo Zhou, Chengcheng Li, Yu Feng, Xuexin Wang, Haifeng Liu, Yuhang Hu, Hongmin Fu, Yingbo Zou, Guoying Zhang, Jianli Chen, Yueqiang Fu, Shufang Xiao, Lan Hu, Chengjun Liu
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引用次数: 0
Abstract
This study is a multicenter, randomized controlled prospective trial aimed at evaluating the effects of two vancomycin pharmacokinetics/pharmacodynamics (PK/PD) parameters on clinical outcomes in children with different severe infections: trough concentration (Cmin) and the area under the curve (AUC0-24/MIC). From January 2023 to December 2024, 472 pediatric patients from seven hospitals in Southwest China were included in the present study. These patients were randomly assigned to the AUC0-24/MIC group or the Cmin group. After excluding 75 patients with renal function impairment caused by the primary disease, three patients with incomplete data, and one patient who received vancomycin for less than 48 h, 393 patients were finally enrolled for the present study. Then, the vancomycin treatment for children was evaluated using two PK/PD parameters, to guide clinical efficacy and monitor the incidence of adverse reactions: AUC0-24/MIC, with a target value of 400–600 mg·h/L; trough concentration (Cmin), with a target value of 5–15 mg/L. The results indicated that there were no significant differences between the two groups in terms of daily dose, clinical efficacy, and adverse reactions. However, patients in the Cmin group had significantly shorter pediatric intensive care unit (PICU) stays (Z = −2.05, p = 0.04), and patients in the 28-day to 1-year-old subgroup had shorter mechanical ventilation times (Z = −2.25, p = 0.024). Both Cmin and AUC0-24/MIC were effective in guiding the vancomycin treatment for children with severe infections. However, patients in the Cmin group presented with advantages in PICU stay and ventilation duration.
Trial Registration: China Clinical Trial Registry: ChiCTR2300067373
期刊介绍：
Clinical and Translational Science (CTS), an official journal of the American Society for Clinical Pharmacology and Therapeutics, highlights original translational medicine research that helps bridge laboratory discoveries with the diagnosis and treatment of human disease. Translational medicine is a multi-faceted discipline with a focus on translational therapeutics. In a broad sense, translational medicine bridges across the discovery, development, regulation, and utilization spectrum. Research may appear as Full Articles, Brief Reports, Commentaries, Phase Forwards (clinical trials), Reviews, or Tutorials. CTS also includes invited didactic content that covers the connections between clinical pharmacology and translational medicine. Best-in-class methodologies and best practices are also welcomed as Tutorials. These additional features provide context for research articles and facilitate understanding for a wide array of individuals interested in clinical and translational science. CTS welcomes high quality, scientifically sound, original manuscripts focused on clinical pharmacology and translational science, including animal, in vitro, in silico, and clinical studies supporting the breadth of drug discovery, development, regulation and clinical use of both traditional drugs and innovative modalities.
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