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
摘要
本研究是一项多中心、随机对照的前瞻性试验，旨在评估万古霉素药代动力学/药效学（PK/PD）两个参数对不同严重感染患儿临床结局的影响：谷浓度（Cmin）和曲线下面积（AUC0-24/MIC）。2023年1月至2024年12月，西南地区7家医院的472名儿童患者被纳入本研究。这些患者被随机分配到AUC0-24/MIC组或Cmin组。在排除了75例原发疾病所致肾功能损害患者、3例资料不完整患者和1例万古霉素治疗时间不足48小时的患者后，最终纳入393例患者。然后，采用两个PK/PD参数评价万古霉素对儿童的治疗效果，指导临床疗效，监测不良反应发生情况：AUC0-24/MIC，目标值400-600 mg·h/L；谷浓度（Cmin），目标值为5 - 15mg /L。结果显示，两组在日剂量、临床疗效、不良反应等方面均无显著差异。然而，Cmin组患者的儿科重症监护病房（PICU）停留时间明显缩短（Z = - 2.05, p = 0.04）， 28天至1岁亚组患者的机械通气时间较短（Z = - 2.25, p = 0.024）。Cmin和AUC0-24/MIC对指导重度感染患儿万古霉素治疗均有效。而Cmin组患者在PICU停留时间和通气时间上均有优势。试验注册：中国临床试验注册中心：ChiCTR2300067373
A Multicenter Randomized Controlled Study on Pharmacokinetic-Guided Vancomycin Use in Children With Severe Infections
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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