Weinelt Ferdinand Anton, Stegemann Miriam Songa, Theloe Anja, Pfäfflin Frieder, Achterberg Stephan, Schmitt Lisa, Huisinga Wilhelm, Michelet Robin, Hennig Stefanie, Kloft Charlotte
Department of Clinical Pharmacy and Biochemistry, Institute of Pharmacy, Freie Universitaet Berlin, 12169 Berlin, Germany.
Graduate Research Training Program PharMetrX, 12169 Berlin, Germany.
Pharmaceutics. 2021 Dec 10;13(12):2128. doi: 10.3390/pharmaceutics13122128.
The prevalence and mortality rates of severe infections are high in intensive care units (ICUs). At the same time, the high pharmacokinetic variability observed in ICU patients increases the risk of inadequate antibiotic drug exposure. Therefore, dosing tailored to specific patient characteristics has a high potential to improve outcomes in this vulnerable patient population. This study aimed to develop a tabular dosing decision tool for initial therapy of meropenem integrating hospital-specific, thus far unexploited pathogen susceptibility information. An appropriate meropenem pharmacokinetic model was selected from the literature and evaluated using clinical data. Probability of target attainment (PTA) analysis was conducted for clinically interesting dosing regimens. To inform dosing prior to pathogen identification, the local pathogen-independent mean fraction of response (LPIFR) was calculated based on the observed minimum inhibitory concentrations distribution in the hospital. A simple, tabular, model-informed dosing decision tool was developed for initial meropenem therapy. Dosing recommendations achieving PTA > 90% or LPIFR > 90% for patients with different creatinine clearances were integrated. Based on the experiences during the development process, a generalised workflow for the development of tabular dosing decision tools was derived. The proposed workflow can support the development of model-informed dosing tools for initial therapy of various drugs and hospital-specific conditions.
重症监护病房(ICU)中严重感染的患病率和死亡率很高。同时,在ICU患者中观察到的高药代动力学变异性增加了抗生素药物暴露不足的风险。因此,根据特定患者特征调整给药方案,对于改善这一脆弱患者群体的治疗效果具有很大潜力。本研究旨在开发一种用于美罗培南初始治疗的表格给药决策工具,整合医院特定的、迄今未利用的病原体敏感性信息。从文献中选择合适的美罗培南药代动力学模型,并使用临床数据进行评估。对临床上感兴趣的给药方案进行目标达成概率(PTA)分析。为了在病原体鉴定之前提供给药信息,根据医院中观察到的最低抑菌浓度分布计算局部病原体独立反应平均分数(LPIFR)。开发了一种简单的、表格化的、基于模型的美罗培南初始治疗给药决策工具。整合了针对不同肌酐清除率患者实现PTA>90%或LPIFR>90%的给药建议。基于开发过程中的经验,得出了表格给药决策工具开发的通用工作流程。所提出的工作流程可以支持针对各种药物和医院特定情况的初始治疗开发基于模型的给药工具。