Department of Clinical Pharmacokinetics, Faculty of Pharmaceutical Sciences, Kobe Gakuin University, Kobe, Japan.
Department of Surgery, Ageo Central General Hospital, Saitama, Japan.
JPEN J Parenter Enteral Nutr. 2022 Jan;46(1):104-113. doi: 10.1002/jpen.2111. Epub 2021 May 12.
A rapid infusion rate for intravenous lipid emulsion (ILE) can cause adverse effects; therefore, safe and efficient infusion rates are desired. This study aimed to develop a triglyceride (TG) kinetic model after soybean oil-based ILE (SO-ILE) administration and individualize the infusion rate via a population pharmacokinetic approach.
Eighty-three inpatients were enrolled in this prospective observational study. A TG kinetic model was applied to the observations based on population pharmacokinetics using a nonlinear mixed-effect model. The patients' characteristics and laboratory parameters were evaluated to identify predictors of TG kinetics, and the maximum acceptable infusion rate was defined as that for which the maximum TG concentration did not exceed 400 mg/dl in 90% of patients.
No adverse events associated with SO-ILE administration were observed. The developed TG kinetic model explained the observed TG concentrations and identified the baseline TG concentration and body weight as predictors of TG kinetics. The estimated maximum acceptable infusion rates greatly varied among individuals, ranging from <0.01 to 0.3 g/kg/h.
The present study suggested the necessity and demonstrated the feasibility of individualizing the infusion rates of SO-ILE, using a population pharmacokinetic approach.
静脉输注脂肪乳（ILE）的输注速率过快可能会引起不良反应；因此，需要寻找安全且有效的输注速率。本研究旨在建立大豆油基脂肪乳（SO-ILE）给药后的甘油三酯（TG）动力学模型，并通过群体药代动力学方法对输注速率进行个体化。
本前瞻性观察性研究纳入了 83 名住院患者。采用非线性混合效应模型，基于群体药代动力学，对 TG 动力学观察数据进行了 TG 动力学模型拟合。评估患者的特征和实验室参数，以确定 TG 动力学的预测因子，并定义最大可接受输注速率为 90%的患者的最大 TG 浓度不超过 400mg/dl 的输注速率。
未观察到与 SO-ILE 给药相关的不良事件。所建立的 TG 动力学模型能够解释观察到的 TG 浓度，并确定基线 TG 浓度和体重是 TG 动力学的预测因子。个体间估计的最大可接受输注速率差异很大，范围从<0.01 至 0.3g/kg/h。
本研究提示需要并证明了使用群体药代动力学方法对 SO-ILE 的输注速率进行个体化的必要性和可行性。
