OBJECTIVE:This study was undertaken to study the pharmacokinetics of intravenously administered amoxicillin in pregnant women with preterm premature rupture of the membranes (PPROM). STUDY DESIGN:Healthy women with PPROM were recruited and treated with amoxicillin (2 g initially and 1 g subsequently). Blood samples were obtained from the opposite arm and concentrations determined with the use of high-pressure liquid chromatography. Nonlinear mixed-effects modeling was performed in nonlinear mixed effect (population) modeling. RESULTS:The pharmacokinetics of 17 patients was described by a 3-compartment model. Clearance and volume of distribution at steady state were 22.8 L/h and 21.4 L/h, respectively, similar to values in nonpregnant individuals. There was little variability between patients. No relationship was observed between values of individual pharmacokinetic parameters and various covariates. CONCLUSION:The pharmacokinetics of amoxicillin in pregnant patients with PPROM similar to nonpregnant individuals. Given the small interindividual variability in pharmacokinetics, no dose adjustments are required to account for differences between subjects under normal circumstances.

译文

目的:本研究旨在研究静脉输注阿莫西林对早产胎膜早破(PPROM)的孕妇的药代动力学。
研究设计:招募健康的PPROM妇女,并用阿莫西林治疗(最初2 g,随后1 g)。从对侧的手臂获得血液样品,并使用高压液相色谱法测定浓度。非线性混合效应建模是在非线性混合效应(种群)建模中执行的。
结果:3室模型描述了17例患者的药代动力学。稳态下的清除率和分布体积分别为22.8 L / h和21.4 L / h,与未怀孕个体中的值相似。患者之间的变异很小。各个药代动力学参数的值与各种协变量之间未发现相关性。
结论:阿莫西林在孕妇PPROM中的药代动力学与非孕妇相似。鉴于药代动力学之间的个体差异很小,在正常情况下无需调整剂量即可解决受试者之间的差异。

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