阿米卡星在新生儿中的药代动力学。

E M Padovani, C Pistolesi, V Fanos, A Messori, N Martini
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引用次数: 35

摘要

到目前为止,关于阿米卡星在新生儿中的药代动力学的数据还很少。为了获得关于这一问题的进一步信息,我们研究了一系列32名因怀疑或记录的细菌感染而接受阿米卡星治疗的新生儿。早产儿19例(平均胎龄32.0±3.6周,平均体重1.74±0.81 kg),足月新生儿13例(平均体重3.19±0.82 kg)。32例新生儿肌注阿米卡星。共测量了121个浓度(每位患者的平均浓度数= 3.8;范围3 - 6)。为估计阿米卡星药动学参数,将该药的血清浓度拟合为单室药动学模型。计算的药代动力学参数如下(平均±SD):清除率= 64.6±30.8 ml/h/kg;分配容积= 0.655 +/- 0.414升/kg;半衰期= 7.6 +/- 4.4 h。这些结果与先前报道的值相似,但重要的例外是分布体积,在我们的研究中要高得多。采用标准两阶段法评价阿米卡星药代动力学的个体变异性,其个体变异性系数为28.9%。迄今为止还没有发表过对这一参数的先前估计。本研究得出的阿米卡星在新生儿中的总体参数(即个体变异系数和清除率和分布体积的平均值+/- SD)可应用于进一步的新生儿系列,以促进贝叶斯方法对阿米卡星个体化剂量的前瞻性应用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Pharmacokinetics of amikacin in neonates.

Only a few data have thus far been published on the pharmacokinetics of amikacin in neonates. To gain further information on this issue, we studied a series of 32 neonates who were treated with amikacin for suspected or documented bacterial infection. Nineteen neonates were preterm (mean gestational age = 32.0 +/- 3.6 weeks, mean body weight = 1.74 +/- 0.81 kg) while the remaining 13 were full-term (mean body weight = 3.19 +/- 0.82 kg). The 32 neonates were given amikacin by intramuscular route. A total of 121 concentrations were measured (average number of concentrations per patient = 3.8; range 3-6). To estimate amikacin pharmacokinetic parameters, the serum concentration values of the drug were fitted to the one-compartment pharmacokinetic model. The calculated pharmacokinetic parameters were the following (mean +/- SD): clearance = 64.6 +/- 30.8 ml/h/kg; volume of distribution = 0.655 +/- 0.414 liters/kg; half-life = 7.6 +/- 4.4 h. These results are similar to the values reported previously, with the important exception of the volume of distribution, which was considerably higher in our study. The intraindividual variability of amikacin pharmacokinetics was evaluated by the standard two-stage method yielding an intraindividual variability coefficient of 28.9%. No previous estimate of this parameter has as yet been published. The population parameters of amikacin in neonates, derived from the present study (i.e. coefficient for intraindividual variability and means +/- SD for clearance and volume of distribution), can be applied to a further series of neonates to facilitate the prospective use of the bayesian method for individualizing amikacin dosage.

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