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用于监测每日一次给药方案的阿米卡星检测的多中心质量控制研究。欧洲癌症研究与治疗组织国际抗菌治疗合作组

Multicenter quality control study of amikacin assay for monitoring once-daily dosing regimens. International Antimicrobial Therapy Cooperative Group of the European Organization for Research and Treatment of Cancer.

作者信息

Blaser J, König C, Fatio R, Follath F, Cometta A, Glauser M

机构信息

Department of Medicine, University Hospital Zurich, Switzerland.

出版信息

Ther Drug Monit. 1995 Apr;17(2):133-6. doi: 10.1097/00007691-199504000-00005.

DOI:10.1097/00007691-199504000-00005
PMID:7624900
Abstract

During once-daily dosing regimens of aminoglycosides, administration of large single doses results in high peak levels and low 24-h trough levels. However, commercial assays for monitoring aminoglycoside levels are designed to cover the smaller range of serum concentrations usually observed during multiple daily dosing regimens. The study assessed (a) the range of serum concentrations during once-daily dosing of amikacin and (b) the performance of a widely used assay system for measuring concentrations within this range. A total of 42 dosing intervals from eight patients receiving a once-daily regimen of amikacin (20 mg/kg) were monitored. Median (and range) of peak, 8- and 24-h trough levels were 61 (25-89), 5.9 (2.2-19), and 1.3 (< 0.8-6.2) mg/L, respectively. The accuracy of a fluorescence polarization immunoassay for measuring concentrations of amikacin during once-daily dosing regimens was assessed in an international multicenter study. The performance of the assay was excellent for peak and 8-h concentrations; median deviations from the target concentrations were < 5%. The majority of the trough levels (26 of 42) measured in patients during once-daily treatment were within the range of 1-2 mg/L and could also be determined with an accuracy sufficient for clinical monitoring (median deviations 14%).

摘要

在氨基糖苷类药物每日一次给药方案中,给予大剂量单次给药会导致高峰浓度和低24小时谷浓度。然而,用于监测氨基糖苷类药物水平的商业检测方法是为覆盖每日多次给药方案中通常观察到的较窄血清浓度范围而设计的。该研究评估了:(a)阿米卡星每日一次给药期间的血清浓度范围;(b)一种广泛使用的检测系统在测量该范围内浓度时的性能。对8名接受阿米卡星(20mg/kg)每日一次给药方案的患者的42个给药间隔进行了监测。峰值、8小时和24小时谷浓度的中位数(及范围)分别为61(25 - 89)、5.9(2.2 - 19)和1.3(<0.8 - 6.2)mg/L。在一项国际多中心研究中评估了荧光偏振免疫分析法在每日一次给药方案中测量阿米卡星浓度的准确性。该检测方法对峰值和8小时浓度的性能极佳;与目标浓度的中位数偏差<5%。在每日一次治疗期间患者中测量的大多数谷浓度(42个中的26个)在1 - 2mg/L范围内,并且也能够以足以进行临床监测的准确性进行测定(中位数偏差14%)。

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