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目的 :研究阿米卡星 (AMK)在呼吸系统感染患者中的临床药动学、体内抗生素后效应 (PAE)及两者间的关系。方法 :采用荧光偏振免疫分析方法测定血清中AMK的浓度 ;采用吸光度法测定AMK对 6株受试菌 (3株标准质控菌 ,3株临床分离菌 )的体内抗生素后效应。以 3P87软件估算药动学参数。结果 :AMK在 7例呼吸系统感染患者体内的消除半衰期、清除率及药 时曲线 (AUC)下面积分别 (3.10± 0 .6 1)h ,(4.18± 0 .84)L·h-1和 (10 0 .12± 2 5 .6 9) μg·h·ml-1。AMK对 6株受试菌具有明显的体内PAE ,给药后 12 .5h体内累加PAE值最大为 32h ,平均为 30h ;AUC与PAE呈良好的线性关系。结论 :AMK的药动学及体内PAE研究表明 ,AMK 40 0mg ,静脉滴注 ,每日 1次的给药方案是合理的。
Objective: To investigate the clinical pharmacokinetics of amikacin (AMK) in patients with respiratory infections, in vivo post-antibiotic effects (PAE) and the relationship between the two. Methods: The concentration of AMK in serum was determined by fluorescence polarization immunoassay. The in vivo antibiotic effect of AMK against 6 tested bacteria (3 standard bacteria and 3 clinical isolates) was determined by absorbance method. Pharmacokinetic parameters were estimated using 3P87 software. Results: The area under the elimination half-life, clearance rate, and time-course curve of AMK were 3.10 ± 0.61 and 4.18 ± 0.84 L · h-1 in 7 patients with respiratory infection respectively (100.12 ± 2.56.9) μg · h · ml-1. AMK had obvious in vivo PAE against 6 tested bacteria. The accumulated PAE value at 12.5h after administration was up to 32h with an average of 30h. AUC showed a good linear relationship with PAE. Conclusion: The pharmacokinetics of AMK and in vivo PAE study showed that AMK 40 mg, intravenous infusion, once daily dosing regimen is reasonable.