Department of Pharmacology, King Abdulaziz University, Jeddah, Kingdom of Saudi Arabia.
Indian J Pharmacol. 2012 Jan;44(1):36-40. doi: 10.4103/0253-7613.91864.
Gentamicin is an essential drug for the treatment of sepsis in neonates. The current work aims to optimize the use of gentamicin in neonates during the first week of life.
The study was done at King Abdul-Aziz university hospital. Seventy-three neonates who received gentamicin 4-5 mg/kg and dosing interval at 24-48 hr were enrolled. Peak and trough serum levels of gentamicin were determined by immunoassay. Pharmacokinetic parameters were estimated assuming one compartment model and first order elimination kinetic. Analysis of variance was used to test the difference between means using Statistical Package for the Social Sciences (SPSS) Version 13.
About 73% of the patients attained peak gentamicin level within therapeutic range (6-12μg/ml), while 12% showed potentially toxic trough level (>2 μg /ml). The incidence of trough level was higher among patients receiving the drug every 24 hr. There was no clear correlation between high trough level and serum creatinine. High volume of distribution (Vd) of gentamicin (0.40-0.45) L/kg was observed. Neonates with proven sepsis showed higher mean Vd. Those with extremely low birth weight showed significantly longer half life of 11.5 h. Other neonates showed half life of (8-9) hr.
Gentamicin dose of 4.5 mg/kg every 36 hr is recommended as simple empirical regimen during the 1(st) week of life for neonates with normal or LBW and every 48 hr for those with ELBW.
庆大霉素是治疗新生儿败血症的基本药物。本研究旨在优化新生儿在生命的第一周内使用庆大霉素。
该研究在阿卜杜勒-阿齐兹国王大学医院进行。纳入 73 名接受 4-5mg/kg 庆大霉素且给药间隔为 24-48 小时的新生儿。通过免疫测定法测定庆大霉素的峰和谷血清水平。假设一室模型和一级消除动力学来估计药代动力学参数。使用社会科学统计软件包（SPSS）版本 13 进行方差分析，以测试平均值之间的差异。
约 73%的患者达到了治疗范围内的庆大霉素峰浓度（6-12μg/ml），而 12%的患者显示出潜在的毒性谷浓度（>2μg/ml）。每 24 小时给药的患者谷浓度发生率较高。高谷浓度与血清肌酐之间没有明显的相关性。观察到庆大霉素的高分布容积（Vd）（0.40-0.45）L/kg。患有败血症的新生儿表现出更高的平均 Vd。极低出生体重的新生儿半衰期明显较长，为 11.5 小时。其他新生儿的半衰期为（8-9）小时。
建议在生命的第一周内，对于正常或 LBW 的新生儿，每 36 小时给予 4.5mg/kg 的庆大霉素剂量，作为简单的经验性方案；对于 ELBW 的新生儿，每 48 小时给予一次。
