Kosalaraksa Pope, Janthep Pakamas, Jirapradittha Junya, Taksaphan Sukanya, Kiatchoosakun Pakaphan
Department of Pediatrics, Faculty of Medicine, Khon Kaen University, Thailand.
J Med Assoc Thai. 2004 Apr;87(4):372-6.
To compare the peak and trough gentamicin concentrations in neonates after a once (ODD) vs. twice daily dosing (TDD) to establish the appropriate dosage for Thai neonates.
Neonates of gestational age > or = 34 weeks, or body weight > or = 2000 g, suspected of having bacterial infection were randomized to receive gentamicin intravenously, either 5 mg/kg every 24 hours or 2.5 mg/kg every 12 hours. The peak and trough serum gentamicin levels (SGLs) were measured. Serum creatinine cued nephrotoxicity.
Neonates were evaluated and baseline characteristics between the groups were compared. The ODD and TDD group had a mean gentamicin peak and trough concentration of 10.1 +/- 3.0 vs. 7.8 +/- 2.0 microg/ml (p < 0.05) and 1.6 +/- 1.1 vs. 2.6 +/- 1.2 microg/ml (p < 0.05), respectively. The peak SGL of > or = 4 microg/ml was achieved in 100% vs. 96% of the ODD vs. TDD group, respectively. SGL troughs > or = 2 microg/ml were detected less often in the ODD group (22% vs. 68%, p < 0.05). Abnormal change in serum creatinine was not observed in either group.
A once daily dose of gentamicin 5 mg/kg achieved a significantly higher peak SGL and safer trough than a twice-daily dose of 2.5 mg/kg albeit about a quarter of the ODD group had high troughs. A single daily dose of gentamicin 3.5-4 mg/kg/d in Thai neonates should be tested.
比较新生儿每日一次给药（ODD）与每日两次给药（TDD）后庆大霉素的峰浓度和谷浓度，以确定泰国新生儿的合适剂量。
将胎龄≥34周或体重≥2000g、疑似细菌感染的新生儿随机分为两组，分别静脉注射庆大霉素，一组每24小时注射5mg/kg，另一组每12小时注射2.5mg/kg。测量庆大霉素的血清峰浓度和谷浓度。血清肌酐提示肾毒性。
对新生儿进行评估并比较两组的基线特征。ODD组和TDD组庆大霉素的平均峰浓度和谷浓度分别为10.1±3.0 vs. 7.8±2.0μg/ml（p<0.05）和1.6±1.1 vs. 2.6±1.2μg/ml（p<0.05）。ODD组和TDD组分别有100%和96%的新生儿达到≥4μg/ml的峰血清庆大霉素浓度（SGL）。ODD组谷SGL≥2μg/ml的情况较少见（22% vs. 68%，p<0.05）。两组均未观察到血清肌酐的异常变化。
每日一次5mg/kg的庆大霉素剂量比每日两次2.5mg/kg的剂量能显著提高SGL峰浓度，且谷浓度更安全，尽管ODD组约四分之一的新生儿谷浓度较高。应测试泰国新生儿每日一次3.5 - 4mg/kg/d的庆大霉素剂量。
