Chotigeat U, Narongsanti A, Ayudhya D P
Pediatric Department, Queen Sirikit National Institute of Child Health, Bangkok, Thailand.
J Med Assoc Thai. 2001 Aug;84(8):1109-15.
Fifty-four neonates were included and completed the study. Twenty-seven neonates were given 2.0-2.5 mg/kg of gentamicin twice daily while 27 neonates were given 4.0-5.0 mg/kg of gentamicin once daily. The twice daily dose and the once daily dose group had mean steady state gentamicin peak concentrations of 5.94 +/- 1.57 mg/l and 8.92 +/- 1.59 mg/l, respectively (p<0.05) while their trough concentrations were 1.44 +/- 0.49 mg/l and 0.90 +/- 0.35 mg/l, respectively (p<0.05). There were 3 neonates (11.11%) in the twice daily dose group whose peak and trough level were not within the desirable therapeutic range, two patients with too high trough level (>2 mg/l) and one with subtherapeutic peak level (<4 mg/l). Only one patient in the once daily group had undesirable trough level that was higher than 1.5 mg/l but less than 2 mg/l. Treatment with a once daily dose did not present more nephrotoxity than a twice daily dose regimen and had the tendency to have less effect on renal function. Once daily dosage can achieve the equivalent efficacy compared to a twice-daily dosage regimen. All neonates in twice daily and once daily dosage groups showed improvement in clinical outcome. Therefore, a once daily dose of gentamicin with 4.0-5.0 mg/kg could be an appropriate regimen in term neonates during the first 7 days of life. This regimen produces peak concentration that may have greater clinical efficacy and trough concentration with less toxicity than conventional dosing regimen.
共有54名新生儿纳入并完成了该研究。27名新生儿每日两次给予2.0 - 2.5mg/kg庆大霉素,而27名新生儿每日一次给予4.0 - 5.0mg/kg庆大霉素。每日两次给药组和每日一次给药组的庆大霉素平均稳态峰值浓度分别为5.94±1.57mg/L和8.92±1.59mg/L(p<0.05),而其谷浓度分别为1.44±0.49mg/L和0.90±0.35mg/L(p<0.05)。每日两次给药组中有3名新生儿(11.11%)的峰值和谷值水平不在理想治疗范围内,2名患者谷值水平过高(>2mg/L),1名患者峰值水平低于治疗剂量(<4mg/L)。每日一次给药组中只有1名患者的谷值水平不理想,高于1.5mg/L但低于2mg/L。每日一次给药方案的肾毒性并不比每日两次给药方案更大,且对肾功能的影响有更小的趋势。每日一次给药与每日两次给药方案相比可达到等效疗效。每日两次和每日一次给药组的所有新生儿临床结局均有改善。因此,出生后7天内的足月儿每日一次给予4.0 - 5.0mg/kg庆大霉素可能是一种合适的给药方案。该方案产生的峰值浓度可能具有更大的临床疗效,谷浓度的毒性低于传统给药方案。