Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Cairo University, Cairo, Egypt.
Saudi Pharm J. 2011 Jan;19(1):9-17. doi: 10.1016/j.jsps.2010.11.001. Epub 2010 Nov 4.
The purpose of this study was to evaluate the once daily dosing (ODD) program in critically ill Egyptian patients compared to individualized multiple daily dosing (MDD) in terms of clinical and bacteriological efficacy. In addition, the incidence of nephrotoxicity associated with both regimens in this specific group of patients was assessed.
Fifty-two patients with suspected or confirmed bacterial infections admitted to the Critical Care Medicine Department, Kasr El-Aini-Cairo University Hospitals comprised the study population. The amikacin group (30 patients) was sub-divided into 14 patients receiving amikacin ODD (1 g i.v.) and 16 patients receiving amikacin in MDD (500 mg i.v./dose). The gentamicin group (22 patients) was sub-divided into 10 patients receiving the drug ODD (240 mg i.v.) and 12 patients receiving gentamicin MDD (80 mg i.v./dose). Amikacin or gentamicin serum levels were determined by the enzyme multiplied immunoassay technique using Emit 2000. MDD regimen was adjusted based on the individual pharmacokinetic parameters using the Sawchuk-Zaske method.
There was no significant difference between the two dosing regimens with regard to clinical and antibacterial efficacy or incidence of nephrotoxicity of both gentamicin and amikacin groups. In the ODD regimen, duration of treatment had no effect on increasing incidence of nephrotoxicity unlike the individualized MDD regimen. No dose adjustments were needed in the once daily dosing regimen since trough concentrations have never been above toxic level.
The study showed that the ODD regimen is preferred in critically ill patients to individualized MDD as shown by comparable efficacy, nephrotoxicity and lesser need for therapeutic drug monitoring and frequent dose adjustments required in the individualized MDD regimen.
本研究旨在评估在埃及危重症患者中,与个体化多次每日剂量(MDD)相比,每日一次剂量(ODD)方案在临床和细菌学疗效方面的优劣。此外,还评估了这两种方案在该特定患者群体中与肾毒性相关的发生率。
研究人群包括来自开罗大学卡西尔艾尔-阿尼医院重症监护医学科的 52 名疑似或确诊细菌感染的患者。阿米卡星组(30 名患者)进一步分为 14 名接受阿米卡星 ODD(1g 静脉注射)和 16 名接受阿米卡星 MDD(500mg 静脉注射/剂量)的患者。庆大霉素组(22 名患者)进一步分为 10 名接受庆大霉素 ODD(240mg 静脉注射)和 12 名接受庆大霉素 MDD(80mg 静脉注射/剂量)的患者。采用酶联免疫吸附试验技术(Emit 2000)测定阿米卡星或庆大霉素的血清水平。根据 Sawchuk-Zaske 方法,基于个体药代动力学参数调整 MDD 方案。
在临床和抗菌疗效或两种庆大霉素和阿米卡星组的肾毒性发生率方面,两种剂量方案之间没有显著差异。与个体化 MDD 方案不同,在 ODD 方案中,治疗时间的长短对增加肾毒性的发生率没有影响。由于谷浓度从未超过毒性水平,因此在每日一次剂量方案中不需要进行剂量调整。
该研究表明,与个体化 MDD 相比,ODD 方案在危重症患者中更为优选,因为它具有相似的疗效、肾毒性和较少需要治疗药物监测以及个体化 MDD 方案中频繁的剂量调整。