Ibrahim S, Derde M P, Kaufman L, Clerckx-Braun F, Jacqmin P, Brulein V, Donnez J, Tulkens P M
Laboratory of Physiological Chemistry, Catholic University of Louvain, Brussels, Belgium.
Ren Fail. 1990;12(3):199-203. doi: 10.3109/08860229009065564.
The safety, pharmacokinetics and efficacy of one daily injection (qd) of amikacin (AK) and netilmicin (NT) was compared with the recommended schedules (cs), i.e. twice-daily or thrice-daily, respectively. Women (17-43 years, n = 78) suffering from pelvic inflammatory disease were randomly assigned to qd or cs of either AK (14 mg/kg per day) or NT (6.6 mg/kg per day). Biometric parameters were similar in the 4 groups and all patients received ampicillin (4 g/day) and tinidazole (0.8 g/day). The Repeated Measures Analysis of Variance was used to distinguish the effects of the schedules and of the drugs choice on critical parameters. Efficacy was similar in the 4 groups and not influenced by the schedule of administration. No significant differences in nephro- and oto-toxicity were observed as assessed by serum creatinine and losses of hearing at low frequencies, but early phospholipiduria and auditory losses at high frequencies were significantly reduced with the qd administration compared to cs and by AK compared to NT. These data suggest that the qd schedule of AK and of NT is as efficacious as their cs schedules, and causes less renal and auditory alterations.
将阿米卡星（AK）和奈替米星（NT）每日一次注射（qd）的安全性、药代动力学和疗效与推荐方案（cs）进行了比较，即分别为每日两次或每日三次。患有盆腔炎的女性（17 - 43岁，n = 78）被随机分配至接受AK（每天14 mg/kg）或NT（每天6.6 mg/kg）的qd或cs方案。4组的生物统计学参数相似，所有患者均接受氨苄西林（4 g/天）和替硝唑（0.8 g/天）。采用重复测量方差分析来区分给药方案和药物选择对关键参数的影响。4组的疗效相似，且不受给药方案的影响。通过血清肌酐评估以及低频听力损失情况来看，在肾毒性和耳毒性方面未观察到显著差异，但与cs方案相比，qd给药方案可使早期磷脂尿和高频听力损失显著减少，且与NT相比，AK导致的上述情况更少。这些数据表明，AK和NT的qd给药方案与其cs给药方案疗效相当，且引起的肾脏和听觉改变更少。
