Holm S E, Hill B, Löwestad A, Maller R, Vikerfors T
J Antimicrob Chemother. 1983 Oct;12(4):393-402. doi: 10.1093/jac/12.4.393.
A multicentre prospective randomized study of amikacin and gentamicin in 135 patients with serious infections is presented. Most patients were additionally given a penicillin derivative according to Swedish therapeutic traditions. Synergism was noted in the majority of the tested strains. Clinical cure was recorded in 80% and 76% respectively of the amikacin and gentamicin patient groups. Nephrotoxic reactions were statistically (P less than 0.05) more common in gentamicin-treated patients (20%) than in the amikacin-treated ones (6%) while the corresponding figures for ototoxicity were 16% and 8% respectively (not statistically significant). Pharmacokinetic studies of the drugs showed that with the dose regimens used serum levels of amikacin above 10 times the MIC for the isolated micro-organism were registered during 75% of the 12-hour therapy interval and during 40% of the 8-hour therapy interval for gentamicin. This difference is statistically significant (P less than 0.01). We suggest that the pharmacokinetic advantages of amikacin in comparison to gentamicin might be of practical importance in the prediction of serum levels thereby lowering the risk of toxic reactions.
本文介绍了一项针对135例严重感染患者进行的阿米卡星和庆大霉素的多中心前瞻性随机研究。根据瑞典治疗传统，大多数患者还额外使用了一种青霉素衍生物。在大多数测试菌株中都观察到了协同作用。阿米卡星和庆大霉素治疗组的临床治愈率分别为80%和76%。庆大霉素治疗患者（20%）的肾毒性反应在统计学上（P<0.05）比阿米卡星治疗患者（6%）更常见，而耳毒性的相应数字分别为16%和8%（无统计学意义）。药物的药代动力学研究表明，在所使用的剂量方案下，阿米卡星的血清水平在12小时治疗间隔的75%时间内以及庆大霉素在8小时治疗间隔的40%时间内高于分离出的微生物的MIC的10倍。这种差异具有统计学意义（P<0.01）。我们认为，与庆大霉素相比，阿米卡星的药代动力学优势在预测血清水平从而降低毒性反应风险方面可能具有实际重要性。
