Lerner S A, Schmitt B A, Seligsohn R, Matz G J
Am J Med. 1986 Jun 30;80(6B):98-104. doi: 10.1016/0002-9343(86)90486-9.
Fifty-four patients treated with gentamicin and 52 patients treated with amikacin were evaluated for nephrotoxicity and ototoxicity in a prospective, randomized, blinded comparative trail. According to our definition of nephrotoxicity (an increase in serum creatinine levels to at least 50 percent and 0.5 mg/dl above the baseline value), nephrotoxicity occurred in eight (15 percent) of the patients who were treated with gentamicin and none of the patients who were treated with amikacin (p = 0.006). Using several other definitions of nephrotoxicity, the differences in incidence between the treatment arms were not significant. Nephrotoxicity appeared to be associated with impaired baseline renal function, greater age, and the presence of bacteremia. Ototoxicity occurred in six (11 percent) of the 54 gentamicin-treated patients; auditory toxicity occurred in three patients, and toxic changes were observed in three of the 33 patients who could also be evaluated for vestibular toxicity. Similarly, ototoxicity was observed in seven (13 percent) of the 52 amikacin-treated patients; auditory toxicity occurred in four patients, and of the 34 patients who could also be evaluated for vestibular toxicity, three exhibited vestibular toxicity without auditory toxicity are one experienced vestibular effects in addition to those affecting the cochlea. We observed a modest association of ototoxicity with nephrotoxicity and with an elevated mean trough aminoglycoside serum level. The results of this study indicate that amikacin may be less nephrotoxic than gentamicin in humans; however, the broad applicability of this finding to other patient populations is uncertain.
在一项前瞻性、随机、双盲对比试验中，对54例接受庆大霉素治疗的患者和52例接受阿米卡星治疗的患者进行了肾毒性和耳毒性评估。根据我们对肾毒性的定义（血清肌酐水平至少升高至基线值的50%且高于基线值0.5mg/dl），接受庆大霉素治疗的患者中有8例（15%）发生了肾毒性，而接受阿米卡星治疗的患者中无一例发生肾毒性（p = 0.006）。使用其他几种肾毒性定义时，治疗组之间的发生率差异不显著。肾毒性似乎与基线肾功能受损、年龄较大以及菌血症的存在有关。54例接受庆大霉素治疗的患者中有6例（11%）发生了耳毒性；3例患者出现听觉毒性，在33例也可评估前庭毒性的患者中，有3例观察到毒性变化。同样，52例接受阿米卡星治疗的患者中有7例（13%）观察到耳毒性；4例患者出现听觉毒性，在34例也可评估前庭毒性的患者中，3例表现为无前庭毒性的前庭毒性，1例除耳蜗受影响外还出现前庭效应。我们观察到耳毒性与肾毒性以及平均谷氨酰胺血清水平升高之间存在适度关联。本研究结果表明，在人类中阿米卡星的肾毒性可能低于庆大霉素；然而，这一发现对其他患者群体的广泛适用性尚不确定。
