Moore R D, Smith C R, Lietman P S
J Infect Dis. 1984 Jan;149(1):23-30. doi: 10.1093/infdis/149.1.23.
Risk factors for the development of auditory toxicity in patients receiving aminoglycosides were determined from the analysis of 135 patients enrolled in three prospective, randomized, double-blind clinical trials of gentamicin, tobramycin, and amikacin. Auditory toxicity, defined as a decrease in auditory acuity of greater than or equal to 15 dB, occurred in 30 patients (22.3%). Patients with auditory toxicity underwent therapy for a longer period, were more likely to be bacteremic, and had, on the average, a higher temperature (P less than 0.05). Using stepwise discriminant analysis, we selected these factors with liver dysfunction and the serum urea nitrogen:serum creatinine ratio in a function that accurately discriminates between toxic and nontoxic patients. Factors not adding significantly to the predictive accuracy of the equation were plasma aminoglycoside levels, aminoglycoside type, furosemide use, diabetes, age, sex, renal function, initial auditory acuity, hematocrit value, and shock. This analysis may be important both for determining the pathophysiology of auditory toxicity and for the prognostic stratification of patients receiving aminoglycosides in clinical trials.
通过对参与庆大霉素、妥布霉素和阿米卡星三项前瞻性、随机、双盲临床试验的135例患者进行分析,确定了接受氨基糖苷类药物治疗的患者发生耳毒性的危险因素。耳毒性定义为听力敏锐度下降大于或等于15 dB,30例患者(22.3%)出现了耳毒性。发生耳毒性的患者治疗时间更长,更可能发生菌血症,平均体温更高(P<0.05)。使用逐步判别分析,我们在一个能准确区分毒性和非毒性患者的函数中选择了这些因素以及肝功能障碍和血清尿素氮:血清肌酐比值。对该方程预测准确性没有显著增加的因素包括血浆氨基糖苷类药物水平、氨基糖苷类药物类型、呋塞米的使用、糖尿病、年龄、性别、肾功能、初始听力敏锐度、血细胞比容值和休克。该分析对于确定耳毒性的病理生理学以及在临床试验中对接受氨基糖苷类药物治疗的患者进行预后分层可能都很重要。