Federspil P
Laryngol Rhinol Otol (Stuttg). 1981 Oct;60(10):553-7.
The problems of the clinical evaluation of the ototoxicity of an aminoglycoside antibiotic are mentioned. The criteria for a correct performance of experimental ototoxicity tests and the applied methods concerning the functional ahd histological investigations are reported on. The results obtained by the experimental evaluation of the ototoxicity of the clinically important newer aminoglycoside antibiotics (gentamicin, tobramycin, sisomicin, dibekacin, and netilmicin) on the market are described my means of representative graphs. Possible sources of error by using the applied or other tests are discussed. An exact correlation of results obtained by neat experiments and the clinical data is found and by that also the necessity of experimental investigations as to the ototoxicity of new ototoxic drugs before their clinical trials.
文中提到了氨基糖苷类抗生素耳毒性临床评估的问题。报告了正确进行实验性耳毒性测试的标准以及有关功能和组织学研究的应用方法。通过具有代表性的图表描述了对市场上临床上重要的新型氨基糖苷类抗生素(庆大霉素、妥布霉素、西索米星、地贝卡星和奈替米星)耳毒性进行实验评估所获得的结果。讨论了使用所应用的测试或其他测试可能产生的误差来源。发现了纯实验获得的结果与临床数据之间的精确相关性,由此也发现了在新的耳毒性药物进行临床试验之前对其耳毒性进行实验研究的必要性。