Dohar J E, Alper C M, Rose E A, Doyle W J, Casselbrant M L, Kenna M A, Bluestone C D
Department of Pediatric Otolaryngology, University of Pittsburgh School of Medicine and Children's Hospital of Pittsburgh, Pennsylvania 15213, USA.
Ann Otol Rhinol Laryngol. 1998 Oct;107(10 Pt 1):865-71. doi: 10.1177/000348949810701010.
To date, only ofloxacin has been approved by the US Food and Drug Administration for treatment of ears with a nonintact tympanic membrane. The purpose of this study was to determine the safety and efficacy of topical ciprofloxacin hydrochloride in the treatment of experimental chronic suppurative otitis media caused by Pseudomonas aeruginosa infection in cynomolgus monkeys. Forty adult cynomolgus monkeys were divided into 4 equal groups, and their ears were challenged with P aeruginosa, drained for 3 weeks, then treated twice daily for 4 weeks with 1 of 4 randomly assigned agents: 1) ciprofloxacin, 2) saline, 3) Cortisporin, or 4) vehicle. The animals were followed up with auditory brain stem response testing, culture, otoscopy, and histopathology. Both ciprofloxacin and Cortisporin treatment resulted in a significantly more rapid rate of clearance of P aeruginosa as compared to treatment with saline (100% versus 20%). Eradication was not associated with resolution of otorrhea after a 4-week period of treatment. There were no significant changes in auditory brain stem response wave latencies for any of the treatment groups. Histopathologic data revealed that there was no statistically significant difference in the amount of outer hair cell loss for the ciprofloxacin group as compared to the control ear and other treatment groups. We conclude, therefore, that topical ciprofloxacin is not ototoxic and is effective in sterilizing the otorrhea, but does not promote resolution of the drainage, in this animal model.
迄今为止，只有氧氟沙星已被美国食品药品监督管理局批准用于治疗鼓膜不完整的耳部疾病。本研究的目的是确定局部应用盐酸环丙沙星治疗食蟹猴实验性铜绿假单胞菌感染引起的慢性化脓性中耳炎的安全性和有效性。将40只成年食蟹猴分成4组，每组数量相等，向它们的耳部接种铜绿假单胞菌，引流3周，然后随机分配4种药物中的1种，每天治疗2次，持续4周：1）环丙沙星，2）生理盐水，3）可的霉素，或4）赋形剂。对动物进行听觉脑干反应测试、培养、耳镜检查和组织病理学检查随访。与生理盐水治疗相比，环丙沙星和可的霉素治疗均使铜绿假单胞菌清除速度显著加快（100%对20%）。治疗4周后，根除感染与耳漏的消退无关。任何治疗组的听觉脑干反应波潜伏期均无显著变化。组织病理学数据显示，与对照耳和其他治疗组相比，环丙沙星组外毛细胞损失量无统计学显著差异。因此，我们得出结论，在这个动物模型中，局部应用环丙沙星没有耳毒性，对耳漏有杀菌作用，但不能促进引流的消退。
