CiprofloxacinDexamethasone ototoxicity in an animal and human model

Abstract

Introduction. Ototoxicity refers to medication-caused auditory and/or vestibular system dysfunction resulting in hearing loss or dysequilibrium. The potential damage that antibiotics eardrops can produce when placed directly into the middle ear in some cases is still unknown.Objectives. To determine the safety of use of the new ciprofloxacin/dexamethasone otic drops in patients without an intact tympanic membrane.Materials and methods. Ciprodex/dexamethasone eardrops were tested in an animal and human model. The animal part was performed in 13 adult chinchillas; Auditory Brainstem Response (ABR) was used. For the human part, twenty subjects were enrolled in the study; Distortion Products Otoacoustic Emissions (DPOAE) testing was used.Results. Animal Part: after the tube insertion ABR threshold mean value was 19.6+/-13.3 dB for all the animals. On the last evaluation (day 60), the mean threshold was 19+/-13 dB for the experimental ears, and 13.7+/-12.2 dB for the control ears, this overall analysis showed no significant effect (p-value = 0.661). Human Part: the mean thresholds for the pre-treatment test were 4.87+/-6,34 dB for the DP value and -0.87+/-7.93 dB for the Ns value. In the post-treatment evaluation the mean thresholds were 3.48+/-4.40 dB for the DP value and -8.02+/-7.57 dB for the Ns value.Conclusions. The use of CiprodexTM eardrops seems to be safe when instilled in ears without an intact tympanic membrane