Topical Ciprofloxacin/Dexamethasone Otic Suspension Is Superior to Ofloxacin Otic Solution in the Treatment of Children With Acute Otitis Media With Otorrhea Through Tympanostomy Tubes

摘要: Objective. To determine the efficacy and safety of topical ciprofloxacin/dexamethasone otic suspension compared with ofloxacin solution in treatment acute otitis media otorrhea through tympanostomy tubes (AOMT) pediatric patients. Methods. This multicenter, prospective, randomized, observer-masked, parallel-group study was conducted at 39 sites 599 children aged ≥6 months to 12 years an AOMT episode ≤3 weeks’ duration. The mean age patients 2.5 (standard deviation: 2.37 years). Patients received either ciprofloxacin 0.3%/dexamethasone 0.1% 4 drops twice daily for 7 days or 0.3% 5 10 days. Clinical signs symptoms were evaluated clinic visits on 1 (baseline), 3 (on therapy), 11 (end 18 (test cure). A patient diary used measure time cessation otorrhea. Principal pretherapy pathogens included Streptococcus pneumoniae (16.8%), Staphylococcus aureus (13.0%), Pseudomonas aeruginosa (12.7%), Haemophilus influenzae (12.4%), S epidermidis (10.2%), Moraxella catarrhalis (4.1%). Results. Ciprofloxacin/dexamethasone is superior clinical cure (90% vs 78%) microbiologic success (92% 81.8%) test-of-cure visit, produces fewer failures (4.4% 14.1%), results a shorter median (4 6 days). also improvement response by absence reduction volume visit. Both preparations are safe well tolerated No change speech recognition threshold decrease hearing from baseline, based audiometric testing, noted regimen. Conclusion. Topical AOMT.