Efficacy and safety of topical ciprofloxacin/dexamethasone versus neomycin/polymyxin B/ hydrocortisone for otitis externa
| Autor: | G. Michael Wall, Dan C. Henry, Susan L. Potts, Sheryl J. Dupre, L. Gail Hogg, Peter S. Roland, Francis D. Pien, Rekha Garadi, David W. Stroman, Craig C. Schultz, Peter J. Conroy |
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| Rok vydání: | 2004 |
| Předmět: |
Adult
Male Adolescent Administration Topical Anti-Inflammatory Agents Ototoxicity Ciprofloxacin Edema Humans Medicine Single-Blind Method Child Dexamethasone Aged Polymyxin B Hydrocortisone business.industry Infant General Medicine Neomycin Middle Aged Otitis Externa medicine.disease Anti-Bacterial Agents Drug Combinations Pharmaceutical Solutions Treatment Outcome Otitis Child Preschool Anesthesia Female medicine.symptom business Framycetin medicine.drug |
| Zdroj: | Current Medical Research and Opinion. 20:1175-1183 |
| ISSN: | 1473-4877 0300-7995 |
| Popis: | To compare the efficacy and safety of ciprofloxacin 0.3%/dexamethasone 0.1% (CIP/DEX) otic suspension with that of neomycin 0.35%/polymyxin B 10,000 IU/mL/hydrocortisone 1.0% (N/P/H) otic suspension in patients with acute otitis externa (AOE).Randomized, observer-masked, parallel-group, multicenter study. Patients were randomized to 7 days treatment with either CIP/DEX 3-4 drops twice daily or N/P/H 3-4 drops three times daily.Patients of either sex and older than 1 year, with a clinical diagnosis of mild, moderate, or severe AOE and intact tympanic membranes were recruited to participate.Signs and symptoms of AOE, including ear inflammation, tenderness, edema and discharge (assessed on Days 3, 8 [End-of-Therapy] and 18 [Test-of-Cure]); microbiologic eradication (presumed or documented); and frequency of adverse events.Patients enrolled numbered 468. In culture-positive patients who met the inclusion criteria (N = 396), clinical cure rates at Day 18 were significantly higher with CIP/DEX than with N/P/H (90.9% vs. 83.9%; p = 0.0375), as were microbiologic eradication rates (94.7% vs. 86.0%; p = 0.0057). In addition, the clinical response was significantly better with CIP/DEX than with N/P/H at Days 3 and 18 (p = 0.0279 and p = 0.0321, respectively), as was the reduction in ear inflammation at Day 18 (p = 0.0268). Both preparations were well tolerated in pediatric and adult patients.7 days treatment with CIP/DEX otic suspension administered twice daily is clinically and microbiologically superior to N/P/H otic suspension administered 3 times daily in the treatment of mild to severe AOE, and is equally well tolerated. |
| Databáze: | OpenAIRE |
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