A single topical agent is clinically equivalent to the combination of topical and oral antibiotic treatment for otitis externa
| Autor: | Peter S, Roland, Barbara P, Belcher, Robert, Bettis, Reynaldo L, Makabale, Peter J, Conroy, G Michael, Wall, Sheryl, Dupre, Susan, Potts, Gail, Hogg, Kaye, Weber, Alex, White |
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| Rok vydání: | 2008 |
| Předmět: |
Adult
Male medicine.medical_specialty Adolescent Hydrocortisone Administration Topical Administration Oral law.invention Cortisporin Anti-Infective Agents Randomized controlled trial Ciprofloxacin law Internal medicine Multicenter trial Humans Medicine Polymyxins Dosing Child Adverse effect business.industry Amoxicillin Infant Neomycin Middle Aged Otitis Externa Confidence interval Anti-Bacterial Agents Treatment Outcome Otitis Therapeutic Equivalency Otorhinolaryngology Child Preschool Anesthesia Acute Disease Female medicine.drug_brand medicine.symptom business medicine.drug |
| Zdroj: | American Journal of Otolaryngology. 29:255-261 |
| ISSN: | 0196-0709 |
| Popis: | Objective To demonstrate clinical equivalence (statistical noninferiority) of topical ciprofloxacin and hydrocortisone (CHC, Cipro HC) and topical neomycin/polymyxin b/hydrocortisone (NPH, Cortisporin) with systemic amoxicillin (AMX, Amoxil), for treatment of acute otitis externa (AOE). Design Randomized, active-control, observer-blind, multicenter trial. Patients Altogether, 206 patients were enrolled (CHC, 106; NPH + AMX, 100). Patients were ≥1 year of age, had AOE >2 days with at least mild symptoms, and gave informed consent. All were evaluable for safety, and 151 were evaluable for efficacy. Interventions Ciprofloxacin and hydrocortisone 3 drops twice daily for 7 days (adults and children) or NPH 4 drops (adults) or 2 drops (children) with AMX 250 mg (adults and children) 3 times daily for 10 days, as directed in approved product labeling. Main Outcome Measures The primary efficacy variable was response to therapy 7 days after treatment ended (test of cure). Secondary variables included time to end of pain, symptom scores (otalgia and tenderness) and microbiological eradication. Noninferiority was declared if the lower confidence limit around the measurement difference was above −10 (nearer zero). Results Response to therapy was higher for CHC (95.71% vs 89.83%) but was statistically noninferior (lower confidence limit, −4.98) to NPH + AMX. Median time to end of pain was 6 days for both groups. Noninferiority was declared for symptom scores at all measurement periods and for microbiological eradication. No serious adverse events related to treatment were reported. Conclusions Ciprofloxacin and hydrocortisone is clinically equivalent to NPH + AMX for the treatment of AOE in adults and children. However, low systemic exposure, absence of ototoxicity, and less frequent dosing clearly favor Cipro HC. |
| Databáze: | OpenAIRE |
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