作者: Joseph E. Dohar , Eric T. Garner , Richard W. Nielsen , Merril A. Biel , Mindell Seidlin
DOI: 10.1001/ARCHOTOL.125.5.537
关键词:
摘要: Objective To determine the safety and efficacy of ofloxacin otic solution in treatment acute otorrhea children with tympanostomy tubes. Design Multicenter study an open-label, prospective arm retrospective historical current practice arms. Setting Ear, nose, throat pediatric general clinics office-based practices. Subjects Children younger than 12 years purulent presumed bacterial origin Intervention Instillation 0.3% ofloxacin, 0.25 mL, twice daily for 10 days arm; review medical records Main Outcome Measures The primary index clinical was absence (cure) or presence (failure) at to 14 after therapy. microbiologic (in only) eradication pathogens isolated baseline. Safety evaluated only. Results Significantly more clinically evaluable ofloxacin-treated subjects were cured (84.4%; 119/141) (64.2%; 140/218) (P≤.001) (70%; 33/47) (P≤.03). All baseline eradicated 103 (96.3%) 107 microbiologically subjects. Adverse events considered "possibly" "probably" related occurred 29 (12.8%) 226 Conclusion Ofloxacin is safe significantly effective treatments used