Estudio sobre eficacia y seguridad de azitromicina vs amoxicilina + ácido clavulánico en el tratamiento de rinosinusitis bacteriana aguda

Abstract

Introduction. The cornerstone for the treatment of acute bacterial rhinosinusitis (ABRS) is the use of penicillins and macrolides. Objective. To prove that azithromycine provides the same or better results than amoxicillin / clavulanic acid in children with ABRS. Methodology. Comparative, randomized, prospective and experimental phase IV study (post-marketing) of 50 patients, 3 to 11 years of age with symptoms of ABRS (25 patients per group of treatment), according to the Sinusitis Committee of the American Academy of Otolaryngology and Head and Neck Surgery, i.e.: the presence of 2 major factors or one major and two minor factors of this pathology. The response and therapeutic effectiveness were determined with the following criteria: cure, improvement or failure. Patients were randomized to receive azithromycine for 3 days or amoxicillin + clavulanic acid for 10 days. Results. Every patient had major and minor factors of ABRS. At the end of treatment and of follow-up, 96% of patients in the azithromycine group were cured. In the group who received amoxicillin/clavulanate, 92% were cured. There were only 3 instances of side effects, one in the azithromycine group unrelated to the drug and two in the group treated with amoxicillin/clavulanate: mild abdominal pain and loose stools. Conclusions. Efficacy of azithromycine and amoxicillin/clavulanate is similar for the treatment of uncomplicated ABRS in children. The advantage of a 3 day treatment with azithromycine is an important factor for the adherence.