Azitromicina no tratamento da polipose nasossinusal eosinofílica: análise clínica e histomorfológica em um estudo randomizado, duplo mascarado, com placebo

Abstract

Introduction: The Eosinophilic Nasal Polyposis (ENP) is a chronic inflammatory disease characterized by the formation of benign, multiple and bilateral nasal polyps. ENP has a multifactorial pathogenesis, being always associated with chronic inflammation. It is a benign disease, but with severe impairment life’s quality of patients. When associated with asthma and a history of aspirin intolerance, it is more serious in relation to paranasal sinus involvement and a greater chance of relapse after surgical treatment. Considering that there is no known efficient treatment for effective control or cure of ENP associated with asthma and history of aspirin intolerance. It is possible to evaluate the action of new treatment (Azithromycin) used as an immunomodulator. Objectives: To evaluate the action of Azithromycin used as immunomodulator in patients with the triad ENP, asthma and clinical history of aspirin intolerance, compared to placebo. Case study and methodology: This is a randomized double-masked placebo-controlled trial in patients with the triad ENP, asthma, and clinical history of aspirin intolerance. A comparison of pre-treatment and post-treatment azithromycin patients at a dose of 500mg orally three times a week for 12 weeks was performed. Patients underwent clinical examination, and application of the AVS, staging, application of SNOT-22 and biopsy of nasal polyps at the beginning and the end of treatment. Results: forty-eight patients completed the study. There were 27 patients treated with azithromycin and 21 with placebo. The medication was well tolerated overall. There was significant clinical improvement in posttreatment (VAS) in both groups, and in the Azithromycin group it was more significant. Regarding SNOT and staging, there was a decrease only in the treated group (p <0.05) and the difference in relation to the placebo group was significant. It was also observed a reduction in the number of eosinophils in the lamina count of the treated group, comparing pre and post-intervention (p <0.05). Of the 48 patients who completed the treatment, 20 patients in the Azithromycin group (74%) were not referred for surgery; in the placebo group only 3 (14%) were not referred for surgery. Conclusion: Azithromycin, based on the study, could be considered a therapeutic option for triad ENP, asthma, and clinical history of aspirin intolerance.