Avaliação histopatológica dos efeitos imediatos e tardios provocados por lipólise enzimática a base de deoxicolato de sódio manipulado no tecido subcutâneo de ratos

Abstract

BACKGROUND: Sodium deoxycholate has been widely used for enzymatic dissolution of the submental fat compartment, and Kybella® is the gold standard product used worldwide. However, countries like Brazil did not authorize the importation and use of Kybella® in national territory, which opened precedents for manipulation laboratories to produce and market 1% sodium deoxycholate for the same purpose. OBJECTIVES: To evaluate the efficacy and possible immediate and late side effects produced by repeated subcutaneous injections of 1% sodium deoxycholate from the Brazilian laboratory BIOMETIL in the subcutaneous tissue of rats, as well as to assess whether there are similarities in results when compared to previous studies that analyzed the behavior from Kybella. METHODS: 50 male Wistar rats divided into two groups of 25 animals were treated. A control group to which 15mg/kg of sterile saline solution was administered and a treated group, which received subcutaneous injections of 1% sodium deoxycholate at 15mg/kg from the BIOMETIL laboratory. Both groups received 3 doses of substances with an interval of 7 days between each session and were euthanized 24hrs, 7 days, 30 days, 60 days and 90 days after the last application. Samples of the injected tissue were removed, fixed in formalin, embedded in paraplast, sectioned at 5 µm and stained with hematoxylin and eosin. Histological analyzes were performed, evaluating the presence of tissue necrosis, inflammatory process and fibrosis, morphology and number of adipocytes. CONCLUSION: Biometil sodium deoxycholate 1% presented adverse effects similar to those presented by Kybella in its histological studies, causing intense local inflammation with gradual remission over time, leading to cell lysis and adipose tissue necrosis, reduction in diameter and number of adipocytes. As a side effect, the presence of focal alopecia was observed in the treated groups.