Clinical Trial
English Abstract
Journal Article
Randomized Controlled Trial
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[Usage of medicines inducing secretolisys in treatment of acute otitis media in children].

Acute otitis media is one of the most common diseases in childhood and adolescence. Its incorrect and non-rational treatment increases the frequency of complicated acute forms of the disease. Objective of the study was to define effectiveness of mucoregulatory medication (namely Sinupret produced by Bionorica A.G. Germany) for treatment of complicated forms of AOM along with antibiotics in children. The trial has been conducted at Tbilisi M. Guramishvili Pediatric Clinic. It represented a randomized controlled trial of two prescribing strategies for acute otitis media. The participants have been 64 children with AOM-preperforation stage. Among them 32 patients (study group) got oral antibiotics--Amoxicillin along with the mucoregulatory remedy (Sinupret) and the rest 32 patients (control group) received Amoxicillin orally (Amoxicillin was used 40-45 mg/kg/24 h in children and 1,5-3 g/24 h in adults) divided in three administrations. The clinical effect of treatment was assessed according to the following data: subjectively-complaints of patients; objectively-clinical examination data (otoscopy), blood test data; tympanometric data. Measurements have been conducted at the beginning of treatment, on the third, seventh days, at the end of the course of treatment and two weeks later. Subjectively patients complained about unbearable pains in the ear, anxiety, abrupt reduction of hearing, murmurs in the ears acquiring pulsative nature, high temperature. For the treatment of complicated forms of acute otitis media (III stage) mucoregulatory remedies in combination with antibiotics were quite effective. It reduces necessity of paracentesys; increases the efficiency of accompanying antibiotic therapy and reduces frequency of complications.

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