Abstract

Study Objective: To study the clinical efficacy of adding the novel mechanical bacterial lysate to the therapy and its effect for the local immunity in children with acute and recurrent respiratory infections in children. Study Design: comparative study. Materials and Methods. The study included 97 children hospitalised with uneventful moderate bronchitis. The subjects were divided into two groups comparable on all selection parameters. Study group: 54 patients, 3 to 10 years old, who had a microbial immunomodulatory (bacterial lysate) added to the standard therapy, 1 sublingual tablet once daily: 25 children with acute bronchitis — for 10 days; 29 children with recurrent bronchitis — 3 x 10 days with 20-day intervals. Control group included 43 children of the same age (22 subjects with acute disease and 21 — with recurrent disease) who were prescribed general therapy only. Clinical examination results and local immunity were assessed using rhinocytogram and cytokine status. Study Results. The clinical effect of the bacterial lysate was 2.4-fold reduction in acute respiratory infection rate. Acute respiratory infection duration reduced by 1.3 times. Arrest of the respiratory syndrome with the help of bacterial lysate was recorded in 10.3 ± 0.2 days, while in control group it was 13.5 ± 0.4 days (р = 0.041). The study group demonstrated statistically significant reduction in the neutrophil and epithelial cell court (rhinocytogram), interleukin-8 and tumour necrosis factor α, markers of a system respiratory inflammation. Conclusion. Prescription of the product for prevention and therapy ensures reduction in morbidity rates; it is well-tolerated, easy-to-use and has no adverse drug reactions, facilitating compliance in children and their parents. Keywords: children, acute and recurrent infections, bacterial lysate.

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