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Safety and Efficacy of Two Courses of OM-85 BV in the Prevention of Respiratory Tract Infections in Children During 12 Months

Safety and Efficacy of Two Courses of OM-85 BV in the Prevention of Respiratory Tract Infections in Children During 12 MonthsRespiratory tract infections (RTIs) are considered by the World Health Organization as the forgotten pandemic; they are the worldwide main cause of death in children < 5 years old and produce 8.2% of the total disease burden. In the developed countries, RTIs are the leading cause of morbidity, accounting for 20% of medical consultations, 30% of labor absenteeism. and 75% of all antibiotic prescriptions. Acute RTIs (ARTIs) in children are associated with acute otitis media, which is an important cost for health-care services and can be related to hearing loss2 and learning problems,- even in those treated properly.
The main measure to avoid deaths and disabilities related to RTI is to prevent these infections and provide early antibiotic treatment when indicat-ed.’’ Several interventions to induce nonspecific protection against ARTIs have been recently studied, such as zinc supplementation, administration of Echinacea purpurea extract, as well as intranasally administered immunoglobulins for the prevention of rhinitis, and the use of xylitol sugar syrup and chewing gum for protection against otitis media. canadian health and care mall

On this line, OM-85 BV (bronchovaxom; OM PHARMA; Geneva, Switzerland; marketed in Mexico by Quimica Knoll de Mexico) is an immunos-timulant for the prevention of ARTIs. OM-85 BV is the product of alkaline proteolysis from lysates of the following bacteria: Haemophilus influenzae; Streptococcus pneumoniae; Klebsiella pneumoniae; Klebsiella ozaenae; Staphylococcus aureus; Staphylococcus pyogenes; Streptococcus viridans; Moraxella catarrha-lis.13 Each strain contributes the same relative proportion to the total protein. OM-85 BV is mainly made of d-amino acids polypeptides (data on file).
OM-85 BV is free of lipopolysaccharides; therefore, it does not act on lipopolysaccharides receptor CD 14. In macrophage and monocytic cells, OM-85 BV increases intracellular calcium levels and induces the production of glucose regulated protein 7815 and c-fos/serum response element protein. These second messengers induce the expression of proinflammatory cytokines interleukin (IL)-1a, IL-6, IL-8, and tumor necrosis factor-a. Additionally, OM-85 BV induces phagocytic cells to produce nitric oxide and oxygen, and to express adhesion molecules.
Patients receiving OM-85 BV have shown enhancement of cellular immune responses, increase in secretory IgA and serum IgA, serum IgG and IgM,> and activation of phagocytic cells.> OM-85 BV has shown safety and efficacy in the prevention of ARTIs in exposed children attending day-care centers and orphanages and in highly susceptible children.> OM-85 BV has been shown to have some effect on children suffering from immune system defects such as IgG or IgA deficiency and common variable immunodeficiency.
The longest OM-85 BV trials have comprised periods of 6 months, with only one course of administration. We proposed that two courses of OM-85 BV would provide protection for 12 months. The aims of the present trial were to evaluate the safety and efficacy of two courses of OM-85 BV in the prevention of ARTIs in susceptible children for 12 months,