Rol de los lisados bacterianos en asma, evidencia y proyección con especial referencia a OM-85 / Role of bacterial lysates in asthma, evidence and projection with special reference to OM-85

Existen diversos lisados bacterianos, siendo OM-85 (Broncho-Vaxom®) el que posee mayor evidencia en cuanto a su rol inmunoprotector sobre infecciones respiratorias en población pediátrica. Sus mecanismos de acción producen efectos inmunomoduladores que potencialmente podrían prevenir el asma en etapas precoces de la vida, actuar sobre la disminución de crisis y ser un aporte a la terapia convencional del asma. Este artículo expone las principales evidencias en relación con estos compuestos, con enfoque en la actualidad y el desarrollo futuro, en especial sobre OM-85.

There are several bacterial lysates, being OM-85 (Broncho-Vaxom®) the one with the greatest evidence regarding its immunoprotective role on respiratory infections in the pediatric population. Its mechanisms of action produce immunomodulatory effects that could potentially prevent asthma in early stages of life, act on the reduction of crisis and be a contribution to conventional asthma therapy. This article shows the main evidences in relation to these compounds, the current focus and future development, especially on OM-85.

The Effect of the Oral Bacterial Extract OM-85 BV on Asthma Control- a Prospective Study.

Aims: To identify the effect of the oral bacterial extract OM-85 on essential parameters of asthma control. Study Design: This was a double blind, prospective study, consistent of a 4 week run-in and a 24 week double blind period. Place and Duration of Study: An outpatient clinic, in collaboration with “St Andrew’s’’ General State Hospital in Patras/Greece, between October 2010 and April 2011. Methods: Patients (aged 15-57, N=130) with persistent allergic asthma, were assessed and divided accordingly, in three strata: Stratum I (not controlled asthma, NCA), stratum 2 (partly controlled asthma, PCA) and stratum 3 (controlled asthma, CA). At the end of the run-in period were randomized to receive additionally to their standard treatment (appropriate doses inhaled budesonide and formoterol), 7mg oral OM-85 BV or matching placebo. Primary end-point was the proportion of patients with controlled asthma in every group. Change from baseline budesonide, mean FEV1, PEF, daytime asthma symptoms score, night awakenings, rescue b2-agonist use and serum interferon-γ (INF-γ) levels were also recorded and included in the final analysis. Results: At the end of the 24 week follow up, stratum I patients, treated additionally with OM-85 BV, presented significantly higher proportion of subjects with controlled (28.09% versus 18.7%, P<0.001), and partly controlled asthma (57% versus 43.7%, (P= 0.04). Almost all patients demonstrated significant increases (P<0.001) from baseline in FEV1.The percentage change from baseline FEV1 was 21.8% for OM-85 BV versus 12.1% for the placebo group. Same tendencies were recorded in every stratum and concerned al secondary end points, despite a lower dose of budesonide. Conclusions: Patients treated additionally with OM-85 BV achieved better asthma control despite a lower dose of budesonide.