Immunostimulants for preventing respiratory tract infection in children

Immunostimulants in the prevention of respiratory infections

“…Most of the trials reported a low incidence of adverse events or no adverse events at all. We observed that most frequent adverse events were gastrointestinal complaints such as nausea, vomit, discomfort and diarrhoea, and skin disorders such as rash, urticaria and pruritus (Berber et al, 2005). According to an expert consensus, the incidence of adverse events in OM-85 BV clinical trials is 3-4% of the treated children.…”

“…Clinical effect of IS as a net difference in ARTIs incidence (confidence interval) compared to the mean number of ARTIs incidence in a placebo group considered as 100% A Cochrane systematic review on the use of IS for preventing ARTIs in children is in preparation (Berber et al, 2005). The review considers only randomised (or quasi-randomised), placebo-controlled trials.…”

Immunostimulants for preventing respiratory tract infection in children: A systematic review and meta-analysis

“…A priori, subgroup analyses were performed as they were relevant in previous versions of the present meta-analysis. 17 Initially, the protocol was published in the Cochrane Database of Systematic Reviews 2004, 19 which did not include a simple pooled analysis, allowing us to consider the characteristics of subgroups and individual studies and avoid the appearance of spurious or counterintuitive results. For the sensitivity analyses, the type of immunostimulants (D53, levamisole, OM-85, RU40171, and Thymomodulin), as well as the number of ARTIs in the control group as <2; 2 to <4; !4; !4 without the outlier were considered.…”

“…Consequently, we determined a priori that ARTIs, expressed as mean and standard deviation (SD), were the most appropriate choice for evaluating studies, as specified in the protocol and previous review. 19 Studies reporting ARTIs as mean and SD also reported on other variables (eg, sick days, school absences, number of antibiotic treatments), which mirrored and were dependent upon the number of ARTIs.…”

Inmunomodulación En Caso De Infecciones Recurrentes De Las vías Respiratorias: Nuevos Conocimientos Y Perspectivas

“…De nuevo, el efecto máximo se observó en aquellos pacientes con el número máximo de casos de recurrencia. 52 La eficacia de OM-85 también se ha evaluado en un ensayo controlado con placebo y aleatorizado con un período de seguimiento superior de 12 meses. Se trataron niños (edades 1−12 años; n=54) con IRR tanto superiores como inferiores con dos cursos de OM-85 (10 días/mes) durante 3 meses, comenzando en los meses 1 y 7.…”