Abstract
In pediatrics, acceptability has emerged as a key factor for compliance, and consequently for treatment safety and efficacy. Polyvalent mechanical bacterial lysate (PMBL) in 50-mg sublingual tablets is indicated in children and adults for the prophylaxis of recurrent respiratory tract infections. This medication may be prescribed in children over 3 years of age; the appropriateness of this sublingual formulation should thus be demonstrated amongst young children. Using a multivariate approach integrating the many aspects of acceptability, standardized observer reports were collected for medication intake over the course of treatment (days 1, 2, and 10) in 37 patients aged 3 to 5 years, and then analyzed in an intelligible model: the acceptability reference framework. According to this multidimensional model, 50-mg PMBL sublingual tablets were classified as “positively accepted” in children aged 3 to 5 years on all three days of evaluation. As the acceptability evaluation should be relative, we demonstrated that there was no significant difference between the acceptability of these sublingual tablets and a score reflecting the average acceptability of oral/buccal medicines in preschoolers. These results highlight that sublingual formulations could be appropriate for use in preschoolers.
Highlights
IntroductionPublisher’s Note: MDPI stays neutral with regard to jurisdictional claims in published maps and institutional affiliations
We investigated in secondary analyses the influence of patient characteristics on the acceptability of 50-mg Polyvalent mechanical bacterial lysate (PMBL) sublingual tablets
There was no significant difference between patients aged 3, 4, or 5 years old in terms of sex test, p =allowed
Summary
Publisher’s Note: MDPI stays neutral with regard to jurisdictional claims in published maps and institutional affiliations. Polyvalent mechanical bacterial lysate (PMBL) is effective in adults and children for preventing RTI [1]. In experimental animal models, the release of soluble factors, most likely anti-microbial peptides, by the airway epithelium seems to play a pivotal role in the protective effect exerted by bacterial lysates against respiratory infections [2]. If these innate mechanisms can be activated by the direct binding of pathogen-associated molecular patterns (PAMPs) to immune receptors present on mucosal cells, it can be envisaged that bacterial lysates with the same PAMPs can trigger these physical mucosal barriers. (CAST) [6,7], to investigate the acceptability of 50-mg PMBL sublingual tablets in children aged 3 to 5 years
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