01-09-2003 | Original Research Article
Ribosomal Immunostimulation
Assessment of Studies Evaluating its Clinical Relevance in the Prevention of Upper and Lower Respiratory Tract Infections in Children and Adults
Published in: BioDrugs | Issue 5/2003
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Objective
To review the efficacy of the ribosomal immunostimulant Ribomunyl® in preventing upper and lower respiratory tract infections.
Design and setting
Review of studies of 3 and 6 months’ duration comprising part of the international registration file.
Patients
Data from 2117 patients (1215 children and 902 adults); ribosomal immunostimulant n = 1062, placebo n = 1055.
Results
Nineteen randomised, double-blind, placebo-controlled clinical trials were performed between 1983 and 1994 in Europe. In children with ear-nose-throat (ENT) infections, 3 months’ ribosomal immunostimulant treatment significantly decreased the mean number of recurrences (27–68% reduction), and reduced the duration of infection (28–66% reduction) and antibacterial requirement (29–60% reduction). Ribosomal immunostimulant was similarly effective in children with ENT and bronchopulmonary infections, reducing the mean number of recurrences by 32–61% compared with placebo. In children with otitis media, ribosomal immunostimulant reduced recurrences by 10–53% and also reduced the duration of infection, antibacterial use and local surgery requirement. Results obtained from studies of 6 months’ duration confirmed or extended these results. In adult patients with ENT or mixed respiratory infections, ribosomal immunostimulant produced similar reductions to those seen in children for recurrent infections (54–78% reduction), duration of infection (42–79% reduction) and antibacterial use (38% reduction).
Conclusions
These results clearly demonstrate that ribosomal immunostimulant is effective in preventing and in reducing upper and lower respiratory tract infections in children and adults.