Ribosomal immunostimulation: assessment of studies evaluating its clinical relevance in the prevention of upper and lower respiratory tract infections in children and adults.
OBJECTIVE
To review the efficacy of the ribosomal immunostimulant Ribomunyl in preventing upper and lower respiratory tract infections.


METHODS
Review of studies of 3 and 6 months' duration comprising part of the international registration file.


METHODS
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.
D000284:Administration, Oral; D000328:Adult; D000942:Antigens, Bacterial / Q000627:therapeutic use*; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D017048:Health Care Costs; D006801:Humans; D007114:Immunization; D010038:Otorhinolaryngologic Diseases / Q000188:drug therapy* / Q000382:microbiology / Q000517:prevention & control*; D012141:Respiratory Tract Infections / Q000188:drug therapy* / Q000382:microbiology / Q000517:prevention & control*; D012270:Ribosomes / Q000276:immunology*; D013997:Time Factors; D016896:Treatment Outcome
D000942:Antigens, Bacterial; C034206:Ribomunyl