IMMUNOACTIVITY OF PIDOTIMOD AGAINST EPISODES OF RECURRENT TONSILLITISIN CHILDHOOD

The therapeutic efficacy of the synthetic immunostimulant pidotimod 2- pyrrolidinyl)carbonyl]-thiazolidine-4-carboxylic acid, PGT/1A, CAS 121 808-62-6) was evaluated in a double-blind placebo-controlled study in parallel groups in the management of recurrences in 235 children with recurrent tonsillitis. The ambulant study provided for 15 days of trea tment with two oral vials of pidotimod 400 mg or placebo daily, in acc ordance with a randomisation list, 60 days of treatment with one oral vial of pidotimod 400 mg or placebo daily, and a 90-day follow-up peri od. The total trial period was 165 days. In addition to evaluating the number of tonsillitis recurrences which occurred during the 75 days o f treatment and the 90-day follow-up period, the number of days on whi ch the principal symptoms of the illness were present and on which dru gs such as antibiotics or anti-inflammatory agents were used concomita ntly, as well as the number of days' absence from school, were analyze d. The findings showed that, taking the treatment phase and the three- month follow-up period together, pidotimod significantly reduces the i ncidence of inflammatory upper airways episodes. The very low incidenc e of adverse effects, which was the same as that in the placebo group, confirmed the excellent safety of the product.