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Pidotimod in the management of recurrent pharyngotonsillar infections in childhood.

Abstract
The efficacy and safety of a new synthetic immunostimulant pidotimod ((R)-3-[(S)-(5-oxo-2-pyrrolidinyl) carbonyl]-thiazolidine-4-carboxylic acid, PGT/1A, CAS 121808-62-6) in recurrent infections of the primary airways were assessed in a group of 416 children with a history of recurrent respiratory infections (RRI). This was a double-blind randomized trial of pidotimod vs. placebo, consisting of a treatment period of 60 days and a follow-up period of 3 months. A reduction in the duration and frequency of infectious episodes in the group of children treated with pidotimod (one 400 mg oral bottle daily) was observed which was statistically different from the placebo group. The protective effect produced by pidotimod was also confirmed by a series of recordings made over the five-month observation period, which showed a significant reduction in the number of days of fever, the severity of the signs and symptoms of acute episodes, use of antibiotics and antipyretic drugs and absence from school or nursery school. Safety was excellent.
AuthorsD Passali, C Calearo, S Conticello
JournalArzneimittel-Forschung (Arzneimittelforschung) Vol. 44 Issue 12A Pg. 1511-6 (Dec 1994) ISSN: 0004-4172 [Print] Germany
PMID7857354 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)
Chemical References
  • Adjuvants, Immunologic
  • Thiazoles
  • Thiazolidines
  • pidotimod
  • Pyrrolidonecarboxylic Acid
Topics
  • Adjuvants, Immunologic (adverse effects, therapeutic use)
  • Adolescent
  • Adult
  • Child
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Pharyngitis (drug therapy)
  • Pyrrolidonecarboxylic Acid (adverse effects, analogs & derivatives, therapeutic use)
  • Recurrence
  • Thiazoles (adverse effects, therapeutic use)
  • Thiazolidines
  • Tonsillitis (drug therapy)

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