Immunoactivity of pidotimod against episodes of recurrent tonsillitis in childhood.
The therapeutic efficacy of the synthetic immunostimulant pidotimod ((R)-3-[(S)-(5-oxo-2-pyrrolidinyl) carbonyl]-thiazolidine-4-carboxylic acid, PGT/1A, CAS 121808-62-6) 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 treatment with two oral vials of pidotimod 400 mg or placebo daily, in accordance 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 period. The total trial period was 165 days. In addition to evaluating the number of tonsillitis recurrences which occurred during the 75 days of treatment and the 90-day follow-up period, the number of days on which the principal symptoms of the illness were present and on which drugs such as antibiotics or anti-inflammatory agents were used concomitantly, as well as the number of days' absence from school, were analyzed. The findings showed that, taking the treatment phase and the three-month follow-up period together, pidotimod significantly reduces the incidence of inflammatory upper airways episodes. The very low incidence of adverse effects, which was the same as that in the placebo group, confirmed the excellent safety of the product.
Motta
G
G
Institute of Otorhinolaryngology and Phoniatrics, Faculty of Medicine and Surgery II, Naples University, Italy.
De Campora
E
E
De Vita
C
C
Esposito
S
S
Galletti
C
C
Incutti
V
V
Mallardi
V
V
Motta
S
S
Pucci
V
V
Salonna
F
F
D000276:Adjuvants, Immunologic / Q000009:adverse effects / Q000627:therapeutic use*; D000293:Adolescent; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D011761:Pyrrolidonecarboxylic Acid / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D012008:Recurrence; D013844:Thiazoles / Q000009:adverse effects / Q000627:therapeutic use*; D053778:Thiazolidines; D014069:Tonsillitis / Q000150:complications / Q000188:drug therapy* / Q000276:immunology
D000276:Adjuvants, Immunologic; D000900:Anti-Bacterial Agents; D000893:Anti-Inflammatory Agents; D013844:Thiazoles; D053778:Thiazolidines; C064893:pidotimod; D011761:Pyrrolidonecarboxylic Acid