P. Careddu et al., PIDOTIMOD IN THE TREATMENT OF RECURRENT RESPIRATORY-INFECTIONS IN PEDIATRIC-PATIENTS, Arzneimittel-Forschung, 44-2(12A), 1994, pp. 1485-1489
50 young patients suffering from recurrent respiratory infections (RRI
),were treated with pidotimod 2-pyrrolidinyl)carbonyl]-thiazolidine-4-
carboxylic acid PGT/1A, CAS 121808-62-6) (one 400 mg ampoule twice a d
ay) or. placebo, according to a double-blind experimental design. The
treatment period was 20 days and there was then a 60-day follow-up per
iod. Evaluation was both clinical (number and severity of the respirat
ory infectious episodes) and immunological, investigating the OKT 4 an
d OKT 8 lymphocyte sub-populations and OKT 4/OKT 8 ratio. The group of
children treated with pidotimod shelved a decrease in the number of i
nfections. Patients fi ee from RRI episodes, after 20 days of therapy
were 68% of the group treated with pidotimod compared with 8% of the p
lacebo group. In addition, the mean duration of the episodes was lower
in treated patients than in patients of the control group. Such diffe
rences were statistically significant. It was also observed that admin
istration of the drug potentiated the immune response such that the cl
inical picture remained improved for a further 60 days after treatment
cessation. Furthermore, only in the pidotimod group there were improv
ing changes of OKT 4 and OKT 8 percentages which affected the OKT 4/OK
T 8 ratio.