Careddu P, Mei V, Venturoli V, Corsini A
1st Department of Paediatric Clinic, University of Milan, Italy.
Arzneimittelforschung. 1994 Dec;44(12A):1485-9.
50 young patients suffering from recurrent respiratory infections (RRI) were treated with pidotimod ((R)-3-[(S)-(5-oxo-2- pyrrolidinyl) carbonyl]-thiazolidine-4-carboxylic acid, PGT/1A, CAS 121808-62-6) (one 400 mg ampoule twice a day) or placebo, according to a double-blind experimental design. The treatment period was 20 days and there was then a 60-day follow-up period. Evaluation was both clinical (number and severity of the respiratory infectious episodes) and immunological, investigating the OKT 4 and OKT 8 lymphocyte sub-populations and OKT 4/OKT 8 ratio. The group of children treated with pidotimod showed a decrease in the number of infections. Patients free from RRI episodes, after 20 days of therapy, were 68% of the group treated with pidotimod compared with 8% of the placebo group. In addition, the mean duration of the episodes was lower in treated patients than in patients of the control group. Such differences were statistically significant. It was also observed that administration of the drug potentiated the immune response such that the clinical picture remained improved for a further 60 days after treatment cessation. Furthermore, only in the pidotimod group there were improving changes of OKT 4 and OKT 8 percentages which affected the OKT 4/OKT 8 ratio.
50名患有反复呼吸道感染（RRI）的年轻患者，根据双盲实验设计，接受匹多莫德（(R)-3-[(S)-(5-氧代-2-吡咯烷基)羰基]-噻唑烷-4-羧酸，PGT/1A，CAS 121808-62-6）治疗（每日两次，每次1支400mg）或安慰剂治疗。治疗期为20天，随后有60天的随访期。评估包括临床评估（呼吸道感染发作的次数和严重程度）和免疫学评估，研究OKT 4和OKT 8淋巴细胞亚群以及OKT 4/OKT 8比值。接受匹多莫德治疗的儿童组感染次数减少。治疗20天后，无RRI发作的患者在匹多莫德治疗组中占68%，而在安慰剂组中占8%。此外，治疗患者发作的平均持续时间低于对照组患者。这些差异具有统计学意义。还观察到，药物给药增强了免疫反应，使得在停止治疗后临床症状在接下来的60天内仍保持改善。此外，只有在匹多莫德组中，OKT 4和OKT 8百分比有改善变化，这影响了OKT 4/OKT 8比值。
