Caramia G, Clemente E, Solli R, Mei V, Cera R, Carnelli V, Venturoli V, Corsini A
Pediatric Department, Ospedale dei Bambini G. Galilei, Italy.
Arzneimittelforschung. 1994 Dec;44(12A):1480-4.
The activity of 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, randomized, multicentre trial, on 120 pediatric patients affected by recurrent respiratory infections. The clinical course of acute infections was favourable both in placebo and in treatment group, but recovery was quicker with pidotimod than with placebo. Antibiotic therapy and time of hospitalization were shorter in the patients taking pidotimod, and main symptomatic parameters (pharyngalgia, dysphagia, mucous membrane inflammation, adenopathy, anorexia) receded quickly. In patients receiving the drug as well as in placebo group changes in laboratory parameters, indicating recovery from the acute infectious events, were observed. A significant trend to normalization of the immune response, evidenced by chemotaxis and leukocyte phagocytosis index, was found only in patients treated with pidotimod. A significant decrease in the risk of relapses was observed in patients treated with pidotimod (35%), as well as a reduction of hospitalization (86%) and a decreased antibiotic therapy (47%). If a relapse occurred, the response of treated patients was quicker (fever, antibiotic therapy, hospitalization). These findings allow to correlate the individual immune response activation to the resistance to recurrent infections and also to a better response to therapy in case of clinically relevant disease. No side effects were observed. Only in 12 patients (5 pidotimod, 7 placebo) mild reactions were observed, but they were attributed to concomitant antibiotic treatment or other factors. No alterations in main laboratory parameters were seen.(ABSTRACT TRUNCATED AT 250 WORDS)
在一项针对120名患有反复呼吸道感染的儿科患者的双盲、安慰剂对照、随机、多中心试验中，对匹多莫德（(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）的活性进行了评估。急性感染的临床病程在安慰剂组和治疗组中均较为有利，但匹多莫德组的恢复速度比安慰剂组更快。服用匹多莫德的患者抗生素治疗时间和住院时间更短，主要症状参数（咽痛、吞咽困难、黏膜炎症、腺病、厌食）消退迅速。在接受药物治疗的患者以及安慰剂组中，均观察到表明从急性感染事件中恢复的实验室参数变化。仅在接受匹多莫德治疗的患者中发现趋化性和白细胞吞噬指数所证明的免疫反应有显著的正常化趋势。接受匹多莫德治疗的患者复发风险显著降低（35%），住院率降低（86%），抗生素治疗减少（47%）。如果发生复发，治疗患者的反应更快（发热、抗生素治疗、住院）。这些发现使个体免疫反应激活与对反复感染的抵抗力相关联，也与临床相关疾病时对治疗的更好反应相关联。未观察到副作用。仅在12名患者（5名匹多莫德组，7名安慰剂组）中观察到轻微反应，但这些反应归因于同时进行的抗生素治疗或其他因素。未观察到主要实验室参数的改变。（摘要截短至250字）
