RESUMO
The therapeutic activity and safety of pidotimod ((R)-3-[(S)-(5-oxo-2-pyrrolidinyl) carbonyl]-thiazolidine-4-carboxylic acid, PGT/1A, CAS 121808-62-6), a new synthetic "biological response modifier", were examined in a double-blind, placebo-controlled, multicentre trial in 101 children, including 53 boys and 48 girls aged 2-13 years (mean +/- SD: 4.7 +/- 2.1 years) with a history of recurrent respiratory infections (RRI). Pidotimod (400 mg/day) or placebo were administered orally for 60 consecutive days, followed by a further 60-day follow-up period. The trial was completed by 89.1% of patients. The results indicate that pidotimod has a beneficial effect in children with recurrent respiratory infections: the percentage of patients presenting symptoms affecting the upper and lower airways was significantly lower after treatment with the active drug than after treatment with placebo. Relevant side effects were not reported during the trial. An evaluation of the expression of CD25 (after in vitro stimulation of circulating mononuclear cells with PHA) before and after treatment with the two products revealed a significant increase in CD25+ cells in the group treated with pidotimod but not in the group treated with placebo.
Assuntos
Adjuvantes Imunológicos/uso terapêutico , Ácido Pirrolidonocarboxílico/análogos & derivados , Infecções Respiratórias/tratamento farmacológico , Infecções Respiratórias/imunologia , Tiazóis/uso terapêutico , Adjuvantes Imunológicos/efeitos adversos , Adolescente , Criança , Pré-Escolar , Método Duplo-Cego , Feminino , Humanos , Interleucina-2/biossíntese , Leucócitos/efeitos dos fármacos , Leucócitos/imunologia , Masculino , Fito-Hemaglutininas , Ácido Pirrolidonocarboxílico/efeitos adversos , Ácido Pirrolidonocarboxílico/uso terapêutico , Receptores de Interleucina-2/efeitos dos fármacos , Recidiva , Tiazóis/efeitos adversos , TiazolidinasRESUMO
In a group of 36 homozigous beta-thalassaemic children we studied the effect of splenectomy on hemorheologic characteristics. The aim of the work was to evaluate the importance of such operation either on anemia or on erythrocyte deformability. Whole blood viscosity was measured with a Brookfield Microviscometer (LVT) and erythrocyte deformability was evaluated with the erythrocyte filtration technique using policarbonate membranes. The more the erythrocyte deformability decreases, the more the erythrocyte filtration rate decreases. Our data show that splenectomized children, have worse hemorheologic characteristics according to the longer survival time of pathological red blood cells in spite of their reduced deformability. This behaviour can be modified only by blood transfusion that we have seen to be able to reduce whole blood viscosity and to increase erythrocyte filtration rate in splenectomized children. We think that splenectomy must be delayed as long as possible so that hemodinamyc conditions cannot be worsened. An hemorheologic monitorage could be useful for diagnostic and prognostic evaluations both in splenectomized and not splenectomized children.