Immunomodulating activity of Pidotimod in children with Down syndrome.

Acute respiratory tract infections (ARTIs) are the most frequent illnesses in pediatric age, frequently experienced in children with Down Syndrome (DS) due to the associated immune defects of both specific and non-specific immunity. Pidotimod, a synthetic immunostimulant, was shown to reduce the rates of ARTIs in children with DS, however the mechanisms associated with this effect is currently unknown. We analyzed immune parameters in DS children who received the seasonal 2011–2012 virosomal-adjuvanted influenza vaccine. Eighteen children aged 3-10 years (mean age 7.1+/-2.6 years) were randomly assigned (1:1 ratio) to receive Pidotimod 400 mg, administered orally once a day for 90 days or placebo. At the recruitment (T0) all children received a single dose of virosomal-adjuvanted influenza vaccine (Flu). Blood samples were collected at T0 and 3 months after the recruitment (T3) in order to evaluate innate and adaptative immune responses pathway. Flu-specific IgG1 and IgG3 levels in plasma samples were determined at pre-vaccination (T0), and 1 (T1) and 3 months (T3) post-vaccination. The use of Pidotimod was associated with the upregulation of a number of genes involved in the activation of innate immune responses and in antimicrobial activity. Interestingly the ratio of Flu-specific IgG1/IgG3 was skewed in pidotimod-treated individuals, suggesting a preferential activation of complement-dependent effector mechanisms. Although preliminary these data suggest that Pidotimod can potentiate the beneficial effect of immunization, possibly resulting in a stronger activity of both innate and adaptive immune responses.

[The metabolic and psychological assessment of 40 adolescents with type-1 diabetes during 6 months of intensified insulin therapy using the pen injector or the traditional syringe]. / Valutazione metabolica e psicologica in 40 adolescenti affetti da diabete tipo I durante 6 mesi di terapia insulinica intensificata mediante stilo-iniettore o siringa tradizionale.

Metabolic control and psychological parameters in forty insulin-dependent diabetic adolescents were evaluated during a sequential crossover study comparing two insulin regimens: a) 6 months of conventional insulin therapy (CIT) (T0-T1) using twice-daily mixture of short-acting and intermediate-acting insulins (AcHM and MoHM); b) 6 months of intensified insulin therapy (IIT) (T1-T2) using two pre-meal injections of short-acting insulin (AcHM) and one pre-dinner mixture of short-acting plus ultralente-acting insulin (AcHM + UtHM). Twenty patients received the pre-meal short-acting insulin with a pen-injector (group A) and twenty with conventional syringes (group B). All of participant received the pre-dinner insulin mixture with traditional syringes. Fasting blood glucose (BG), fructosamine, HbA1c, anxiety, depression levels and patient daily life adjustment (T1, T2) were investigated. The metabolic parameters showed similar results in both groups. There was no fasting BG variation during IIT, while post-meal (lunch and dinner) BG reduction (p less than 0.01) was observed. HbA1c levels didn't decrease but fructosamine levels significantly decreased at T2 time. Severe hypoglycemia where never observed, while the frequency of slight hypoglycaemic reactions didn't change during the study. The psychological parameters showed no differences at T0 and T1, while the differences became remarkable between the groups at T2 time. Home anxiety slightly decreased in group A and increased in group B (p less than 0.05). In group A an improvement of self-care initiative (self-injections) occurred too. In conclusion this study showed that, in a limited group of insulin-dependent diabetic adolescents, IIT with three daily injections improved fructosamine and post-meal BG levels.(ABSTRACT TRUNCATED AT 250 WORDS)