Primary care experience on Stimunex® gocce in children with recurrent respiratory infections: a real-world study during the COVID-19 pandemic era.

BACKGROUND: Respiratory infections (RI) significantly burden society, mainly when there are recurrent respiratory infections (RRI). Thus, there is a need to prevent RI in clinical practice. In this regard, the modulation of the immune system and resolution of the inflammatory cascade could represent an ideal way to prevent RI. Stimunex® gocce, a multicomponent food supplement, contains Sambucus nigra extract, ß-glucan, Zinc, and Vitamin D3. This study investigated its ability to prevent RRI in children using a real-world setting: the pediatric primary care. MATERIALS AND METHODS: Two hundred and ninety-eight children with RRI were enrolled in the current study. The food supplement was randomly prescribed to 160 children with RRI daily for 4 months (Active group); the remaining 138 children with RRI were treated only with standard therapy for RI (Control group). The number and duration of RI, parental perception of symptom severity and treatment efficacy, use of medications, and school and working absence were evaluated. RESULTS: Children treated with Stimunex® gocce had significantly less RI than the Control group, both concerning upper and lower RI (p˂0.001 and 0.003, respectively) during the follow-up period. Moreover, children in the Active group experienced shorter RI duration during the treatment and follow-up phases (p˂0.001 for both). In addition, parents of treated children perceived less severe symptoms and better treatment efficacy during the first and follow-up phases (p˂0.001 for all). The food supplement was well tolerated and there was no adverse event. CONCLUSIONS: The current real-world study demonstrated that Stimunex® gocce supplementation in children with RRI might safely prevent RI episodes and reduce RI duration. These outcomes should be highlighted as obtained during the COVID-19 pandemic era, characterized by a dramatic reduction of RI.

Use of Streptococcus salivarius K12 to reduce the incidence of pharyngo-tonsillitis and acute otitis media in children: a retrospective analysis in not-recurrent pediatric subjects.

BACKGROUND: Previous trials, performed in subjects affected by recurrent streptococcal pharyngo-tonsillar infection, have shown that the use for 90 days of Streptococcus salivarius K12 (K12), an oral colonizing probiotic producing lantibiotic bacteriocins, reduces the occurrence of streptococcal and viral pharyngitis and acute otitis media (AOM). The aim was to evaluate the role of K12 in reducing the incidence of streptococcal and viral pharyngo-tonsillitis and AOM when administered in two separate trimesters, from October to December and then from April to June, in pediatric subjects with non-recurrent streptococcal infection. METHODS: We retrospectively analyzed the incidence of pharyngo-tonsillitis and AOM in 133 children by comparing the number of episodes occurring between September 1st, 2014 and August 31st, 2015, when no treatment with K12 was given, with the period between September 1st, 2015 and August 31st, 2016, when K12 was administered. RESULTS: Analysis of the findings for the 133 children demonstrated that K12 use decreased the incidence of pharyngo-tonsillitis by about 90% (P<0.001) and the occurrence of AOM by about 70% (P<0.001) and confirms the high safety profile of the strain. CONCLUSIONS: As already demonstrated in subjects with recurrent streptococcal pharyngo-tonsillar infection, K12, if administered for two trimesters out of 12 months, is associated with a reduced incidence of pharyngitis and AOM in pediatric subjects with non-recurrent streptococcal infection.

Graves disease in children: thyroid-stimulating hormone receptor antibodies as remission markers.

OBJECTIVE: To evaluate clinical and biochemical features of 115 children (98 female, mean age 11.3 ± 3.5 years) with Graves disease to identify possible determinants of remission. STUDY DESIGN: We defined as positive outcome the improvement of clinical features and restoration of euthyroidism or induction of hypothyroidism after antithyroid drug (ATD) therapy and as negative outcome hyperthyroidism persistent over 2 years of ATD therapy or relapsed after ATD withdrawal. RESULTS: Thirty-eight children (33%) had remission after 2 years of ATD therapy. The absence of goiter at diagnosis was correlated with a better outcome. Median thyroid-stimulating hormone receptor antibody (TRAb) values at diagnosis were significantly lower in patients with a positive outcome (P = .031). We found a significant relationship between the time required for TRAb normalization and the patient outcome; TRAb normalization within 1 year from time of Graves disease diagnosis was significantly more common among patients with a positive outcome (P < .0001), and the mean time for TRAb normalization was significantly shorter in patients with a positive outcome (1.3 ± 0.8 years) compared with that observed in patients with a negative outcome (2.5 ± 2.7 years, P = .026). CONCLUSIONS: Although no clinical variable investigated is constantly associated with a definite outcome, the absence of goiter at the diagnosis may be associated with a better outcome. The most relevant predictor of Graves disease outcome was serum level; TRAb at time of Graves disease diagnosis less than 2.5 times the upper reference limit, TRAb normalization during ATD, and TRAb normalization timing each may predict positive outcomes. These results may have a role in the empiric clinical management of pediatric patients with Graves disease.

Primary care experience on Stimunex® gocce in children with recurrent respiratory infections: a real-world study during the COVID-19 pandemic era

Background:Respiratory infections (RI) significantly burden society, mainly when there are recurrent respiratory infections (RRI). Thus, there is a need to prevent RI in clinical prac-tice. In this regard, the modulation of the immune system and resolution of the inflamma-tory cascade could represent an ideal way to prevent RI. Stimunex® gocce, a multicomponent food supplement, contains Sambucus nigra extract, β-glucan, Zinc, and Vitamin D3. This study investigated its ability to prevent RRI in children using a real-world setting: the pediatric pri-mary care. Materials and methods:Two hundred and ninety-eight children with RRI were enrolled in the current study. The food supplement was randomly prescribed to 160 children with RRI daily for 4 months (Active group); the remaining 138 children with RRI were treated only with stan-dard therapy for RI (Control group). The number and duration of RI, parental perception of symptom severity and treatment efficacy, use of medications, and school and working absence were evaluated.Results:Children treated with Stimunex® gocce had significantly less RI than the Control group, both concerning upper and lower RI (p<0.001 and 0.003, respectively) during the follow-up period. Moreover, children in the Active group experienced shorter RI duration during the treatment and follow-up phases (p<0.001 for both). In addition, parents of treated children perceived less severe symptoms and better treatment efficacy during the first and follow-up phases (p<0.001 for all). The food supplement was well tolerated and there was no adverse event.Conclusions: The current real-world study demonstrated that Stimunex® gocce supplemen-tation in children with RRI might safely prevent RI episodes and reduce RI duration. These outcomes should be highlighted as obtained during the COVID-19 pandemic era, characterized by a dramatic reduction of RI. (AU)

[ECG for non-competitive sports in childhood: strengths and disputes]. / ECG per l'idoneità all'attività sportiva non agonistica in età pediatrica: punti di forza e controversie.

BACKGROUND: Sport is very important for health promotion and conservation. Active lifestyle and regular exercise reduce cardiovascular disease incidence. The Italian Ministry of Health issued the Law Decree no. 243 (10/18/2014) concerning "guidelines for certification about non-competitive sports" to promote safety in sports. This regulation defines the activities for which a certificate is required, the professional actors involved and the clinical exams to be performed according to the patient's health status. In particular, the Law Decree recommends to perform an electrocardiogram (ECG) "at least once in a lifetime", introducing much greater news into pediatric practice. METHODS: We proposed a survey evaluating frequency of ECG implementation for non-competitive sports and cardiovascular diseases incidence was administered to 7 Ligurian pediatricians. RESULTS: The number of ECG/year for pediatrician increased from 10 ECG/year to 50 ECG/year with an indication of suitability to non-competitive sports. One case of QT prolongation and 2 cases of type 1 Brugada ECG pattern were diagnosed. In addition, 3 patients had an atrial septal defect and 3 children had a ventricular septal defect. Forty-three percent of the pediatricians considered useful performing the ECG. CONCLUSIONS: ECG in children has enhanced the positive effects on the community health. However, it remains to be defined in agreement with scientific societies the age at which to perform ECG, the sports for which ECG is required and the cost-benefit ratio for the National Health System and families.

Beta-cell autoimmunity in pediatric celiac disease: the case for routine screening?

OBJECTIVE: To evaluate the prevalence of beta-cell autoimmunity and the usefulness of a type 1 diabetes screening in patients with celiac disease. RESEARCH DESIGN AND METHODS: We measured GAD antibodies (GADAs), insulinoma-associated protein 2 antigens (IA-2As), and insulin autoantibodies (IAAs) in 188 young Italian patients with celiac disease (66 male [35.1%]). Mean age at celiac disease diagnosis was 5.4 years (0.5-17.1), and mean celiac disease duration was 4.2 years (0-28.8). Celiac disease was diagnosed by jejunal biopsy after positivity for endomysial and tissue transglutaminase antibody was confirmed. RESULTS: GADAs were positive in seven patients (3.7%), and IA-2As were positive in two patients. IAAs were negative in all cases. Metabolic evaluation was normal, and no patients developed diabetes during follow-up. There was no significant association among beta-cell autoimmunity and sex, age, pubertal stage, family history, or coexistence of other autoimmune disorders; compliance to a gluten-free diet was confirmed. CONCLUSIONS: Our results showed a low prevalence of beta-cell autoimmunity and do not support a precocious screening for beta-cell autoimmunity in young celiac disease patients.

Surgical site infections in an Italian surgical ward: a prospective study.

BACKGROUND: Surgical site infection (SSI) remains a major cause of morbidity and death. This study analyzed the results of surveillance to evaluate the incidence, risk factors, and characteristics of SSI in patients who underwent an operation in a typical Italian surgical ward. METHODS: A group of 1,281 patients operated on from August 2005 to December 2007 underwent prospective and direct observation of incisions by a surgeon according to the U.S. Centers for Disease Control and Prevention (CDC) National Nosocomial Infections Surveillance (NNIS) method. The minimum follow-up was 30 days. A locally-modified risk index score (LRI) based on the NNIS was calculated for each patient, using as a cut point the 75(th) percentile of the duration of surgery (in minutes) for that particular procedure. RESULTS: Seventy-six patients were affected by incision site infection, and the SSI rate was 5.9%. Thirty-four (2.6% of the series) were superficial incisional, 32 (2.5%) deep incisional, and 10 (0.8%) organ/space SSIs. An increasing value of the LRI was significantly (p < 0.05) related to an increasing risk of infection. The SSI rates were 0.6%, 3.7%, 7.3%, and 26.8% for LRI value of M = - 1, 0, 1, and >or=2, respectively. Obesity (body mass index >30 kg/m(2)), diabetes mellitus, and emergency surgery were associated with a higher risk of infection by multivariable analysis independent of the LRI. CONCLUSIONS: The NNIS method can be useful for SSI surveillance and monitoring in single surgical wards. Longer operations, diabetes mellitus, and obesity increase the risk of SSI, as does performance of surgery in an emergency situation.