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Background: Familial chylomicronemia syndrome (FCS) is a rare inherited condition due to lipoprotein lipase deficiency, characterized by hyperchylomicronemia and severe hypertriglyceridemia. Diagnosis is often delayed, thus increasing the risk of acute pancreatitis and hospitalization. Hypertriglyceridemia is a common finding in patients with type 2 diabetes (T2D), who may harbor FCS among the most severe forms. Aim of the Study: We investigated the prevalence and clinical characteristics associated with severe hypertriglyceridemia in a range indicative of FCS, in a large population of subjects with T2D. Methods: Within the large population of the AMD Annals Initiative, patients with T2D with a lipid profile suggestive of FCS [triglycerides >880 mg/dL and/or high-density lipoprotein (HDL)-cholesterol <22 mg/dL or non-HDL-cholesterol ≤70 mg/dL] and their clinical features have been identified. Results: Overall, 8592 patients had triglyceride values >880 mg/dL in a single examination, 613 in two examinations, and 34 in three or more measurements. Patients with high triglyceride levels were mostly male (80%), with a relatively young age (54 years), short duration of diabetes (6.3 years), and elevated hemoglobin A1c (HbA1c) levels (9.4%). By stratifying this group of patients according to the severity of hypertriglyceridemia, more severe hypertriglyceridemia (triglyceride levels ≥2000 mg/dL) was associated with an even younger age (52 vs. 54 years), even higher mean HbA1c values (10.0% vs. 9.4%), and significantly higher HDL-cholesterol levels (37.9 vs. 32.4 mg/dL; P < 0.0001). Patients with persistently elevated triglyceride levels (n = 34), on three measurements, had a younger age; lower body mass index, HbA1c, and HDL-cholesterol levels; more frequent use of fibrates and insulin; and a higher prevalence of major cardiovascular events. Conclusions: Severe hypertriglyceridemia is a frequent condition in outpatients with T2D participating in the AMD Annals Initiative, and it is associated with male sex, young age, short disease duration, and a worse glycemic profile. Among patients with persistent severe hypertriglyceridemia, hidden FCS may be present.
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INTRODUCTION: Growth patterns in Noonan syndrome (NS) remain relatively unknown. The objective of this study was to provide growth reference curves for patients with NS and identify correlations between their growth, genotype, and clinical features. METHODS: This was a 15-year-long, monocentric, observational, retrospective, non-interventional study. Children with NS followed up between 2005 and 2022 at "Bambino Gesù" Children's Hospital, Italy, were included and excluded if they had received growth hormone treatment. Comparison of growth curves of participants with NS versus the general Italian population and further genotypic analyses were performed. RESULTS: Overall, 190 eligible participants with NS were identified, with median (interquartile range) age of 14.01 (9.05-19.25) years (55.8% male). Cardiovascular anomalies were present in 85.3% of participants, most commonly pulmonary stenosis (52.6%) and atrial septal defects (36.8%); 48.1% of male participants had cryptorchidism. The most frequently detected mutations were in PTPN11 (66.3%) and SOS1 (13.9%). NS sex-specific centile curves for height, weight, body mass index, and height velocity were produced. For both sexes, the 50th percentile of height and weight for participants with NS overlapped with the 3rd percentile for the general Italian population. Both sexes with a PTPN11 mutation had a significantly lower height and weight than those with "other mutations" at 5 years old. No significant associations were observed between cardiac anomalies and PTPN11 mutation status. CONCLUSION: We present longitudinal data describing growth curves and trends, the natural history, and genotypes of the NS population, which provide a useful tool for clinicians in the management of NS.
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AIMS: Glargine 300 U/mL (Gla-300) has been recently approved for use in children and adolescents with type 1 diabetes (T1D). However, real-world effectiveness data are scarce, and aim of this analysis was to assess clinical outcomes in young patients with T1D switching from 1st generation basal insulin (1BI) to Gla-300. METHODS: ISPED CARD is a retrospective, multicenter study, based on data anonymously extracted from Electronic Medical Records. The study involved a network of 20 pediatric diabetes centers. Data on all patients aged < 18 years with T1D switching from 1BI to Gla-300 were analyzed to assess clinical characteristics at the switch and changes after 6 and 12 months in glycated hemoglobin (HbA1c), fasting blood glucose (FBG), and standardized body mass index (BMI/SDS). Titration of basal and short-acting insulin doses was also evaluated. RESULTS: Overall, 200 patients were identified. The mean age at the switch to Gla-300 was 13 years, and mean duration of diabetes was 3.9 years. Average HbA1c levels at switch were 8.8%. After 6 months, HbA1c levels decreased by - 0.88% (95% CI - 1.28; - 0.48; p < 0.0001). The benefit was maintained after 12 months from the switch (mean reduction of HbA1c levels - 0.80%, 95% CI - 1.25; - 0.35, p = 0.0006). Trends of reduction in FBG levels were also evidenced both at 6 months and 12 months. No significant changes in short-acting and basal insulin doses were documented. CONCLUSIONS: The study provides the first real-world evidence of the effectiveness of Gla-300 in children and adolescents with T1D previously treated with 1BI. The benefits in terms of HbA1c levels reduction were substantial, and sustained after 12 months. Additional benefits can be expected by improving the titration of insulin doses.
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BACKGROUND: Metabolic dysfunction-associated steatotic liver disease (MASLD) represents the hepatic manifestation of increased adiposopathy, whose pathogenetic features have been proposed as tumourigenic triggers for colorectal cancer (CRC). We aim to identify specific metabolic signatures involved in CRC development that may be used as non-invasive biomarkers, paving the way for specific and personalized strategies of CRC prevention and early detection. METHODS: We retrospectively assessed CRC onset during a time frame of 8 years in a cohort of 1145 out-patients individuals who had previously been evaluated for Metabolic Syndrome. RESULTS: 28 patients developed CRC. No association between CRC development and visceral and general obesity was detected, while baseline fasting plasma glucose (FPG) and non-invasive liver fibrosis scores were significantly higher in patients with CRC, compared to those who did not develop cancer. Liver steatosis and MASLD were more frequently diagnosed in patients who developed CRC compared to no cancer developers. Canonical correlations among metabolic biomarkers were not present in CRC developers, differently from no cancer group. In ROC analysis, FPG and non-invasive scores also showed good sensitivity and specificity in predicting colon cancer. We then calculated ORs for metabolic biomarkers, finding that higher FPG and non-invasive scores were associated with an increased risk of developing CRC. CONCLUSION: MASLD and increased FPG may play a role in the clinical background of CRC, bringing to light the fascinating possibility of a reversed gut-liver axis communication in the pathogenesis of CRC. Thus, the use of non-invasive scores of fatty liver may be helpful to predict the risk of CRC and serve as novel prognostic factors for prevention and therapeutic strategies.
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Neoplasias Colorrectales , Hígado Graso , Hiperglucemia , Humanos , Masculino , Estudios Retrospectivos , Neoplasias Colorrectales/fisiopatología , Femenino , Persona de Mediana Edad , Hígado Graso/fisiopatología , Hígado Graso/complicaciones , Anciano , Hiperglucemia/complicaciones , Hiperglucemia/fisiopatología , Ayuno/sangre , Factores de Riesgo , AdultoRESUMEN
OBJECTIVE: This study aimed to assess the prevalence and types of oral adverse events following immunization (AEFIs) in people who received at least one dose of any type of vaccine. MATERIALS AND METHODS: We conducted a bibliographic search about oral AEFIs in MEDLINE, Embase, PubMed, and Ovid from database inception to November 07, 2022. Risk of bias was assessed using the MURAD or the Quality In Prognosis Studies tools. Random-effects proportional meta-analysis was applied. RESULTS: A total of 119 studies involving 343 people were eligible. These reported AEFIs occurred following administration of the coronavirus disease 2019 vaccine, anti-influenza vaccine, hepatitis B vaccine, and anti-smallpox vaccine. The most common to be affected in vaccinated people were buccal mucosa (63.1%; 95% confidence interval (CI) 33.4-88.2) and lips (55.7%; 95% CI, 41.1-69.8). The most prevalent oral AEFIs were ulceration (55.2%; 95% CI 24.4-84.0), swelling (65.2%; 95% CI 34.9-89.8), and burning sensation (18.3%; 95% CI 7.9-31.8). CONCLUSIONS: The mechanisms underlying oral AEFIs should be further investigated to promptly recognize oral manifestations and provide optimal management for people undergoing vaccination.
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AIM: In Italy, the ISPED CARD initiative was launched to measure and improve quality of care in children and adolescents with type 1 diabetes. METHODS: Process and outcome indicators and the related information derived from electronic medical records were identified. A network of pediatric diabetes centers was created on a voluntary basis. RESULTS: Overall, 20 centers provided data on 3284 patients aged < = 18 years. HbA1c was monitored ≥ 2/year in 81.2% of the cases. BMI was monitored ≥ 1/year in 99.0%, lipid profile in 45.3%, and blood pressure in 91.7%. Pubertal status, albuminuria, eye examination, and screening of celiac disease and thyroiditis were underreported. From 2017 to 2021, average HbA1c levels decreased from 7.8 ± 1.2 to 7.6 ± 1.3%, while patients with LDL cholesterol > 100 mg/dl increased from 18.9 to 36.7%. Prevalence of patients with elevated blood pressure and BMI/SDS values also increased. In 2021, 44.7% of patients were treated with the newest basal insulins, while use of regular human insulin had dropped to 7.7%. Use of insulin pump remained stable (37.9%). CONCLUSIONS: This report documents the feasibility of the ISPED CARD initiative and shows lights and shadows in the care provided. Improving care, increasing number of centers, and ameliorating data recording represent future challenges.
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Diabetes Mellitus Tipo 1 , Mejoramiento de la Calidad , Sistema de Registros , Humanos , Niño , Adolescente , Masculino , Femenino , Sistema de Registros/estadística & datos numéricos , Diabetes Mellitus Tipo 1/terapia , Italia/epidemiología , Hemoglobina Glucada/análisis , Hemoglobina Glucada/metabolismo , Preescolar , Calidad de la Atención de Salud/normas , LactanteRESUMEN
Human mastadenoviruses, frequently denominated adenoviruses (HAdVs), may cause respiratory tract, gastrointestinal or, less frequently, other involvements. Epidemics of HAdV infections occur globally, in communities, and in closed or crowded settings. In our institution, a cluster of infants and children admitted for HAdV infection was recently observed. The aim of this study was to describe the pattern of their presenting features and investigate the possible correlation between the HAdV copy number and the clinical picture. Two main patterns of clinical presentation were observed: 68 patients had mainly respiratory symptoms (pharyngitis n = 67, cough n = 44; tonsillar exudate n = 17; other respiratory signs n = 4) while 26 patients showed prevalent gastrointestinal involvement (diarrhea n = 26, vomiting n = 8). Patients with respiratory symptoms had a significantly higher count of WBC, PMN, and platelets, while CRP level approached statistical significance (p = 0.07) for higher values in the patients with diarrhea. In order to explore the impact of selected presenting features, the possible association between the level of CRP and the presence of pharyngeal exudate, cough, vomiting, diarrhea, duration of fever, number of neutrophils, and administration of antibiotics was analyzed. Patients falling in the tertile with more elevated CRP values had tonsillar exudate and diarrhea significantly more often, while those in the lower tertile had a 4.4-day duration fever vs. ≥5.0 days in the remaining patients. Antibiotic therapy was administered more frequently to patients with higher values of CRP (p = 0.006). The duration of hospitalization was not associated with the CRP level. The median time from the receipt of a positive HAdV PCR test result to patient discharge was 1 day in 73% of cases. The number of copies of HAdV detected via PCR ranged between 47 million and 15/µL. Falling in the highest tertile of copy number was significantly associated with pharyngitis. The 24 patients with evidence of viral coinfection had no difference in the demographics or presenting features, with the only exception being a significantly higher leukocyte count. The rapid turn-around of the results of the molecular testing of the HAdV genome on a pharyngeal swab allowed us to rapidly diagnose HAdV infection, allowing us to stop antibiotic therapy and immediately discharge the patients, with reduced discomfort for the families and more appropriate use of hospital beds. A high copy number of HAdV from a pharyngeal swab should not be taken as an indicator of worse prognosis, thus allowing for the preferential use of qualitative rather than quantitative assay.
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Introduction: Thyroid cancer incidence is increasing, and adiposity-related conditions are gaining space in its pathogenesis. In this study, we aimed to detect any anthropometric, biohumoral, and clinical features that might be associated with thyroid nodule malignancy, potentially representing novel non-invasive markers of thyroid cancer. Materials and methods: The study was conducted in a group of 142 consecutive outpatients (47 men and 95 women) who underwent fine-needle aspiration biopsy/cytology (FNAB/C) due to suspicion of malignancy from January 2018 to September 2022. We compared lipid and glycemic blood profiles as well as non-invasive liver fibrosis indexes such as aspartate aminotransferase (AST) to alanine aminotransferase (ALT) ratio (AAR), AST to platelet ratio index (APRI), and fibrosis index based on four factors (FIB-4) between patients with benign and malignant newly diagnosed nodules. Then, we performed receiver operating characteristic (ROC) analysis to assess their best cutoff values for discrimination of malignant nodules and chi-squared test to evaluate the association of specific dysmetabolic conditions with malignancy. To understand whether and to what degree dysmetabolic conditions increased the risk of thyroid nodule malignancy, we also calculated the odds ratio (OR) of the main biomarkers. Results: After FNAB/C, 121 (85%) patients were diagnosed with benign thyroid nodules, while 21 (15%) individuals were diagnosed with thyroid cancer. Comparing patients with benign and malignant nodules, we found that individuals with thyroid cancer exhibited increased body mass index (BMI) (p = 0.048) and fasting plasma glucose (p = 0.046). Intriguingly, considering non-invasive scores for liver fibrosis, subjects with thyroid cancer presented increased AAR (p < 0.001) and APRI (p = 0.007), and these scores were associated with malignancy (p < 0.005) with OR = 7.1 and OR = 5, respectively. Moreover, we showed that only in the cancer group, low levels of vitamin D correlated with stigmata of impaired metabolism. Discussion: In our study, AAR and APRI scores were associated with thyroid nodule malignancy and could be used to predict it and to speed up the diagnostic process. From a pathogenic point of view, we speculated that metabolic-associated fatty liver disease (MAFLD) along with hyperglycemia and vitamin D deficiency may represent putative drivers of thyroid carcinogenesis.
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Non-alcoholic fatty liver disease (NAFLD), specifically liver steatosis and fibrosis with steatohepatitis (NASH), is often associated with visceral adiposopathy, whose pathogenetic features have been proposed as tumorigenic triggers. We performed a prospective analysis in 653 metabolic women to reveal any conditions that may predict and concur to cancer development during a 8-years period of follow-up. Among clinical and biochemical variables, only AST and non-invasive liver fibrosis scores (AARPRI, APRI, FIB-4, mFIB4) significantly distinguished cancer-developer women (n = 62, 9.5%) from those who did not develop cancer (p < 0.001). In ROC analysis, these scores also showed good sensitivity and specificity in differentiating women who developed cancer (all p < 0.001). We then calculated OR for these indexes finding that increased AARPRI was associated with the highest risk (OR = 6, p < 0.001) of gynaecological cancers development. We further validated these cut-off values in women who had developed other types of cancer, confirming that AARPRI is able to identify the risk for cancer development (OR = 5, p < 0.001). Our findings support the hypothesis that NAFLD, more than obesity per se, is directly associated with the clinical and pathogenic metabolic scenario of gynaecological cancers and encourage the use of liver fibrosis indexes to detect risk of cancer onset in women. Preventing adiposopathy and NAFLD through lifestyle and therapies may represent an instrumental strategy for cancer prevention and/or co-treatment in oncology.
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Neoplasias de los Genitales Femeninos , Enfermedad del Hígado Graso no Alcohólico , Humanos , Femenino , Enfermedad del Hígado Graso no Alcohólico/complicaciones , Enfermedad del Hígado Graso no Alcohólico/diagnóstico , Enfermedad del Hígado Graso no Alcohólico/patología , Estudios de Seguimiento , Cirrosis Hepática/patología , Sensibilidad y Especificidad , BiopsiaRESUMEN
Bronchiolitis causes a remarkable number of hospitalizations; its epidemiology follows that of respiratory syncytial virus (RSV), its main pathogen. The aim of this study was to evaluate the presenting features, treatment approach, and impact of medical therapy in four pediatric hospitals in Italy. Data on infants < 24 months of age hospitalized with bronchiolitis in the 2021-2022 season were collected. Between October 2021 and February 2022, 214 children were admitted. Median hospital stay was 5 days; none of the patients died. The distribution of the presenting features is largely comparable in the 33 (15.8%) RSV-negative versus the 176 (84.2%) RSV-positive children; also, no difference was observed in medical therapy provided: duration of oxygen therapy, administration of steroid, and duration of hospital stay. Systemic steroids, inhalation, or antibiotic therapy were given to 34.6%, 79.4%, and 49.1% of children respectively. Of the 214 patients with bronchiolitis, only 19 (8.8%) were admitted to ICU. Conclusion: Our data suggest that, irrespective of treatments provided, RSV-positive and RSV-negative children had a similar clinical course. The results of our retrospective study further underline the need to improve adherence to existing guidelines on bronchiolitis treatment. What is Known: ⢠Bronchiolitis is a common diseases with seasonal peak. The outcome is usually favorable but hospitalization and even ICU admission is not exceptional. What is New: ⢠Children with RSV associated bronchiolitis do not have a different course and outcome. The analysis of the 2021-2022 cohort, following COVID pandemic peaking, did not show a different course and outcome. ⢠Adherence to literature recommendation, i.e. to focus on oxygen and hydration therapy while avoiding unnecessary systemic therapy with steroid and antibiotics, should be improved.
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Bronquiolitis , COVID-19 , Infecciones por Virus Sincitial Respiratorio , Virus Sincitial Respiratorio Humano , Lactante , Humanos , Niño , Infecciones por Virus Sincitial Respiratorio/terapia , Infecciones por Virus Sincitial Respiratorio/tratamiento farmacológico , Estudios Retrospectivos , Bronquiolitis/diagnóstico , Bronquiolitis/epidemiología , Bronquiolitis/terapia , Hospitalización , OxígenoRESUMEN
Benign paroxysmal positional vertigo (BPPV) usually has a favorable course, although it is possible to observe BPPV with a high recurrence rate. Previous studies suggested that vitamin D deficiency might affect BPPV recurrences, and oxidative stress might play a complementary role in BPPV pathogenesis. This multicentric trial aimed to evaluate the effectiveness of oral nutritional supplementation with a compound of alpha-lipoic acid, Carnosine, and Zinc (LICA® (Difass International, Coriano (RN), Italy)), vitamins of group B and vitamin D in preventing BPPV recurrences. A total of 128 patients with high recurrence-BPPV were randomized in three arms: Arm 1 consisted of subjects with "insufficient" or "deficient" vitamin D blood levels, treated with daily oral supplementation of LICA®, vitamins of group B and vitamin D3 (800 UI), Arm 2 included BPPV subjects with "sufficient" vitamin D who did not receive any nutritional support, and Arm 3 included subjects with a "sufficient" serum concentration of vitamin D who received supplementation with a compound of LICA® and Curcumin. After six months of follow-up, a significant reduction of BPPV relapses compared to the baseline was found only in Arm 1 (−2.32, 95% CI: 3.41−1.62, p-value < 0.0001). Study results suggested that oral nutritional supplementation with vitamin D3 plus antioxidants can prevent relapses in patients suffering from high recurrence-BPPV.
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Aims: This study aims to evaluate the effectiveness and tolerability of once-weekly glucagon-like peptide receptor agonists (OW GLP-1RAs) and to assess the clinical benefits of switching from one GLP-1RA to another (switchers) in a routine clinical setting. Materials and Methods: This is a retrospective, real-world cohort study, based on electronic medical records utilized in one Italian diabetes clinic. Estimated mean changes in HbA1c and body weight after 6 and 12 months from the first prescription of a long-acting GLP1-RA were evaluated using longitudinal linear mixed models for repeated measures. The effectiveness of the three long-acting GLP1-RAs was compared separately in the GLP1-RA naive and switchers cohorts, after propensity score adjustment. Results: Initiating a long-acting GLP1-RA was associated with statistically significant improvements in HbA1c (-1%) and body weight (-2.6 kg) after 6 months, and benefits were maintained after 12 months. In GLP1-RA naive cohort, semaglutide showed the largest effect on HbA1c (-1.55%; 95%CI, -1.77;-1.34) and body weight (-3.76 kg; 95%CI, -5.05;-2.47) at 6 months, maintained at 12 months (-1.55%; 95%CI, -1.82;-1.28 and -6.29 kg; 95%CI, -7.94;-4.63). In the switchers' cohort, statistically significant reductions at 6 months in HbA1c and body weight were documented with semaglutide and dulaglutide only, with semaglutide associated with the most marked reduction (-0.84%; 95%CI, -1.03;-0.65 and -3.43 kg; 95%, -4.67;-2.19). Dropout rates were 9.2%, 28.5%, and 41.7% in semaglutide, dulaglutide, and exenatide groups, respectively. Conclusions: The effectiveness and tolerability of the OW GLP-1RAs in the real world were documented. Semaglutide was associated with the highest response without impact on safety. Clinical improvements were obtained even in switchers, especially in those switching to semaglutide.
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Diabetes Mellitus Tipo 2 , Peso Corporal , Estudios de Cohortes , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Esquema de Medicación , Receptor del Péptido 1 Similar al Glucagón/agonistas , Hemoglobina Glucada/análisis , Humanos , Hipoglucemiantes/uso terapéutico , Estudios RetrospectivosRESUMEN
Objective: To evaluate the long-term quality of life (QoL) in patients operated for cholesteatoma by canal wall-up tympanoplasty (CWUT) or canal wall-down tympanoplasty (CWDT) with mastoid obliteration. Methods: QoL was evaluated by the Chronic Otitis Media Questionnaire - 12 (COMQ-12). For each patient, the total score and three partial subscores, concerning disease activity, functional impairment and general impact on the patient's life were calculated. These scores were correlated with the surgical technique, as well as anatomical and functional results. Results: 68 procedures were classified as CWUT and 78 as CWDT with obliteration. The mean follow-up was 65 months. Total and partial COMQ-12 scores did not show any significant difference between the two groups. Correlation analysis showed a significant direct association between the postoperative Air-Bone Gap (ABG) and both the COMQ-12 total score and functional subscore in the CWUT group. Conclusions: This is the first study comparing CWUT and CWDT with obliteration with the COMQ-12, thus confirming the overlapping results in terms of QoL. These findings, together with the evidence of the significantly lower rates of recidivism, show that CWDT with obliteration should be considered as a good alternative to CWUT.
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Colesteatoma del Oído Medio , Otitis Media , Colesteatoma del Oído Medio/cirugía , Enfermedad Crónica , Humanos , Apófisis Mastoides/cirugía , Otitis Media/cirugía , Calidad de Vida , Resultado del Tratamiento , Timpanoplastia/métodosRESUMEN
Several studies highlighted the importance of platelets in the tumor microenvironment due to their ability to interact with other cell types such as leukocytes, endothelial, stromal and cancer cells. Platelets can influence tumor development and metastasis formation through several processes consisting of the secretion of growth factors and cytokines and/or via direct interaction with cancer cells and endothelium. Patients with visceral obesity (VO) are susceptible to pro-thrombotic and pro-inflammatory states and to development of cancer, especially colon cancer. These findings provide us with the impetus to analyze the role of platelets isolated from VO patients in tumor growth and progression with the aim to explore a possible link between platelet activation, obesity and colon cancer. Here, using xenograft colon cancer models, we prove that platelets from patients with visceral obesity are able to strongly promote colon cancer growth. Then, sequencing platelet miRNome, we identify miR-19a as the highest expressed miRNA in obese subjects and prove that miR-19a is induced in colon cancer. Last, administration of miR-19a per se in the xenograft colon cancer model is able to promote colon cancer growth. We thus elect platelets with their specific miRNA abundance as important factors in the tumor promoting microenvironment of patients with visceral obesity.
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Neoplasias del Colon , MicroARNs , Plaquetas/metabolismo , Neoplasias del Colon/metabolismo , Humanos , MicroARNs/genética , Obesidad Abdominal/complicaciones , Obesidad Abdominal/metabolismo , Obesidad Abdominal/patología , Microambiente TumoralRESUMEN
Anthracyclines are widely employed in lymphoma's chemotherapy and has been shown to induce heart failure. Echocardiographic parameters of left ventricular (LV) systolic function are usually used to monitor the cardiac side effects during and after anthracyclines treatment. The measurement of theTei index could anticipate the onset of LV dysfunction. The aim of this study was to evaluate the performance of the delta Tei index for the early detection of cardiac toxicity in a prospective population of anthracycline-treated lymphoma patients. Our preliminary data suggest that the Tei index may predict the risk for cardiotoxicity in this subset of patients earlier than LV ejection fraction alteration.
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MenB-FHBp was licensed in Europe in 2017 from the age of 10. In the "postmarketing life" of a new vaccine, surveillance of Adverse Events Following Immunization (AEFI) is crucial, to better understand the pattern of safety and the effectiveness. This paper describes the MenB-FHBp AEFIs notified in Puglia in 2018-2021, to take a picture of the safety profile of this vaccine in the real life, four years after its introduction in Italy. This is a retrospective observational study. Data were collected from the list of AEFIs notified after MenB-FHBp vaccine administration in Puglia in 2018-2020, and the number of doses of this vaccine administered in the same period. AEFIs were classified according to WHO's algorithm, and causality assessment was carried out for serious AEFIs. From January 2018 to December 2020, in Puglia, 43,061 doses of MenB-FHBp were administered and 42 MenB-FHBp AEFIs (reporting rate: 97.5 per 100,000 doses administered) were reported. Among these, 12 were classified as severe (28.6%; reporting rate 27.9 per 100,000 doses). Overall, the male/female ratio in AEFIs was 1:1. The median age of people who suffered from AEFIs was 12 years (range 11-13). For the 11 serious AEFIs for which the classification was "consistent causal association," the diagnosis was hyperpyrexia (reporting rate 13.9 per 100,000 doses), fainting (rate 4.6 per 100,000 doses), urticaria (rate 2,3 per 100,000 doses), convulsions (rate 2,3 per 100,000 doses), and vomit (rate 2,3 per 100,000 doses). No deaths or impairment were notified in studied AEFIs. The picture of MenB-FHBp vaccine supports that the risk of AEFIs is in line with previous published data and in general acceptable.
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Vacunas Meningococicas , Neisseria meningitidis Serogrupo B , Adolescente , Niño , Femenino , Humanos , Inmunización , Italia/epidemiología , Masculino , Vacunación/efectos adversosRESUMEN
Introduction: Aim of the present study was to evaluate the real-world impact of once-weekly (OW) subcutaneous semaglutide on different end-points indicative of metabolic control, cardiovascular risk factors, and beta-cell function in type 2 diabetes (T2D). Methods: This was a retrospective, observational study conducted in 5 diabetes clinics in Italy. Changes in HbA1c, fasting blood glucose (FBG), body weight, blood pressure, lipid profile, renal function, and beta-cell function (HOMA-B) during 12 months were evaluated. Results: Overall, 594 patients (97% GLP-1RA naïve) were identified (mean age 63.9 ± 9.5 years, 58.7% men, diabetes duration 11.4 ± 8.0 years). After 6 months of treatment with OW semaglutide, HbA1c levels were reduced by 0.90%, FBG by 26 mg/dl, and body weight by 3.43 kg. Systolic blood pressure, total and LDL-cholesterol significantly improved. Benefits were sustained at 12 months. Renal safety was documented. HOMA-B increased from 40.2% to 57.8% after 6 months (p<0.0001). Discussion: The study highlighted benefits of semaglutide on metabolic control, multiple CV risk factors, and renal safety in the real-world. Semaglutide seems to be an advisable option for preservation of ß-cell function and early evidence suggests it might have a role in modifying insulin resistance (HOMA-IR), the pathogenetic basis of prediabetes and T2D.
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Diabetes Mellitus Tipo 2 , Masculino , Humanos , Persona de Mediana Edad , Anciano , Femenino , Hipoglucemiantes/uso terapéutico , Hemoglobina Glucada , Estudios Retrospectivos , Estudios de Cohortes , Peso CorporalRESUMEN
PURPOSE: To evaluate the recently proposed SAMEO-ATO framework for middle ear and mastoid surgery, by correlating it with the functional outcome in a large cohort of patients operated for middle ear and mastoid cholesteatoma in a tertiary referral center. METHODS: We retrospectively included all surgeries for middle ear and mastoid cholesteatoma undergone in our Department between January 2009 and December 2014, by excluding revision surgeries, congenital and petrous bone cholesteatoma. All surgeries were classified according to the SAMEO-ATO framework. The post-operative air bone gap (ABG) was calculated and chosen as benchmark parameter for the correlation analysis. RESULTS: 282 consecutive surgeries for middle ear and mastoid cholesteatoma were released in the study period on a total of 273 patients, with a mean age of 41.2 years. All patients were followed for an average period of 55.3 months. 54% of patients underwent M2c mastoidectomy (Canal Wall Down, CWD), while the remaining underwent Canal Wall Up (CWU) procedures, being M1b2a mastoidectomy the most common one (33%). Mean pre-operative and post-operative ABGs were 29.2 and 23.5 dB, with a significant improvement (p < 0.0001). 'Mastoidectomy' and 'Ossicular reconstruction' parameters of SAMEO-ATO showed significant association with postoperative ABG, with smaller residual gaps for the classes Mx and On, and worse hearing results for M3a and Ox. CONCLUSION: Our results show the utility of SAMEO-ATO framework, and in particular of 'M' (Mastoidectomy) and 'O' (Ossicular reconstruction) parameters, in predicting the hearing outcome.
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Colesteatoma del Oído Medio , Timpanoplastia , Adulto , Colesteatoma del Oído Medio/complicaciones , Colesteatoma del Oído Medio/cirugía , Humanos , Apófisis Mastoides/cirugía , Estudios Retrospectivos , Resultado del Tratamiento , Timpanoplastia/métodosRESUMEN
PURPOSE: The national lockdown established by the Italian government began on the 11th of March 2020 as a means to control the spread of SARS-CoV-2 infections. The purpose of this brief report is to evaluate the effect of the national lockdown on the occurrence and characteristics of trauma in children during lockdown. METHODS: All children admitted to our paediatric orthopaedic unit with a diagnosis of fracture or trauma, including sprains and contusions, between 11 March 2020 and 11 April 2020, were retrospectively reviewed. Their demographic data, type of injury, anatomical location and need for hospitalisation were compared with the equivalent data of children admitted for trauma in the same period of 2018 and 2019. RESULTS: Sixty-nine patients with trauma were admitted in 2020, with a significant decrease in comparison with 2019 (n = 261) and 2018 (n = 289) (p < 0.01). The patients were significantly younger, and the rate of fractures significantly increased in 2020 (p < 0.01). CONCLUSIONS: Home confinement decreased admissions to the emergency department for trauma by shutting down outdoor activities, schools and sports activities. However, the rate of fractures increased in comparison with minor trauma, involved younger children and had a worse prognosis.
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AIMS: The European Society of Cardiology (ESC) recently defined cardiovascular risk classes for subjects with diabetes. Aim of this study was to explore the distribution of subjects with type 1 diabetes (T1D) by cardiovascular risk groups according to the ESC classification and to describe the quality indicators of care. METHODS: The study is based on data extracted from electronic medical records of patients treated at the 258 Italian diabetes centers participating in the AMD (Associazione Medici Diabetologi) Annals initiative. Patients with T1D were stratified by cardiovascular risk. Measures of intermediate outcomes, intensity/appropriateness of pharmacological treatment, and overall quality of care were evaluated. RESULTS: Overall, 29.368 subjects with type 1 diabetes (64.7% at very high cardiovascular risk, 28.5% at high risk and 6.8% at moderate risk) were evaluated. A lack of use of drugs in case of high values and an inadequate control despite the antihypertensive and lipid-lowering treatment was recognized. The overall quality of care tended to be lower as the level of cardiovascular risk increased. CONCLUSION: A large proportion of subjects with T1D is at high or very high risk. Antihypertensive and lipid-lowering treatment seem not adequately used. Several actions are necessary to improve the quality of care.