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The gastrointestinal system may be affected by COVID-19 infection with an incidence variable from 3% up to 79%. Several works show that the pan-creas, both in its exocrine and endocrine function, can be affected by this viral infection, although this organ has been poorly analyzed in this current epidemic context. This mini-review aims to provide a summary of available studies on exocrine pancreas involvement during COVID-19 infection. A search through MEDLINE/PubMed was conducted on the topic in hand. With regard to exocrine function, some studies highlight the presence of an associated hyperenzymemia (hyperamylasemia, hyperlipasem-ia), while others describe isolated and rare cases of acute pancreatitis. More attention should be paid to pancreatic impairment in subjects with COVID-19, as this may prove to be one of the elements aggra-vating its clinical course. Indeed, acute pancreatitis, especially when presenting in severe forms with hy-perstimulation of the pro-inflammatory response, may represent a crucial factor in the progression of COVID-19, entailing both an increase in hospitaliza-tion days and in mortality rate.

Switching between different erythropoiesis-stimulating agents (ESAs) during the first year of therapy is frequent (15–20%), much more so toward reference products than biosimilars. The objectives of this study were to investigate the frequency and identify the potential predictors of switching between biosimilar and originator ESAs during the first year of treatment in patients with chronic kidney disease (CKD), or chemotherapy-related anemia from six large Italian geographic areas in the years 2009–2015. A retrospective cohort study was conducted using six Italian regional claims databases (≥ 13 million inhabitants) during 2009–2015. Among incident epoetin users, the frequency of single, multiple, and backward switch during the first year of treatment was evaluated. Using frailty Cox models, potential predictors of first switch were identified. All analyses were stratified by the main indications for use. Among 102,240 incident epoetin users, 15,853 (15.5%) switched to another epoetin during the first year of therapy; only 18% of these switched to biosimilars. Single switch was more common (62.2% of the switchers) than multiple (23.5%) or backward switch (14.3%). In cancer, the cumulative number of transfusions and iron preparations dispensed, as well as hyperparathyroidism, were predictors of switching. In CKD, the cumulative number of transfusions, number of vitamin A/D preparations dispensed, and CKD severity increased the probability of switching. Switching between ESAs was frequent in both CKD and cancer patients. The number of cumulative transfusions and severity of disease seemed to affect the switch.

Introduction Real-world data on the comparative effectiveness and safety of switching among different epoetins (including originators and biosimilars) are limited. In light of current debate about interchangeability, prescribers, some patient groups and decision makers are calling for additional post-marketing evidence on the clinical effects of switching between originator and biosimilar epoetins in chronic kidney disease (CKD) patients. Objective The objective of this study was to evaluate the effectiveness and safety of switching versus non-switching and of switching from originator/biosimilar epoetin alpha (ESA α) to any other epoetin in CKD patients. Methods An observational, record-linkage, multi-database, retrospective cohort study was carried out in four Italian geographical areas. All subjects with at least one ESA α dispensing between 1 January 2009 and 31 December 2015 were retrieved. Switching was defined as any transition between originator/biosimilar ESA α to any other epoetin in a series of two consecutive prescriptions up to 2 years. Switchers were matched 1:1 with non-switchers by baseline propensity score and by duration of ESA α treatment. Switchers and non-switchers were followed up from switching date to a maximum of 1 year. Lack of effectiveness and safety of switching versus non-switching were evaluated through Cox regression models (hazard ratio [HR], 95% confidence interval [CI]). A direct comparison between the two switcher categories (switchers from originator/biosimilar ESA α to any other epoetin) was also performed. Results Overall, 14,400 incident users of ESA α for anaemia due to CKD (61.4% originator, 38.6% biosimilar) were available for analysis. During the follow-up, we found no differences on effectiveness (HR 1.02, 95% CI 0.79–1.31 originators; HR 1.16, 95% CI 0.75–1.79 biosimilars) and safety outcomes (HR 1.08, 95% CI 0.77–1.50 originators; HR 1.20, 95% CI 0.66–2.21 biosimilars) between switchers and non-switchers of ESA α. Cumulative probabilities of recording an adverse event, either in terms of lack of effectiveness or safety issue, were the same for two switching categories Conclusions In this large-scale Italian observational multi-database study, switching versus non-switching as well as switching from biosimilar/originator ESA α to any other epoetin in CKD patients is not associated with any effectiveness and safety outcomes. Electronic supplementary material The online version of this article (10.1007/s40264-019-00845-y) contains supplementary material, which is available to authorized users.

Il volume descrive e valuta un progetto pilota per l'integrazione di giovani migranti nel sistema scolastico italiano

The volume describes and evaluates a pilot project aimed at the integration of young migrants, in the Italian school system

Objective: To evaluate the risk of upper gastrointestinal complications (UGIC) associated with drug use in the paediatric population. Methods: This study is part of a large Italian prospective multicentre study. The study population included children hospitalised for acute conditions through the emergency departments of eight clinical centres. Patients admitted for UGIC (defined as endoscopically confirmed gastroduodenal lesions or clinically defined haematemesis or melena) comprised the case series; children hospitalised for neurological disorders formed the control group. Information on drug and vaccine exposure was collected through parental interview during the children's hospitalisation. Logistic regression was used to estimate ORs for the occurrence of UGIC associated with drug use adjusted for age, clinical centre and concomitant use of any drug. Results: 486 children hospitalised for UGIC and 1930 for neurological disorders were enrolled between November 1999 and November 2010. Drug use was higher in cases than in controls (73% vs 54%; p

In order to ensure enteral feeding, placement of a percutaneous endoscopic gastrostomy (PEG) is considered a standard care for patients with oropharyngeal malignancies. Benign pneumoperitoneum is a complication of PEG feeding tube placement and it is usually an incidental finding that arises, generally, immediately following the procedure. We report a case of a benign pneumoperitoneum, developed 48 hours after the procedure, which was treated conservatively.

While it is well recognized that peptic ulcer disease is the most common cause of nonvariceal upper gastrointestinal bleeding, other lesions cause of haemorrhage, even if rare, may potentially life-threatening. These include arteriovenous malformations such as Dieulafoy's lesion, defined as caliber-persistent submucosal vessel. The endoscopy with its hemostatic techniques is usually the treatment of choice for such patients. In those cases, in which these techniques fail due to the difficult in the correct localization, angiography with embolization may be a good alternative. The use of microcatheters and new embolic agents have improved this procedure. In fact, transcatheter arterial embolization represents a minimally invasive alternative to surgery when endoscopic treatment fails to control gastrointestinal bleeding, especially for the upper tract. This technique proved to be safe, fast and effective. According to our knowledge, only one case of a Dieulafoy's lesion of the duodenum treated with "adjuvant" embolization followed by laser coagulation has been reported in literature. Herein, we report a case of a Dieulafoy's lesion of the stomach, in which "adjuvant" transcatheter arterial embolization has permitted a more easier endoscopic diagnosis and treatment.

•Vaccine effectiveness in children visiting an Emergency Department for influenza.•Test negative case-control study in 11 paediatric centres in two influenza seasons.•Vaccine effectiveness in preventing ED visits: 38% (95% CI -52% to 75%).•Add information for recommendation for vaccination in children. Objective: To evaluate the effectiveness of seasonal influenza vaccine in preventing Emergency Department (ED) visits and hospitalisations for influenza like illness (ILI) in children. Methods: We conducted a test negative case-control study during the 2011-2012 and 2012-2013 influenza seasons. Eleven paediatric hospital/wards in seven Italian regions participated in the study. Consecutive children visiting the ED with an ILI, as diagnosed by the doctor according to the European Centre for Disease Control case definition, were eligible for the study. Data were collected from trained pharmacists/physicians by interviewing parents during the ED visit (or hospital admission) of their children. An influenza microbiological test (RT-PCR) was carried out in all children. Results: Seven-hundred and four children, from 6 months to 16 years of age, were enrolled: 262 children tested positive for one of the influenza viruses (cases) and 442 tested negative (controls). Cases were older than controls (median age 46 vs. 29 months), though with a similar prevalence of chronic conditions. Only 25 children (4%) were vaccinated in the study period. The overall age-adjusted vaccine effectiveness (VE) was 38% (95% confidence interval -52% to 75%). A higher VE was estimated for hospitalised children (53%; 95% confidence interval -45% to 85%). Discussion: This study supports the effectiveness of the seasonal influenza vaccine in preventing visits to the EDs and hospitalisations for ILI in children, although the estimates were not statistically significant and with wide confidence intervals. Future systematic reviews of available data will provide more robust evidence for recommending influenza vaccination in children. © 2014 The Authors.

A 46-year-old man was referred to our Unit for hematemesis. The medical history of the patient revealed an HCV-related cirrhosis, a human immunodeficiency virus (HIV) infection and recent and persistent episodes of emesis. An urgent gastroscopy disclosed evidence of active bleeding from varices of the lower third of the esophagus and a concomitant laceration of the esophageal wall due to the emesis. These two conditions have been endoscopically diagnosed and successfully treated by sclerotherapy and endoscopic clipping.

Argon plasma coagulation (APC) is a non-contact thermal method of hemostasis that has generated much attention in recent years. This endoscopic procedure is used primarily to control bleeding from lesions in the gastrointestinal tract, and also sometimes to debulk tumours in the case of patients for whom surgery is not recommended. APC involves the use of a jet of ionized argon gas (plasma) that is directed through a probe passed through the endoscope. The probe is placed at some distance from the lesion, and tissue damage is limited to superficial layers. The depth of coagulation is usually only a few millimetres. Theoretical advantages of APC include facility application, speedy treatment of multiple lesions in the case of angiodysplasias or wide areas (the base of resected polyps or tumor bleeding), safety due to reduced depth of penetration, and lower cost compared to laser.

Key points - • National Health Service (NHS) is becoming increasingly aware of the need to support independent research to answer some important questions for patient care in areas of scant commercial interest. • This article reports the main features and strategies of the independent research programme on drugs launched by the Italian Medicines Agency (AIFA) in 2005. • In the three bids launched between 2005 and 2007, a total of 151 studies have been approved for funding for a total of about 78 million Euro. • In this article we describe the Italian legislative framework under which the programme was launched, the types of research funded and discuss how the supported studies could contribute, in an international framework, to the knowledge needed on drug efficacy, effectiveness and safety.