Changes in body weight and composition, metabolic parameters, and quality of life in patients with type 2 diabetes treated with subcutaneous semaglutide in real-world clinical practice.

Subcutaneous once-weekly (ow) semaglutide is a recent treatment option for type 2 diabetes (T2D) and obesity, but real-world data on weight loss and associated changes in body composition, nutrients intake, and quality of life are still scarce. This observational, prospective clinical study involved all T2D patients starting ow semaglutide according to routine care between December 2021 and February 2022. Clinical information was collected after 6 months (T6) and 12 months (T12) from semaglutide initiation (T0). Bioelectrical Impedance Analysis (BIA) was performed to measure changes in body composition. Diabetes Treatment Satisfaction Questionnaire (DTSQ) and the 36 - items Short Form Health Survey (SF-36) were administered as patient-reported outcomes (PROs). Changes in continuous endpoints (weight, body composition, nutrients intake, other clinical parameters, and PROs) were assessed using mixed models for repeated measurements. Overall, 90 patients (age 63.0 ± 10.0 years; diabetes duration 7.6 ± 5.9 years; 58.9% men; HbA1c 7.7 ± 1.1%; weight 95.4 ± 19.4 Kg, BMI 34.6 ± 6.4 Kg/m2; 36.7% naïve to diabetes treatment, 43.3% on metformin, 10.0% on dual oral therapy, and 10.0% treated with schemes including insulin) were included in the study. After 6 months from semaglutide initiation, body weight significantly decrease by -4.69 Kg (95%CI -6.19;-3.19) (primary endpoint). After 12 months, body weight was further reduced (-5.38 Kg; 95%CI -7.79;-2.97). At BIA, fat mass was significantly reduced by 2.1 Kg after 6 months but only slightly reduced after 12 months vs. baseline; lean mass was also significantly reduced by over 3 Kg both at 6 and 12 months. Intake of all nutrients declined in the first 6 months of therapy, although only lipids reduction reached the statistical significance (-6.73 g; p=0.02). Statistically significant improvements in BMI, waist circumference, glycemic control, blood pressure and lipid profile were documented. Satisfaction with treatment (DTSQ questionnaire) and mental health (MCS score of SF-36 questionnaire) significantly increased during the follow-up. The study documented real-world benefits of semaglutide for treating obesity in T2D subjects, with important changes on clinical and patient-reported outcomes. Loss of lean mass associated with weight loss warrants attention; parallel strategies to preserve skeletal muscle and improve physical function, i.e. nutritional education and structured exercise, are of great importance.

Yoga or Mindfulness on Diabetes: Scoping Review for Theoretical Experimental Framework.

Background: About one in 11 adults worldwide suffers from diabetic disease with constantly increasing prevalence; from the 529 million patients registered in 2021, the number of people with diabetes was predicted to rise to approximately 1.31 billion in 2050. In Italy, 5.9% of the population is diabetic, with a higher prevalence with increasing age and in the South of the country. Yoga and Mindfulness could represent a valid support for the care of diabetic subjects especially in a stressful caring context such as the Covid-19 pandemic. Study Design: A scoping review was conducted to achieve the goals of the study. Yoga or Mindfulness interventions on diabetic subjects were specifically analyzed and qualitative-quantitative data collected in the selected randomized controlled trials were extensive for possible meta-analysis. Methods: The review was conducted by two independent practitioners and a third one was consulted in case of conflict. The PRISMA method was used for both the selection and reporting of the studies to be included. Specific PICOS and search strategies have been developed on PubMed, Embase and PsycINFO databases. Included in the review were: randomised controlled trials, full dissertation articles and papers in English with a time limit on May 31, 2022. Results: The Review included 22 studies; 12 on Mindfulness, 9 on Yoga and one about both disciplines; among these, one studied patients with Type 1 Diabetes, 14 with Type 2 Diabetes, 6 with both and one with Gestational Diabetes. Only one paper studied adolescent subjects while the other 21 focused on a range of adult subjects. The studies showed that Yoga and Mindfulness have strong potential not only on stress management, but also on clinical-metabolic parameters. Conclusions: The recent Covid-19 pandemic has certainly redesigned a new way of treating and managing chronic diseases, such as diabetes. An increasingly fragile population, and with the growing need to reduce overall stress levels, could find alternative practices in Yoga and Mindfulness to support conventional therapies.

Eating and lifestyle habits and primary school health-related pro-grams: a survey involving Italian children and teachers.

Background: Childhood overweight and obesity represent serious public health concerns in several countries worldwide, including Italy, where the highest prevalence in Europe of overweight and obesity among primary school children was recorded. Among others, primary schools represent suitable social environments for health education projects. In this perspective, to optimize resources and plan successful activities, it is necessary, first of all, to analyze the context of the intervention. Study design: A pilot survey involving children and teachers was conducted in a primary school in Jesi (Le Marche Region, Italy). Methods: A questionnaire was submitted by teachers between May and June 2023 to 104 pupils (aged 6-11) from the five different primary school system classes. A qualitative questionnaire was also filled out by the same teachers (n = 5) who were present while the children were filling the eating/lifestyle questionnaire. Results: Most of the children (96.1%) had breakfast before school, with milk and cereal (51.5%) representing the preferred com-bination. During recess, 59.2% of pupils usually have a sandwich, 23.3% usually have sweet snacks, whereas only 2.9% have a fruit. Over 55% of the sample preferred drinking high-sugar beverages to water, and 15.5% declared going to a fast-food restaurant more than once a week. Over 17% of children did sport only once a week or less often. Over 64% of children habitually played videogames, and 77.6% normally watched TV or played with a tablet/smartphone while eating. Finally, the teachers' interview highlighted that there were no active health-related projects addressed to the pupils, and the school did not normally organize me-etings with health professionals to increase children's and their parents' knowledge and awareness about healthy eating habits. Conclusions: This preliminary investigation analyzed the context for a future health and nutrition education project and will assist researchers in planning successful activities and increasing the efficiency of the intervention.

Mediterranean Diet (MedDiet) and Lifestyle Medicine (LM) for support and care of patients with type II diabetes in the COVID-19 era: a cross-observational study.

INTRODUCTION: Diabetes affects 425 million people worldwide (range 20-79 years). Of these, between 87% and 91% are affected by type 2 diabetes mellitus (DM2), and 79% live in medium/low income countries. OBJECTIVES: the main objective of the study was to observe, through the administration of specific questionnaires, the relationship existing between metabolic clinical parameters, quality of life of patients with DM2 and adherence to the MedDiet at first access to Diabetes Center in the period after the COVID-19 pandemic. The secondary objective was to observe the results obtained both qualitatively and quantitatively. MATERIALS AND METHODS: the study was a cross-sectional study. Two types of questionnaires were administered; the first (Medi-Lite) that expresses with specific score the level of "Mediterraneanness" diet while the second concerns the assessment of the SF-36 quality of life. Quantitative data such as biochemical and anthropometric parameters were collected and, through multiple regression, based on the method of least squares (OLS Model) and through the Gretl open source software were analyzed. RESULTS: fifty-two of the 90 patients at first access to the recruiting center in the period considered, met the inclusion criteria and and written consent. None of the estimated coefficients was statistically significant except Diastolic Blood Pressure (DBP), with a p-value < 0.0466. With an improvement in the level of "Mediterraneanness" there is a favorable relationship regarding creatinine, High-Density Lipoprotein (HDL), DBP and glycemia. CONCLUSIONS: The necessary post-COVID-19 territorial management cannot fail to take into consideration this new method of care which puts the patient and the community to which they belong at the center of the complex process of assistance.

Metformin and Covid-19: a systematic review of systematic reviews with meta-analysis.

INTRODUCTION: the COVID-19 infection, caused by severe Coronavirus 2 syndrome (Sars-Cov-2), immediately appeared to be the most tragic global pandemic event of the twentieth century. Right from the start of the pandemic, diabetic patients treated with metformin experienced a reduction in mortality and complications from COVID-19 compared to those with different treatments or no treatment. Objective The main objective of the study was to observe the effects of metformin in hospitalized subjects infected with COVID-19. Specifically, the outcomes of hospitalization in Intensive Care Units or death were examined. Materials and Methods A specific research PICOS was developed and the Pubmed, Embase and Scopus databases were consulted down to April 30, 2022. To estimate the extent of the metformin effect and risk of severity in SARS-CoV-2 infection, the Odd Ratio (OR) with 95% Confidence Interval (CI) published by the authors of the selected systematic reviews was used. Results from five systematic reviews 36 studies were selected. The final meta-analysis showed that thanks to treatment with metformin, DM2 patients affected by COVID-19 had protection against risk of disease severity, complications (ES 0.80; 95% CI) and mortality (ES 0.69; 95% CI). Conclusions More in-depth studies on the use of metformin, compared to other molecules, may be required to understand the real protective potential of the drug against negative outcomes caused by COVID-19 infection in DM2 patients.

12 Years of honey surveys in northern Italy: How anthropic activities can influence honey quality.

Bees and hive products, such as honey, can act as indicators of environmental quality. Our research aimed to evaluate historical data of honey quality in Lombardy (Northern Italy) and consider the possible sources of air contamination that can influence it. We collected analytical data from the local Health Protection Agency on residues of 57 honey samples from 2011 to 2022, comparing a rural area and an industrial area. At the same time, we consulted estimated air emissions in the same areas through the INEMAR database used by the local Environmental Protection Agency. Data revealed antibiotic contamination in one case and, regarding heavy metals, lead contamination in several samples in the industrial area. Pb contamination could derive from multiple sources. The INEMAR database permitted us to hypothesize that combustion in industry and road transportation could have a role in honey contamination, being among the main sources of Pb emission in that area.

Use of an Online Platform to Evaluate the Impact of Social Distancing Measures on Psycho-Physical Well-Being in the COVID-19 Era.

Background: The SARS-CoV-2 pandemic (Severe Acute Respiratory Syndrome Coronavirus 2) and the worldwide health crisis have significantly changed both people's habits and lifestyles. Most of the studies found in the literature were carried out on specific professional categories in the socio-health sector, taking into consideration psychological disorders in relation to work. The purpose of this study was to analyze the psychological impact on a portion of the normal population subjected to lockdown. Methods: A questionnaire was distributed in the period between 23 March 2020 and 18 May 2020 (during Italian lockdown) using an online platform. The scales GAD-7, IES-r, PHQ-9 and MANSA were used to investigate the level of anxiety, the presence of post-traumatic stress disorder, the severity of depression and the perceived quality of life, respectively. Results: Four hundred and eight Italian subjects responded. Females and younger people were more affected by anxiety and depression. Post-traumatic stress disorder affected about 40% of the population sample, significantly young people and women, thus attesting to an important psychopathological response. About one-fifth of the sample population recorded an unsatisfactory quality of life. Conclusions: The results highlight the need to set up preventive interventions (primary and secondary), trying to focus on the most fragile group of subjects from a psychosocial point of view, in order to obtain a significant reduction in psychophysical damage in terms of relapses and outcomes.

Quality of life among chronic myeloid leukemia patients in the second-line treatment with nilotinib and influential factors.

PURPOSE: This study aims to evaluate the quality of life (QoL) of chronic myeloid leukemia (CML) patients prescribed with nilotinib as a second-line therapy and explores the influential factors. METHODS: A multicenter retrospective survey was conducted via face-to-face interviews based on the EORTC QLQ-C30 questionnaire. A total of 121 adult CML patients resistant to imatinib and used nilotinib for at least 3 months were enrolled. The influential features were assessed by multiple linear regression models. RESULTS: Patients had the mean age of 47.49 (SD = 13.67) years, dominated by middle-aged and male groups. The mean scores of functions ranged from 75 to 83, and those of symptoms were from 5 to 28, with the highest of fatigue (28.28), insomnia (22.87), and pain (21.07). The mean global health status/QoL score was 67.70 (SD = 16.80) with considerable financial difficulties (52.34 (SD = 32.15)). Male patients reported higher functional scores and fewer symptoms compared with female patients. All aspects of QoL became worse with increasing age. Besides age and gender, level of education, duration of nilotinib usage, and comorbidities were also significantly influential factors in many QoL domains. A predicted model for expected mean scores of QoL domains was built based on these factors. CONCLUSIONS: The CML patients treated with nilotinib had the above-moderate QoL scores, a light decrease of functional scores, great financial difficulties, and still experienced symptoms. Strategies and more therapeutic considerations to enhance QoL for CML patients targeted toward women, the old, low educational level, and long duration of nilotinib usage, and many comorbidities are needed in the setting.

Pro-Environmental Behaviors: Determinants and Obstacles among Italian University Students.

The awareness of citizens concerning the health risks caused by environmental pollution is growing, but studies on determinants of pro-environmental behaviors have rarely examined health-related aspects. In this study, we investigated these determinants using data from a large survey among Italian university students (15 Universities: 4778 filled questionnaires). Besides the health-related aspects, represented by environmental health risk perception and functional health literacy, we considered social and demographic characteristics (gender, area of residence, sources of information, trust in institutional and non-institutional subjects, and students' capacity of positive actions, indicated as internal locus of control). The attitudes towards pro-environmental behaviors were positive for more than 70% of students and positively related with health risk perception, internal locus of control, and health literacy. The correspondence between the positive attitudes towards pro-environmental behaviors and the real adoption of such behaviors was approximately 20% for most behaviors, except for the separate collection of waste (60%). Such a discrepancy can be attributable to external obstacles (i.e., lack of time, costs, lack of support). The health-related aspects were linked to the pro-environmental attitudes, but to a lesser extent to pro-environmental behaviors, owing to the complexity of their determinants. However, they should be taken in account in planning education interventions.

HPV Type-Specific Prevalence a Decade after the Implementation of the Vaccination Program: Results from a Pilot Study.

Human papillomavirus infection is a cause of the development of invasive cervical cancer. Three types of vaccine are currently available to prevent precancerous/cancerous lesions due to persistent infection, which is supported mainly by 7 different high-risk genotypes. The aim of this pilot study was to acquire preliminary data on type-specific prevalence 10 years after the implementation of the HPV vaccination program in Italy, in order to subsequently plan appropriate observational studies in the Italian population. First-voided urine samples were collected from 393 consenting subjects, both females and males, aged 18-40 years, and HPV DNA was detected by PCR amplification of a 450 bp L1 fragment. All amplified products were genotyped by means of the Restriction Fragment Length Polymorphism (RFLP) method. The female population was divided into three cohorts ("vaccine-eligible", "pre-screening" and "screening" cohorts) according to the preventive intervention scheduled by age; males were included in the same three cohorts according to their year of birth. The overall prevalence of HPV infection was 19%, being higher in females than in males (22.1% vs. 13.6%, p = 0.03729). In the female population, 10 years after the start of the national immunization program, we observed a reduction in the prevalence of vaccine types and the number of circulating genotypes, especially in the "vaccine-eligible" cohort. The frequency of HPV vaccine types increased with age, particularly in males in the "pre-screening" and "screening" cohorts. Our study highlights the importance of monitoring HPV infection in both genders, to validate the effect of the HPV vaccination program.

Diabetes and technology: A pilot study on the management of patients with insulin pumps during the COVID-19 pandemic.

BACKGROUND: The recent COVID-19 pandemic has accelerated the treatment process through IT/technological supports, useful in the management of chronic patients such as those affected by type 1 Diabetes Mellitus (T1DM). Specific routes for fragile patients such as those with micro-infusers have been created thanks to the application of "Diabetes Technology," which allows patients to monitor blood glucose quickly and easily. The present pilot study aimed to assess the quality of care provided to patients with micro-infusers in a delicate phase such as a pandemic lockdown. MATERIALS AND METHODS: A mixed-methods approach was used. In the first part, with prior written consent, patients with insulin pumps enrolled voluntarily. In the second part, the focus group discussion (FGD) was carried out with the voluntarily enrolled participants. The FGD data were organized and analyzed by the thematic areas. RESULTS: The number of patients with afferent insulin pumps at the center was 50 individuals. Among them, 20 patients voluntarily joined the first part of the study by completing the PACIC questionnaire, which gave an average result of 3.34 (min. 2.2 and max. 4.2). In the second part, the application of the focus group technique demonstrated that technology is decisive in the management of diabetic pathology, not only in the emergency phase. CONCLUSIONS: At the time of public health crises, alternative strategies such as Tele-Nursing or Telemedicine could be crucial for the management of patients with micro-infuser not only in critical moments, such as lockdown, but also in ordinary health management.

Psychological symptoms and quality of life after repeated exposure to earthquake: A cohort study in Italy.

In 2005, a random sample of 200 people were assessed in Camerino, Italy, eight years after an earthquake. Psychological symptom levels were low and only one person had current Post-Traumatic Stress Disorder (PTSD). In 2016 a new earthquake occurred in Camerino. The study aims to assess the impact of the second exposure in the same cohort. A longitudinal study was conducted, 130 participants were re-interviewed between July and December 2017. Psychological symptoms were self-rated on the Brief Symptom Inventory (BSI) and the Global Severity Index (GSI) was analysed. Post-traumatic stress symptoms were self-rated on the Impact of Event Scale-Revised (IES-R). Subjective quality of life (SQOL) was assessed on the Manchester Short Assessment of Quality of Life (MANSA). Mean scores of GSI and IES-R were significantly higher than in 2005 (p<0.01 and p<0.001), whilst SQOL remained almost unchanged (p = 0.163). In 2017, 16.9% of the sample had reached the PTSD threshold whilst in 2005 only the 0.5% had reached it. Despite low symptom levels several years after an earthquake, people can show psychological distress after a new exposure, whilst average quality of life levels are not affected.

Food knowledge of patients at the first access to a Diabetology center. / Conoscenze alimentari in pazienti afferenti ad un centro di diabetologia

Il diabete rappresenta una patologia in costante aumento: familiarità, età e stili di vita rappresentano i principali fattori di rischio per questa malattia e per le complicanze ad essa correlate. Considerando l'importanza del regime alimentare per la prevenzione e il trattamento di questa patologia, scopo del presente studio è stato quello di valutare le conoscenze alimentari di pazienti al primo accesso presso un centro di Diabetologia e di indagare sulla loro eventuale influenza su alcuni parametri ematici. È stato somministrato il questionario di Moynihan. La relazione tra i punteggi ottenuti e le variabili emoglobina glicata, BMI, glicemia a digiuno, è stata analizzata attraverso regressione multipla basata sul metodo dei minimi quadrati ordinari (modello OLS). Il response rate è stato del 73,3%. Il punteggio medio totale ottenuto dal questionario è stato di 23,61 ed è stata osservata una correlazione statisticamente significativa (p<0,0473) tra i migliori punteggi del questionario e i valori di Hb1Ac. Questo studio è il primo passo di un'indagine più ampia che verrà condotta nell'ottica di promuovere una formazione del paziente volta a verificare nel tempo le ricadute positive sulle scelte alimentari e sui parametri clinici.

Genetic characterization of variants of HPV­16, HPV­18 and HPV­52 circulating in Italy among general and high­risk populations.

Viral factors, such as high­risk human papillomavirus variants, can increase the risk of viral persistence and influence the progression to cancer. In the present study, the long control region (LCR) of human papillomavirus (HPV)­16 and HPV­52, and the L1 region of HPV­16 and HPV­18, identified from subjects belonging to both general and high­risk populations (migrants, HIV+ subjects and adolescent/young people) residing in Italy, were characterized using molecular and phylogenetic techniques. To the best of our knowledge, this is the first Italian study to analyze a large number of sequences (n=458) and report phylogenetic data on the HPV­52 variants. The phylogenetic analysis showed that 90% of the LCR variants of HPV­16 and HPV­52 clustered within lineage A (European lineage) and only sequences identified from subjects belonging to high­risk populations fell into the non­European lineages. Analysis of the LCRs revealed a high genomic diversity with a large number of changes. Several mutations in the binding sites for viral and cellular transcription factors characterized the HPV­16 LCR variants belonging to the African lineages B and C, were observed in subjects with cytological abnormalities (high squamous intraepithelial lesions). The HPV­16 and HPV­18 L1 molecular characterization identified 30% of changes in the immune­dominant epitope loops. These data give a clear picture of the situation in Italy, and a starting point for understanding the molecular pathogenesis and developing molecular diagnostics for HPV, vaccines and other therapeutic approaches in order to control and/or eliminate virus­induced diseases.

Evaluation of the antimicrobial activity of novel composite plastics containing two silver (I) additives, acyl pyrazolonate and acyl pyrazolone.

BACKGROUND: Public health systems today face the dual challenges of controlling infections and curbing the increase in antimicrobial resistance manifested in drug-resistant microorganisms in hospitals and elsewhere. In the last ten years, research has been conducted to develop new materials with antimicrobial properties to be used in medical devices, increasingly found to harbour critical nosocomial infections. METHODS: Two next-generation composites using the antimicrobial qualities of silver were tested against Escherichia coli, Staphylococcus aureus and Candida albicans with the purpose of evaluating their antimicrobial and antifungal activity. These tests applied the standardized method according to ISO-2216: Plastics-Measurement of Antibacterial Activity on Plastics Surfaces. Testing was carried out using polyethylene (PE) enriched with AgNO3 as a positive control and PE as a negative control. RESULTS: The antimicrobial activity of the composites proved to be between medium (bacteriostatic) and very good (bactericidal). In particular, PE2 showed the highest scores against all microorganisms, with values ranging from good to very good. Instead, PE1 had lower scores, with a value of medium for Escherichia coli and slight for Candida albicans. Statistical analysis carried out with the t-test for unpaired data showed a statistically significant difference between the positive control and the other polymers (p< .0001). CONCLUSIONS: Based on our findings, we conclude that the test, conducted to ISO-2216 standards, could be extended to include fungal strains and that the new composites could be used to produce antimicrobial surfaces for medical devices, for example, intubation tubes, urinary catheters, vascular prostheses, and mechanical heart valves. This would reduce the risk of microbial contamination and biofilm formation, ensuring better health outcomes for patients treated with these devices. Further testing should be done to evaluate potential future applications of these composites and the possibility of adding fungal strains to the IS0-2216 standard.

Environment and health: Risk perception and its determinants among Italian university students.

Among the determinants of environmental health risk perception, health literacy and social media messages have been generally neglected. This study details the environmental health risk perception and its determinants in Italian university students, including a measure of functional health literacy and an analysis of newspapers and social media. A cross sectional survey was carried out among students from 15 Italian universities and different disciplines (grouped into Scientific-Health and Humanistic-Legal-Social sectors) using a self-administered anonymous questionnaire, divided into six sections: socio-demographic characteristics, information on health and environment, environmental health risk perception, trust, attitudes and behaviors and functional health literacy. Local newspapers and tweets in the same areas and period were analyzed in relation to quantity and topics. The study population included 4778 students (65.1% female) aged 21 ±â€¯4.3 years, and functional health literacy was low (below the cutoff value) for 44.4% of students. A new outcome of the survey is that the detected association between high functional health literacy a higher global health risk perception and trust in institutions both as sources of information and as actors for protection against environmental risks. The internet and social networks were the most frequently consulted sources of information (77.7%), which was predictive of a higher risk perception. The possible relation between environmental health risk perception and tweet communication was highlighted by a comparison between the risk perception in the city with the highest number of tweets (Modena) and another one similar for socio-demographic characteristics (Pisa). In conclusion, the results of our study may be of help to strengthen information and education programs: functional health literacy should be taken into account in school programs, to produce a basic knowledge for a better understanding of health and environment. Moreover, mass and social media should be included in planning communication intervention and in verifying their results.

The requirements for manufacturing highly active or sensitising drugs comparing Good Manufacturing Practices.

BACKGROUND: To date there exist no internationally recognised Good Manufacturing Practices (GMP) that clearly outline universally accepted standards for manufacturing highly active or sensitising ingredients. The pharmaceutical industry is faced with a twofold problem: determining which drugs need dedicated production areas and identifying the different regulations required in different countries. The aim of this paper is to find, by comparing the current regulations of the various Regulatory Agencies, the differences between containment requirements for the production of highly active or sensitising ingredients. METHODS: An analysis of the following Regulatory Agencies' GMPs was performed: Europe (EMA), China (CFDA), Mexico (COFEPRIS), United States (FDA), Canada (Health Canada) Brazil (ANVISA), India (CDSCO), PIC/S and WHO in order to examine the differences in terms of  containment requirements set by the different Regulatory Authorities for the manufacture of highly active or sensitising ingredients. RESULTS: Our analysis found that the majority of Regulatory Agencies require that beta-lactams (sensitising materials) be produced in dedicated and segregated facilities. For "certain" highly active pharmaceutical ingredients (APIs), COFEPRIS, FDA, HC, EMA, PIC/S and WHO require that they be produced in facilities similar to those required for beta-lactams, while CDSCO, CFDA and ANVISA require that production takes place in segregated areas. Further differences between the Agencies  have emerged regarding classes of highly APIs that require dedicated production. CONCLUSION: A study of GMP adopted by Regulatory Agencies has uncovered significant differences, in particular concerning containment requirements for the production of APIs. For this reason, the harmonisation of GMP following  up-to-date quality standards based on cutting-edge science which are globally applicable is fundamental and will benefit companies and patients alike. Pharmaceutical companies would not be obliged to follow requirements enforced by the State in which they intend to manufacture a product, and patients would benefit from high-quality drugs regardless of their place of production.

Food safety on board tankers. Results of analysis from 'Healthy Ship' project.

BACKGROUND: Microbiological monitoring of surfaces used for food preparation, as required by the Hazard Analysis and Critical Control Points (HACCP) plan, is important in risky conditions as those observed in the kitchens of ships. Limits to introduce a classification of risk levels and methods to adopt in conditions as those occurring in tankers have not been investigated. This paper presents the results of the "Healthy Ship" project on HACCP monitoring of surfaces used in food preparation on Italian flag tankers. MATERIALS AND METHODS: Microbiological monitoring was carried out on 19 tankers between 2013 and 2017. Food handlers were also trained on board ship according to HACCP standards. Contact plates (ISO 18593:2004 compliant) were used to determine the colonies and bacterial charge according to the Wirtanen and Salo's method. RESULTS: A total of 1074 samples, 108 before the first course, 168 after the first course, 390 during the period of refresher (2015-2016), and 408 after the refresher training, were obtained from the three main kitchen surfaces: the worktop, cutting board, and kitchen sink. A good level of hygiene was observed in 56.9% of all samples, 0.1% were classified as adequate, and the remaining 43% as poor. The highest contamination was observed on the cutting board and kitchen sink and involved the total aerobic count. The only surface with inadequate levels of hygiene was the worktop. A reduction of contaminated samples was noted after training. CONCLUSIONS: Our results suggest that continuous training should be provided for personnel responsible for handling foodstuffs on board ships.

A Clinical Evidence of a Correlation Between Insulin Resistance and the ALCAT Food Intolerance Test.

Insulin resistance (IR) is defined as the inability of a known quantity of exogenous or endogenous insulin to increase glucose uptake and utilization. Several mechanisms have been proposed as possible causes underlying the development of IR and the IR syndrome. IR occurs as part of a cluster of cardiovascular-metabolic abnormalities commonly referred to as "The Metabolic Syndrome." This may lead to the development of type 2 diabetes, accelerated atherosclerosis, hypertension, dysmenorrhea, hirsutism, and polycystic ovarian syndrome, depending on the genetic background of the individual developing IR. The aim of this study was to assess, in 123 female and 35 male (mean age, 42 y ± 10.3; range 19-75 y) volunteers) whether IR could be partly related to a dietary sugar intolerance and whether there could be a correlation between the ALCAT intolerance test and a mutation of the TCFTL2 gene (it promotes the trascription of the proglucagone and plays a key role in the development of the Langherans islands). Results evidenced that subjects with an intolerance to sugar, also showed a statistically significant complete or incomplete alteration of the TCFTL2 genetic test. Based upon these findings, our study demonstrated that there is a clinical correlation between the ALCAT food intolerance test and the IR. The positivity to the ALCAT test of one of the sugars tested (fructose, sugar cane, and sugar beet) indicates, in the majority of the subjects, the presence of a mutation of the gene TCF7L2 and could contribute to the prevention and treatment of the IR.

A systematic review of pharmacoeconomic evaluations of erlotinib in the first-line treatment of advanced non-small cell lung cancer.

OBJECTIVE: To review and assess the quality of the available evidence on the cost-effectiveness of erlotinib in the first-line treatment of advanced non-small cell lung cancer (NSCLC). METHODS: A systematic review was conducted to identify full-text original economic evaluations of erlotinib in the first-line treatment of advanced NSCLC written in English and published from the year 2000 onwards. Study characteristics and results were recorded and compared. The quality of the studies was assessed by the Quality of Health Economic Studies (QHES) questionnaire. RESULTS: Eleven out of 130 papers were chosen for this review. Comparative regimens consisted of a best supportive care, reverse strategy, bevacizumab, cisplatin plus pemetrexed, carboplatin plus gemcitabine or gefitinib. The methods most used in these studies were modeling and sensitivity analysis and cost-effectiveness analysis. All of the studies evaluated direct costs and used quality-adjusted life-year (QALY) and life-years gained (LYG) as outcome, with 3% and 3.5% discount rate. The studies assigned ICER that ranged from dominant to I$305,510.31/QALY and from I$31,209.55/LYG to I$66,540.20/LYG. Based on the willingness to pay threshold, seven studies concluded that erlotinib was cost-effective, two studies showed that erlotinib was cost-effective on specific patients with certain conditions, and two studies comparing erlotinib with reverse strategy did not find a difference in cost-effectiveness. The high quality of these studies was confirmed using the QHES tool: the mean score was 75.77 out of 100 (SD 9.38). CONCLUSION: Most of these high-quality studies suggested that erlotinib was cost-effective in the first-line treatment of advanced NSCLC.