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Background: Augusta-Priolo (SR), Gela (CL), and Milazzo (ME) cities, located in Sicily Region (Southern Italy), are included among the areas at high environmental risk in Italy and the national legislation classifies them among the polluted sites of national interest for environmental remediation. In the past, these areas had high contamination from industrial complexes., Objectives: assessment of reproductive health through the analysis of data from the birth reports of all hospital of Sicily Region in 2007-2013., Design and Setting: geographical population study; analysis of reproductive health through analysis of pregnancy outcomes occurred in Sicily from women of childbearing age (10-55 years; excluding women who remain anonymous) with record linkage with population data (neighbouring municipalities and whole region, considered as not exposed areas)., Main Outcome Measures: sex ratio, stillbirth rates, proportion of multiple births, low birth weight, very low birth weight, gestational age <37 weeks, proportion of small for gestational age., Results: in the period 2007-2013, an average annual number of 43,000 births (51.4% males) occurred. Sex ratio was not significantly modified in comparison with local and regional values. Several indicators in each area were similar when compared with the local reference population or with regional population. Stillbirths were significantly higher only in Augusta-Priolo area vs. the local population (OR: 2.26; CI95% 1.07-4.80), and slightly higher vs. regional population. Multiple births were significantly higher in Augusta-Priolo area (OR: 1.19; CI95% 1.01-1.41) and in the town of Siracusa (OR: 1.15; CI95% 1.01-1.316) when compared with regional population, and slightly higher vs. local population. Prematurity was significantly higher only in the area of Milazzo compared to the regional population (OR: 1.20; CI95% 1.02-1.41), and slightly higher compared to the local population. No excess of low birth weight (<2,500 grams) and small for gestational age (almost 37 weeks) babies was observed in these areas., Conclusions: according to this study, pregnancy outcomes were not clearly affected in these areas although some modifications were noted in Augusta and in Milazzo. The surveillance of reproductive health is of paramount importance to understand the effects of air pollution on morbidity and mortality in these areas.

This study analysed cases of imported malaria notified to the District Health Units of Palermo from 1998 to 2014. The aim was to assess epidemiological differences among cases, related to their reasons for travel. Eighty one cases were reported: 83% developed symptoms following a trip to Africa while 17% had travelled to Asia. Seventy-three percent of cases had travelled to visit family or friends in malaria-endemic countries (Visiting Friends and Relatives: VFRs), confirming the need for preventive measures targeted towards this at-risk population group.

Purpose: To explore the prescription patterns of erythropoiesis-stimulating agents (ESAs) in four large Italian geographic areas, where different health policy interventions to promote biosimilar use in routine care are undertaken., Methods: A retrospective drug utilization study was conducted during the years 2009-2013. The data sources were the administrative databases of the Tuscany region and of the Caserta, Palermo, and Treviso Local Health Units (LHUs). The characteristics, prevalence, and switching patterns of different ESAs (biosimilars and reference products), stratified by indication for use, were calculated over time and across centers., Results: Overall, 49,491 patients were treated with ESAs during the years 2009-2013 in the four centers. Of these, 41,286 patients (83.4 %) were naive users. The prevalence of ESA use increased from 2.9 to 3.4 per 1000 inhabitants in the years 2009-2011 but decreased thereafter (3.0 per 1000 in 2013). Moreover, the proportion of biosimilar users increased overall from 1.8 % in 2010 to 33.6 % in 2013, with larger increase in Treviso (from 0.0 to 45.0 %) and Tuscany (from 0.7 to 37.6 %) than in Caserta (from 7.5 to 22.9 %) and Palermo (from 0.0 to 27.7 %). Switching between different ESAs during the first year of therapy was frequent (17.0 %), much more toward reference products than toward biosimilars., Conclusion: Overall, the prevalence of ESA use decreased slightly, while use of biosimilar ESAs, especially in naive patients, increased significantly but to different extents in these four large Italian geographic areas. Switching between different ESAs during the first year of treatment was very frequent, which may affect pharmacovigilance monitoring. New strategies are necessary to further improve market penetration of low-cost medicines, such as biosimilars, and also to harmonize effective health policy interventions that aim to reduce pharmaceutical expenses and optimize patient benefit across all regions.

Few months after the publication of the monographic section of Annali dell'Istituto Superiore di Sanità second issue of 2014 "Health impact of fibres with fluoro-edenitic composition", the carcinogenicity of fluoro-edenite was assessed by the International Agency for Research on Cancer (IARC) in the frame of Monograph 111. The IARC Working Group concluded that there is sufficient evidence in humans that exposure to fluoro-edenite fibrous amphibole causes mesothelioma, and sufficient evidence of carcinogenicity in experimental animals. Fluoro-edenite was allocated to Group 1 (the agent is carcinogenic to humans). Now, in view of the recent IARC evaluation, preventive action in Biancavilla requires an upgrade. First of all, environmental monitoring has to be further implemented. All operations of house cleaning should be performed employing wet tools, in order to avoid dust-raising. It is very important that environmental and biological monitoring be related to epidemiological surveillance. The recently approved act of the Sicilian Government concerning a plan of health interventions in Biancavilla will favour cooperation between national, regional and local health institutions with the common goal of improving the quality and appropriateness of diagnostic and therapeutics procedures offered by the health services.

Objectives: to analyse the effect of distance between the Municipality of residence and the nearest hospital on out-of-hospital mortality rate of patients died for acute myocardial infarction (AMI)., Design: analysis of out-of-hospital mortality using a record linkage database., Setting and Participants: Sicilian Municipalities; 4,999 deaths with acute myocardial infarction as primary cause of death, by excluding patients hospitalised within the 15 days before the death event., Main Outcome Measures: acute myocardial infarction out-of-hospital mortality in Sicilian Municipalities, with the exclusion of patients hospitalised within 15 days before the death event., Results: during the years 2009-2011, 7,473 subjects died for acute myocardial infarction in Sicily. 4,999 (66.92%) patients were not hospitalised in the 15 days before the death event; 2,001 of these (40.01%) lived quite far from the nearest hospital (more than 17 minutes of traveling time). After adjustment for age, gender and socioeconomic status, the distance between the residential Municipality and the nearest hospital was significantly associated with increased mortality (27% higher risk of out-of-hospital mortality for patients living far from the nearest hospital, compared to those living in municipalities with at least one hospital)., Conclusions: the distance between the residential Municipality and the nearest Municipality with at least one hospital is associated with an increase in out-of-hospital mortality rate after acute myocardial infarction. However, besides the limitations of using a distance metric (at a municipality level), the clinical history of the subjects under study is not explicitly taken into account. Further studies are needed in order to explore the reasons for this correlation and to further analyse the relationship between distance and mortality (in- and out-of-hospital). Nevertheless, the results presented provide useful information for healthcare service management policies.

The SESPIR Project (Epidemiological Surveillance of Health Status of Resident Population Around the Waste Treatment Plants) assessed the impact on health of residents nearby incinerators, landfills and mechanical biological treatment plants in five Italian regions (Emilia-Romagna, Piedmont, Lazio, Campania, and Sicily). The assessment procedure took into account the available knowledge on health effects of waste disposal facilities. Analyses were related to three different scenarios: a Baseline scenario, referred to plants active in 2008-2009; the regional future scenario, with plants expected in the waste regional plans; a virtuous scenario (Green 2020), based on a policy management of municipal solid waste (MSW) through the reduction of production and an intense recovery policy. Facing with a total population of around 24 million for the 5 regions, the residents nearby the plants were more than 380,000 people at Baseline. Such a population is reduced to approximately 330.000 inhabitants and 170.000 inhabitants in the regional and Green 2020 scenarios, respectively. The health impact was assessed for the period 2008-2040. At Baseline, 1-2 cases per year of cancer attributable to MSW plants were estimated, as well as 26 cases per year of adverse pregnancy outcomes (including low birth weight and birth defects), 102 persons with respiratory symptoms, and about a thousand affected from annoyance caused by odours. These annual estimates are translated into 2,725 years of life with disability (DALYs) estimated for the entire period. The DALYs are reduced by approximately 20% and 80% in the two future scenarios. Even in these cases, health impact is given by the greater effects on pregnancy and the annoyance associated with the odours of plants. In spite of the limitations due to the inevitable assumptions required by the present exercise, the proposed methodology is suitable for a first approach to assess different policies that can be adopted in regional planning in the field of waste management. The greatest reduction in health impact is achieved with a virtuous policy of reducing waste production and a significant increase in the collection and recycling of waste.

Protecting children's health from the effects of environmental contamination is a public health priority. In recent years, particular care has been devoted in Italy to the study of the relationship between environmental pollutants and health during infancy. The SENTIERI Project has called attention to increases in infant mortality in National Priority Contaminated Sites (NPCSs). SENTIERI KIDS provides a blueprint for the establishment of a task force charged with establishing multi and inter-disciplinary cooperation between central and regional institutions on the subject of children's health in contaminated sites. SENTIERI KIDS introduces a multiple outcome analytical model based on updated health outcomes (mortality, cancer incidence, hospital discharges) in order to establish a permanent observation system to monitor the state of health of infants residing in contaminated areas. This will pave the way for more in-depth epidemiological enquiries on an individual basis, and support the establishment and continued monitoring of primary prevention projects. Particular attention is devoted to issues of information and communication.

Introduction: The objective of this chapter is to study the health impact of the exposure to fibres with fluoro-edenitic composition on the residents in Biancavilla (Sicily, Italy), in terms of mortality and hospitalization. The diseases which international scientific literature indicates as associated with asbestos exposure were taken into consideration: mesothelioma of pleura, peritoneum, pericardium and tunica vaginalis testis, malignant neoplasm of larynx, malignant neoplasm of trachea, bronchus and lung, malignant neoplasm of ovary, pneumoconiosis; moreover, in order to describe the health profile of the study population, large groups of diseases were taken into consideration., Material and Methods: Current data (available in the Data Bases of the Unit of Statistics of ISS) regarding mortality and hospitalization were analyzed. Standardized Mortality Ratios, Standardized Hospitalization Ratios and Age-standardized Death Rates were calculated. The demographic background of the population residing in Biancavilla was also outlined., Conclusions: Our findings support the etiologic role of fibres with fluoro-edenitic composition in the occurrence of the above mentioned diseases, already observed in other studies.

Subsequently to the observation of a localized excess of mortality from malignant pleural neoplasms in the town of Biancavilla (Sicily), previously unknown amphibolic fibres with fluoro-edenitic composition were detected as naturally occurring soil contaminants. Less then two years after the initial report, ISS provided a set of public health recommendations that were complied by regional and local institutions. The recognition of Biancavilla as a National Priority Contaminated Site in 2002 opened the way to clean-up interventions. An up-dating of epidemiological studies, exposure assessment investigations and in vivo and in vitro mechanistic studies on fluoro-edenite fibres is provided in this issue. Scientific evidence can provide a sound foundation to public health action and environmental remediation. Finally, it is now necessary to properly tune the response of the health system to the community needs in terms of diagnostic procedures and medical treatment.

Introduction: Amphibolic fibres with fluoro-edenitic composition characterize Biancavilla soil, including the major quarry from which building materials have been extensively extracted. These fibres induce mesothelioma in experimental animals and their in vitro biological action is similar to that of crocidolite., Materials and Methods: Malignant mesothelioma case series and incidence were examined to evaluate the disease burden on Biancavilla inhabitants., Results: The incidence of pleural mesothelioma in Biancavilla is steadily higher than in the Sicilian Region, risk estimates are more elevated in women than in men, the most affected age class is constituted by subjects aged less than 50., Discussion and Conclusions: Environmental exposure to fibres with fluoro-edenitic composition appears to be causally related to the elevated mesothelioma occurrence in Biancavilla. In this frame, environmental clean-up is the main goal to be pursued in public health terms. A contribution of scientific research to public health decision making with respect to priority setting for environmental clean-up can derive from some further selected epidemiological investigations.

Background: Infant mortality rate (IMR) is a key public health indicator. Maternal age is a well-known determinant of pregnancy and delivery complications and of infant morbidity and mortality. In Italy the Infant Mortality Rate was 3.7/1000 during 2005, lower than the average IMR for the European Union (4.94/1000). Sicily is the Italian region with the highest IMR, 5/1000, and neonatal mortality rate (NMR), 3.8/1000, with substantial variation among its nine districts. The present study compared a high IMR/NMR district (Messina) with a low IMR/NMR district (Palermo) during the period 2004-2006 to evaluate potential determinants of the IMRs' differences between the two districts and specifically the impact of maternal age., Methods: The Death Causes Registers identified all deaths during the first year of life recorded among infants born to residents of the two districts in 2004-2006. For every case, available hospital charts records were abstracted using a standardized form designed to capture information on potential determinants of infant death. For each district and for each year, IMRs and NMRs were computed. Chi-squared statistics tested the significance of differences between district-specific IMRs. A Poisson regression model was used to analyze the relationship between maternal age, district of residence and IMR., Results: The 246 death registry-confirmed cases included 143 (58.1%) males and 103 (41.2%) females, with mean age at death of 33.3 days (SD: 64.5, median: 5.5). The average IMR for 2004-2006 was significantly higher for the Messina district than for the Palermo district (p = 0.0001). The IMR ratio was 1.6 (95%CI: 1.2 - 2.1). The IMRs declined from 2004 to 2006. A significant interaction (p = 0.04) between maternal age and district of residence was documented., Conclusion: The association between advanced maternal age and infant deaths in the Messina district was due in part to the excess of newborns from advanced age mothers, but also to increased risk of death among such newborns. The significant interaction between district of residence and maternal age indicated that the IMR excess in the Messina district cannot be explained by disproportionately high live birth rates among older mothers and suggested the hypothesis that health care facilities in the Messina district could be less well prepared to provide assistance to the excess of high risk pregnancies and deliveries, as compared to Palermo district.

Objective: to construct a composite municipal index of socioeconomic position (SEP) and to describe socioeconomic disparities in mortality within Sicilian elderly inhabitants (age 65+)., Design: 2001 Sicily Census data were used to develop a 5-level SEP index for the 390 municipalities of the Region. Education, occupation, housing tenure, family composition and immigration were considered in order to perform a factor analysis. We used Sicilian Mortality Registry data to compute standardized mortality rates by gender. The SEP index was used for mortality from all causes and for most common causes of death in elderly population. Rates, with 95% confidence intervals, were computed to compare mortality in each level of SEP to the highest level., Results: there were socioeconomic disparities both in overall and in cause-specific mortality. Progressively higher mortality rates with lower SEP were observed for overall mortality (ratio between extreme categories: 1.16 in men, 1.14 in women), as well for mortality from cardiovascular diseases in both genders (ratio between extreme categories: 1.12 in men, 1.09 in women), from respiratory disease in men (ratio between extreme categories: 1.20), and from endocrine glands diseases in women (ratio between extreme categories: 1.35). For deaths from cancer and from diseases of the digestive system mortalities, in both genders, we found higher risks within the lowest SEP level as compared to the highest. Cardiovascular diseases contributed the most to the socioeconomic differences in overall mortality., Conclusion: Within the Sicilian elderly population, socioeconomic position is associated with mortality. The highest mortality rates were observed in the most disadvantaged municipalities. Moreover, mortality rates were oddly distributed by gender.

Context: Italy implemented a law in January 2005 banning smoking in all enclosed public spaces., Objectives: To document perceived obstacles and effects of the law and observed client smoking behaviours in bars and restaurants., Design: Four surveys were conducted between December 2004 and February 2006. Protocols and questionnaires were posted on a public health website to solicit participation among local health units (LHUs). Participating LHUs randomly selected 50 bars and restaurants using the electronic Yellow Pages. Self-administered questionnaires were delivered to owners or managers of selected locales; all of them were revisited during peak hours to collect questionnaires and observe client smoking., Results: Before the ban, smokers were observed in 31% of locales; 24% of owners predicted major financial losses. One year later, no smokers were observed and only 7% reported major financial losses. Only 30% had received law enforcement visits. Most owners/managers (88%) reported positive attitudes about the law and 79% reported such attitudes among clients., Conclusions: The Italian smoking law has drastically reduced smoking in bars and restaurants despite minimal enforcement visits. Perceived negative effects on profits appear limited, and the owners and managers and their clients are satisfied.

Objective: The volcanic area of Biancavilla (Sicily Italy) has been included by the Italian national law among the areas of "environmental reclamation" due to the presence of amphibole fluoro-edenitic fibres in the environment. The aim of the study was to evaluate the health of residents in the area, through the analysis of the mortality registry and the hospital discharge records., Design: Age, cause and gender specific indirect standardized mortality ratios SMR (1995-2000) and morbidity ratios SHR (2001-2003) were computed with 95% confidence intervals, using the population of surrounding municipalities as reference., Results: statistically significant increases in mortality and morbidity were observed, both in men and women, for malignant pleural neoplasms (mortality: men SMR= 700, 6 observed; women SMR= 840, 3 observed; hospital admissions: women SHR= 1210, 5 observed), cardiovascular diseases (mortality: men SMR= 115, 267 observed, women SMR= 115, 278 observed; hospital admissions: men SHR= 109, 631 observed; women SHR= 114, 528 observed) and respiratory diseases (mortality: men SMR= 164, 68 observed; women: SMR= 215, 44 observed; hospital admissions: men SHR= 139, 558 observed, women SHR= 125, 374 observed)., Conclusions: the excesses observed in this study are consistent with previous findings and suggest the need for further investigations aimed at improving the knowledge of the mineralogical aspects of the fibres, the assessment of human exposure and at estimating the prevalence of pleural plaques and lung fibrosis.

Aims: the area of Gela (Sicily Italy) has been included by the Italian national law among the "areas of environmental concern", due to several industrial plants located in the area: a refinery, a petrolchemical plant and an industrial waste disposal. The aim of the study was to evaluate the health of residents in the area, through the analysis of the mortality registry and the hospital discharge records., Design: cause and gender specific indirect Standardized Mortality (1995-2000) and Morbidity (2001-2003) Ratios were computed, with 95% confidence intervals, using the population of surrounding municipalities as reference., Results: increases of malignant neoplasm of stomach, colon rectum, larynx, lung, bladder and non Hodgkin lymphoma were observed in the area, both in men and women. Moreover, an increased frequency of hospital admissions for cardiovascular diseases and for respiratory diseases (acute and chronic diseases, asthma both among adults and among children) were observed. Excesses of pneumoconiosis among men and of renal diseases among women were also present., Conclusion: the excesses in mortality and morbidity observed in this study are consistent with previous findings and might partly be explained by occupational exposures. However, the excesses found among women suggest a possible role of environmental pollutants.

Objective: During autumn 2002 a large eruption of Mount Etna (Sicily, Italy) occurred. High levels (over 200 microg/m3) of total suspended particles (PM10) were recorded. The aim of the study was to evaluate the acute health effects on mortality and hospital admissions in the area around the volcano., Design: Deaths and hospital admissions occurring during the eruption period were compared with the corresponding figures during the same periods of the previous year (same day of the week). Relative risks, RR, and their 95% confidence intervals, CI, were computed. Variations in daily hospital admissions for cardiovascular diseases associated with daily level of PM10 were estimated., Results: No effects on overall and cause-specific mortality were observed during the eruption period. Increases were observed in hospital admissions for cardiovascular diseases (ischemic diseases: RR 1.31, 95% CI 1.10-1.56; myocardial infarction: RR 1.34, 95% CI 1.02-1.76) and for cerebrovascular diseases (RR 1.24, 95% CI 1.05-1.47). The excesses were stronger among the elderly. Daily admissions for cardiovascular diseases were not associated to PM10 levels., Conclusion: The effects of the eruption of Mount Etna were limited to a temporary increase of cardiovascular morbidity, especially among the elderly, possibly as a consequence of stress.

[3H]Flunitrazepam (FNZ) binding to cortical neurons from fetal rat brain was investigated in vitro. The use of a synthetic medium specific for neurons made it possible to plot a developmental curve of 3H-FNZ binding in an almost pure neuronal culture. Detectable specific binding was present in vitro at time 0 (that is, the 16th gestational day). A progressive increase of binding, due to an increment in the number of recognition sites, was observed on the subsequent days. The affinity of the specific binding sites to 3H-FNZ was enhanced by the addition of exogenous GABA, whereas the density was not affected.