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1. Medicinal products, medical devices, or accessories of medical devices: How to qualify gases for spirometry?

Author

Manellari, Sara, Leone, Maria Grazia, Casiraghi, Antonella, Gennari, Chiara Grazia Milena, and Minghetti, Paola

Abstract

European legislation provides that each product used for healthcare purposes be regulated according to specific directives and regulations based on its intended use and mechanism of action. However, qualification issues may arise for medical devices, their accessories, and medicinal products. This is the case with gases for spirometry, which support spirometers in measuring patients' pulmonary capacities. This article discusses criticisms connected to their proper regulatory qualification, detailing why they should be more properly qualified as accessories of medical devices instead of as medicinal products or medical devices. [ABSTRACT FROM AUTHOR]

Published
2024
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4. Medical Devices Made of Substances: A New Challenge

Author

Leone, Maria Grazia

Abstract

Regulation (EU) 2017/745 provides for new provisions for medical devices made of substances as well as specific classification rules and requirements. The demarcation line between medical devices composed of substances and medicinal products is not always easy to define. The recent publication by the European Commission of the guidance on borderline between medical devices and medicinal products under the Regulation (EU) 2017/745 on medical devices, MDCG 2022-5, addresses some important issues in this topic. This article will discuss some controversial aspects in this field in order to clarify the product qualification process.

Published
2022
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12. Association of maternal hypertension and chorioamnionitis with preterm outcomes

Author

Gagliardi, Luigi, Rusconi, Franca, Bellù, Roberto, Zanini, Rinaldo, Mirri, Gianpaolo, Condò, Manuela, Turoli, Daniela, Vanzati, Mara, Mosca, Fabio, De Nisi, Giuseppe, Polacco, Paola, Villa, Elena, Barbarini, Mario, Fasolato, Valeria, Franco, Caterina, Contiero, Raffaella, Ellero, Serena, Cattarossi, Luigi, Abbiati, Laura, Borroni, Cesarina, Prandi, Giovanna, Fabris, Claudio, Vielmi, Francesca, Borgione, Silvia, Agosti, Massimo, Tandoi, Francesco, Guidali, Rosanna, De Curtis, Mario, Tozzi, Claudio, Lucchini, Renato, Battaglioli, Marina, Lista, Gian Luca, Introvini, Paola, Ferrari, Fabrizio, Gallo, Claudio, Bellante, Elvira, Bottura, Chiara, Zeringyte, Aurelija, Pasquali, Francesca, Boccacci, Simona, Latini, Giuseppe, Giannuzzi, Raffaella, Martinelli, Stefano, Brunelli, Alberto, Di Nunzio, Maria Lucia, Vendemmiati, Antonio, Carli, Giovanna, Bordigato, Michela Alfiero, Filippone, Marco, Meneghesso, Davide, Romeo, Nicola, Mammoliti, Palma, Mastretta, Emanuele, Barberis, Laura, Farina, Daniele, Gancia, Gianpaolo, Dalmazzo, Cristina, Napolitano, Marcello, Messina, Francesco, Villa Betania, Napoli, Magaldi, Rosario, Rinaldi, Matteo, Litta, Rosangela, Lago, Paola, Zanardo, Vincenzo, Chiandetti, Lino, Visentin, Stefano, Presta, Giuseppe, Cella, Davide, Poggiani, Carlo, Ferrari, Daniela, Parati, Sara, Lombardo, Francesco, Grigorio, Rosetta, Barera, Graziano, Bove, Maddalena, Poloniato, Antonella, Burgio, Giampiero, Sala, Elena, Barberi, Ignazio, Tiralongo, Venera, Arco, Alessandro, Mazzeo, Danila, Dani, Carlo, Pratesi, Simone, Mignatti, Valeria, Ancora, Gina, Faldella, Giacomo, Grandi, Sara, Locatelli, Chiara, Stronati, Mauro, Perotti, Gianfranco, Chirico, Gaetano, Migliori, Claudio, De Marini, Sergio, Forleo, Vincenzo, Paludetto, Roberto, Capasso, Letizia, Mansi, Giuseppina, Raimondi, Francesco, Bona, Gianni, Stucchi, Ilaria, Savastio, Silvia, Ferrero, Federica, Parola, Andrea, Padovani, Ezio Maria, Viviani, Elena, Pecoraro, Laura, Agostino, Rocco, Gizzi, Camilla, Massenzi, Luca, Messner, Hubert, Staffler, Alex, Salvia, Gennaro, Esposito, Luigi, Forziati, Vincenzo, Latorre, Giuseppe, Sandri, Fabrizio, Alati, Stefania, Demarca, Fabrizio, Lombardi, Oreste, Costabile, Carmine Deni, Scarpelli, Gianfranco, Cavalli, Claudio, Volante, Enrico, Moretti, Sabrina, Ganguzza, Olga, Spinella, Bartolomeo, Haass, Cristina, Scapillati, Eleonora, Consigli, Chiara, Gatta, Alberto, Quitadamo, Pasqua, Boldrini, Antonio, Vuerich, Marco, Sigali, Emilio, Fiorini, Patrizio, Petrucci, Letizia, Moroni, Marco, Meyer, Firenze, Bragetti, Patrizia, Casucci, Paola, Minelli, Liliana, Mezzetti, Daniele, Orfeo, Luigi, De Luca, Maria Gabriella, Laforgia, Nicola, Grassi, Alessandro, Dotta, Andrea, Savignoni, Ferdinando, Bagnoli, Franco, De Felice, Claudio, Badii, Silvia, Biasini, Augusto, Belluzzi, Antonio, Stella, Marcello, Romagnoli, Costantino, Zecca, Enrico, Barone, Giovanni, Colleselli, Paolo, Vecchiato, Luca, Nicolussi, Silvia, Giliberti, Paolo, Chello, Giovanni, Rojo, Silvana, De Vivo, Massimiliano, Giovanettoni, Chiara, Colnaghi, Clelia A., Manfredini, Valeria, Verucci, Elena, Placidi, Giulia, Belloni, Cesare, Carrera, Giuseppe, Zambetti, Chiara, Biban, Paolo, Serra, Alessandra, Sacco, Francesco, Vetrano, Gennaro, Furcolo, Giuseppe, Pasquariello, Brigida, Falco, Luigi, Ausanio, Gaetano, Bernardo, Italo, Capasso, Antonella, Marchesano, Giuseppe, Nosari, Norberto, Sarnelli, Paola, Ciraci, Giovanni, Merazzi, Daniele, Gazzolo, Diego, Temperini, Francesca, Sabatini, Miriam, Colivicchi, Micaela, Del Vecchio, Antonio, Tarantino, Marzia, Gargano, Giancarlo, Pedori, Simona, Bellettato, Massimo, Pesavento, Roberta, Cesaro, Alessandra, Scollo, Massimo, Mondello, Isabella, Pugliese, Aniello, Iervolino, Claudio, Corsello, Giovanni, Giuffré, Mario, Betta, Pasqua, Romeo, Mario Giuseppe, Saporito, Alessandro, Leone, Maria Grazia, Rodonò, Alessandro, Franceschi, Alessia, Risso, Francesco M., Carpentieri, Mauro, Vecchiano, Teresa, Cigliano, Maria Pia, Paolillo, Piermichele, Picone, Simonetta, Marra, Antonio, Rossetti, Gessica, Testa, Tiziana, Del Cuore, Fernando, Crescenzi, Francesco, Poloni, Gianna, Russo, Maria Chiara, Nigro, Francesco, Tina, Gabriella Lucia, Brindisino, Patrizia, Gurrado, Raffaele, Felice, Maurizio, Formica, Isabella, Gagliardi, L, Rusconi, F, Bellu, R, Zanini, R, Corsello, G, Giuffre, M, Italian Neonatal Network, Luigi Gagliardi, Franca Rusconi, Roberto Bellù, Rinaldo Zanini, the Italian Neonatal Network [.., Gina Ancora, Giacomo Faldella, Sara Grandi, Chiara Locatelli, ]., Gagliardi, Luigi, Rusconi, Franca, Bellù, Roberto, Zanini, Rinaldo, Mirri, Gianpaolo, Condò, Manuela, Turoli, Daniela, Vanzati, Mara, Mosca, Fabio, De Nisi, Giuseppe, Polacco, Paola, Villa, Elena, Barbarini, Mario, Fasolato, Valeria, Franco, Caterina, Contiero, Raffaella, Ellero, Serena, Cattarossi, Luigi, Abbiati, Laura, Borroni, Cesarina, Prandi, Giovanna, Fabris, Claudio, Vielmi, Francesca, Borgione, Silvia, Agosti, Massimo, Tandoi, Francesco, Guidali, Rosanna, De Curtis, Mario, Tozzi, Claudio, Lucchini, Renato, Battaglioli, Marina, Lista, Gian Luca, Introvini, Paola, Ferrari, Fabrizio, Gallo, Claudio, Bellante, Elvira, Bottura, Chiara, Zeringyte, Aurelija, Pasquali, Francesca, Boccacci, Simona, Latini, Giuseppe, Giannuzzi, Raffaella, Martinelli, Stefano, Brunelli, Alberto, Di Nunzio, Maria Lucia, Vendemmiati, Antonio, Carli, Giovanna, Bordigato, Michela Alfiero, Filippone, Marco, Meneghesso, Davide, Romeo, Nicola, Mammoliti, Palma, Mastretta, Emanuele, Barberis, Laura, Farina, Daniele, Gancia, Gianpaolo, Dalmazzo, Cristina, Napolitano, Marcello, Messina, Francesco, Villa Betania, Napoli, Magaldi, Rosario, Rinaldi, Matteo, Litta, Rosangela, Lago, Paola, Zanardo, Vincenzo, Chiandetti, Lino, Visentin, Stefano, Presta, Giuseppe, Cella, Davide, Poggiani, Carlo, Ferrari, Daniela, Parati, Sara, Lombardo, Francesco, Grigorio, Rosetta, Barera, Graziano, Bove, Maddalena, Poloniato, Antonella, Burgio, Giampiero, Sala, Elena, Barberi, Ignazio, Tiralongo, Venera, Arco, Alessandro, Mazzeo, Danila, Dani, Carlo, Pratesi, Simone, Mignatti, Valeria, Ancora, Gina, Faldella, Giacomo, Grandi, Sara, Locatelli, Chiara, Stronati, Mauro, Perotti, Gianfranco, Chirico, Gaetano, Migliori, Claudio, De Marini, Sergio, Forleo, Vincenzo, Paludetto, Roberto, Capasso, Letizia, Mansi, Giuseppina, Raimondi, Francesco, Bona, Gianni, Stucchi, Ilaria, Savastio, Silvia, Ferrero, Federica, Parola, Andrea, Padovani, Ezio Maria, Viviani, Elena, Pecoraro, Laura, Agostino, Rocco, Gizzi, Camilla, Massenzi, Luca, Messner, Hubert, Staffler, Alex, Salvia, Gennaro, Esposito, Luigi, Forziati, Vincenzo, Latorre, Giuseppe, Sandri, Fabrizio, Alati, Stefania, Demarca, Fabrizio, Lombardi, Oreste, Costabile, Carmine Deni, Scarpelli, Gianfranco, Cavalli, Claudio, Volante, Enrico, Moretti, Sabrina, Ganguzza, Olga, Spinella, Bartolomeo, Haass, Cristina, Scapillati, Eleonora, Consigli, Chiara, Gatta, Alberto, Quitadamo, Pasqua, Boldrini, Antonio, Vuerich, Marco, Sigali, Emilio, Fiorini, Patrizio, Petrucci, Letizia, Moroni, Marco, Meyer, Firenze, Bragetti, Patrizia, Casucci, Paola, Minelli, Liliana, Mezzetti, Daniele, Orfeo, Luigi, De Luca, Maria Gabriella, Laforgia, Nicola, Grassi, Alessandro, Dotta, Andrea, Savignoni, Ferdinando, Bagnoli, Franco, De Felice, Claudio, Badii, Silvia, Biasini, Augusto, Belluzzi, Antonio, Stella, Marcello, Romagnoli, Costantino, Zecca, Enrico, Barone, Giovanni, Colleselli, Paolo, Vecchiato, Luca, Nicolussi, Silvia, Giliberti, Paolo, Chello, Giovanni, Rojo, Silvana, De Vivo, Massimiliano, Giovanettoni, Chiara, Colnaghi, Clelia A., Manfredini, Valeria, Verucci, Elena, Placidi, Giulia, Belloni, Cesare, Carrera, Giuseppe, Zambetti, Chiara, Biban, Paolo, Serra, Alessandra, Sacco, Francesco, Vetrano, Gennaro, Furcolo, Giuseppe, Pasquariello, Brigida, Falco, Luigi, Ausanio, Gaetano, Bernardo, Italo, Capasso, Antonella, Marchesano, Giuseppe, Nosari, Norberto, Sarnelli, Paola, Ciraci, Giovanni, Merazzi, Daniele, Gazzolo, Diego, Temperini, Francesca, Sabatini, Miriam, Colivicchi, Micaela, Del Vecchio, Antonio, Tarantino, Marzia, Gargano, Giancarlo, Pedori, Simona, Bellettato, Massimo, Pesavento, Roberta, Cesaro, Alessandra, Scollo, Massimo, Mondello, Isabella, Pugliese, Aniello, Iervolino, Claudio, Corsello, Giovanni, Giuffré, Mario, Betta, Pasqua, Romeo, Mario Giuseppe, Saporito, Alessandro, Leone, Maria Grazia, Rodonò, Alessandro, Franceschi, Alessia, Risso, Francesco M., Carpentieri, Mauro, Vecchiano, Teresa, Cigliano, Maria Pia, Paolillo, Piermichele, Picone, Simonetta, Marra, Antonio, Rossetti, Gessica, Testa, Tiziana, Del Cuore, Fernando, Crescenzi, Francesco, Poloni, Gianna, Russo, Maria Chiara, Nigro, Francesco, Tina, Gabriella Lucia, Brindisino, Patrizia, Gurrado, Raffaele, Felice, Maurizio, and Formica, Isabella

Subjects
Male, Pediatrics, Logistic models, Mortality, Outcomes, Pregnancy complications, Preterm infants, Risks, Female, Gestational Age, Humans, Infant, Newborn, Infant, Premature, Diseases, Pregnancy, Pregnancy Outcome, Prospective Studies, Chorioamnionitis, Hypertension, Pregnancy-Induced, Pediatrics, Perinatology and Child Health, Medicine (all), Arts and Humanities (miscellaneous), Diseases, outcomes, Maternal hypertension, risk, Obstetrics, pregnancy complications, Gestational age, Retinopathy of prematurity, Perinatology and Child Health, Settore MED/38 - PEDIATRIA GENERALE E SPECIALISTICA, Logistic models, Mortality, Outcomes, Pregnancy complications, Preterm infants, Risks, Necrotizing enterocolitis, Hypertension, outcome, Human, medicine.medical_specialty, Pregnancy-Induced, preterm infant, Pregnancy complication, medicine, preterm infants, Premature, logistic model, Chorioamnioniti, business.industry, Infant, Infant, Premature, Disease, Odds ratio, medicine.disease, Newborn, mortality, Prospective Studie, Bronchopulmonary dysplasia, business, logistic models, risks
Abstract

OBJECTIVES: We compared the relative effect of hypertensive disorders of pregnancy and chorioamnionitis on adverse neonatal outcomes in very preterm neonates, and studied whether gestational age (GA) modulates these effects. METHODS: A cohort of neonates 23 to 30 weeks' GA, born in 2008 to 2011 in 82 hospitals adhering to the Italian Neonatal Network, was analyzed. Infants born from mothers who had hypertensive disorders (N = 2096) were compared with those born after chorioamnionitis (N = 1510). Statistical analysis employed logistic models, adjusting for GA, hospital, and potential confounders. RESULTS: Overall mortality was higher after hypertension than after chorioamnionitis (odds ratio [OR], 1.39; 95% confidence interval [CI], 1.08–1.80), but this relationship changed across GA weeks; the OR for hypertension was highest at low GA, whereas from 28 weeks' GA onward, mortality was higher for chorioamnionitis. For other outcomes, the relative risks were constant across GA; infants born after hypertension had an increased risk for bronchopulmonary dysplasia (OR, 2.20; 95% CI, 1.68–2.88) and severe retinopathy of prematurity (OR, 1.48; 95% CI, 1.02–2.15), whereas there was a lower risk for early-onset sepsis (OR, 0.25; 95% CI, 0.19–0.34), severe intraventricular hemorrhage (OR, 0.65; 95% CI, 0.48–0.88), periventricular leukomalacia (OR, 0.70; 95% CI, 0.48–1.01), and surgical necrotizing enterocolitis or gastrointestinal perforation (OR, 0.47; 95% CI, 0.31–0.72). CONCLUSIONS: Mortality and other adverse outcomes in very preterm infants depend on antecedents of preterm birth. Hypertension and chorioamnionitis are associated with different patterns of outcomes; for mortality, the effect changes across GA weeks.

Published
2014

13. The C807T/G873A polymorphism in the platelet glycoprotein Ia gene and the risk of acute coronary syndrome in the Italian population

Author

Casorelli, I., De Stefano, Valerio, Leone, Antonio Maria, Chiusolo, Patrizia, Burzotta, Francesco, Paciaroni, Katia, Rossi, Elena, Andreotti, Felicita, Leone, Maria Grazia, and Maseri, A.

Subjects
Adult, Male, Integrins, Receptors, Collagen, Genotype, Myocardial Infarction, Coronary Disease, Unstable, Genetic, Risk Factors, Receptors, Odds Ratio, Humans, Angina, Unstable, Polymorphism, Platelet glycoprotein GP Ia/IIa, Aged, Polymorphism, Genetic, Middle Aged, Angina, Italy, Case-Control Studies, Acute Disease, Settore MED/11 - MALATTIE DELL'APPARATO CARDIOVASCOLARE, Female, Acute coronary syndrome, Collagen, Unstable angina, GP Ia C807T/G873A polymorphism
Published
2001

14. Gender and Women’s Studies in Italy: Looking back to look forward

Author

Magaraggia, S, Leone Maria, G, MAGARAGGIA Sveva, Leone Maria Grazia, Magaraggia, S, Leone Maria, G, MAGARAGGIA Sveva, and Leone Maria Grazia

Abstract

Between the 1970s and the 1990s, women’s studies research and theoretical confrontations became common both inside and outside Italian universities, producing a substantial cultural and scientific inheritance. However, the teaching of such content had to follow an accidental path deprived of any institutional visibility. Women’s studies was forced to adapt itself to existing didactic structures, ‘hidden’ inside single courses and single disciplines, without being evident itself in the university. Only in the late 1990s did such studies become institutionally formalized. Nowadays, there is a rapid growth in women’s studies in Italy, thanks particularly to the course,Women Politics and Institutions, created in 2004. In this Open forum, the authors try to suggest what future scenarios might look like, anticipating a not yet realized horizon.

Published
2010

15. Use of G-CSF during acute on chronic liver failure: Clinical and biochemical safety profile

Author

Novi, M, Di Campli, C, Di Gioacchino, G, Zocco, Maria Assunta, Rutella, S, Ainora, Maria Elena, Addolorato, Giovanni, Abenavoli, L, Miele, Luca, Forgione, Alessandra, Grieco, A, Leone, Maria Grazia, Gasbarrini, Giovanni Battista, Rapaccini, Gian Ludovico, Pola, P, Gasbarrini, Antonio, Zocco, MA (ORCID:0000-0002-0814-9542), Ainora, ME, Addolorato, G (ORCID:0000-0002-1522-9946), Miele, L (ORCID:0000-0003-3464-0068), Forgione, A, Leone, G, Gasbarrini, GB, Rapaccini, GL (ORCID:0000-0002-6467-857X), Gasbarrini, A (ORCID:0000-0002-7278-4823), Novi, M, Di Campli, C, Di Gioacchino, G, Zocco, Maria Assunta, Rutella, S, Ainora, Maria Elena, Addolorato, Giovanni, Abenavoli, L, Miele, Luca, Forgione, Alessandra, Grieco, A, Leone, Maria Grazia, Gasbarrini, Giovanni Battista, Rapaccini, Gian Ludovico, Pola, P, Gasbarrini, Antonio, Zocco, MA (ORCID:0000-0002-0814-9542), Ainora, ME, Addolorato, G (ORCID:0000-0002-1522-9946), Miele, L (ORCID:0000-0003-3464-0068), Forgione, A, Leone, G, Gasbarrini, GB, Rapaccini, GL (ORCID:0000-0002-6467-857X), and Gasbarrini, A (ORCID:0000-0002-7278-4823)

Abstract

N/a

Published
2006

16. Glycoprotein la C807T qene polymorphism and increased risk of recurrent acute coronary syndromes: A five year follow up

Author

Leone, Antonio Maria, De Stefano, Valerio, Burzotta, Francesco, Chiusolo, Patrizia, Casorelli, I., Paciaroni, Katia, Rossi, Elena, Sciahbasi, A., Testa, L., Leone, Maria Grazia, Crea, Filippo, Andreotti, Felicita, Leone A. M. (ORCID:0000-0002-1276-9883), De Stefano V. (ORCID:0000-0002-5178-5827), Burzotta F. (ORCID:0000-0002-6569-9401), Chiusolo P. (ORCID:0000-0002-1355-1587), Paciaroni K., Rossi E. (ORCID:0000-0002-7572-9379), Leone G., Crea F. (ORCID:0000-0001-9404-8846), Andreotti F. (ORCID:0000-0002-1456-6430), Leone, Antonio Maria, De Stefano, Valerio, Burzotta, Francesco, Chiusolo, Patrizia, Casorelli, I., Paciaroni, Katia, Rossi, Elena, Sciahbasi, A., Testa, L., Leone, Maria Grazia, Crea, Filippo, Andreotti, Felicita, Leone A. M. (ORCID:0000-0002-1276-9883), De Stefano V. (ORCID:0000-0002-5178-5827), Burzotta F. (ORCID:0000-0002-6569-9401), Chiusolo P. (ORCID:0000-0002-1355-1587), Paciaroni K., Rossi E. (ORCID:0000-0002-7572-9379), Leone G., Crea F. (ORCID:0000-0001-9404-8846), and Andreotti F. (ORCID:0000-0002-1456-6430)

Abstract

N/A

Published
2004

17. G20210A Prothrombin gene polymorphism and coronary ischaemic syndromes: A phenotype-specific meta-analysis of 12 034 subjects

Author

Burzotta, Francesco, Paciaroni, K., De Stefano, Valerio, Crea, Filippo, Maseri, A., Leone, Maria Grazia, Andreotti, Felicita, Burzotta F. (ORCID:0000-0002-6569-9401), De Stefano V. (ORCID:0000-0002-5178-5827), Crea F. (ORCID:0000-0001-9404-8846), Leone G., Andreotti F. (ORCID:0000-0002-1456-6430), Burzotta, Francesco, Paciaroni, K., De Stefano, Valerio, Crea, Filippo, Maseri, A., Leone, Maria Grazia, Andreotti, Felicita, Burzotta F. (ORCID:0000-0002-6569-9401), De Stefano V. (ORCID:0000-0002-5178-5827), Crea F. (ORCID:0000-0001-9404-8846), Leone G., and Andreotti F. (ORCID:0000-0002-1456-6430)

Abstract

Objective: To investigate the possible link between the G20210A prothrombin gene variant and different forms of ischaemic heart disease. Design: Phenotype-specific meta-analysis of 19 studies published within March 2002, globally including 4944 patients and 7090 controls. Sample size, inclusion criteria, geographical location, clinical presentation, age, cardiovascular risk factors, and angiographic extent of disease were extracted from each study. Analyses were done according to Mantel-Haenszel. Results: Overall, the odds ratio (OR) for unspecified ischaemic heart disease associated with the 20210A allele was 1.21 (95% confidence interval (Cl) 0.99 to 1.59, n = 12 034). Similar findings were seen for acute coronary syndromes (unstable angina and myocardial infarction) and for myocardial infarction without age limits (OR 1.24, 95% Cl 0.98 to 1.63, n = 10 240; and OR 1.19, 95% Cl 0.93 to 1.58, n = 9765). The effects were similar in male and female subjects. In the 1931 subjects < 55 years of age, the OR for myocardial infarction increased to 1.77 (95% Cl 1.16 to 3.42) and in the 1359 subjects < 45 years to 2.30 (95% Cl 1.27 to 4.59). No significant association was found between the 20210A allele and the presence of angiographically documented coronary disease (OR 1.08, 95% Cl 0.70 to 1.64, n = 3444). However, patients with 0/1 vessel disease at angiography showed a greater prevalence of the A allele than those with multivessel disease (relative risk 2.0, 95% Cl 1.2 to 3.1, n = 2376). Conclusions: G20210A prothrombin gene polymorphism may represent a modest but significant risk factor for myocardial infarction at yaung ages and favour the expression of ischaemic heart disease among individuals who have a limited extent of coronary atherosclerosis at angiography.

Published
2004

18. Increased prevalence of the G20210A prothrombin gene variant in acute coronary syndromes without metabolic or acquired risk factors or with limited extent of disease

Author

Burzotta, Francesco, Paciaroni, Katia, De Stefano, Valerio, Chiusolo, Patrizia, Manzoli, A., Casorelli, I., Leone, Antonio Maria, Rossi, Elena, Leone, Maria Grazia, Maseri, A., Andreotti, Felicita, Burzotta F. (ORCID:0000-0002-6569-9401), Paciaroni K., De Stefano V. (ORCID:0000-0002-5178-5827), Chiusolo P. (ORCID:0000-0002-1355-1587), Leone A. M. (ORCID:0000-0002-1276-9883), Rossi E. (ORCID:0000-0002-7572-9379), Leone G., Andreotti F. (ORCID:0000-0002-1456-6430), Burzotta, Francesco, Paciaroni, Katia, De Stefano, Valerio, Chiusolo, Patrizia, Manzoli, A., Casorelli, I., Leone, Antonio Maria, Rossi, Elena, Leone, Maria Grazia, Maseri, A., Andreotti, Felicita, Burzotta F. (ORCID:0000-0002-6569-9401), Paciaroni K., De Stefano V. (ORCID:0000-0002-5178-5827), Chiusolo P. (ORCID:0000-0002-1355-1587), Leone A. M. (ORCID:0000-0002-1276-9883), Rossi E. (ORCID:0000-0002-7572-9379), Leone G., and Andreotti F. (ORCID:0000-0002-1456-6430)

Abstract

Aims: To investigate the prevalence of the G20210A prothrombin and G1691A factor V gene variants in patients with acute coronary syndrome stratified according to risk factor profile and to extent of coronary disease, in comparison with matched healthy controls. Methods and Results: The 20210 prothrombin and the 1691 factor V loci were genotyped in 247 patients ≤65 years of age (190 myocardial infarction and 57 unstable angina as first presentation of disease) and in 247 healthy age- and sex-matched controls. The prevalence of the 1691A factor V allele was similar in cases and controls. The frequency of heterozygotes for the 20210A prothrombin allele was 6·5% among patients and 2·8% among controls (OR 2·4, 95% CI 1·0-5·9), increasing to 8·7% in patients with a family history of myocardial infarction (OR 3·3, 95% CI 1·2-9·1), to 9·9% in patients (n=81) with ≤1 vessel disease (OR 3·8, 95% CI 1·3-10·8), and to 13·0% in patients who were normocholesterolaemic, non-diabetic, normotensive and non-smokers (OR 5·1, 95% CI 1·2-21·4). Conclusions: These findings suggest that the 20210A prothrombin allele represents an inherited risk factor for acute coronary syndrome among patients who have limited extent of coronary disease at angiography or who lack major metabolic and acquired risk factors. © 2001 The European Society of Cardiology.

Published
2002

29. Relaxant Effects of Aflatoxins on Isolated Guinea Pig Trachea.

Author

Abdel-Haq, Hanin, Palmery, Maura, Leone, Maria Grazia, Saso, Luciano, and Silvestrini, Bruno

Subjects
DYSPNEA, AFLATOXINS, TRACHEA, GUINEA pigs, TOXICOLOGY
Abstract

Dyspnea is one of the symptoms of acute aflatoxicosis. Contrary to expectations, we observed that naturally occurring aflatoxins (AF) AFB1, AFB2, AFG1, and AFG2 and their major metabolites AFM1, AFM2, AFP1, AFQ1, and AFG2a relaxed carbachol (C) precontracted guinea pig trachea to different degrees. The efficacies but not the potencies of AFB1, AFB2, AFG1, and AFG2 were similar to that of the β-agonist, isoprenaline, whose activity was potentiated by the AF. Their mechanism of action is not clearly understood but several mechanistic indications were obtained with AFB1: 1) its effect was not influenced by the β-blocker, timolol, indicating that a direct interaction with β2-adrenergic receptors was not involved. 2) AFB1 potentiated PGE1 and PGE2, two relaxant prostaglandins, and its activity was reduced by indomethacin. 3) The cAMP level in the guinea pig trachea relaxed by AFB1 increased, possibly due to inhibition of phosphodiesterase; direct interaction with PG receptors; and/or interaction with A2 adenosinic receptors, suggested by the inhibitory activity of XAC, a specific antagonist. 4) Finally, since tetrodotoxin reduced the relaxant activity of AFB1, it is speculated that this mycotoxin could stimulate inhibitory nonadrenergic, noncholinergic nerves (i-NANC). In conclusion, the symptoms of acute aflatoxicosis do not seem to be due to a direct activity on the tracheal muscle, but rather, to the well-known pro-inflammatory activity of the aflatoxins, which are capable of releasing arachidonic acid from cell membranes. [ABSTRACT FROM PUBLISHER]

Published
2000
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31. Rat Prostaglandin D2Synthetase: Its Tissue Distribution, Changes during Maturation, and Regulation in the Testis and Epididymis1

Author

Sorrentino, Claudio, Silvestrini, Bruno, Braghiroli, Laura, Chung, Sanny S.W., Giacomelli, Sabrina, Leone, Maria-Grazia, Xie, Yan-bo, Sui, Ya-ping, Mo, Meng-yun, and Cheng, C. Yan

Abstract

The changes in glutathione-independent prostaglandin D2synthetase (PGD-S) during maturation in the rat were determined in selected organs by an RIA using PGD-S purified from rat cerebrospinal fluid and a monospecific anti-rat PGD-S polyclonal antibody. In a survey of its tissue distribution in various organ extracts and biological fluids, it was found that the concentration of PGD-S was highest in the epididymis—about 6- and 80-fold greater than that in the brain and testis, respectively. During maturation, PGD-S concentration increased steadily in the testis and epididymis; this is in contrast to the pattern of changes in the brain and liver, which showed a general trend of decline. Reverse transcription-polymerase chain reaction and Southern blotting were used to demonstrate the presence of PGD-S mRNA transcript in the testis and in Sertoli and germ cells. In the epididymis, the steady-state PGD-S mRNA level was highest in the caput, followed by the cauda and corpus. Orchiectomy induced a drastic reduction of PGD-S concentration in all three epididymal compartments. Administration of dihydrotestosterone (DHT) failed to restore the reduced epididymal PGD-S level except in the caput epididymis, where 4 days after DHT treatment the level of PGD-S was restored to about 50% of the pre-orchiectomized level; this suggests that the epididymal PGD-S level is not entirely regulated by androgen and that another yet to be identified testicular factor(s) is likely to be involved in its regulation. Germ cell-conditioned medium was also shown to stimulate PGD-S expression in the Sertoli cell. These results illustrate that PGD-S is an important molecule in testicular and epididymal function and that it is likely involved in spermatogenesis and sperm maturation.

Published
1998
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32. Management of pregnancy in women with antithrombin III congenital defect: Report of four cases

Author

De Stefano, Valerio, Leone, Maria Grazia, De Carolis, Sara, Ferrelli, R., Di Donfrancesco, A., Moneta, E., Bizzi, B., De Stefano V. (ORCID:0000-0002-5178-5827), Leone G., De Carolis S. (ORCID:0000-0002-5160-7609), De Stefano, Valerio, Leone, Maria Grazia, De Carolis, Sara, Ferrelli, R., Di Donfrancesco, A., Moneta, E., Bizzi, B., De Stefano V. (ORCID:0000-0002-5178-5827), Leone G., and De Carolis S. (ORCID:0000-0002-5160-7609)

Abstract

Four pregnant women with antithrombin III congenital deficiency underwent thrombosis prophylaxis including oral anticoagulants administered from the 16-18th week to the 36-37th week of pregnancy, subcutaneous heparin before the 16-18th week and after the 36-37th week, and a single infusion of AT III concentrate in the peripartum period in order to obtain a minimal level of 0.8 U/ml of AT III functional activity. The level of circulating AT III after the concentrate infusion needs to be evaluated by functional methods, because of a consistent amount in the concentrates of inactive AT III immunoreactive material. No thrombotic or haemorrhagic complication occurred after starting prophylaxis in any woman either in any newborn.

Published
1988

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