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1. Predictors of serious adverse events and non-response in cirrhotic patients with primary biliary cholangitis treated with obeticholic acid

Author

De Vincentis, A, D'Amato, D, Cristoferi, L, Gerussi, A, Malinverno, F, Lleo, A, Colapietro, F, Marra, F, Galli, A, Fiorini, C, Coco, B, Brunetto, M, Niro, G, Cotugno, R, Saitta, C, Cozzolongo, R, Losito, F, Giannini, E, Labanca, S, Marzioni, M, Marconi, G, Morgando, A, Pellicano, R, Vanni, E, Cazzagon, N, Floreani, A, Chessa, L, Morelli, O, Muratori, L, Pellicelli, A, Pompili, M, Ponziani, F, Tortora, A, Rosina, F, Russello, M, Cannavo, M, Simone, L, Storato, S, Vigano, M, Abenavoli, L, D'Anto, M, De Gasperi, E, Distefano, M, Scifo, G, Zolfino, T, Calvaruso, V, Cuccorese, G, Palitti, V, Sacco, R, Bertino, G, Frazzetto, E, Alvaro, D, Mulinacci, G, Palermo, A, Scaravaglio, M, Terracciani, F, Galati, G, Ronca, V, Zuin, M, Claar, E, Izzi, A, Picardi, A, Invernizzi, P, Vespasiani-Gentilucci, U, Carbone, M, Feletti, V, Mussetto, A, Venere, R, Bernaccioni, G, Graciella Pigozzi, M, Fagiuoli, S, Terreni, N, Pozzoni, P, Baiocchi, L, Grassi, G, Vinci, M, Bellia, V, Boldizzoni, R, Casella, S, Omazzi, B, Poggi, G, De Vincentis A., D'Amato D., Cristoferi L., Gerussi A., Malinverno F., Lleo A., Colapietro F., Marra F., Galli A., Fiorini C., Coco B., Brunetto M., Niro G. A., Cotugno R., Saitta C., Cozzolongo R., Losito F., Giannini E. G., Labanca S., Marzioni M., Marconi G., Morgando A., Pellicano R., Vanni E., Cazzagon N., Floreani A., Chessa L., Morelli O., Muratori L., Pellicelli A., Pompili M., Ponziani F., Tortora A., Rosina F., Russello M., Cannavo M., Simone L., Storato S., Vigano M., Abenavoli L., D'Anto M., De Gasperi E., Distefano M., Scifo G., Zolfino T., Calvaruso V., Cuccorese G., Palitti V. P., Sacco R., Bertino G., Frazzetto E., Alvaro D., Mulinacci G., Palermo A., Scaravaglio M., Terracciani F., Galati G., Ronca V., Zuin M., Claar E., Izzi A., Picardi A., Invernizzi P., Vespasiani-Gentilucci U., Carbone M., Feletti V., Mussetto A., Venere R., Bernaccioni G., Graciella Pigozzi M., Fagiuoli S., Terreni N., Pozzoni P., Baiocchi L., Grassi G., Vinci M., Bellia V., Boldizzoni R., Casella S., Omazzi B., Poggi G., De Vincentis, A, D'Amato, D, Cristoferi, L, Gerussi, A, Malinverno, F, Lleo, A, Colapietro, F, Marra, F, Galli, A, Fiorini, C, Coco, B, Brunetto, M, Niro, G, Cotugno, R, Saitta, C, Cozzolongo, R, Losito, F, Giannini, E, Labanca, S, Marzioni, M, Marconi, G, Morgando, A, Pellicano, R, Vanni, E, Cazzagon, N, Floreani, A, Chessa, L, Morelli, O, Muratori, L, Pellicelli, A, Pompili, M, Ponziani, F, Tortora, A, Rosina, F, Russello, M, Cannavo, M, Simone, L, Storato, S, Vigano, M, Abenavoli, L, D'Anto, M, De Gasperi, E, Distefano, M, Scifo, G, Zolfino, T, Calvaruso, V, Cuccorese, G, Palitti, V, Sacco, R, Bertino, G, Frazzetto, E, Alvaro, D, Mulinacci, G, Palermo, A, Scaravaglio, M, Terracciani, F, Galati, G, Ronca, V, Zuin, M, Claar, E, Izzi, A, Picardi, A, Invernizzi, P, Vespasiani-Gentilucci, U, Carbone, M, Feletti, V, Mussetto, A, Venere, R, Bernaccioni, G, Graciella Pigozzi, M, Fagiuoli, S, Terreni, N, Pozzoni, P, Baiocchi, L, Grassi, G, Vinci, M, Bellia, V, Boldizzoni, R, Casella, S, Omazzi, B, Poggi, G, De Vincentis A., D'Amato D., Cristoferi L., Gerussi A., Malinverno F., Lleo A., Colapietro F., Marra F., Galli A., Fiorini C., Coco B., Brunetto M., Niro G. A., Cotugno R., Saitta C., Cozzolongo R., Losito F., Giannini E. G., Labanca S., Marzioni M., Marconi G., Morgando A., Pellicano R., Vanni E., Cazzagon N., Floreani A., Chessa L., Morelli O., Muratori L., Pellicelli A., Pompili M., Ponziani F., Tortora A., Rosina F., Russello M., Cannavo M., Simone L., Storato S., Vigano M., Abenavoli L., D'Anto M., De Gasperi E., Distefano M., Scifo G., Zolfino T., Calvaruso V., Cuccorese G., Palitti V. P., Sacco R., Bertino G., Frazzetto E., Alvaro D., Mulinacci G., Palermo A., Scaravaglio M., Terracciani F., Galati G., Ronca V., Zuin M., Claar E., Izzi A., Picardi A., Invernizzi P., Vespasiani-Gentilucci U., Carbone M., Feletti V., Mussetto A., Venere R., Bernaccioni G., Graciella Pigozzi M., Fagiuoli S., Terreni N., Pozzoni P., Baiocchi L., Grassi G., Vinci M., Bellia V., Boldizzoni R., Casella S., Omazzi B., and Poggi G.

Abstract

Background & Aims: Obeticholic acid (OCA) has recently been restricted in patients with primary biliary cholangitis (PBC) with “advanced cirrhosis” because of its narrow therapeutic index. We aimed to better define the predicting factors of hepatic serious adverse events (SAEs) and non-response in cirrhotic patients undergoing OCA therapy. Methods: Safety and efficacy of treatment were evaluated in a cohort of consecutive PBC cirrhotic patients started with OCA. OCA response was evaluated according to the Poise criteria. Risk factors for hepatic SAEs and non-response were reported as risk ratios (RR) with 95% confidence intervals (CIs). Results: One hundred PBC cirrhotics were included, 97 Child-Pugh class A and 3 class B. Thirty-one had oesophageal varices and 5 had a history of ascites. Thirty-three per cent and 32% of patients achieved a biochemical response at 6 and 12 months respectively. Male sex (adjusted-RR 1.75, 95%CI 1.42–2.12), INR (1.37, 1.00–1.87), Child-Pugh score (1.79, 1.28–2.50), MELD (1.17, 1.04–1.30) and bilirubin (1.83, 1.11–3.01) were independently associated with non-response to OCA. Twenty-two patients discontinued OCA within 12 months: 10 for pruritus, 9 for hepatic SAEs (5 for jaundice and/or ascitic decompensation; 4 for upper digestive bleeding). INR (adjusted-RR 1.91, 95%CI 1.10–3.36), lower albumin levels (0.18, 0.06–0.51), Child-Pugh score (2.43, 1.50–4.04), history of ascites (3.5, 1.85–6.5) and bilirubin (1.30, 1.05–1.56), were associated with hepatic SAEs. A total bilirubin≥1.4 mg/dl at baseline was the most accurate biochemical predictor of hepatic SAEs under OCA. Conclusions: An accurate baseline assessment is crucial to select cirrhotic patients who can benefit from OCA. Although OCA is effective in one third of cirrhotics, bilirubin level ≥1.4 mg/dl should discourage from its use.

Published
2022

2. The role of antiplatelet therapies on incidence and mortality of hepatocellular carcinoma

Author

Lai, Quirino, De Matthaeis, Nicoletta, Finotti, Michele, Galati, Giovanni, Marrone, Giuseppe, Melandro, Fabio, Morisco, Filomena, Nicolini, Daniele, Pravisani, Riccardo, Giannini, Edoardo G, Aglitti, A, Aliberti, C, Baccarani, U, Bhoori, S, Borzio, M, Brancaccio, G, Burra, P, Cabibbo, G, Casadei Gardini, A, Carrai, P, Cillo, U, Conti, F, Cucchetti, A, D'Ambrosio, R, Dell'Unto, C, Di Costanzi, Gg, Di Sandro, S, Foschi, Fg, Fucilli, F, Gambato, M, Gasbarrini, Antonio, Giuliante, Felice, Ghinolfi, D, Grieco, Antonio, Gruttaduria, S, Guarino, M, Kostandini, A, Iavarone, M, Lenci, I, Levi Sandri, Gb, Losito, F, Lupo, Lg, Manzia, Tm, Mazzocato, S, Mescoli, C, Miele, Luca, Muley, M, Persico, M, Plaz Torres, Mc, Pompili, Maurizio, Ponziani, Francesca Romana, Rapaccini, Gian Ludovico, Rendina, M, Renzulli, M, Rossi, Marco, Rreka, E, Russo, Fp, Sacco, R, Sangiovanni, A, Sessa, A, Simonetti, N, Sposito, C, Tortora, R, Trevisani, F, Viganò, L, Viganò, M, Villa, E, Vincenzi, V, Violi, P, Vitale, A, Gasbarrini, A (ORCID:0000-0002-7278-4823), Giuliante, F (ORCID:0000-0001-9517-8220), Grieco, A (ORCID:0000-0002-0544-8993), Miele, L (ORCID:0000-0003-3464-0068), Pompili, M (ORCID:0000-0001-6699-7980), Ponziani, FR (ORCID:0000-0002-5924-6238), Rapaccini, GL (ORCID:0000-0002-6467-857X), Rossi, M (ORCID:0000-0002-4539-5670), Lai, Quirino, De Matthaeis, Nicoletta, Finotti, Michele, Galati, Giovanni, Marrone, Giuseppe, Melandro, Fabio, Morisco, Filomena, Nicolini, Daniele, Pravisani, Riccardo, Giannini, Edoardo G, Aglitti, A, Aliberti, C, Baccarani, U, Bhoori, S, Borzio, M, Brancaccio, G, Burra, P, Cabibbo, G, Casadei Gardini, A, Carrai, P, Cillo, U, Conti, F, Cucchetti, A, D'Ambrosio, R, Dell'Unto, C, Di Costanzi, Gg, Di Sandro, S, Foschi, Fg, Fucilli, F, Gambato, M, Gasbarrini, Antonio, Giuliante, Felice, Ghinolfi, D, Grieco, Antonio, Gruttaduria, S, Guarino, M, Kostandini, A, Iavarone, M, Lenci, I, Levi Sandri, Gb, Losito, F, Lupo, Lg, Manzia, Tm, Mazzocato, S, Mescoli, C, Miele, Luca, Muley, M, Persico, M, Plaz Torres, Mc, Pompili, Maurizio, Ponziani, Francesca Romana, Rapaccini, Gian Ludovico, Rendina, M, Renzulli, M, Rossi, Marco, Rreka, E, Russo, Fp, Sacco, R, Sangiovanni, A, Sessa, A, Simonetti, N, Sposito, C, Tortora, R, Trevisani, F, Viganò, L, Viganò, M, Villa, E, Vincenzi, V, Violi, P, Vitale, A, Gasbarrini, A (ORCID:0000-0002-7278-4823), Giuliante, F (ORCID:0000-0001-9517-8220), Grieco, A (ORCID:0000-0002-0544-8993), Miele, L (ORCID:0000-0003-3464-0068), Pompili, M (ORCID:0000-0001-6699-7980), Ponziani, FR (ORCID:0000-0002-5924-6238), Rapaccini, GL (ORCID:0000-0002-6467-857X), and Rossi, M (ORCID:0000-0002-4539-5670)

Abstract

Aim To evaluate the impact of antiplatelet therapy (APT)on the incidence of hepatocellular carcinoma (HCC) and mortality following its treatment. Methods A systematic literature search was performed using PubMed and Cochrane Central Register of Controlled Trials Databases. Two HCC clinical settings were explored: (i) incidence, and (ii) death after any HCC treatment. Odds ratios (OR) and 95% confidence intervals (95%CI) were calculated to compare the pooled data between patients who received or did not receive APT. Results A total of 20 studies were identified, of whom 15 focused on HCC incidence, including 2,685,009 patients, and five on post-treatment death, including 3281 patients. APT was associated with an overall reduced risk of HCC incidence (OR: 0.63; 95%CI = 0.51-0.79; p < 0.001) as well as of post-treatment mortality (OR: 0.54; 95%CI = 0.35-0.83; p = 0.006). Conclusions Current data suggest that APT correlated with higher HCC incidence and poor overall survival following tumour treatment.

Published
2023

3. The role of antiplatelet therapies on incidence and mortality of hepatocellular carcinoma

Author

Lai, Q., De Matthaeis, N., Finotti, M., Galati, G., Marrone, G., Melandro, F., Morisco, F., Nicolini, D., Pravisani, R., Giannini, E. G., Aglitti, A., Aliberti, C., Baccarani, U., Bhoori, S., Borzio, M., Brancaccio, G., Burra, P., Cabibbo, G., Casadei Gardini, A., Carrai, P., Cillo, U., Conti, F., Cucchetti, A., D'Ambrosio, R., Dell'Unto, C., Di Costanzo, G. G., Di Sandro, S., Foschi, F. G., Fucilli, F., Gambato, M., Gasbarrini, A., Giuliante, F., Ghinolfi, D., Grieco, A., Gruttaduria, S., Guarino, M., Kostandini, A., Iavarone, M., Lenci, I., Levi Sandri, G. B., Losito, F., Lupo, L. G., Manzia, T. M., Mazzocato, S., Mescoli, C., Miele, L., Muley, M., Persico, M., Plaz Torres, M. C., Pompili, M., Ponziani, F. R., Rapaccini, G. L., Rendina, M., Renzulli, M., Rossi, M., Rreka, E., Russo, F. P., Sacco, R., Sangiovanni, A., Sessa, A., Simonetti, N., Sposito, C., Tortora, R., Trevisani, F., Vigano, L., Vigano, M., Villa, E., Vincenzi, V., Violi, P., and Vitale, A.

Subjects
clopidogrel, aspirin, Clinical Biochemistry, incidence, occurrence, survival, General Medicine, Biochemistry, Settore MED/18
Abstract

To evaluate the impact of antiplatelet therapy (APT)on the incidence of hepatocellular carcinoma (HCC) and mortality following its treatment.A systematic literature search was performed using PubMed and Cochrane Central Register of Controlled Trials Databases. Two HCC clinical settings were explored: (i) incidence, and (ii) death after any HCC treatment. Odds ratios (OR) and 95% confidence intervals (95%CI) were calculated to compare the pooled data between patients who received or did not receive APT.A total of 20 studies were identified, of whom 15 focused on HCC incidence, including 2,685,009 patients, and five on post-treatment death, including 3281 patients. APT was associated with an overall reduced risk of HCC incidence (OR: 0.63; 95%CI = 0.51-0.79; p 0.001) as well as of post-treatment mortality (OR: 0.54; 95%CI = 0.35-0.83; p = 0.006).Current data suggest that APT correlated with higher HCC incidence and poor overall survival following tumour treatment.

Published
2023

4. Overview of prognostic systems for hepatocellular carcinoma and ITA.LI.CA external validation of MESH and CNLC classifications

Author

Vitale, A, Farinati, F, Finotti, M, Di Renzo, C, Brancaccio, G, Piscaglia, F, Cabibbo, G, Caturelli, E, Missale, G, Marra, F, Sacco, R, Giannini, E, Trevisani, F, Cillo, U, Bhoori, S, Borzio, M, Burra, P, Casadei Gardini, A, Carrai, P, Conti, F, Cozzolongo, R, Cucchetti, A, D'Ambrosio, R, Dell'Unto, C, De Matthaeis, N, Di Costanzo, G, Di Sandro, S, Famularo, S, Foschi, F, Fucilli, F, Galati, G, Gambato, M, Gasbarrini, A, Giuliante, F, Ghinolfi, D, Grieco, A, Gruttadauria, S, Guarino, M, Iavarone, M, Kostandini, A, Lai, Q, Lenci, I, Levi Sandri, G, Losito, F, Lupo, L, Marasco, G, Manzia, T, Mazzocato, S, Masarone, M, Melandro, F, Mescoli, C, Miele, L, Morisco, F, Muley, M, Nicolini, D, Pagano, D, Persico, M, Pompili, M, Ponziani, F, Pravisani, R, Rapaccini, G, Rendina, M, Renzulli, M, Romano, F, Rossi, M, Rreka, E, Russo, F, Sangiovanni, A, Sessa, A, Simonetti, N, Sposito, C, Tortora, R, Vigano, L, Vigano, M, Villa, E, Vincenzi, V, Violi, P, Azzaroli, F, Brunetto, M, Di Marco, A, Masotto, A, Mega, A, Nardone, G, Oliveri, F, Raimondo, G, Svegliati Baroni, G, Vidili, G, Zoli, M, Vitale A., Farinati F., Finotti M., Di Renzo C., Brancaccio G., Piscaglia F., Cabibbo G., Caturelli E., Missale G., Marra F., Sacco R., Giannini E. G., Trevisani F., Cillo U., Bhoori S., Borzio M., Burra P., Casadei Gardini A., Carrai P., Conti F., Cozzolongo R., Cucchetti A., D'ambrosio R., Dell'unto C., De Matthaeis N., Di Costanzo G. G., Di Sandro S., Famularo S., Foschi F. G., Fucilli F., Galati G., Gambato M., Gasbarrini A., Giuliante F., Ghinolfi D., Grieco A., Gruttadauria S., Guarino M., Iavarone M., Kostandini A., Lai Q., Lenci I., Levi Sandri G. V., Losito F., Lupo L. G., Marasco G., Manzia T. M., Mazzocato S., Masarone M., Melandro F., Mescoli C., Miele L., Morisco F., Muley M., Nicolini D., Pagano D., Persico M., Pompili M., Ponziani F. R., Pravisani R., Rapaccini G. L., Rendina M., Renzulli M., Romano F., Rossi M., Rreka E., Russo F. P., Sangiovanni A., Sessa A., Simonetti N., Sposito C., Tortora R., Vigano L., Vigano M., Villa E., Vincenzi V., Violi P., Azzaroli F., Brunetto M. R., Di Marco A., Masotto A., Mega A., Nardone G., Oliveri F., Raimondo G., Svegliati Baroni G., Vidili G., Zoli M., Vitale, A, Farinati, F, Finotti, M, Di Renzo, C, Brancaccio, G, Piscaglia, F, Cabibbo, G, Caturelli, E, Missale, G, Marra, F, Sacco, R, Giannini, E, Trevisani, F, Cillo, U, Bhoori, S, Borzio, M, Burra, P, Casadei Gardini, A, Carrai, P, Conti, F, Cozzolongo, R, Cucchetti, A, D'Ambrosio, R, Dell'Unto, C, De Matthaeis, N, Di Costanzo, G, Di Sandro, S, Famularo, S, Foschi, F, Fucilli, F, Galati, G, Gambato, M, Gasbarrini, A, Giuliante, F, Ghinolfi, D, Grieco, A, Gruttadauria, S, Guarino, M, Iavarone, M, Kostandini, A, Lai, Q, Lenci, I, Levi Sandri, G, Losito, F, Lupo, L, Marasco, G, Manzia, T, Mazzocato, S, Masarone, M, Melandro, F, Mescoli, C, Miele, L, Morisco, F, Muley, M, Nicolini, D, Pagano, D, Persico, M, Pompili, M, Ponziani, F, Pravisani, R, Rapaccini, G, Rendina, M, Renzulli, M, Romano, F, Rossi, M, Rreka, E, Russo, F, Sangiovanni, A, Sessa, A, Simonetti, N, Sposito, C, Tortora, R, Vigano, L, Vigano, M, Villa, E, Vincenzi, V, Violi, P, Azzaroli, F, Brunetto, M, Di Marco, A, Masotto, A, Mega, A, Nardone, G, Oliveri, F, Raimondo, G, Svegliati Baroni, G, Vidili, G, Zoli, M, Vitale A., Farinati F., Finotti M., Di Renzo C., Brancaccio G., Piscaglia F., Cabibbo G., Caturelli E., Missale G., Marra F., Sacco R., Giannini E. G., Trevisani F., Cillo U., Bhoori S., Borzio M., Burra P., Casadei Gardini A., Carrai P., Conti F., Cozzolongo R., Cucchetti A., D'ambrosio R., Dell'unto C., De Matthaeis N., Di Costanzo G. G., Di Sandro S., Famularo S., Foschi F. G., Fucilli F., Galati G., Gambato M., Gasbarrini A., Giuliante F., Ghinolfi D., Grieco A., Gruttadauria S., Guarino M., Iavarone M., Kostandini A., Lai Q., Lenci I., Levi Sandri G. V., Losito F., Lupo L. G., Marasco G., Manzia T. M., Mazzocato S., Masarone M., Melandro F., Mescoli C., Miele L., Morisco F., Muley M., Nicolini D., Pagano D., Persico M., Pompili M., Ponziani F. R., Pravisani R., Rapaccini G. L., Rendina M., Renzulli M., Romano F., Rossi M., Rreka E., Russo F. P., Sangiovanni A., Sessa A., Simonetti N., Sposito C., Tortora R., Vigano L., Vigano M., Villa E., Vincenzi V., Violi P., Azzaroli F., Brunetto M. R., Di Marco A., Masotto A., Mega A., Nardone G., Oliveri F., Raimondo G., Svegliati Baroni G., Vidili G., and Zoli M.

Abstract

Prognostic assessment in patients with HCC remains an extremely difficult clinical task due to the complexity of this cancer where tumour characteristics interact with degree of liver dysfunction, patient general health status, and a large span of available treatment options. Several prognostic systems have been proposed in the last three decades, both from the Asian and European/North American countries. Prognostic scores, such as the CLIP score and the recent MESH score, have been generated on a solid statistical basis from real life population data, while staging systems, such as the BCLC scheme and the recent CNLC classification, have been created by experts according to recent HCC prognostic evidences from the literature. A third category includes combined prognostic systems that can be used both as prognostic scores and staging systems. A recent example is the ITA.LI.CA prognostic system including either a prognostic score and a simplified staging system. This review focuses first on an overview of the main prognostic systems for HCC classified according to the above three categories, and, second, on a comprehensive description of the methodology required for a correct comparison between different systems in terms of prognostic performance. In this second section the main studies in the literature comparing different prognostic systems are described in detail. Lastly, a formal comparison between the last prognostic systems proposed for each of the above three categories is performed using a large Italian database including 6882 HCC patients in order to concretely apply the comparison rules previously described.

Published
2021

5. Real-world experience with obeticholic acid in patients with primary biliary cholangitis

Author

D'Amato, D, De Vincentis, A, Malinverno, F, Vigano, M, Alvaro, D, Pompili, M, Picciotto, A, Palitti, V, Russello, M, Storato, S, Pigozzi, M, Calvaruso, V, De Gasperi, E, Lleo, A, Castellaneta, A, Pellicelli, A, Cazzagon, N, Floreani, A, Muratori, L, Fagiuoli, S, Niro, G, Feletti, V, Cozzolongo, R, Terreni, N, Marzioni, M, Pellicano, R, Pozzoni, P, Baiocchi, L, Chessa, L, Rosina, F, Bertino, G, Vinci, M, Morgando, A, Vanni, E, Scifo, G, Sacco, R, D'Anto, M, Bellia, V, Boldizzoni, R, Casella, S, Omazzi, B, Poggi, G, Cristoferi, L, Gerussi, A, Ronca, V, Venere, R, Ponziani, F, Cannavo, M, Mussetto, A, Fontana, R, Losito, F, Frazzetto, E, Distefano, M, Colapietro, F, Labanca, S, Marconi, G, Grassi, G, Galati, G, O'Donnell, S, Mancuso, C, Mulinacci, G, Palermo, A, Claar, E, Izzi, A, Picardi, A, Invernizzi, P, Carbone, M, Vespasiani-Gentilucci, U, D'Amato D., De Vincentis A., Malinverno F., Vigano M., Alvaro D., Pompili M., Picciotto A., Palitti V. P., Russello M., Storato S., Pigozzi M. G., Calvaruso V., De Gasperi E., Lleo A., Castellaneta A., Pellicelli A., Cazzagon N., Floreani A., Muratori L., Fagiuoli S., Niro G. A., Feletti V., Cozzolongo R., Terreni N., Marzioni M., Pellicano R., Pozzoni P., Baiocchi L., Chessa L., Rosina F., Bertino G., Vinci M., Morgando A., Vanni E., Scifo G., Sacco R., D'Anto M., Bellia V., Boldizzoni R., Casella S., Omazzi B., Poggi G., Cristoferi L., Gerussi A., Ronca V., Venere R., Ponziani F., Cannavo M., Mussetto A., Fontana R., Losito F., Frazzetto E., Distefano M., Colapietro F., Labanca S., Marconi G., Grassi G., Galati G., O'Donnell S. E., Mancuso C., Mulinacci G., Palermo A., Claar E., Izzi A., Picardi A., Invernizzi P., Carbone M., Vespasiani-Gentilucci U., D'Amato, D, De Vincentis, A, Malinverno, F, Vigano, M, Alvaro, D, Pompili, M, Picciotto, A, Palitti, V, Russello, M, Storato, S, Pigozzi, M, Calvaruso, V, De Gasperi, E, Lleo, A, Castellaneta, A, Pellicelli, A, Cazzagon, N, Floreani, A, Muratori, L, Fagiuoli, S, Niro, G, Feletti, V, Cozzolongo, R, Terreni, N, Marzioni, M, Pellicano, R, Pozzoni, P, Baiocchi, L, Chessa, L, Rosina, F, Bertino, G, Vinci, M, Morgando, A, Vanni, E, Scifo, G, Sacco, R, D'Anto, M, Bellia, V, Boldizzoni, R, Casella, S, Omazzi, B, Poggi, G, Cristoferi, L, Gerussi, A, Ronca, V, Venere, R, Ponziani, F, Cannavo, M, Mussetto, A, Fontana, R, Losito, F, Frazzetto, E, Distefano, M, Colapietro, F, Labanca, S, Marconi, G, Grassi, G, Galati, G, O'Donnell, S, Mancuso, C, Mulinacci, G, Palermo, A, Claar, E, Izzi, A, Picardi, A, Invernizzi, P, Carbone, M, Vespasiani-Gentilucci, U, D'Amato D., De Vincentis A., Malinverno F., Vigano M., Alvaro D., Pompili M., Picciotto A., Palitti V. P., Russello M., Storato S., Pigozzi M. G., Calvaruso V., De Gasperi E., Lleo A., Castellaneta A., Pellicelli A., Cazzagon N., Floreani A., Muratori L., Fagiuoli S., Niro G. A., Feletti V., Cozzolongo R., Terreni N., Marzioni M., Pellicano R., Pozzoni P., Baiocchi L., Chessa L., Rosina F., Bertino G., Vinci M., Morgando A., Vanni E., Scifo G., Sacco R., D'Anto M., Bellia V., Boldizzoni R., Casella S., Omazzi B., Poggi G., Cristoferi L., Gerussi A., Ronca V., Venere R., Ponziani F., Cannavo M., Mussetto A., Fontana R., Losito F., Frazzetto E., Distefano M., Colapietro F., Labanca S., Marconi G., Grassi G., Galati G., O'Donnell S. E., Mancuso C., Mulinacci G., Palermo A., Claar E., Izzi A., Picardi A., Invernizzi P., Carbone M., and Vespasiani-Gentilucci U.

Abstract

Background & aims: Obeticholic acid (OCA) is the second-line treatment approved for patients with primary biliary cholangitis (PBC) and an inadequate response or intolerance to ursodeoxycholic acid. We aimed to evaluate the effectiveness and safety of OCA under real-world conditions. Methods: Patients were recruited into the Italian PBC Registry, a multicentre, observational cohort study that monitors patients with PBC at national level. The primary endpoint was the biochemical response according to Poise criteria; the secondary endpoint was the biochemical response according to normal range criteria, defined as normal levels of bilirubin, alkaline phosphatase (ALP), and alanine aminotransferase (ALT) at 12 months. Safety and tolerability were also assessed. Results: We analysed 191 patients until at least 12 months of follow-up. Median age was 57 years, 94% female, 61 (32%) had cirrhosis, 28 (15%) had histologically proven overlap with autoimmune hepatitis (PBC-AIH). At 12 months, significant median reductions of ALP (-32.3%), ALT (-31.4%), and bilirubin (-11.2%) were observed. Response rates were 42.9% according to Poise criteria, and 11% by normal range criteria. Patients with cirrhosis had lower response than patients without cirrhosis (29.5% vs. 49.2%, p = 0.01), owing to a higher rate of OCA discontinuation (30% vs. 12%, p = 0.004), although with similar ALP reduction (29.4% vs. 34%, p = 0.53). Overlap PBC-AIH had a similar response to pure PBC (46.4% vs. 42.3%, p = 0.68), with higher ALT reduction at 6 months (-38% vs. -29%, p = 0.04). Thirty-three patients (17%) prematurely discontinued OCA because of adverse events, of whom 11 experienced serious adverse events. Treatment-induced pruritus was the leading cause of OCA discontinuation (67%). Conclusions: Effectiveness and safety of OCA under real-world conditions mirror those in the Poise trial. Patients with cirrhosis had lower tolerability. Overlap PBC-AIH showed higher ALT reduction at 6 months compare

Published
2021

6. Platelets and hepatocellular cancer: Bridging the bench to the clinics

Author

Lai, aEmail Author, Q., Vitale, bEmail Author, A., Manzia, cEmail Author, T. M., Foschi, dEmail Author, F. G., Sandri, eEmail Author, G. B. L., Gambato, bEmail Author, M., Melandro, fEmail Author, F., Russo, bEmail Author, F. P., Miele, gEmail Author, L., Viganò, hEmail Author, L., Burra, bEmail Author, P., Giannini, iEmail Author, E. G., Aliberti, C., Baccarani, U., Bhoori, S., Borzio, M., Brancaccio, G., Cabibbo, G., Casadei, Gardini, Carrai, A., Cillo, P., Conti, U., Cucchetti, F., D’Ambrosio, A., Dell’Unto, R., Dematthaeis, C., Costanzo, Di, G. G., Di Sandro, S., Fucilli, F., Galati, G., Gasbarrini, A., Giuliante, F., Ghinolfi, D., Grieco, A., Gruttaduria, S., Guarino, M., Kostandini, A., Iavarone, M., Lenci, I., Losito, F., Lupo, L. G., Mazzocato, S., Mescoli, C., Miele, L., Morisco, F., Muley, M., Nicolini, D., Persico, M., Pompili, M., Ponziani, F. R., Pravisani, R., Rapaccini, G. L., Rendina, M., Renzulli, M., Rossi, M., Rreka, E., Sacco, R., Sangiovanni, A., Sessa, A., Simonetti, N., Sposito, C., Tortora, R., Trevisani, F., Viganò, M., Villa, E., Vincenzi, V., Violi, P., Associazione Italiana per lo Studio del Fegato (AISF) HCC Special Interest Group, Lai, Q., aEmail Author, Vitale, A., bEmail Author, Manzia, T. M., cEmail Author, Foschi, F. G., dEmail Author, Sandri, G. B. L., eEmail Author, Gambato, M., bEmail Author, Melandro, F., fEmail Author, Russo, F. P., bEmail Author, Miele, L., gEmail Author, Viganò, L., hEmail Author, Burra, P., bEmail Author, Giannini, E. G., iEmail Author, Aliberti, C., Baccarani, U., Bhoori, S., Borzio, M., Brancaccio, G., Cabibbo, G., Casadei, Gardini, A., Carrai, P., Cillo, U., Conti, F., Cucchetti, A., D’Ambrosio, R., Dell’Unto, C., Dematthaei, Di, Costanzo, G., G., Di Sandro, S., Fucilli, F., Galati, G., Gasbarrini, A., Giuliante, F., Ghinolfi, D., Grieco, A., Gruttaduria, S., Guarino, M., Kostandini, A., Iavarone, M., Lenci, I., Losito, F., Lupo, L. G., Mazzocato, S., Mescoli, C., Miele, L., Morisco, F., Muley, M., Nicolini, D., Persico, M., Pompili, M., Ponziani, F. R., Pravisani, R., Rapaccini, G. L., Rendina, M., Renzulli, M., Rossi, M., Rreka, E., Sacco, R., Sangiovanni, A., Sessa, A., Simonetti, N., Sposito, C., Tortora, R., Trevisani, F., Viganò, M., Villa, E., Vincenzi, V., Violi, P., Associazione Italiana per lo Studio del Fegato (AISF) HCC Special Interest, Group, Lai Q., Vitale A., Manzia T.M., Foschi F.G., Sandri G.B.L., Gambato M., Melandro F., Russo F.P., Miele L., Vigano L., Burra P., Giannini E.G., Aglitti A., Aliberti C., Baccarani U., Bhoori S., Borzio M., Brancaccio G., Cabibbo G., Casadei Gardini A., Carrai P., Cillo U., Conti F., Cucchetti A., D'ambrosio R., Dell'unto C., Dematthaeis N., Di Costanzo G.G., Di Sandro S., Fucilli F., Galati G., Gasbarrini A., Giuliante F., Ghinolfi D., Grieco A., Gruttaduria S., Guarino M., Kostandini A., Iavarone M., Lenci I., Losito F., Lupo L.G., Mazzocato S., Mescoli C., Morisco F., Muley M., Nicolini D., Persico M., Pompili M., Ponziani F.R., Pravisani R., Rapaccini G.L., Rendina M., Renzulli M., Rossi M., Rreka E., Sacco R., Sangiovanni A., Sessa A., Simonetti N., Sposito C., Tortora R., Trevisani F., Vigano M., Villa E., Vincenzi V., Violi P., Lai, Q., Vitale, A., Manzia, T. M., Foschi, F. G., Sandri, G. B. L., Gambato, M., Melandro, F., Russo, F. P., Vigano, L., Burra, P., Giannini, E. G., Casadei Gardini, A., Carrai, P., Cillo, U., Conti, F., Cucchetti, A., D'Ambrosio, R., Dell'Unto, C., Dematthaeis, N., Di Costanzo, G. G., and Vigano, M.

Subjects
Cancer Research, Integrins, Platelet-derived growth factor, Endothelium, Settore MED/12 - GASTROENTEROLOGIA, medicine.medical_treatment, Integrin, Review, lcsh:RC254-282, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Platelet-to-lymphocyte ratio, Selectins, Vascular endothelial growth factor, medicine, Platelet, Selectin, business.industry, Growth factor, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Extravasation, Settore MED/01, medicine.anatomical_structure, Oncology, chemistry, Tumor progression, 030220 oncology & carcinogenesis, Cancer research, 030211 gastroenterology & hepatology, business
Abstract

Growing interest is recently being focused on the role played by the platelets in favoring hepatocellular cancer (HCC) growth and dissemination. The present review reports in detail both the experimental and clinical evidence published on this topic. Several growth factors and angiogenic molecules specifically secreted by platelets are directly connected with tumor progression and neo-angiogenesis. Among them, we can list the platelet-derived growth factor, the vascular endothelial growth factor, the endothelial growth factor, and serotonin. Platelets are also involved in tumor spread, favoring endothelium permeabilization and tumor cells' extravasation and survival in the bloodstream. From the bench to the clinics, all of these aspects were also investigated in clinical series, showing an evident correlation between platelet count and size of HCC, tumor biological behavior, metastatic spread, and overall survival rates. Moreover, a better understanding of the mechanisms involved in the platelet-tumor axis represents a paramount aspect for optimizing both current tumor treatment and development of new therapeutic strategies against HCC. Growing interest is recently being focused on the role played by the platelets in favoring hepatocellular cancer (HCC) growth and dissemination. The present review reports in detail both the experimental and clinical evidence published on this topic. Several growth factors and angiogenic molecules specifically secreted by platelets are directly connected with tumor progression and neo-angiogenesis. Among them, we can list the platelet-derived growth factor, the vascular endothelial growth factor, the endothelial growth factor, and serotonin. Platelets are also involved in tumor spread, favoring endothelium permeabilization and tumor cells’ extravasation and survival in the bloodstream. From the bench to the clinics, all of these aspects were also investigated in clinical series, showing an evident correlation between platelet count and size of HCC, tumor biological behavior, metastatic spread, and overall survival rates. Moreover, a better understanding of the mechanisms involved in the platelet–tumor axis represents a paramount aspect for optimizing both current tumor treatment and development of new therapeutic strategies against HCC.

Published
2019

7. Water supply, sanitation and health risks in Douala 5 municipality, Cameroon

Author

Sanou, S. M., Temgoua, E., Guetiya, W. R., Arienzo, A., Losito, F., Fokam, J., Onohiol, J. -F, Djeunang, B., Zambou, N. F., Gianluca Russo, Antonini, G., Panà, A., Colizzi, V., Sanou, Sobze Martin, Temgoua, Emile, Guetiya, Wadoum Raoul, Arienzo, Alyexandra, Losito, Francesca, Fokam, Joseph, Onohiol, James Franci, Djeunang, Bruna, Zambou, Ngoufack Françoi, Russo, Gianluca, Antonini, Giovanni, Pana', Augusto, and Colizzi, Vittorio

Subjects
Settore MED/04 - Patologia Generale
Abstract

In the poor zones of sub-Saharan Africa, the conventional drinking water network is very weak. The populations use alternative groundwater sources which are wells and springs. However, because of urbanization, the groundwater sources are degrading gradually making pure, safe, healthy and odourless drinking water a matter of deep concern. There are many pollutants in groundwater due to seepage of organic and inorganic pollutants, heavy metals as well as microbiological contamination. This study was carried out in October 2012 and aimed to analyze the practices and behaviors of populations related to water supply that may constitute potential risks of microbiological contamination and emergence of waterborne diseases.

8. Real-world experience with obeticholic acid in patients with primary biliary cholangitis

Author

Anna Morgando, Mauro Viganò, Ana Lleo, Maurizio Pompili, Elisabetta De Gasperi, Daphne D’Amato, Alessandro Mussetto, Nora Cazzagon, Pietro Invernizzi, Francesca Colapietro, Vincenzo Ronca, Sara Labanca, Ester Vanni, M.R. Cannavò, Francesco Losito, Ernesto Claar, G. Scifo, Giovanni Galati, Umberto Vespasiani-Gentilucci, Silvia Storato, Alessio Gerussi, Grazia Anna Niro, Antonio Izzi, Barbara Omazzi, Antonio De Vincentis, Valentina Feletti, Giuseppe Grassi, Valeria Pace Palitti, Clara Mancuso, Vincenza Calvaruso, Evelise Frazzetto, Roberto Boldizzoni, Marco Marzioni, Floriano Rosina, Andrea Palermo, Antonino Picciotto, Valentina Bellia, Gaetano Bertino, Italian Pbc Registry, Guido Poggi, Rodolfo Sacco, Domenico Alvaro, Luigi Muratori, Maria Vinci, Marie Graciella Pigozzi, Raffaele Cozzolongo, Natalia Terreni, Annarosa Floreani, Maurizio Russello, Marco Distefano, Rinaldo Pellicano, Maria D'Antò, Marco Carbone, Rosanna Venere, R. Fontana, Antonio Picardi, Silvia Casella, S. E. O'Donnell, Federica Malinverno, Stefano Fagiuoli, Laura Cristoferi, Luchino Chessa, Giacomo Mulinacci, Pietro Pozzoni, Antonino Castellaneta, Giulia Marconi, Adriano M. Pellicelli, Francesca Romana Ponziani, Leonardo Baiocchi, D'Amato, D, De Vincentis, A, Malinverno, F, Vigano, M, Alvaro, D, Pompili, M, Picciotto, A, Palitti, V, Russello, M, Storato, S, Pigozzi, M, Calvaruso, V, De Gasperi, E, Lleo, A, Castellaneta, A, Pellicelli, A, Cazzagon, N, Floreani, A, Muratori, L, Fagiuoli, S, Niro, G, Feletti, V, Cozzolongo, R, Terreni, N, Marzioni, M, Pellicano, R, Pozzoni, P, Baiocchi, L, Chessa, L, Rosina, F, Bertino, G, Vinci, M, Morgando, A, Vanni, E, Scifo, G, Sacco, R, D'Anto, M, Bellia, V, Boldizzoni, R, Casella, S, Omazzi, B, Poggi, G, Cristoferi, L, Gerussi, A, Ronca, V, Venere, R, Ponziani, F, Cannavo, M, Mussetto, A, Fontana, R, Losito, F, Frazzetto, E, Distefano, M, Colapietro, F, Labanca, S, Marconi, G, Grassi, G, Galati, G, O'Donnell, S, Mancuso, C, Mulinacci, G, Palermo, A, Claar, E, Izzi, A, Picardi, A, Invernizzi, P, Carbone, M, Vespasiani-Gentilucci, U, D'Amato D, De Vincentis A, Malinverno F, Viganò M, Alvaro D, Pompili M, Picciotto A, Palitti VP, Russello M, Storato S, Pigozzi MG, Calvaruso V, De Gasperi E, Lleo A, Castellaneta A, Pellicelli A, Cazzagon N, Floreani A, Muratori L, Fagiuoli S, Niro GA, Feletti V, Cozzolongo R, Terreni N, Marzioni M, Pellicano R, Pozzoni P, Baiocchi L, Chessa L, Rosina F, Bertino G, Vinci M, Morgando A, Vanni E, Scifo G, Sacco R, D'Antò M, Bellia V, Boldizzoni R, Casella S, Omazzi B, Poggi G, Cristoferi L, Gerussi A, Ronca V, Venere R, Ponziani F, Cannavò M, Mussetto A, Fontana R, Losito F, Frazzetto E, Distefano M, Colapietro F, Labanca S, Marconi G, Grassi G, Galati G, O'Donnell SE, Mancuso C, Mulinacci G, Palermo A, Claar E, Izzi A, Picardi A, Invernizzi P, Carbone M, Vespasiani-Gentilucci U, and Italian PBC Registry and the Club Epatologi Ospedalieri (CLEO)/Associazione Italiana Gastroenterologi ed Endoscopisti Digestivi Ospedalieri (AIGO) PBC Study Group.

Subjects
upper limit of normal, Cirrhosis, ALT, AMA, Autoimmunity, antinuclear antibodies, ULN, PBC, Gastroenterology, UDCA, Settore MED/12, ULN, upper limit of normal, obeticholic acid, aRR, adjusted risk ratio, CRFs, case record form, AST, aspartate transferase, Clinical endpoint, GGT, gamma-glutamyl transferase, QC, primary biliary cholangitis, Ursodeoxycholic acid, ANA, TCC, Cholestasi, TIPS, Treatment Completer Cohort, ANA, antinuclear antibodie, medicine.medical_specialty, RR, UDCA, ursodeoxycholic acid, TIPS, transjugular intrahepatic portosystemic shunt, OCA, Cirrhosi, ALP, alkaline phosphatase, autoimmune hepatitis, medicine.disease, digestive system diseases, Discontinuation, Keywords: AIH, autoimmune hepatiti, QC, quality control, chemistry, gamma-glutamyl transferase, randomised controlled trial, electronic data capture, antimitochondrial antibodies, aspartate transferase, Autoimmune hepatitis, chemistry.chemical_compound, AIH, CRFs, Immunology and Allergy, adjusted risk ratio, ANA, antinuclear antibodies, RR, risk ratio, Overall cohort, ALT, alanine transferase, AMA, antimitochondrial antibodie, Cholestasis, CRFs, case record forms, Obeticholic acid, Overlap PBC-AIH, ursodeoxycholic acid, OCA, obeticholic acid, Tolerability, alkaline phosphatase, RCT, Research Article, medicine.drug, case record forms, Context (language use), AMA, antimitochondrial antibodies, Internal medicine, EDC, electronic data capture, transjugular intrahepatic portosystemic shunt, Internal Medicine, medicine, RCT, randomised controlled trial, OC, lcsh:RC799-869, quality control, alanine transferase, AST, aRR, Hepatology, business.industry, AIH, autoimmune hepatitis, TCC, Treatment Completer Cohort, PBC, primary biliary cholangiti, GGT, risk ratio, OC, Overall cohort, ALP, lcsh:Diseases of the digestive system. Gastroenterology, PBC, primary biliary cholangitis, business, EDC
Abstract

Background & aims Obeticholic acid (OCA) is the second-line treatment approved for patients with primary biliary cholangitis (PBC) and an inadequate response or intolerance to ursodeoxycholic acid. We aimed to evaluate the effectiveness and safety of OCA under real-world conditions. Methods Patients were recruited into the Italian PBC Registry, a multicentre, observational cohort study that monitors patients with PBC at national level. The primary endpoint was the biochemical response according to Poise criteria; the secondary endpoint was the biochemical response according to normal range criteria, defined as normal levels of bilirubin, alkaline phosphatase (ALP), and alanine aminotransferase (ALT) at 12 months. Safety and tolerability were also assessed. Results We analysed 191 patients until at least 12 months of follow-up. Median age was 57 years, 94% female, 61 (32%) had cirrhosis, 28 (15%) had histologically proven overlap with autoimmune hepatitis (PBC-AIH). At 12 months, significant median reductions of ALP (-32.3%), ALT (-31.4%), and bilirubin (-11.2%) were observed. Response rates were 42.9% according to Poise criteria, and 11% by normal range criteria. Patients with cirrhosis had lower response than patients without cirrhosis (29.5% vs. 49.2%, p = 0.01), owing to a higher rate of OCA discontinuation (30% vs. 12%, p = 0.004), although with similar ALP reduction (29.4% vs. 34%, p = 0.53). Overlap PBC-AIH had a similar response to pure PBC (46.4% vs. 42.3%, p = 0.68), with higher ALT reduction at 6 months (-38% vs. -29%, p = 0.04). Thirty-three patients (17%) prematurely discontinued OCA because of adverse events, of whom 11 experienced serious adverse events. Treatment-induced pruritus was the leading cause of OCA discontinuation (67%). Conclusions Effectiveness and safety of OCA under real-world conditions mirror those in the Poise trial. Patients with cirrhosis had lower tolerability. Overlap PBC-AIH showed higher ALT reduction at 6 months compared with patients with pure PBC. Lay summary Obeticholic acid (OCA) was shown to be effective in more than one-third of patients not responding to ursodeoxycholic acid in a real-world context in Italy. Patients with cirrhosis had more side effects with OCA, and this led to suspension of the drug in one-third of patients. OCA was also effective in patients who had overlap between autoimmune hepatitis and primary biliary cholangitis., Graphical abstract, Highlights • Under real-world conditions, OCA was effective in ~43% of patients who were non-responders to UDCA, according to Poise criteria. • Patients with cirrhosis showed lower efficacy (29.5%), mainly attributed to reduced tolerability and higher discontinuation rate. • Patients with overlap AIH-PBC showed a comparable efficacy to pure PBC, with a higher ALT reduction at 6 months. • Most patients with PBC are still in need of additional therapy if aiming to normalise liver biochemistry.

Published
2021

9. A new device for the prompt diagnosis of urinary tract infections

Author

Alberto Mari, Paolo Visca, Alyexandra Arienzo, Giorgia Bottini, Giovanni Antonini, Francesca Romana Priolisi, Francesca Losito, Arienzo, Alyexandra, Losito, F, Bottini, G, Priolisi F., R, Mari, A, Visca, P, Antonini, G., Arienzo, A, Priolisi, Fr, Visca, Paolo, Antonini, Giovanni, Alyexandra, Arienzo, Francesca, Losito, Giorgia, Bottini, Francesca Romana, Priolisi, and Alberto, Mari

Subjects
Pediatrics, medicine.medical_specialty, Validation study, Susceptibility testing, Time Factors, medicine.drug_class, Urinary system, Point-of-care testing, Point-of-Care Systems, Clinical Biochemistry, Antibiotics, utinary tract infections, Urine, Internal medicine, medicine, New device, Point-of-care test, Susceptibility pattern, Urinary tract infection, business.industry, Biochemistry (medical), General Medicine, point-of-care-testing, Bacterial Load, Anti-Bacterial Agents, Urinary Tract Infections, business, microbiological analysi, Diagnosi
Abstract

Background: Urinary tract infections (UTIs) are among the most common infectious diseases. Results obtained from conventional microbiological analysis of urine and anti-biotic susceptibility testing are available only after a few days, delaying precise diagnosis and appropriate therapy. Micro Biological Survey (MBS) srl (a spin-off of Roma Tre University, Rome, Italy) has developed and patented an automated colorimetric test for rapid bacterial counting. In a preliminary validation study it was demonstrated that the results obtained with the MBS method are equivalent to the results obtained with conventional culture-based microbiological analysis. Methods: In this study, sterile urine samples were artifi-cially contaminated with bacterial species that are most frequently responsible for UTIs. The MBS method was used to evaluate the presence of bacteria and their sen-sitivity to some of the most commonly used antibiotics in UTIs. Results: The MBS method was able to detect in a few hours the presence or absence of bacteria at clinically significant concentrations ( > 105 CFU/mL), and to provide their sus-ceptibility pattern to a limited panel of antibiotics. Discussion: The results obtained demonstrate that the MBS point-of-care testing (POCT) device could be devel-oped into a valuable aid for the management of UTIs, pos-sibly addressing more precise diagnosis and appropriate therapy.

Published
2014

10. Exploring the Relationship of rs2802292 with Diabetes and NAFLD in a Southern Italian Cohort-Nutrihep Study.

Author

Forte G, Donghia R, Lepore Signorile M, Tatoli R, Bonfiglio C, Losito F, De Marco K, Manghisi A, Guglielmi FA, Disciglio V, Fasano C, Sanese P, Cariola F, Buonadonna AL, Grossi V, Giannelli G, and Simone C

Subjects
Humans, Male, Female, Italy epidemiology, Middle Aged, Cohort Studies, Genotype, Alleles, Adult, Non-alcoholic Fatty Liver Disease genetics, Non-alcoholic Fatty Liver Disease epidemiology, Polymorphism, Single Nucleotide, Diabetes Mellitus, Type 2 genetics, Diabetes Mellitus, Type 2 epidemiology, Forkhead Box Protein O3 genetics, Genetic Predisposition to Disease
Abstract

Background: The minor G-allele of FOXO3 rs2802292 is associated with human longevity. The aim of this study was to test the protective effect of the variant against the association with type 2 Diabetes and NAFLD. Methods: rs2802292 was genotyped in a large population of middle-aged subjects (n = 650) from a small city in Southern Italy. All participants were interviewed to collect information about lifestyle and dietary habits; clinical characteristics were recorded, and blood samples were collected from all subjects. The association between rs2802292 and NAFLD or diabetes was tested using a logistic model and mediation analysis adjusted for covariates. Results: Overall, the results indicated a statistical association between diabetes and rs2802292, especially for the TT genotype (OR = 2.14, 1.01 to 4.53 95% C.I., p = 0.05) or in any case for those who possess the G-allele (OR = 0.45, 0.25 to 0.81 95% C.I., p = 0.008). Furthermore, we found a mediation effect of rs2802292 on diabetes (as mediator) and NAFLD. There is no direct relationship between rs2802292 and NAFLD, but the effect is direct (β = 0.10, -0.003 to 0.12 95% C.I., p = 0.04) on diabetes, but only in TT genotypes. Conclusions: The data on our cohort indicate that the longevity-associated FOXO3 variant may have protective effects against diabetes and NAFLD.

Published
2024
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11. Hepatitis E Virus: What More Do We Need to Know?

Author

Shahini E, Argentiero A, Andriano A, Losito F, Maida M, Facciorusso A, Cozzolongo R, and Villa E

Subjects
Humans, Virion physiology, Animals, Hepatitis E virus physiology, Hepatitis E virus pathogenicity, Hepatitis E transmission, Hepatitis E virology
Abstract

Hepatitis E virus (HEV) infection is typically a self-limiting, acute illness that spreads through the gastrointestinal tract but replicates in the liver. However, chronic infections are possible in immunocompromised individuals. The HEV virion has two shapes: exosome-like membrane-associated quasi-enveloped virions (eHEV) found in circulating blood or in the supernatant of infected cell cultures and non-enveloped virions ("naked") found in infected hosts' feces and bile to mediate inter-host transmission. Although HEV is mainly spread via enteric routes, it is unclear how it penetrates the gut wall to reach the portal bloodstream. Both virion types are infectious, but they infect cells in different ways. To develop personalized treatment/prevention strategies and reduce HEV impact on public health, it is necessary to decipher the entry mechanism for both virion types using robust cell culture and animal models. The contemporary knowledge of the cell entry mechanism for these two HEV virions as possible therapeutic target candidates is summarized in this narrative review.

Published
2024
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12. Prevention of influenza complications in patients with liver disease: a retrospective cohort study.

Author

Bianchi FP, Losito F, Labarile N, Shahini E, and Cozzolongo R

Subjects
Humans, Retrospective Studies, Vaccination, Influenza Vaccines, Influenza, Human complications, Influenza, Human prevention & control, Liver Diseases complications
Abstract

Introduction: Patients with chronic liver disease are highly prone to acquiring influenza infection diseases and experiencing associated complications. National and international guidelines recommend the influenza vaccine for patients with liver disorders to reduce the risk of influenza complications. Our study aims to evaluate the risk of flu complications faced by patients with liver disease and assess influenza vaccination coverage., Methods: The archive of hospital discharge forms was used to define the list of Apulian patients with liver disease, considering data from 2017 through 2022. The vaccination status of these patients was assessed via data collected from the Regional Immunization Database. We focused on influenza vaccine shots administered during the 2020/21, 2021/22, and 2022/23 flu seasons., Results: A declining trend across the flu seasons was observed, with a VC of 49.5% in the 2020/21 flu season, 48.1% in the 2021/22 season, and 45.0% in the 2022/23 season. Subjects with multiple comorbidities have higher vaccination rates. Additionally, the multivariate models demonstrate that vaccination compliance increases with age and is strongly associated with having received a previous influenza vaccine shot., Conclusion: The VC rates reported in our study are unsatisfactory and did not reach the minimum achievable goal (75%) the Italian Ministry of Health set. A multifactorial approach is required to raise the immunization rates and therefore protect the patients from the influenza-associated risk of collateral liver damage; the role of gastroenterologists and hepatologists is crucial, as their responsibilities should extend beyond patient care to the prevention of complications after infectious diseases., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Bianchi, Losito, Labarile, Shahini and Cozzolongo.)

Published
2023
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13. A new point-of-care test for the rapid antimicrobial susceptibility assessment of uropathogens.

Author

Arienzo A, Murgia L, Cellitti V, Ferrante V, Stalio O, Losito F, Gallo V, Tomassetti F, Marino R, Cristofano F, Orrù M, Visca P, Di Somma S, Silvestri L, Ziparo V, and Antonini G

Subjects
Humans, Anti-Bacterial Agents pharmacology, Anti-Bacterial Agents therapeutic use, Drug Resistance, Microbial, Microbial Sensitivity Tests, Point-of-Care Testing, Urinary Tract Infections diagnosis, Urinary Tract Infections drug therapy, Urinary Tract Infections microbiology
Abstract

Bacterial resistance to antimicrobials is considered a major issue worldwide. This condition may account for treatment failure of urinary tract infections, which are among the most common infections both in community and healthcare settings. Therapy against uropathogens is generally administered empirically, possibly leading to unsuccessful therapy, recurrence and development of antibiotic resistance. The reduction in analytical time to obtain antimicrobial susceptibility test (AST) results could play a key role in reducing the cost of healthcare, providing information about antibiotic efficacy and thus preventing from either exploiting new and expensive antibiotics unnecessarily or using obsolete and ineffective ones. A more rational choice among treatment options would hence lead to more effective treatment and faster resolution. In this paper we evaluated the performance of a new Point Of Care Test (POCT) for the rapid prediction of antimicrobial susceptibility in urine samples performed without the need of a laboratory or specialized technicians. 349 patients were enrolled in two open-label, monocentric, non-interventional clinical trials in partnership with an Emergency Medicine ward and the Day Hospital of two large healthcare facilities in Rome. Antibiogram was carried out on 97 patients. Results from analysis of urine samples with the POCT were compared with those from routine AST performed on culture-positive samples, displaying high accuracy (>90%) for all tested antimicrobial drugs and yielding reliable results in less than 12 hours from urine collection thus reducing analytical and management costs., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Arienzo et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Published
2023
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14. Real-world experience with obeticholic acid in patients with primary biliary cholangitis.

Author

D'Amato D, De Vincentis A, Malinverno F, Viganò M, Alvaro D, Pompili M, Picciotto A, Palitti VP, Russello M, Storato S, Pigozzi MG, Calvaruso V, De Gasperi E, Lleo A, Castellaneta A, Pellicelli A, Cazzagon N, Floreani A, Muratori L, Fagiuoli S, Niro GA, Feletti V, Cozzolongo R, Terreni N, Marzioni M, Pellicano R, Pozzoni P, Baiocchi L, Chessa L, Rosina F, Bertino G, Vinci M, Morgando A, Vanni E, Scifo G, Sacco R, D'Antò M, Bellia V, Boldizzoni R, Casella S, Omazzi B, Poggi G, Cristoferi L, Gerussi A, Ronca V, Venere R, Ponziani F, Cannavò M, Mussetto A, Fontana R, Losito F, Frazzetto E, Distefano M, Colapietro F, Labanca S, Marconi G, Grassi G, Galati G, O'Donnell SE, Mancuso C, Mulinacci G, Palermo A, Claar E, Izzi A, Picardi A, Invernizzi P, Carbone M, and Vespasiani-Gentilucci U

Abstract

Background & Aims: Obeticholic acid (OCA) is the second-line treatment approved for patients with primary biliary cholangitis (PBC) and an inadequate response or intolerance to ursodeoxycholic acid. We aimed to evaluate the effectiveness and safety of OCA under real-world conditions., Methods: Patients were recruited into the Italian PBC Registry, a multicentre, observational cohort study that monitors patients with PBC at national level. The primary endpoint was the biochemical response according to Poise criteria ; the secondary endpoint was the biochemical response according to normal range criteria , defined as normal levels of bilirubin, alkaline phosphatase (ALP), and alanine aminotransferase (ALT) at 12 months. Safety and tolerability were also assessed., Results: We analysed 191 patients until at least 12 months of follow-up. Median age was 57 years, 94% female, 61 (32%) had cirrhosis, 28 (15%) had histologically proven overlap with autoimmune hepatitis (PBC-AIH). At 12 months, significant median reductions of ALP (-32.3%), ALT (-31.4%), and bilirubin (-11.2%) were observed. Response rates were 42.9% according to Poise criteria , and 11% by normal range criteria . Patients with cirrhosis had lower response than patients without cirrhosis (29.5% vs. 49.2%, p  = 0.01), owing to a higher rate of OCA discontinuation (30% vs. 12%, p  = 0.004), although with similar ALP reduction (29.4% vs. 34%, p  = 0.53). Overlap PBC-AIH had a similar response to pure PBC (46.4% vs. 42.3%, p  = 0.68), with higher ALT reduction at 6 months (-38% vs. -29%, p  = 0.04). Thirty-three patients (17%) prematurely discontinued OCA because of adverse events, of whom 11 experienced serious adverse events. Treatment-induced pruritus was the leading cause of OCA discontinuation (67%)., Conclusions: Effectiveness and safety of OCA under real-world conditions mirror those in the Poise trial. Patients with cirrhosis had lower tolerability. Overlap PBC-AIH showed higher ALT reduction at 6 months compared with patients with pure PBC., Lay Summary: Obeticholic acid (OCA) was shown to be effective in more than one-third of patients not responding to ursodeoxycholic acid in a real-world context in Italy. Patients with cirrhosis had more side effects with OCA, and this led to suspension of the drug in one-third of patients. OCA was also effective in patients who had overlap between autoimmune hepatitis and primary biliary cholangitis., Competing Interests: The authors have no conflicts of interest to declare related to this work. Please refer to the accompanying ICMJE disclosure forms for further details., (© 2021 The Author(s).)

Published
2021
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15. Application of the Micro Biological Survey analytical method for the determination of bacterial load in cow raw milk.

Author

Cornacchia A, Saletti MA, Di Marzio V, Salini R, Marfoglia C, Tieri E, D'Alterio N, Marri N, Losito F, Arienzo A, Murgia L, Antonini G, Amatiste S, Leboffe L, and Pomilio F

Abstract

The aim of this study was to evaluate the performance of "Micro Biological Survey - MBS Test" in the enumeration of bacterial load in cow raw milk. The MBS test is based on a colorimetric method recently developed and patented by "Roma Tre" University, Italy. The evaluation of the performance of the MBS method was carried out by comparison with plate count at 30°C (gold standard) and flow cytometry. Thirteen independent set of experiments were performed analyzing a total of 104 samples of cow raw milk with the selected methods. Results obtained using the MBS method are comparable with those obtained with the plate count method at 30°C (CFU/mL) and flow cytometry technology; in particular, the results obtained with the MBS method are very close to plate count's at 30°C. On the other hand, there are statistically significant differences between these two methods' and flow cytometry technology's results that could be due to the different experimental conditions., Competing Interests: Conflict of interests: The authors declare no potential conflict of interests., (©Copyright: the Author(s).)

Published
2020
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16. Rapid Microbiological Assessment in Raw Milk: Validation of a Rapid Alternative Method for the Assessment of Microbiological Quality in Raw Milk.

Author

Marri N, Losito F, Le Boffe L, Giangolini G, Amatiste S, Murgia L, Arienzo A, and Antonini G

Abstract

The consumption of dairy products and the dairy industry are one of the main global agri-food sectors for its size, economic importance, and level of technology. Microbiological quality of pasteurized milk or other milk products is dependent on microbiological quality of raw milk. A variety of microbiological count methods is available for monitoring the hygienic quality of raw milk. Among them, the pour plate method is the official essay for counting the number of colony-forming units in milk samples according to International Organization for Standardization (ISO) No. 4833-1:2013. The aim of the present study is the validation of the Micro Biological Survey (MBS) method, against the reference plate-count method, for the assessment of the microbiological quality of raw milk. This comparative study, performed in collaboration with the Istituto Zooprofilattico Sperimentale del Lazio e della Toscana M. Aleandri (IZSLT), demonstrates the accuracy of this alternative method for the determination of total viable bacterial count in cow's raw milk. The results obtained with the MBS method highlight its potential as a valid tool for reliable microbiological analysis in dairy industries.

Published
2020
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17. Integrating running water monitoring tools with the Micro Biological Survey (MBS) method to improve water quality assessment.

Author

Traversetti L, Losito F, Arienzo A, Stalio O, Antonini G, and Scalici M

Subjects
Animals, Bacterial Load methods, Bacterial Load statistics & numerical data, Colorimetry methods, Ecosystem, Environmental Monitoring statistics & numerical data, Humans, Invertebrates, Italy, Linear Models, Water Quality, Environmental Monitoring methods, Rivers microbiology, Water Microbiology
Abstract

Running water habitats are among the most altered aquatic systems by human activities driving an increase in the organic components and the associated bacterial load as well. To contribute in improving the monitoring activities in running waters, here we tested the validity of the new Micro Biological Survey (MBS) method to specifically assess the bacterial load in running waters focusing on Total Viable Counts (at 22°C and 37°C) and Escherichia coli (at 44°C) in order to propose a new prognostic tool for watercourses. MBS method is an alternative colorimetric method for counting bacterial load in water and food samples that is easy to use and leads to a reliable and simple interpretation of results, being also faster and less expensive than traditional methods. Then, we compared MBS with the traditionally used reference method for the bacterial load, and with the most used biotic index for Italian watercourses based on the benthic invertebrates: the Extended Biotic Index (EBI). The last comparison was performed to validate the use of MBS in biomonitoring activities since the benthic invertebrate multi-species assemblage (and then EBI) alter own structure mainly depending on the organic component variation. During the first part of the study, the assessment of both linearity (regressions among bacterial concentrations) and accuracy (significant correlation between a measured value and a value used as reference) confirmed the validity of the MBS method. Second, the linear regressions between the three investigated microbial parameters vs. both physical-chemical descriptors and EBI, revealed the usefulness of MBS as a valid tool for routine microbiological analyses involved in rapid and easy field monitoring activities. This represents the first attempt to evaluate the river microbial status by exploiting the innovative MBS on running waters to propose it as new valuable monitoring tool in the biomonitoring field.

Published
2017
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18. Field Application of the Micro Biological Survey Method for the Assessment of the Microbiological Safety of Different Water Sources in Horn of Africa and the Evaluation of the Effectiveness of Moringa Oleifera in Drinking Water Purification.

Author

Losito F, Arienzo A, Somma D, Murgia L, Stalio O, Zuppi P, Rossi E, and Antonini G

Abstract

Water monitoring requires expensive instrumentations and skilled technicians. In developing Countries as Africa, the severe economic restrictions and lack of technology make water safety monitoring approaches applied in developed Countries, still not sustainable. The need to develop new methods that are suitable, affordable, and sustainable in the African context is urgent. The simple, economic and rapid Micro Biological Survey (MBS) method does not require an equipped laboratory nor special instruments and skilled technicians, but it can be very useful for routine water analysis. The aim of this work was the application of the MBS method to evaluate the microbiological safety of different water sources and the effectiveness of different drinking water treatments in the Horn of Africa. The obtained results have proved that this method could be very helpful to monitor water safety before and after various purification treatments, with the aim to control waterborne diseases especially in developing Countries, whose population is the most exposed to these diseases. In addition, it has been proved that Moringa oleifera water treatment is ineffective in decreasing bacterial load of Eritrea water samples.

Published
2017
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19. Field Application of the Micro Biological Survey Method for a Simple and Effective Assessment of the Microbiological Quality of Water Sources in Developing Countries.

Author

Arienzo A, Sobze MS, Wadoum RE, Losito F, Colizzi V, and Antonini G

Subjects
Cameroon, Humans, Risk Factors, Surveys and Questionnaires, Water Supply standards, Developing Countries, Drinking Water microbiology, Water Microbiology, Water Quality
Abstract

According to the World Health Organization (WHO) guidelines, "safe drinking-water must not represent any significant risk to health over a lifetime of consumption, including different sensitivities that may occur between life stages". Traditional methods of water analysis are usually complex, time consuming and require an appropriately equipped laboratory, specialized personnel and expensive instrumentation. The aim of this work was to apply an alternative method, the Micro Biological Survey (MBS), to analyse for contaminants in drinking water. Preliminary experiments were carried out to demonstrate the linearity and accuracy of the MBS method and to verify the possibility of using the evaluation of total coliforms in 1 mL of water as a sufficient parameter to roughly though accurately determine water microbiological quality. The MBS method was then tested "on field" to assess the microbiological quality of water sources in the city of Douala (Cameroon, Central Africa). Analyses were performed on both dug and drilled wells in different periods of the year. Results confirm that the MBS method appears to be a valid and accurate method to evaluate the microbiological quality of many water sources and it can be of valuable aid in developing countries.

Published
2015
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20. Microbiological safety and quality of Mozzarella cheese assessed by the microbiological survey method.

Author

Losito F, Arienzo A, Bottini G, Priolisi FR, Mari A, and Antonini G

Subjects
Animals, Bacteria isolation & purification, Cheese analysis, Colony Count, Microbial, Fermentation, Italy, Microbial Viability, Reproducibility of Results, Sensitivity and Specificity, Cheese microbiology, Food Contamination prevention & control, Food Microbiology, Food Quality
Abstract

Dairy products are characterized by reduced shelf life because they are an excellent growth medium for a wide range of microorganisms. For this reason, it is important to monitor the microbiological quality of dairy products and, in particular, the total viable count and concentration of Escherichia coli, as they are indicators of the hygienic state of these products. In addition, in dairy products such as Mozzarella cheese, it is important to monitor the concentration of lactic acid bacteria (LAB), as they are the major components of starter cultures used in cheese production, contributing to the taste and texture of fermented products and inhibiting food spoilage bacteria by producing growth-inhibiting substances. For these reasons, to ensure the quality and safety of their products, cheese makers should monitor frequently, during fresh cheese production, the concentration of LAB and spoilage bacteria. However, usually, small- to medium-size dairy factories do not have an internal microbiological laboratory and external laboratories of analysis are often too expensive and require several days for the results. Compared with traditional methods, the microbiological survey (MBS) method developed by Roma Tre University (Rome, Italy) allows faster and less-expensive microbiological analyses to be conducted wherever they are necessary, without the need for a microbiological laboratory or any instrumentation other than MBS vials and a thermostat. In this paper, we report the primary validation of the MBS method to monitor LAB concentration in Mozzarella cheese and the analysis, using the MBS method, of total viable count, E. coli, and LAB concentrations in the production line of Mozzarella cheese as well as during the shelf life of the product stored at 20°C. The results obtained indicate that the MBS method may be successfully used by small- to medium-size dairy factories that do not have an internal microbiological laboratory. Using the MBS method, these dairy factories can monitor autonomously the microbiological safety and quality of their products, saving both time and money., (Copyright © 2014 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.)

Published
2014
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