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Effect of a Combination of Berberine and Monacolin on CYP Enzymes： An Oral Cocktail Interaction Study in Healthy Volunteers

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Journal of Pharmacy and Pharmacology 2014年第11期2卷 660-668页

作者： Stefano Persiani Federica Sala Carla Manzotti Milena Colovic Yves Donazzolo Beatrice Barbetta Cristina Vitalini giampaolo Giacovelli Claudio Benvenuti Lucio C. Rovati R&D Division Rottapharm | Madaus Monza 20900 Italy Eurofins|Optimed Gieres 38610 France

Objectives： This study was aimed at investigating the potential of the herbal exctracts, berberine and monacolin, administered in combination at the recommended dose, to generate clinically relevant inhibition of the CYP （cytochromes P450） enzyme system after a single oral administration in human healthy volunteers. Methods： Twelve healthy male volunteers received a five-probe drug cocktail alone （reference） or with the combination of berberine and monacolin （test）, in a randomized, open label, crossover fashion. Plasma concentrations of cocktail components, caffeine （CYP1A2）, metoprolol （CYP2D6）, omeprazole （CYP2C 19）, midazolam （CYP3A4）, warfarin （CYP2C9）, and plasma concentrations of berberine, monacolin and its metabolite were measured by LC-MS/MS. Pharmacokinetic parameters were determined by non-compartmental analysis. Lack of inhibition was assumed if the 90% CI （confidence interval） for estimated ratio test/reference was included in the acceptance limits 0.70-1.43 for phenotyping metrics AUClast and Cmax. Key findings： All test/reference ratios were close to unity and CIs （confidence intervals） were within the acceptance limits, except for the upper value of omeprazole Cmax. Given the high intraindividual variability, this finding was considered clinically irrelevant. Conclusions： Clinically relevant inhibition of the activities of the CYP isoenzymes investigated can be excluded when berberine and monacolin are administered in combination at the recommended dose.

关键词： Herbal extracts cocktail cytochrome P450 berberine monacolin healthy volunteers.

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Carboxytherapy and Platelet Rich Plasma： A New Therapy for Trigonitis, Abacterial and Interstitial Cystitis

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Journal of Pharmacy and Pharmacology 2015年第9期3卷 405-410页

作者： Muzi Fabrizio Delicato giampaolo D'Andria Daniele Baffigo Giulio Tartaglia Edoardo Tati Eleonora Corvese Francesco Signore Stefano Perla Alessandro Montagna Giuseppe Tati Gaetano Department of Urology and Oncologic Urology S. Eugenio Hospital Rome 00144 Rome Italy

Cystitis often appears even in absence of bacteria colonization. Trigonitis and interstitial inflammation are the most common morphological features of abacterial cystitis in young and post menopausal women. Arterial obstructive disease and bladder ischemia might play an important role in bladder dysfunction. Activated inflammatory cells produce ROS （radicals of oxygen）, NF kB seems involved in ROS synthesis. Clinical studies have indicated that high CO2 levels can impact upon peripheral tissue, reducing ischaemia, responsible of recurrent inflammation and consequently reducing oxydative phenomena. PRP （platelet-rich plasma） is a volume of fractionated plasma from the patient＇s own blood that contains platelet concentrate rich of alpha granules. PRP interacts tissue repair mechanisms by placing supra-physiological concentrations of autologous platelets at the site of tissue damage. This study proposes a single PRP transvaginal injection followed by 10 weekly applications of carboxytherapy, using subcutaneous injections of sterile CO2 gas. We have selected 6 Women （50-75 years）, affected by recurrent abacterial cystitis with Pain and urge incontinence. All patients showed a subjective sensible reduction of symptoms. After 2 months all patients have neither inflammatory symptoms nor endoscopic evidence of trigonitis. Preliminary qualitative results could encourage the use of carboxytherapy and PRP in treatment of abacterial and interstitial cystitis.

关键词： Carboxytherapy platelet rich plasma cystitis trigonitis interstitial cystitis.

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Effect of food on the Oral Bioavailability of Berberine and Monacolin Administered in Combination in Healthy Male Volunteers

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Journal of Pharmacy and Pharmacology 2014年第12期2卷 703-712页

作者： Stefano Persiani Federica Sala Monique Zangarini Carla Manzotti Milena Colovic Yves Donazzolo Beatrice Barbetta Cristina Vitalini giampaolo Giacovelli Claudio Benvenuti Lucio C. Rovati R&D Division Rottapharm Biotech S.r.l. Monza 20900 Italy Eurofins/Optimed Gieres 38610 France Medical Department RottapharmlMadaus Monza 20900 Italy

Objectives： To investigate the effect of food on the bioavailability of a combination of monacolin and berberine in healthy volunteers. Methods： Eighteen male volunteers received a single recommended oral dose of the combination under fasted conditions （reference） and fed conditions （high fat meal; test）, in a randomized, open label, crossover fashion. Plasma concentrations of berberine, monacolin and its metabolite were measured by LC-MS/MS. Pharmacokinetic parameters were determined by non-compartmental analysis. No effect of food was assumed if the 90% CIs （confidence intervals） for estimated ratio test/reference was included in the acceptance limits 0.80-1.25 for phenotyping metrics AUCt and Cmax- Key findings： For berberine, the Cmax and AUCt test/reference ratios were 2.97 and 2.69, respectively, and relevant 90% CIs （2.25-3.91 and 2.15-3.36, respectively） were above the acceptance limit. For lovastatin hydroxy acid, the active metabolite of monacolin, the test/reference ratios were 1.18 （Cmax） and 0.98 （ALJCt）. The 90% CIs fell entirely within the acceptance limit for AUCt, （0.85-1.13）, whereas the upper bound of the 90% CIs for Cmax （1.01-1.37） was just above the predefined interval. Conclusions： Food intake significantly increases berberine bioavailability and does not significantly affect monacolin bioavailability when these two extracts are administered in combination.

关键词： Berberine monacolin food effects bioavailability ArrnoLIPID PLUS healthy volunteers.

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Metastatic pancreatic cancer: Is there a light at the end of the tunnel?

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World Journal of Gastroenterology 2015年第16期21卷 4788-4801页

作者： Vanja Vaccaro Isabella Sperduti Sabrina Vari Emilio Bria Davide Melisi Carlo Garufi Carmen Nuzzo Aldo Scarpa giampaolo Tortora Francesco Cognetti Michele Reni Michele Milella Medical Oncology A Regina Elena National Cancer Institute Medical Oncology A and Biostatistics Regina Elena National Cancer Institute Medical Oncology University of VeronaAzienda Ospedaliera Universitaria Integrata ARC-Net Research Centre and Department of Pathology Diagnostics and SurgeryUniversity of Verona Medical Oncology Unit Department of OncologySan Raffaele Scientific Institute

Due to extremely poor prognosis,pancreatic cancer(PDAC)represents the fourth leading cause of cancerrelated death in Western *** more than a decade,gemcitabine(Gem)has been the mainstay of first-line PDAC *** efforts aimed at improving single-agent Gem efficacy by either combining it with a second cytotoxic/molecularly targeted agent or pharmacokinetic modulation provided disappointing ***,the field of systemic therapy of advanced PDAC is finally moving *** has shown promise over single-agent Gem:regimens like PEFG-PEXG-PDXG and GTX provide significant potential advantages in terms of survival and/or disease control,although sometimes at the cost of poor *** PRODIGE 4/ACCORD 11 was the first phaseⅢtrial to provide unequivocal benefit using the polychemotherapy regimen FOLFIRINOX;however the less favorable safety profile and the characteristics of the enrolled population,restrict the use of FOLFIRINOX to young and fit PDAC *** nanoparticle albumin-bound paclitaxel(nab-Paclitaxel)formulation was developed to overcome resistance due to the desmoplastic stroma surrounding pancreatic cancer *** of whether or not this is its main mechanisms of action,the combination of nabPaclitaxel plus Gem showed a statistically and clinically significant survival advantage over single agent Gem and significantly improved all the secondary ***,recent findings on maintenance therapy are opening up potential new avenues in the treatment of advanced PDAC,particularly in a new era in which highly effective first-line regimens allow patients to experience prolonged disease ***,we provide an overview of recent advances in the systemic treatment of advanced PDAC,mostly focusing on recent findings that have set new standards in metastatic *** avenues for further development in the metastatic setting and current efforts to integratenew effective chemotherapy regimens

关键词： Pancreatic cancer Metastatic disease Chemotherapy Folfirinox nab -Paclitaxel

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Evaluation of the prognostic value of liver stiffness in patients with hepatitis C virus treated with triple or dual antiviral therapy:A prospective pilot study

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World Journal of Gastroenterology 2015年第10期21卷 3013-3019页

作者： Cristina Stasi Alessia Piluso Umberto Arena Elena Salomoni Paolo Montalto Monica Monti Barbara Boldrini giampaolo Corti Fabio Marra Giacomo Laffi Stefano Milani Anna Linda Zignego Department of Experimental and Clinical Medicine University of Florence Health Agency of Tuscany Gastrointestinal Endoscopy Unit Ospedale SS Cosma e Damiano Department of Biomedical Experimental and Clinical sciencesUniversity of Florence

AIM:To evaluate the association between liver stiffness(LS) prior to the initiation of dual/triple therapy and viral ***:LS was measured in all patients before treatment was *** therapeutic approach was based on hepatic,virological,and immunological evaluations and considered the fact that patients with severe fibrosis(F3)or compensated cirrhosis(F4)in Child-Pugh class A are the primary candidates for triple *** total,65 hepatitis C virus(HCV)patients were treated with Peg-interferon/ribavirin(Peg-IFN/RBV);24patients were classified as genotypes 1/4(36.92%),and41 patients were classified as genotypes 2/3(63.08%)(dual therapy).In addition,20 HCV treatment-experienced genotype 1 patients were treated with Peg IFN-RBV and boceprevir(triple therapy).Wilcoxon rank-sum tests were used to compare the ***:LS significantly differed between dual therapy and triple therapy(P=0.002).The mean LS value before dual therapy treatment was 8.61±5.79k Pa and was significantly different between patients achieving a sustained virologic response(SVR)24weeks after therapy and those who did not(7.23±5.18 k Pa vs 11.72±5.99 k Pa,respectively,P=0.0003).The relative risk of non-response to therapy was 4.45(95%CI:2.32-8.55).The attributable risk of non-response to therapy was 49%.The mean LSvalue before triple therapy treatment was 13.29±8.57k Pa and was significantly different between patients achieving and not achieving SVR24(9.41±5.05 vs19.11±9.74,respectively;P=0.008).The relative risk of non-response to therapy was 5.57%(95%CI:1.50-20.65).The attributable risk of non-response to therapy(70%)was increased compared with dual therapy ***-treatment stiffness>12 k Pa was significantly associated with non-SVR(P<0.025)in both ***:Pre-treatment liver stiffness may be useful for predicting the response to treatment in patients treated with either dual or triple anti-HCV therapy.

关键词： Antiviral therapy Chronic hepatitis C Fibrosis Liv

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Pulmonary or otolaryngologic extraesophageal manifestations in patients with gastroesophageal reflux disease

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World Journal of Gastrointestinal Endoscopy 2010年第2期2卷 47-49页

作者： giampaolo Bresci Rodolfo Sacco Gastroenterology Department Cisanello Pisa University Hospital Pisa 56124 Italy Institute of Internal Medicine University of Foggia Viale Pinto Foggia 71100 Italy

The extraesophageal manifestations of gastroesophageal reflux disease that are similar to a heart attack or gastric diseases are well known, while those categorized as pulmonary or otolaryngological are less known and... 详细信息

关键词： Gastroesophageal reflux Extraesophageal symptoms Gastroesophageal reflux disease

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Prognostication and response assessment in liver and pancreatic tumors:The new imaging

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World Journal of Gastroenterology 2015年第22期21卷 6794-6808页

作者： Riccardo De Robertis Paolo Tinazzi Martini Emanuele Demozzi Gino Puntel Silvia Ortolani Sara Cingarlini Andrea Ruzzenente Alfredo Guglielmi giampaolo Tortora Claudio Bassi Paolo Pederzoli Mirko D'Onofrio Department of Radiology Verona Comprehensive Cancer Network G.B. Rossi Hospital University of Verona Department of Radiology Casa di Cura Pederzoli Department of Oncology Verona Comprehensive Cancer Network G.B.Rossi Hospital University of Verona Department of Hepato-Biliary Surgery Verona Comprehensive Cancer NetworkG.B. Rossi Hospital University of Verona Department of Pancreatic Surgery Verona Comprehensive Cancer Network G.B. Rossi Hospital University of Verona Department of Pancreatic Surgery Casa di Cura Pederzoli

Diffusion-weighted imaging(DWI), dynamic contrastenhanced magnetic resonance imaging(DCE-MRI) and perfusion computed tomography(CT) are technical improvements of morphologic imaging that can evaluate functional properties of hepato-bilio-pancreatic tumors during conventional MRI or CT ***, the term "functional imaging" is commonly used to describe molecular imaging techniques, as positron emission tomography(PET)CT/MRI, which still represent the most widely used methods for the evaluation of functional properties of solid neoplasms; unlike PET or single photon emission computed tomography, functional imaging techniques applied to conventional MRI/CT examinations do not require the administration of radiolabeled drugs or specific equipments. Moreover, DWI and DCE-MRI can be performed during the same session, thus providing a comprehensive "one-step" morphological and functional evaluation of hepato-bilio-pancreatic tumors. Literature data reveal that functional imaging techniques could be proposed for the evaluation of these tumors before treatment, given that they may improve staging and predict prognosis or clinical outcome. Microscopic changes within neoplastic tissues induced by treatments can be detected and quantified with functional imaging,therefore these techniques could be used also for posttreatment assessment, even at an early stage. The aim of this editorial is to describe possible applications of new functional imaging techniques apart frommolecular imaging to hepatic and pancreatic tumors through a review of up-to-date literature data, with a particular emphasis on pathological correlations,prognostic stratification and post-treatment monitoring.

关键词： Diffusion magnetic resonance imaging Perfusion imaging Hepatocellular carcinoma Liverneoplasms Pancreatic neoplasms

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Assessment of clinical and radiological response to sorafenib in hepatocellular carcinoma patients

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World Journal of Hepatology 2015年第1期7卷 33-39页

作者： Rodolfo Sacco Valeria Mismas Antonio Romano Marco Bertini Michele Bertoni Graziana Federici Salvatore Metrangolo Giuseppe Parisi Emanuele Tumino giampaolo Bresci Luca Giacomelli Sara Marceglia Irene Bargellini Dipartimento di Gastroenterologia-UO Gastroenterologia e Malattie del Ricambio Azienda Ospedaliero Universitaria Pisana56124 PisaItaly Dipartimento di Elettronica Informazione e BioingegneriaPolitecnico di Milano20100 MilanItaly Dipartimento di Radiologia-Azienda Ospedaliero Universitaria Pisana 56124 PisaItaly

Sorafenib is an effective anti-angiogenic treatment forhepatocellular carcinoma(HCC). The assessment of tumor progression in patients treated with sorafenib is crucial to help identify potentially-resistant patients,avoiding unnecessary toxicities. Traditional methods to assess tumor progression are based on variations in tumor size and provide unreliable results in patients treated with sorafenib. New methods to assess tumor progression such as the modified Response Evaluation Criteria in Solid Tumors or European Association for the Study of Liver criteria are based on imaging to measure the vascularization and tumor volume(viable or necrotic). These however fail especially when the tumor response results in irregular development of necrotic tissue. Newer assessment techniques focus on the evaluation of tumor volume,density or perfusion. Perfusion computed tomography and Dynamic ContrastEnhanced-UltraS ound can measure the vascularization of HCC lesions and help predict tumor response to antiangiogenic therapies. Mean Transit Time is a possible predictive biomarker to measure tumor response. Volumetric techniques are reliable,reproducible and time-efficient and can help measure minimal changes in viable tumor or necrotic tissue,allowing the prompt identification of non-responders. Volume ratio may be a reproducible biomarker for tumor response. Larger trials are needed to confirm the use of these techniques in the prediction of response to sorafenib.

关键词： Hepatocellular carcinoma Sorafenib ResponseEvaluation Criteria in Solid Tumors Perfusioncomputed tomography Dynamic Contrast-Enhanced-UltraSound Volumetric assessment

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Transarterial radioembolization for hepatocellular carcinoma:An update and perspectives

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World Journal of Gastroenterology 2015年第21期21卷 6518-6525页

作者： Rodolfo Sacco Valeria Mismas Sara Marceglia Antonio Romano Luca Giacomelli Marco Bertini Graziana Federici Salvatore Metrangolo Giuseppe Parisi Emanuele Tumino giampaolo Bresci Ambra Corti Manuel Tredici Michele Piccinno Luigi Giorgi Carlo Bartolozzi Irene Bargellini Department of Gastroenterology Pisa University Hospital Department of Electronics Information technology and BioengineeringEngineering School of Milan Department of Nuclear Medicine Pisa University Hospital Division of Health Physics Pisa University Hospital Department of Radiology Pisa University Hospital

In the last decade trans-arterial radioembolization has given promising results in the treatment of patients with intermediate or advanced stage hepatocellular carcinoma(HCC),both in terms of disease control and tolerability *** technique consists of the selective intra-arterial administration of microspheres loaded with a radioactive compound(usually Yttrium90),and exerts its therapeutic effect through the radiation carried by these microspheres.A careful and meticulous selection of patients is crucial before performing the radioembolization to correctly perform the procedure and reduce the incidence of *** is a technically complex and expensive technique,which has only recently entered clinical practice and is supported by scant results from phase Ⅲ clinical ***,it may represent a valid alternative to transarterial chemoembolization(TACE) in the treatment of intermediate-stage HCC patients,as shown by a comparative retrospective assessment that reported a longer time to progression,but not of overall survival,and a more favorable safety profile for *** addition,this treatment has reported a higher percentage of tumor shrinkage,if compared to TACE,for pre-transplant downsizing and it represents a promising therapeutic option in patients with large extent of disease and insufficient residual liver volume who are not immediately eligible for *** might also be a suitable companion to sorafenib in advanced HCC or it can be used as a potential alternative to this treatment in patients who are not responding or do not tolerate sorafenib.

关键词： Hepatocellular carcinoma Radioembolization Transarterial chemoembolization Sorafenib Staging RECIST, Modified RECIST Downsizing Clinical trial

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WORLD ASSOCIATION FOR SEDIMENTATION AND EROSION RESEARCH (WASER)

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International Journal of Sediment Research 2016年第2期 94-94页

作者： giampaolo Di Silvio Ulrich C.E.Zanke Zhao-yin Wang

The World Association for Sedimentation and Erosion Research(WASER),inaugurated on Oct.19,2004,is an independent non-governmental,non-profit *** mission of WASER is to promote international co-operation on the study a... 详细信息

关键词： WORLD ASSOCIATION FOR SEDIMENTATION AND EROSION RESEARCH WASER

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