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1.
Ana Lleo Andrea Aglitti Alessio Aghemo Patrick Maisonneuve Savino Bruno Marcello Persico 《Digestive and liver disease》2019,51(2):310-317
Background
Despite the dramatic improvement in viral eradication rates that has been reached with direct antiviral agents (DAAs), the real benefit of viral eradication after DAAs on hepatocellular carcinoma (HCC) development is still controversial.Aim
To prospectively assess the risk of HCC occurrence and early recurrence in a large cohort of DAA-treated HCV-cirrhotic patients and to identify potential predictors of HCC development.Methods
We analyzed data prospectively collected from 1927 consecutive HCV-infected cirrhotic patients treated with DAA from January to December 2015 in 10 tertiary liver centers in Italy and followed-up for one year after therapy. 161 patients had a previous HCC.Results
38/161 subjects developed tumor recurrence during the follow-up (recurrence rate?=?24.8 per 100-year), patients with SVR had a significantly lower rate of recurrence. Lack of SVR and alpha-fetoprotein (AFP) were independent predictors of HCC recurrence. 50/1766 patients without a previous HCC history developed HCC during follow-up (incidence rate?=?2.4 per 100-year). Lack of SVR was the strongest predictor of HCC development. Furthermore, patients with SVR and no stigmata of portal hypertension have a lower incidence rate of HCC (1.0 per 100-year).Conclusions
SVR is associated with a significant decrease of recurrent or de novo HCC. Baseline AFP and signs of portal hypertension can help to stratify the risk of HCC. 相似文献2.
Jun Won Kim Do Young Kim Kwang-Hyub Han Jinsil Seong 《Digestive and liver disease》2019,51(3):445-451
Background
To report the results of a phase I/II study of helical IMRT-based stereotactic body radiotherapy (SBRT) for hepatocellular carcinoma (HCC).Methods
Eligibility included Child–Turcotte–Pugh class A or B, ≤3 lesions, and cumulative tumor diameter ≤6?cm. Dose was escalated from 36?Gy to 60?Gy delivered in 4 fractions. Grade ≥3 gastrointestinal toxicities (CTCAE v3.0) or radiation-induced liver disease defined dose-limiting toxicity (DLT).Results
Thirty-two patients were enrolled: seven in dose levels 1–2 (36–44?Gy) and 25 in levels 3–4 (42–60?Gy). Failures included 1 local, 14 outfield intrahepatic, 2 distant, 1 concurrent local and outfield, 1 concurrent outfield and distant, and 1 concurrent local, outfield, and distant. Nine had grade 3 hematologic toxicities and 5 had grade 2 hepatic toxicities; no patient experienced DLT. Two-year local control (LFFS), outfield intrahepatic control (OutFFS), and overall survival (OS) rates were 80.9%, 46.7%, and 81.3%, respectively. Dose levels 3–4 and pre-radiotherapy multi-segment recurrence were independent prognostic factors for LFFS and OutFFS, respectively. Two-year LFFS, OutFFS, and OS were significantly higher for patients who were treated with dose-levels 3/4 for tumor(s) involving single segment compared with the rest of the patients.Conclusions
Helical IMRT-based SBRT was safe and effective, and patients with multi-segment recurrences prior to SBRT need to be closely followed. 相似文献3.
Alessandro Loglio Mauro Viganò Glenda Grossi Sara Labanca Maria Goldaniga Alessandra Pompa Lucia Farina Mariagrazia Rumi Paolo Corradini Floriana Facchetti Giovanna Lunghi Luca Baldini Pietro Lampertico 《Digestive and liver disease》2019,51(3):419-424
Backgound
A significant proportion of hepatitis B surface antigen (HBsAg) negative/anti-hepatitis B core antigen (anti-HBc) positive patients with non-Hodgkin lymphoma (NHL) undergoing rituximab-based chemotherapy (R-CT) may suffer hepatitis B virus (HBV) reactivation.Aims
We wanted to assess efficacy and safety of lamivudine (LMV) prophylaxis to prevent this complication.Methods
Eighty-five consecutive HBsAg negative/anti-HBc positive NHL patients (71 years, 100% serum HBV DNA undetectable, 74% anti-HBs positive) received LMV coadministered with R-CT and for 18 months after the end of R-CT. Serum ALT, HBsAg, anti-HBs and HBV DNA were assessed every 4 months during and after end of LMV.Results
During 39 (2–108) months of study period, including 21 months of LMV and 27 additional months after LMV discontinuation, one patient (2%) had HBV reactivation, 31 months after stopping LMV and during administration of new immunosuppressive regimens, without LMV prophylaxis, owing to incomplete oncological response. A 50% decline of anti-HBs titers occurred in 22/63 (35%) patients, including 12 who became anti-HBs seronegative. Five (6%) patients had ALT increase during R-CT but none required R-CT discontinuation. Seventeen (20%) patients died, all for tumour progression.Conclusion
LMV prophylaxis is safe and effective in preventing HBV reactivation in HBsAg negative/anti-HBc positive NHL patients receiving R-CT. 相似文献4.
Yan-Yan Wang Li-Jun Wang Da Xu Ming Liu Hong-Wei Wang Kun Wang Xu Zhu Bao-Cai Xing 《HPB : the official journal of the International Hepato Pancreato Biliary Association》2019,21(4):425-433
Background
Microvascular invasion (MVI) is a powerful predictor of recurrence in patients who undergo liver resection for hepatocellular carcinoma (HCC). This study aimed to evaluate the efficacy of postoperative adjuvant transarterial chemoembolization (PA-TACE) in HCC patients with MVI, and further select potential patients benefitting from PA-TACE.Methods
Patients who had HCC with MVI and underwent liver resection between September 2004 and December 2015 were identified for further analysis. Overall survival (OS) and disease-free survival (DFS) were compared between patients treated with and without PA-TACE. Propensity score matching analysis was used to minimize inter-group differences.Results
A total of 176 patients with HCC and MVI were included. In both the entire and propensity-matched cohorts, OS and DFS were higher in PA-TACE group than non-TACE group (all P < 0.05). In subgroup analyses, PA-TACE showed efficacy in improving OS and DFS in HCC patients at early stage beyond Milan criteria and intermediate stage, but not in patients within Milan criteria. Multivariable analysis identified PA-TACE as a significantly favorable factor of OS and DFS for patients beyond Milan criteria, but not for those within Milan criteria.Conclusion
PA-TACE could be beneficial for patients who have HCC with MVI beyond Milan criteria, but not for those within Milan criteria. 相似文献5.
Tommaso Stroffolini Evangelista Sagnelli Caterina Sagnelli Antonina Smedile Caterina Furlan Filomena Morisco Nicola Coppola Angelo Andriulli Piero Luigi Almasio 《Digestive and liver disease》2019,51(3):434-437
Background
There is increasing awareness of HBV reactivation in HCV-RNA-positive/HBV-coinfected patients with chronic liver disease (CLD) treated with oral direct-acting antivirals (DAAs).Aim
To provide figures on the prevalence of HBV markers in HCV-RNA-positive subjects in Italy, where these findings are lacking.Methods
All subjects aged ≥18?years with CLD consecutively referring to Italian liver units located throughout country were prospectively enrolled in two national surveys in 2001 and 2014.Results
The total number of HCV-RNA-positive cases was 6984; 356 (5.1%) subjects vaccinated against HBV were excluded. A total of 6628 cases were evaluated. The prevalence rates of HBsAg, isolated anti-HBc and anti-HBc/anti-HBs-positivity were 2.9%, 8.1% and 14.7%, respectively. Among the estimated one million HCV-RNA-positive subjects in Italy, a substantial number of subjects are at risk of HBV reactivation due to DAA therapy. The prevalence of liver cirrhosis was higher than that of CLD in HBsAg-positive subjects (4.4% vs. 2.6%, p?<?0.01) but not in those positive for other HBV markers.Conclusions
These findings outline the burden of HBV markers among HCV-RNA-positive subjects in Italy, where in 2017 reimbursement for DAA therapy by the National Health System became universal for all patients with chronic HCV infection. HBV vaccination coverage should be greatly extended, since nearly two thirds of subjects in this study resulted negative for any HBV marker. 相似文献6.
Marina Coletta Arianna Zefelippo Stefano Mazza Vera D’Abrosca Fiorenzo Botti Barbara Oreggia Matteo Prati Luigi Boni Maurizio Vecchi Flavio Caprioli 《Digestive and liver disease》2019,51(2):206-211
Background
Despite the improvement of medical therapies, nearly half of patients with Crohn’s disease require surgery within 10?years after diagnosis. However, intestinal resection is not curative and recurrence may occur.Aims
To evaluate post-surgical outcomes for patients with Crohn’s disease in a large monocentric cohort, and to identify variables associated with clinical and surgical relapse.Methods
Patients with Crohn’s disease who had surgery for ileal and colonic Crohn’s disease between 2004 and 2016 and on at least one-year follow-up following surgery were included.Results
One hundred ninety-three patients were included in the study. Crohn’s disease recurrence concerned 53% of patients after a median 56-month (6–158) follow-up and 29% of patients required a second surgical intervention. At logistic regression analysis, active smoking and young age at diagnosis were identified as independent risk factor for post-surgical relapse (p?=?0.01), while colonic or ileocolonic resection was recognized as a risk factor for surgical Crohn’s disease relapse (p?=?0.003).Conclusions
Post-surgery recurrence is frequent for patients with Crohn’s disease. Active smoking and young age at diagnosis are risk factors for Crohn’s disease recurrence. As compared with patients undergoing small-bowel surgery, patients with colonic resection are proner to relapse requiring a second surgical intervention. 相似文献7.
Lucille Quénéhervé Caroline Dagouat Marianne Le Rhun Enrique Perez-Cuadrado Robles Emilie Duchalais Stanislas Bruley des Varannes Yann Touchefeu Nicolas Chapelle Emmanuel Coron 《Digestive and liver disease》2019,51(3):386-390
Background
Sigmoid volvulus is a common cause of colonic obstruction in old and frail patients. Its standard management includes the endoscopic detorsion of the colonic loop, followed by an elective sigmoidectomy to prevent recurrence. However, these patients are often poor candidates for surgery.Aim
The aim of this study was to compare death rate between elective sigmoidectomy and conservative management following endoscopic detorsion for sigmoid volvulus.Methods
The medical records of 83 patients undergoing endoscopic detorsion of a sigmoid volvulus from 2008 to 2014 were retrospectively reviewed. Patients were divided into two groups: ‘elective surgery’ and ‘no surgery’.Results
Patients in the ‘no surgery’ group (n?=?42) were older and had more loss of autonomy than in the ‘elective surgery’ group. Volvulus endoscopic detorsion was successful in 96% of patients with no complications. The median follow-up was 13 months (1 day-67 months). The death rate was 62% in the ‘no surgery’ group versus 32% in the ‘elective surgery’ group (p?=?0.02). In the ‘no surgery’ group, 23/42 of patients had volvulus recurrence. No recurrence occurred after surgery.Conclusion
Elective surgery must be planned as soon as possible after the first episode of sigmoid volvulus. In frail patients, other options must be developed. 相似文献8.
Giuseppina Brancaccio Alessandra Nardi Salvatore Madonia Massimo Fasano Gabriella Verucchi Marco Massari Sergio Maimone Carlo Contini Fabio Levantesi Arianna Alfieri Caius Gavrila Pietro Andreone Michele Milella Giovanni B. Gaeta 《Digestive and liver disease》2019,51(3):438-442
Background
Chronic hepatitis B virus (HBV) infection remains a primary cause of morbidity and mortality worldwide.Aim
The study is aimed at updating the clinical and epidemiological profile of chronic HBV infection in Italy.Methods
A cross-sectional multicenter prospective study enrolled consecutive HBsAg positive patients seen in 73 Italian centers in the period 2012–2015. Individual patient data were collected using an electronic platform and analyzed using standard statistical methods.Results
Among 2877 HBsAg positive individuals (median age 49.8?years, 68% males), 27% were non-Italian natives (NINs); 20% had chronic infection, 58.5% chronic hepatitis and 21.5% cirrhosis. Among NINs, age was younger, male gender was less prevalent and liver disease less advanced than in Italians (all p?<?0.0001). HBeAg positive cases were 23.6% among NINs vs 8.2% in Italians (p?<?0.0001); HDV coinfections 11.1% vs 7.3% (p?=?0.006) and HCV coinfections 2.3% vs 4.2% (p?=?0.017), respectively. Anti-HDV or anti-HCV antibodies were detected more frequently in patients with cirrhosis. Fifty percent of NINs with cirrhosis were aged below 45?years.Conclusion
The study offers an insight into the evolving burden of chronic hepatitis B virus infection in the near future and highlights new territories for public health interventions. 相似文献9.
Pei Hu Changzheng Ke Xingrong Guo Pan Ren Yaoyao Tong Sen Luo Yulin He Zhiqiang Wei Bin Cheng Ruiming Li Jie Luo Zhongji Meng 《Digestive and liver disease》2019,51(1):120-126
Aim
The aim of this study is to investigate the role of glypican-3(GPC3)/wnt/β-catenin signaling pathway and autophagy in the regulation of hepatocellular carcinoma (HCC) growth mediated by curcumin.Methods
HepG2 cells were treated with various concentrations of curcumin and/or GPC3-targeting siRNA in the presence or absence of 3-MA. Cell proliferation and apoptosis were determined by MTT and TUNEL assay, respectively. Expression of GPC3, β-catenin, c-myc, LC3, and Beclin1 was determined by western blotting. In addition, curcumin was tested in tumor xenografts mice model, Caliper IVIS Lumina II was used to monitor the tumor growth, and GPC3/wnt/β-catenin signaling proteins were determined by western blotting.Results
Curcumin treatment led to proliferation inhibition and apoptosis induction in HepG2 cells in a concentration-dependent manner, and suppressed HCC tumor growth in vivo. Further analysis showed that curcumin treatment inactivated Wnt/β-catenin signaling and decreased GPC3 expression, silencing of GPC3 expression promoted the effects of curcumin on Wnt/β-catenin signaling. In addition, inhibiting autophagy by 3-MA relieved curcumin-dependent down-regulation of GPC3.Conclusion
Curcumin suppressed HCC tumor growth through down-regulating GPC3/wnt/β-catenin signaling pathway, which was partially mediated by activation of autophagy. 相似文献10.
Daniel Navarro-de la Cruz Sonia Pérez-Castro Matilde Trigo-Daporta Antonio Aguilera-Guirao 《Enfermedades infecciosas y microbiología clínica》2019,37(4):256-259
Introduction
We present the largest study conducted in Galicia on the prevalence and distribution of HCV genotypes/subtypes.Methods
Retrospective study collecting the total number of patients chronically infected by HCV between 2000.01.01 to 2015.12.31 in 3 of the main health areas: Santiago, Pontevedra and Vigo.Results
We collected a total of 4469 patients. The median age was 50 years (IQR 57-45), 72,3% were men, 0,4% were coinfected with another genotype, 20,6% were coinfected with HIV and 35.2% with HBV. The main route of transmission was parenteral (83,1%), followed by unknown (15,3%), sexual (1,4%) and vertical (0,2%). The distribution of genotypes was: 62,9% HCV-1 (29,2% HCV-1a and 31,9% HCV-1b), 3,4% HCV-2, 21,0% HCV-3, 12,6% HCV-4 and 0,1% HCV-5.Conclusion
The distribution of genotypes in Galicia shows significant differences with respect to that observed in Spain. This distribution varies with age, gender, coinfection with HIV and/or HBV, and within geographical areas. 相似文献11.
Zhou-wei Xu Shang-xue Yan Hua-xun Wu Ying Zhang Wei Wei 《Digestive and liver disease》2019,51(2):263-274
Purpose
To investigate the effects of angiotensin II (Ang II) and tumor necrosis factor-α (TNF-α) on the biological characteristics of hepatocellular carcinoma (HCC) cells and the associated changes in G protein-coupled receptor kinase 2 (GRK2) expression.Methods
The mean serum levels of Ang II and TNF-α in normal subjects and patients with benign liver tumors (BLTs) and HCC were evaluated by enzyme-linked immunosorbent assay (ELISA), and liver samples from the patients with HCC and HCC mice were used to assess the protein levels of both cytokines, their major receptors and GRK2. In addition, the dynamics of Bel-7402 cells were determined with cell counting kit-8 (CCK-8) and Transwell experiments, while the levels of the primary cytokine receptors Ang II type-1 receptor (AT1R) and type-2 receptor (AT2R) as well as TNF receptor 1 (TNFR1) were detected by flow cytometry (FCM). The effects of Ang II and TNF-α on the GRK2 levels in Bel-7402 cells and on the dynamics of GRK2-knockdown HCC cells were also investigated.Results
Both cytokines independently enhanced Bel-7402 cell growth, migration and invasion by decreasing the GRK2 level. In contrast, down-regulating the GRK2 level in Bel-7402 cells suppressed these effects. No synergistic effects were discovered when Ang II and TNF-α were administered together. Furthermore, increased AT1R and TNFR1 levels stimulated HCC initiation and progression, whereas AT2R overexpression produced the opposite effect.Conclusions
The present results suggested that Ang II and TNF-α promote Bel-7402 cell growth, migration and invasion by down-regulating GRK2 expression, and that the associated receptors AT1R, AT2R and TNFR1 participate in HCC initiation and progression. 相似文献12.
MELD is the only predictor of short-term mortality in cirrhotic patients with C. difficile infection
Background
Clostridium difficile infection (CDI) is the most common nosocomial infection in the US and cirrhotic patients with CDI have increased risk for poor outcome.Aim
The aim of this study is to evaluate the impact of CDI on short-term mortality in patients with cirrhosis and identify predictors of mortality in these patients.Methods
We retrospectively identified patients at Montefiore Medical Center from 2010 to 2014 with cirrhosis, diarrhea and a C. difficile toxin assay. Demographics, co-morbidities, medications, laboratory data and outcomes were recorded.Results
Of 701 patients with cirrhosis who had a CDI assay, 183 were CDI+ and 518 CDI?. Patients with CDI were older, had more frequent CKD on hemodialysis and heart failure, were less frequently on rifaximin and lactulose and had increased glucocorticoid exposure. 30-day mortality was higher in patients with CDI (23.0% vs 16.6%, p?<?0.05) compared to those without. Univariate predictors of 30-day mortality included WBC, corticosteroid use, AST, ALT, MELD, albumin, HBV and HCV infection; however, via multivariate analysis, only MELD (HR: 1.04?±?0.02, p?<?0.05) remained significant.Conclusion
Patients with cirrhosis and CDI are at greater risk of 30-day mortality than those without CDI and the only multivariate predictor of mortality is MELD. These patients should have their disease severity triaged based upon MELD score. 相似文献13.
Mohamed A. Mekky Mohamed O. Abdel-Malek Heba A. Osman Essam M. Abdel-Aziz Abdel-Kader A. Hashim Helal F. Hetta Khairy H. Morsy 《Clinics and research in hepatology and gastroenterology》2019,43(1):82-87
Background
Till now, pooled data about the safety and efficacy of different direct-acting antiviral (DAAs) regimens in different renal situations are still under evaluation.Aim
To evaluate a real-life experience of the efficacy and safety of ombitasvir/paritaprevir/ritonavir plus ribavirin (OBV/PTV/r plus RIB) in patients with end-stage kidney disease (ESKD).Patients and methods
Between January 2017 and January 2018, an open-label multicenter prospective study was designed to enroll all consecutive patients with proven CHC genotype 4 infections and concomitant ESKD based on estimated glomerular filtration rate (eGFR) with (HD group) or without hemodialysis (non-HD group). Patients were given a co-formula of OBV/PTV/r (25/150/100?mg) once-daily plus RIB was given for 12?weeks. Sustained virologic response (SVR 12) was the primary endpoint.Results
A total of 110 patients were enrolled. An overall SVR 12 was reported in 104 (94.5%) patients, and treatment failure were reported in 6 patients [2 patients (1.8%) were relapsed, and 4 patients (3.6%) patients were non-responders]. SVR12 was 96% in HD and 91.4% in non-HD patients (P?=?0.286).There were no reported serious adverse events. Anemia was reported in 66.6% (n?=?50) in HD group and in 31.4% (n?=?11) in non-HD group.Conclusion
Although it is still challenging, achievement of SVR12 in patients with chronic HCV and concomitant end-stage kidney disease in the era of DAAs became possible with a 12?weeks course of a co-formula of ombitasvir/paritaprevir /ritonavir plus ribavirin.ClinicalTrials.gov ID
NCT03341988. 相似文献14.
Tatiana Duarte Sara Gonçalves Catarina Sá Rita Marinheiro Marta Fonseca José Farinha Rita Rodrigues Filipe Seixo Leonor Parreira Rui Caria 《Revista portuguesa de cardiologia》2019,38(2):105-111
Introduction
In iatrogenic or potentially reversible bradyarrhythmia, drug discontinuation or metabolic correction is recommended before permanent cardiac pacemaker (PM) implantation. These patients often have conduction system disease and there are few data on recurrence or the need for a permanent PM.Objective
To analyze the need for PM implantation in patients with iatrogenic bradyarrhythmia or bradyarrhythmia associated with other potentially reversible causes.Methods
We assessed consecutive symptomatic patients admitted to the emergency department with a primary diagnosis of bradyarrhythmia (atrioventricular [AV] node disease – complete or second‐degree AV block (AVB) [CAVB: 2nd‐degree AVB – 2:1], sinus bradycardia [SB] and atrial fibrillation [AF] with slow ventricular response [SVR]) in the context of iatrogenic causes or metabolic abnormalities. We determined the percentage of patients who required PM implantation.Results
We studied 153 patients (47% male) admitted for iatrogenic or potentially reversible bradyarrhythmia. Diagnoses were SB 16%, CAVB 63%, second‐degree AVB 12%, and AF with SVR 10%. Eighty‐five percent of patients were under negative chronotropic therapy, 3% had hyperkalemia and 12% had a combined etiology. After correction of the cause, 55% of patients (n=84) needed a PM. In these patients the most common type of bradyarrhythmia was CAVB, in 77% (n=65) patients.Conclusion
In a high percentage of patients with bradyarrhythmia associated with a potentially reversible cause, the arrhythmia recurs or does not resolve during follow‐up. Patients with AV node disease constitute a subgroup with a higher risk of recurrence who require greater vigilance during follow‐up and should be considered for PM implantation after the first episode. 相似文献15.
Pablo Olivera Silvio Danese Lieven Pouillon Stefanos Bonovas Laurent Peyrin-Biroulet 《Digestive and liver disease》2019,51(3):327-334
Background
Biologics against tumor necrosis factor (anti-TNF) have dramatically changed the management of moderate-to-severe ulcerative colitis (UC). In pivotal clinical trials, golimumab showed efficacy as induction and maintenance therapy in anti-TNF naïve UC patients. However, confirmatory data on effectiveness in the real world setting are needed.Aim
to summarize recent evidence on the effectiveness of golimumab in observational real-world studies.Methods
A literature search was conducted using Medline, Embase, and congresses databases for English language articles or abstracts on the effectiveness of golimumab published between January 1, 2014 and May 15, 2018. Pooled short-term (6–14 weeks) and mid- and long-term (24–54 weeks) clinical response and remission rates were calculated.Results
24 abstracts were included; of those 8 were published full-text articles and 16 were abstracts from medical conferences. Overall, pooled short-term clinical response and remission rates were 59.3% (range 35–85.5%; 13 studies; 1429 patients) and 35.9% (range 14–51.7%; 9 studies; 666 patients), respectively. Pooled mid- and long-term clinical response and remission rates were 60.3% (range 37.1–89.5%; 4 studies; 356 patients) and 39.2% (range 12–84%; 8 studies; 822 patients), respectively.Conclusions
Results: of observational studies confirm that golimumab is an effective therapy for UC in clinical practice. 相似文献16.
17.
Jean-Marc Phelip Julien Edeline Jean-Frédéric Blanc Emilie Barbier Pierre Michel Vincent Bourgeois Cindy Neuzillet David Malka Sylvain Manfredi Jérôme Desrame 《Digestive and liver disease》2019,51(2):318-320
Introduction
Combination of cisplatine and Gemcitabine (CisGem) is the reference 1st line Chemotherapy in patients with advanced biliary cancer. FOLFIRINOX demonstrated an overall survival superiority when compared to gemcitabine in 1st line for patients with metastatic pancreatic adenocarcinoma. Because of similarities between pancreatic and biliary cancers, we proposed a randomized trial comparing mFOLFIRINOX and CisGEm.Aim
PRODIGE38-AMEBICA is a phase II/III trial evaluating efficacy of modifed FOLFIRINOX (D1 bolus removed) or CisGEm on patients with locally advanced non resectable or metastatic biliary tract cancer.Patients and methods
Main inclusion criteria are histologically or cytologically proven biliary tract tumor (intra or extra hepatic or hilar or gallbladder carcinoma), measurable disease (metastases and/or primary tumor), Bilirubin <1,5?N and transaminases <5?N. The randomization (ratio 1:1) will be stratified on center, stage of the disease, tumor localization and previous adjuvant treatment. The Phase II trial has an objective of 73% patients alive and without progression at 6?months for Folfirinox (versus 59% for Gemcis). 128 additional patients should be added in the phase III trial with an objective of overall survival improvement of 4?months in favor of mFOLFIRINOX.Conclusion
The study is opened in France (EudraCT no.: 2015-002282-35). All the patients (188) of the phase II part are currently randomized. 相似文献18.
Cristina Bezzio Nicola Imperatore Alessandro Armuzzi Fernando Rizzello Gianpiero Manes Fabrizio Bossa Emma Calabrese Flavio Caprioli Marco Daperno Filippo Mocciaro Ambrogio Orlando Claudio Papi Antonio Rispo Simone Saibeni 《Digestive and liver disease》2019,51(2):212-217
Background
Little is known about the unmet needs of physicians caring for patients with inflammatory bowel disease (IBD).Aims
This study explored the practical difficulties and needs for professional updating of Italian IBD physicians.Methods
A questionnaire was distributed to 600 physicians attending IG-IBD meetings.Results
280 physicians completed the questionnaire (46.7%). On a 5-point Likert scale (from 1, strongly disagree to 5, strongly agree), they identified the most problematic issues in managing IBD patients as increasing bureaucracy (3.9), lack of extra-gastroenterological IBD expertise (3.4), lack of diagnostic techniques (3.1) and budget limitations (2.9). The most lacking techniques, ranked from 1 (greatest need) to 9 (lowest need), were: anti-drug antibody and trough level assays (2.7), device-assisted enteroscopy (3.1), exploration under anaesthesia (3.2), MR enterography (3.2), and bowel ultrasonography (3.3). About professional updating, respondents indicated (on a 5-point Likert scale) that helpful topics were practical medicine (4.3), managing difficult patients (4.1), and guidelines (4.0). The most desired modality for updating was residential courses on clinical practice (4.3).Conclusion
Several factors potentially limit the best management of IBD patients in Italy. Satisfying these unmet needs could improve care for IBD patients. 相似文献19.
Anna Viola Daniela Pugliese Sara Renna Federica Furfaro Flavio Caprioli Renata D’Incà Fabrizio Bossa Stefano Mazza Giuseppe Costantino Massimo Claudio Fantini Gionata Fiorino Angela Alibrandi Ambrogio Orlando Alessandro Armuzzi Walter Fries 《Digestive and liver disease》2019,51(4):510-515
Background
Anti-TNF therapies infliximab (IFX), adalimumab (ADA), and golimumab (GOL) are approved for treating moderate to severe ulcerative colitis (UC). In UC, only the switch from IFX to ADA has been investigated, reaching no more than 10–43% remission rates at 12 months.Aim
Of the present study was to investigate disease outcome after a switch from subcutaneous (SC) agents to the intravenous (IV) agent (IFX).Methods
In this retrospective multicentre study, we analysed the charts of UC patients unresponsive/intolerant or with secondary loss of response (LOR) to ADA or GOL who were switched to IFX. We evaluated clinical response and remission together with adverse events at 3, 6, and 12 months follow-up.Results
Seventy-six patients were included; 38 patients started ADA and 38 started GOL for a mean therapy duration of 6?±?6 months. Indications for switch were adverse events in 3%, primary failure in 79%, and LOR in 18% of patients. Clinical remission was reached by 47%, 50%, and 77% of patients, respectively. Patients that switched for LOR did numerically, but not statistically, better than patients who switched for primary failure.Conclusions
Our data show a superior remission rate in SC to IV anti-TNF switch in UC compared to the IV to SC switch reported in literature. 相似文献20.
Catarina Perez‐Brandão Conceição Trigo Fátima F. Pinto 《Revista portuguesa de cardiologia》2019,38(2):97-101