RESUMEN
BACKGROUND: Immune checkpoint inhibitors (ICI) improve the prognosis of many cancers but cause immune-related adverse events (IrAEs). Limited data are available on upper gastrointestinal (UGI) IrAEs. We describe the clinical characteristics, prognosis, and efficacy of medical therapy in patients with UGI IrAEs. METHODS: This is a retrospective, multicenter cohort study of patients with UGI symptoms and moderate to severe endoscopic UGI lesions, occurring after ICI. Efficacy of induction medical therapy and at the most recent follow-up was assessed. RESULTS: Forty patients were included; of these, 34 (85%) received anti-PD(L)1, either alone (n = 24) or combined with anti CTLA-4 (n = 10). Eighteen patients (45%) had concomitant enterocolitis. All patients had severe endoscopic lesions (erosions, ulcerations, hemorrhage, or necrotic lesions). Three patients who received an inefficient initial medical treatment had a complicated course: One patient died of enterocolitis, one had a pneumomediastinum, and one developed an ulcerated stricture of the pylorus. Thirty-five patients (88%) were treated with corticosteroids; 28 patients (80%) responded, and 20 (57%) reached clinical remission. Eight patients were treated with infliximab, and six responded (75%). After a median follow-up of 11 months, 36 patients (90%) were in corticosteroid-free clinical remission for their UGI symptoms. Endoscopic lesions persisted in 68% of patients. CONCLUSIONS: ICI cause severe UGI IrAEs, which are associated with enterocolitis in approximately half of the patients. Most patients with UGI IrAEs respond to corticosteroids or infliximab. These data support the recommendation to treat these patients without delay and in the same way as those with enterocolitis.
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Enterocolitis , Enfermedades Gastrointestinales , Neoplasias , Humanos , Inhibidores de Puntos de Control Inmunológico/efectos adversos , Estudios Retrospectivos , Estudios de Cohortes , Infliximab/uso terapéutico , Enfermedades Gastrointestinales/tratamiento farmacológico , Neoplasias/complicaciones , Enterocolitis/inducido químicamente , Corticoesteroides/uso terapéuticoRESUMEN
BACKGROUND: Alcohol-related cirrhosis is a frequent and difficult-to-treat disease. Despite the low hepatic metabolism of baclofen, data on its use in this subgroup are scarce. The French multicenter Observatory of patients treated with Baclofen for Alcohol DEpendence real-life cohort assessed: (a) prescription modalities of baclofen in liver units; (b) safety profile of baclofen; and (c) declared alcohol intake, biological markers of excessive alcohol intake and hepatic function at 12 months. METHODS: All consecutive patients with cirrhosis who received baclofen to reduce alcohol consumption or maintain abstinence were prospectively included. Psychosocial management was always associated. Clinical and biological data were collected every 3 months for 1 year. RESULTS: Between November 2013 and December 2016, 71 in- or outpatients were included from 10 liver units. Of the patients, 25% had ascites. After 12 months, 52 patients (73%) were still being followed, and 41 (57.7%) were still receiving baclofen at a mean dosage of 75 mg/day (r30-210). The overall declared consumption decreased from 100.2 to 14.7 g/day (P < 0.0001), and 29 patients (40.8%) reached abstinence. Significant improvement in the usual biomarkers of excessive alcohol intake (AST, GGT and MCV) and liver function (Prothrombin ratio (PTr), albumin levels) were observed. The usual side effects such as drowsiness were frequent (22%) but no serious adverse events (AEs) or overt encephalopathy related to baclofen was reported. CONCLUSION: In this 1-year follow-up series, baclofen was combined with psychosocial treatment in patients with cirrhosis and was well tolerated. This treatment was associated with a significant decrease in declared alcohol consumption as well as improvement in hepatic function.
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Alcoholismo , Rehabilitación Psiquiátrica , Humanos , Baclofeno/uso terapéutico , Cirrosis Hepática Alcohólica/complicaciones , Alcoholismo/psicología , Consumo de Bebidas Alcohólicas/psicología , Cirrosis Hepática/complicacionesRESUMEN
INTRODUCTION AND AIM: Data on the efficacy and tolerance of interferon-free treatment in chronic hepatitis C (CHC) in elderly patients are limited in phase II-III trials. MATERIAL AND METHODS: A prospective cohort of adult patients with CHC treated in French general hospitals. RESULTS: Data from 1,123 patients, distributed into four age groups, were analyzed. Of these, 278 were > 64 years old (fourth quartile) and 133 were > 73 years old (tenth decile). Elderly patients weighed less, were more frequently treatment-experienced women infected with genotype 1b or 2, while they less frequently had genotype 3 or HIV coinfection, but had more frequent comorbidities and drug consumption. Half of the patients had cirrhosis, whatever their ages. The main treatment regimens were sofosbuvir/ledipasvir (37.8%), sofosbuvir/daclatasvir (31.8%), sofosbuvir/simeprevir (16.9%), sofosbuvir/ribavirin (7.8%); ribavirin was given to 24% of patients. The overall sustained virological response (SVR) rate was 91.0 % (95% CI: 89.292.5%) with no difference according to age. Logistic regression of the independent predictors of SVR were albumin, hepatocellular carcinoma and treatment regimen, but not age. The rate of severe adverse events (66 in 59/1062 [5.6%] patients) tended to be greater in patients older than 64 years of age (21/261,8.1%), but the only independent predictors of SAE by logistic regression were cirrhosis and baseline hemoglobin. Patient-reported overall tolerance was excellent in all age groups, and patient-reported fatigue decreased during and after treatment, independent of age. CONCLUSIONS: The high efficacy and tolerance of interferon-free regimens is confirmed in elderly patients in real-life conditions.
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Antivirales/uso terapéutico , ADN Viral/análisis , Hepacivirus/genética , Hepatitis C Crónica/tratamiento farmacológico , Medición de Resultados Informados por el Paciente , Factores de Edad , Anciano , Bencimidazoles/uso terapéutico , Carbamatos , Quimioterapia Combinada , Femenino , Fluorenos/uso terapéutico , Estudios de Seguimiento , Francia/epidemiología , Genotipo , Hepatitis C Crónica/epidemiología , Hepatitis C Crónica/virología , Humanos , Imidazoles/uso terapéutico , Masculino , Persona de Mediana Edad , Morbilidad/tendencias , Estudios Prospectivos , Pirrolidinas , Ribavirina/uso terapéutico , Simeprevir/uso terapéutico , Sofosbuvir/uso terapéutico , Tasa de Supervivencia/tendencias , Resultado del Tratamiento , Valina/análogos & derivadosRESUMEN
BACKGROUND: Recent data suggest that alcohol-related hepatocellular carcinoma (HCC) is diagnosed at a later stage. The aim of this study was to compare HCC characteristics and outcomes in an alcohol-related group (group A) and a non-alcohol-related group (group NA). METHODS: A total of 1207 patients with newly diagnosed HCC were prospectively included between May 2008 and October 2009. Patients with multiple causes (alcohol plus another cause) were excluded. Patients were followed every year for 5 years. Recorded variables, including etiologies were tested as prognostic factors of survival in a multivariate Cox model after adjustments for a lead-time bias. RESULTS: In all, 894 patients were analyzed: 582 (65.1%) were in group A, and 312 (34.9%) were in group NA. Alcohol-related HCC was more likely to be diffuse and detected in patients with a worse performance status and worse liver function. After adjustments for a lead-time bias, the median overall survival (OS) was 9.7 and 5.7 months in groups NA and A, respectively (P = .0002), and 5.8 and 5.0 months in alcohol-abstinent and alcohol non-abstinent groups, respectively (P = .09). The prognostic role of alcohol disappeared when survival was assessed at each Barcelona Clinic Liver Cancer (BCLC) stage. Patients with HCC detected during a cirrhosis follow-up program (n = 199 [22.3% of the whole cohort]) had increased lead time-adjusted median OS in comparison with patients with HCC diagnosed incidentally (11.7 vs 5.4 months; P < .0001). CONCLUSIONS: In comparison with patients with non-alcohol-related HCC, patients with alcohol-related HCC have reduced OS, mainly because of worse liver function and tumor characteristics at diagnosis, as attested by similar survival within each BCLC stage. Cancer 2018;124:1964-72. © 2018 American Cancer Society.
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Carcinoma Hepatocelular/diagnóstico , Cirrosis Hepática/patología , Hepatopatías Alcohólicas/patología , Neoplasias Hepáticas/diagnóstico , Anciano , Anciano de 80 o más Años , Carcinoma Hepatocelular/mortalidad , Carcinoma Hepatocelular/patología , Progresión de la Enfermedad , Femenino , Estudios de Seguimiento , Francia/epidemiología , Humanos , Estimación de Kaplan-Meier , Cirrosis Hepática/epidemiología , Hepatopatías Alcohólicas/epidemiología , Neoplasias Hepáticas/mortalidad , Neoplasias Hepáticas/patología , Masculino , Persona de Mediana Edad , Estadificación de Neoplasias , Pronóstico , Estudios Prospectivos , Factores de TiempoRESUMEN
Hepatic encephalopathy (HE) is a severe complication of cirrhosis, independently associated with a poor survival. The objectives of this study were to describe the prevalence of overt hepatic encephalopathy (OHE) requiring hospitalization, and the healthcare pathways and outcomes of patients hospitalized for OHE in France. Data from the French Hospital-Discharge Database (Programme de Medicalisation des Systemes d'information, PMSI) within the 5-year period from 2014 to 2018 were analysed. Since the disease lacks a PMSI code in the ICD-10, an identification algorithm was developed. The analysis identified 57,191 patients with OHE including 48,566 patients (85 %) who had been hospitalized twice or more during the study period. Each year, an average of over 20,000 patients were hospitalized in France for OHE as the primary or secondary reason for hospitalization. Among these patients, between 11,500 and 13,500 had been hospitalized at least twice in that year with an average of 3.4 hospitalisations per year. 25 % of admissions occurred following consultation at the emergency unit. Among hospitalisations, 15 % involved admission to the critical care resuscitation unit or intensive care. For all patients identified as suffering from OHE and hospitalized, the 5-year mortality was 46.5 % (26,621 patients). This pioneering study revealed that, in France, despite a probable underestimation of OHE episodes due to the lack of specific PMSI coding, the prevalence of OHE was very high, with frequent recurrences and readmissions, and high mortality.
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Encefalopatía Hepática , Alta del Paciente , Humanos , Encefalopatía Hepática/epidemiología , Encefalopatía Hepática/etiología , Encefalopatía Hepática/terapia , Cirrosis Hepática/complicaciones , Cirrosis Hepática/epidemiología , Francia/epidemiología , HospitalesRESUMEN
BACKGROUND: New treatments and therapeutic approaches repeatedly emerged in the field of inflammatory bowel disease. AIM: to update the French treatment algorithms for Crohn's disease (CD) and ulcerative colitis (UC). METHODS: A formal consensus method was used to determine changes to the treatment algorithms for various situations of CD and UC. Thirty-seven experts voted on questions that had been drafted by the steering committee ahead of time. Consensus was defined as at least 66% of experts agreeing on a response. RESULTS: Anti-TNF were reinforced as a first-line therapy rather than the use of immunosuppressant alone. Vedolizumab for UC, ustekinumab for CD took place as second-line maintenance therapy and potentially as a first-line therapy in the setting of unrestricted reimbursement for vedolizumab. Tofacitinib was recommended by the experts in case of vedolizumab failure for UC. Algorithms for complicated CD with abscess, intestinal and complex anal fistula were updated according to recent prospective cohort studies. CONCLUSION: The changes incorporated to the algorithms provide up-to-date and easy-to-use guidelines to treat patients with IBD.
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Colitis Ulcerosa/terapia , Enfermedad de Crohn/terapia , Fármacos Gastrointestinales/uso terapéutico , Inmunosupresores/uso terapéutico , Inhibidores del Factor de Necrosis Tumoral/uso terapéutico , Anticuerpos Monoclonales Humanizados/uso terapéutico , Consenso , Francia , Humanos , Índice de Severidad de la EnfermedadRESUMEN
For inflammatory bowel disease, traditional dose escalation approaches that are based on clinical symptoms are being replaced by more aggressive treat-to-target approaches, in which treatment is adjusted promptly when predefined clinical and mucosal targets are not met. There is, however, an ongoing need to combine up-to-date treat-to-target strategies with easy-to-implement recommendations. Herein, we present consensus-recommendations for treatment targets that reflect current best practices in France. Methods Thirty-four gastroenterologists practicing in France participated in a meeting during which consensus statements about treat-to-target strategies for following patients with Crohn's disease (CD) and ulcerative colitis were developed. Targets, their definitions, and the timeframes for reaching them were defined. Consensus was defined as ≥66% of experts agreeing with a statement. Results For both diseases, the agreed targets were: patient related outcomes on disease (PRO-1), patient related outcomes on gastrointestinal symptoms (PRO-2), endoscopic healing and biomarkers of inflammation. Nutritional status has been defined as a target for CD only. Histological healing and transmural healing were not defined as targets. Deadlines to achieve targets and monitoring frequency have been agreed as well. Conclusions These consensus statements provide simple, easy-to-follow guidelines that should help gastroenterologists in France implement treat-to-target approaches, optimize treatments, and thus, reduce the burden of disease.
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Colitis Ulcerosa/tratamiento farmacológico , Enfermedad de Crohn/tratamiento farmacológico , Gastroenterólogos , Pautas de la Práctica en Medicina , Antiinflamatorios no Esteroideos/uso terapéutico , Colitis Ulcerosa/patología , Consenso , Conferencias de Consenso como Asunto , Enfermedad de Crohn/patología , Francia , Humanos , Inmunosupresores/uso terapéutico , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Enfermedades Inflamatorias del Intestino/patología , Inducción de RemisiónRESUMEN
BACKGROUND: Crohn's disease (CD) is a chronic disorder requiring long-term treatment. However, up to 20% of patients interrupt temporarily or permanently anti-TNFα. Primary aim was to identify internal and external factors influencing patient's motivation to pursue anti-TNFα in active CD. METHODS: This was a French, multicentre, prospective study enrolling CD patients on anti-TNFα therapy since more than 3 months. Patients completed the Satisfaction of Patients with Crohn's Disease questionnaire (SPACE-Q) and other patient-reported-outcome tools at inclusion visit, and after 6 and 12 months. RESULTS: A total of 274 patients were included: 146 (53.3%) received adalimumab, while 128 (46.7%) infliximab. Most patients (78%) were still treated with anti-TNFα 12 months after enrolment. Patients' perception of necessity (pâ¯=â¯0.01) and concerns (p<0.0001) regarding medication, evaluated through the Belief about Medicines Questionnaire (BMQ), and expectation confirmation towards treatment convenience (pâ¯=â¯0.02), towards efficacy (pâ¯=â¯0.04), and treatment satisfaction (pâ¯=â¯0.03) according to SPACE-Q, correlated with motivation to pursue treatment. Patients with higher treatment satisfaction (pâ¯=â¯0.0004), stronger belief in treatment necessity (p<0.0001) and fewer concerns (pâ¯=â¯0.0002) were more likely to be very motivated. CONCLUSION: Treatment satisfaction, treatment necessity, and concerns are correlated to motivation to pursue anti-TNFα. Specific questions focused on these patients' perceptions could help physicians to identify patients at risk of non-adherence and prevent therapy interruption.
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Adalimumab/uso terapéutico , Enfermedad de Crohn/tratamiento farmacológico , Infliximab/uso terapéutico , Motivación , Inhibidores del Factor de Necrosis Tumoral/uso terapéutico , Adulto , Enfermedad de Crohn/fisiopatología , Enfermedad de Crohn/psicología , Femenino , Francia , Humanos , Modelos Lineales , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Satisfacción del Paciente , Estudios Prospectivos , Encuestas y Cuestionarios , Resultado del TratamientoRESUMEN
BACKGROUND: The role of the gut microbiota in Crohn's disease (CD) is established and fecal microbiota transplantation (FMT) is an attractive therapeutic strategy. No randomized controlled clinical trial results are available. We performed a randomized, single-blind, sham-controlled pilot trial of FMT in adults with colonic or ileo-colonic CD. METHOD: Patients enrolled while in flare received oral corticosteroid. Once in clinical remission, patients were randomized to receive either FMT or sham transplantation during a colonoscopy. Corticosteroids were tapered and a second colonoscopy was performed at week 6. The primary endpoint was the implantation of the donor microbiota at week 6 (Sorensen index > 0.6). RESULTS: Eight patients received FMT and nine sham transplantation. None of the patients reached the primary endpoint. The steroid-free clinical remission rate at 10 and 24 weeks was 44.4% (4/9) and 33.3% (3/9) in the sham transplantation group and 87.5% (7/8) and 50.0% (4/8; one patient loss of follow-up while in remission at week 12 and considered in flare at week 24) in the FMT group. Crohn's Disease Endoscopic Index of Severity decreased 6 weeks after FMT (p = 0.03) but not after sham transplantation (p = 0.8). Conversely, the CRP level increased 6 weeks after sham transplantation (p = 0.008) but not after FMT (p = 0.5). Absence of donor microbiota engraftment was associated with flare. No safety signal was identified. CONCLUSION: The primary endpoint was not reached for any patient. In this pilot study, higher colonization by donor microbiota was associated with maintenance of remission. These results must be confirmed in larger studies (NCT02097797). Video abstract.
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Enfermedad de Crohn/terapia , Trasplante de Microbiota Fecal , Corticoesteroides/uso terapéutico , Adulto , Heces/microbiología , Femenino , Humanos , Masculino , Microbiota , Proyectos Piloto , Inducción de Remisión , Proyectos de Investigación , Índice de Severidad de la Enfermedad , Método Simple Ciego , Resultado del TratamientoAsunto(s)
Anemia/inducido químicamente , Antivirales/efectos adversos , Hepatitis C/tratamiento farmacológico , Enfermedades Renales/inducido químicamente , Riñón/fisiopatología , Oligopéptidos/efectos adversos , Anemia/sangre , Anemia/diagnóstico , Biomarcadores/sangre , Quimioterapia Combinada , Tasa de Filtración Glomerular , Hemoglobinas/metabolismo , Hepatitis C/diagnóstico , Humanos , Enfermedades Renales/diagnóstico , Enfermedades Renales/fisiopatología , Factores de Riesgo , Factores de TiempoRESUMEN
BACKGROUND AND AIMS: According to clinical trials, the treatment of patients with chronic hepatitis C (CHC) with second-generation direct acting antiviral agents (DAAs) is highly efficient and well tolerated. The goal of this study was to investigate the effectiveness and safety of various combinations of these drugs during their first 2 years of use in the real-world practice of French general hospitals. METHODS: Data from patients treated with all-oral DAAs in 24 French non-academic hospital centers from March 1, 2014 to January 1, 2016, were prospectively recorded. The sustained virological response 12-24 weeks after treatment (SVR 12-24) was estimated and severe adverse events (SAE) were evaluated and their predictive factors were determined using logistic regression. RESULTS: Data from 1123 patients were analyzed. The population was 69% genotype (G) 1, 13% G3, 11.5% G4, 5% G2, 49% with cirrhosis and 55% treatment-experienced. The treatment regimens were sofosbuvir/ledipasvir (38%), sofosbuvir/daclatasvir (32%), sofosbuvir/simeprevir (17%), ombitasvir+paritaprevir+ritonavir (5%) (with dasabuvir 3.5%), and sofosbuvir/ribavirin (8%). Ribavirin was given to 24% of patients. The SVR 12-24 was 91.0% (95% CI: 89.2-92.5%). Sofosbuvir-ribavirin was less effective than other regimens. The independent predictors of SVR 12-24 by logistic regression were body weight, albumin, previous hepatocellular carcinoma and treatment regimen (sofosbuvir/ribavirin vs. others). Sixty-four severe adverse events (SAE) were observed in 59 [5.6%] patients, and were independently predicted by cirrhosis and baseline hemoglobin. Serum creatinine increased during treatment (mean 8.5%, [P<10-5]), satisfying criteria for acute kidney injury in 62 patients (7.3%). Patient-reported overall tolerance was excellent, and patient-reported fatigue decreased during and after treatment. CONCLUSIONS: Second generation DAAs combinations are as effective and well tolerated in a « real-world ¼ population as in clinical trials. Further studies are needed on renal tolerance.
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Antivirales/administración & dosificación , Hepatitis C Crónica/tratamiento farmacológico , Administración Oral , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Antivirales/efectos adversos , Quimioterapia Combinada , Femenino , Francia , Hospitales Generales , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Resultado del Tratamiento , Adulto JovenRESUMEN
BACKGROUND & AIMS: Upper-gastrointestinal bleeding (UGIB) in the elderly is associated with high morbidity and mortality. The aims of this study were to determine the prognostic factors of UGIB in a large cohort of elders. METHODS: From March 2005 to February 2006, we conducted a prospective multicenter study in 53 French hospitals that consecutively enrolled 3287 patients for UGIB. A total of 1041 patients (47.8% women) were older than 74 years. Their epidemiologic characteristics and prognosis were compared with the 2246 younger patients (26.8% women). RESULTS: Elders more frequently took drugs causing UGIB: 65% versus 32% for younger patients (P < 10(-6)). Peptic ulcers, erosive gastritis, and esophagitis accounted for 63.6% of UGIB causes in elders versus 39.7% in younger patients (P < 10(-4)). Conversely, esogastric varices and gastropathy were responsible for 11% of UGIB in elders versus 44% in younger patients (P < 10(-6)). The rebleeding rate, morbidity, and in-hospital mortality were not statistically different between elders and younger patients: 11.8% versus 9.7% (P = .07), 22.6% versus 21.6% (P = .5), and 8.9% versus 8.2% (P = .5), respectively. Transfusion requirements, need for surgery, and length of stay were significantly different between elders and younger patients: 73% versus 57.5% (P < 10(-6)), 4% versus 2.5% (P < .02), 10.6 +/- 15.6 versus 8.5 +/- 12.4 days (P < 10(-6)), respectively. Whatever the etiology (peptic lesions or portal hypertension) in-hospital mortality was the same: 6.5% versus 7.3% and 10.9% versus 11.3%, respectively. CONCLUSIONS: Elders can do as well as younger patients with acute UGIB. Although the reasons are not completely clear, they may be related to differences in treatment.
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Hemorragia Gastrointestinal/etiología , Tracto Gastrointestinal Superior/patología , Adulto , Factores de Edad , Anciano , Anciano de 80 o más Años , Várices Esofágicas y Gástricas/epidemiología , Esofagitis/epidemiología , Femenino , Francia , Gastritis/epidemiología , Hemorragia Gastrointestinal/epidemiología , Hemorragia Gastrointestinal/mortalidad , Hospitales , Humanos , Masculino , Persona de Mediana Edad , Úlcera Péptica/epidemiología , Prevalencia , Pronóstico , Estudios ProspectivosRESUMEN
BACKGROUND: Crohn's disease (CD) is a chronic and disabling condition. There is no curative medical treatment but current treatments provide increasingly sustainable control of the disease and allow patients a better quality of life. There is limited evidence supporting CD management in specific clinical situations, thus precluding an evidence-based approach. AIMS: To help clinicians in making informed treatment decisions, a group of 59 French gastroenterologists with experience in the management of CD met to develop straightforward and practical algorithms based on the European Crohn's and Colitis Organisation (ECCO) recommendations. METHODS: This experts' opinion was developed following a Nominal Group consensus methodology. Nine clinical situations were identified: mildly active CD; uncomplicated moderately active CD, with, and without poor prognostic factors; uncomplicated severely active CD; perianal CD with a single fistula; perianal CD with complex fistula with or without abscess; complicated CD with abscess; intestinal stricture; and post-operative CD. Two working groups were formed and proposed algorithms that were then approved by a two-thirds majority of the Nominal Group. RESULTS: These algorithms represent the pragmatic consensus of a group of experts in gastroenterology on the modalities of therapeutic care in different clinical situations in CD. They are available via a web application at: www.algorithmici.com.
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Enfermedad de Crohn/diagnóstico , Enfermedad de Crohn/terapia , Algoritmos , Consenso , Francia , Humanos , Calidad de Vida , Recurrencia , Índice de Severidad de la EnfermedadRESUMEN
BACKGROUND: Several studies have suggested the efficacy of baclofen in reducing alcohol consumption, leading to a temporary recommendation for use in France. AIM: Our aim was to report our experience in using baclofen in alcohol-dependant patients with or without liver cirrhosis. PATIENTS AND METHODS: Consecutive patients from two liver and alcohol units were recruited over a 3-year period and received increasing doses of baclofen associated with social, psychological, and medical care. RESULTS: One hundred patients were treated, of whom 65 were cirrhotic. After 1 year, 86 patients were still being followed up. At a mean dosage of 40 mg/day (extremes: 30-210), the median daily alcohol consumption reduced from 80 to 0 g/day (P<0.001). Twenty patients drank a small amount of alcohol of up to 30 g/day and 44 patients were completely abstinent. These declarative results were associated with a significant improvement in alcohol-related biological markers in this 'low-consumption' group of 64 patients: the median γ-glutamyl transferase decreased from 3.9 to 2.0 UNL (P<0.001), the mean aspartate transaminase decreased from 2.6 to 1.2 UNL (P<0.001), and the mean corpuscular volume decreased from 101 to 93 µm (P<0.001). In cirrhotic patients, bilirubinemia decreased significantly from 22 to 11 µmol/l (P=0.026), prothrombin time increased from 68 to 77% (P<0.001), and albuminemia increased from 34.1 to 37.4 g/l (P<0.001). Twenty patients reported grades 1-2 adverse events. No liver or renal function deterioration occurred in cirrhotic patients. CONCLUSION: In our cohort, baclofen associated with a global care was very well tolerated even in cirrhotic patients. The marked reduction in alcohol consumption in 64 patients translated into a significant improvement in biological markers and in liver function tests. Baclofen could be very useful, especially in cases of severe alcoholic liver disease.
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Abstinencia de Alcohol , Consumo de Bebidas Alcohólicas/prevención & control , Alcoholismo/tratamiento farmacológico , Baclofeno/administración & dosificación , Agonistas de Receptores GABA-B/administración & dosificación , Cirrosis Hepática Alcohólica/etiología , Adulto , Consumo de Bebidas Alcohólicas/efectos adversos , Consumo de Bebidas Alcohólicas/psicología , Alcoholismo/complicaciones , Alcoholismo/diagnóstico , Alcoholismo/psicología , Baclofeno/efectos adversos , Femenino , Francia , Agonistas de Receptores GABA-B/efectos adversos , Humanos , Cirrosis Hepática Alcohólica/diagnóstico , Cirrosis Hepática Alcohólica/psicología , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Recurrencia , Factores de Tiempo , Resultado del TratamientoRESUMEN
AIM OF THE STUDY: The aim of this retrospective multicenter study was to collect data from patients with chronic alcoholic pancreatitis and cystic dystrophy of the duodenal wall in order to better understand the outcome after medical, endoscopic and/or surgical treatment. PATIENTS AND METHODS: The data from medical records of 23 patients consecutively seen in ten primary referral centers from January 1990 to July 2004 were studied. Clinical, biological, and endoscopic features as well as imaging findings were recorded. Response to treatment was noted. RESULTS: Twenty-three patients (20 men), aged 45 years (range: 30-66), with chronic alcohol intake, cystic dystrophy of the duodenal wall, and previously known (N=14) or simultaneously diagnosed (N=9) chronic pancreatitis were included. Symptoms most frequently encountered were abdominal pain (N=22) and weight loss (N=16). An abdominal ultrasound was available for 10 patients, abdominal computed tomography for 22, upper endoscopy for 18, and endoscopic ultrasonography for 22. Endoscopic ultrasonography enabled diagnosis of cystic dystrophy of the duodenal wall in 19/22 patients. Six patients were symptom-free after alcohol withdrawal. Seven patients received octreotide 200 to 400 microg per day, 5 of whom subsequently underwent surgery (71%). Fourteen patients out of 23 were operated on (61%), 11 of whom underwent pancreaticoduodenectomy and remained symptom-free for 47 months follow-up. Mean follow-up was 56 months (range: 2-78) for non surgical patients (39%) and 47 months (range: 12-108) for surgical patients (61%). CONCLUSION: Cystic dystrophy of the duodenal wall complicating chronic alcoholic pancreatitis may be the revealing sign of pancreatitis. Endoscopic ultrasongraphy is the most reliable imaging method for diagnosis. Pancreaticoduodenectomy is the most frequently employed definitive treatment.
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Quistes , Enfermedades Duodenales , Duodeno/patología , Pancreatitis Alcohólica/complicaciones , Dolor Abdominal/etiología , Adulto , Anciano , Quistes/complicaciones , Quistes/diagnóstico por imagen , Quistes/patología , Quistes/cirugía , Enfermedades Duodenales/complicaciones , Enfermedades Duodenales/diagnóstico por imagen , Enfermedades Duodenales/patología , Enfermedades Duodenales/cirugía , Endosonografía , Femenino , Humanos , Masculino , Persona de Mediana Edad , Pancreaticoduodenectomía , Estudios Retrospectivos , Pérdida de PesoRESUMEN
BACKGROUND: Ulcerative colitis (UC) is a chronic inflammatory bowel disease of multifactorial etiology that primarily affects the colonic mucosa. The disease progresses over time, and clinical management guidelines should reflect its dynamic nature. There is limited evidence supporting UC management in specific clinical situations, thus precluding an evidence-based approach. AIM: To use a formal consensus method - the nominal group technique (NGT) - to develop a clinical practice expert opinion to outline simple algorithms and practices, optimize UC management, and assist clinicians in making treatment decisions. METHODS: The consensus was developed by an expert panel of 37 gastroenterologists from various professional organizations with experience in UC management using the qualitative and iterative NGT, incorporating deliberations based on the European Crohn's and Colitis Organisation recommendations, recent reviews of scientific literature, and pertinent discussion topics developed by a steering committee. Examples of clinical cases for which there are limited evidence-based data from clinical trials were used. Two working groups proposed and voted on treatment algorithms that were then discussed and voted for by the nominal group as a whole, in order to reach a consensus. RESULTS: A clinical practice guideline covering management of the following clinical situations was developed: (i) moderate and severe UC; (ii) acute severe UC; (iii) pouchitis; (iv) refractory proctitis, in the form of treatment algorithms. CONCLUSIONS: Given the limited available evidence-based data, a formal consensus methodology was used to develop simple treatment guidelines for UC management in different clinical situations that is now accessible via an online application.
Asunto(s)
Colitis Ulcerosa/tratamiento farmacológico , Consenso , Manejo de la Enfermedad , Francia , HumanosRESUMEN
BACKGROUND AND STUDY AIMS: The purpose of this study was to describe the real-life conditions of use, efficacy, safety, and acceptability of sodium phosphate (NaP) tablets for colon cleansing in routine medical practice in France. PATIENTS AND METHODS: A total of 996 patients undergoing bowel preparation were enrolled by 108 gastroenterologists in this observational, longitudinal, prospective, multicenter study. The conditions of use of NaP tablets were assessed with a composite endpoint, which included six criteria for patient compliance with the recommended administration scheme and a criterion for the absence of contraindications to NaP use. RESULTS: Adequate use of NaP was reported for 75.1â% of the patients. The main reasons for misuse were a smaller fluid intake than expected with a dose of 4 tablets and noncompliance with age-related contraindications. The quality of cleansing was satisfactory: the Boston Bowel Preparation Scale (BBPS) total score was 7 or higher in 75.4â% of the patients. Gastroscopy associated with colonoscopy in 38.9â% of the patients revealed gastric lesions, which were considered as possibly related to the use of NaP tablets in 10.3â% of them. Vomiting occurred in 9.8â% of the patients, and 0.6â% discontinued bowel preparation after an adverse event. No electrolyte disorders or renal impairment was reported, even if not systematically sought. The acceptability of the NaP tablets was high, particularly among patients who previously had undergone other methods of bowel preparation. CONCLUSIONS: Despite being defined according to strict criteria, adequate use of NaP tablets was observed in a high percentage of patients. The quality of colon cleansing and the safety and acceptability of NaP tablets were satisfactory and consistent with data from randomized clinical studies.
RESUMEN
Chronic granulomatous disease may lead to inflammatory bowel disease with endoscopic and histological aspects similar to that observed in patients with Crohn's disease. Inflammatory symptoms are generally controlled by steroids, but resistant forms may need total colectomy. Therapeutic strategy in steroid-dependent cases is not yet established. We report here the case of a patient with chronic granulomatous enteritis dependent on steroids at a daily dose of 20 mg. Azathioprine made it possible to withdraw steroid therapy without relapse over twenty Months and without infectious complication during the follow up.
Asunto(s)
Corticoesteroides/uso terapéutico , Colitis/tratamiento farmacológico , Enfermedad Granulomatosa Crónica/tratamiento farmacológico , Adulto , Azatioprina/uso terapéutico , Colitis/etiología , Enfermedad Granulomatosa Crónica/complicaciones , Humanos , Inmunosupresores/uso terapéutico , Masculino , Inducción de Remisión/métodosRESUMEN
Leiden Factor V mutation, associated with resistance to activated protein C, is a prothrombotic state found in 20% of the patients with a first episode of deep-vein thrombosis. We report the case of a 30-Year-old woman with a history of intermittent abdominal pain who developed small bowel infarction requiring extensive small bowel resection. Biological search for prothrombotic disorder showed resistance to activated protein C due to homozygosity for the factor V Leiden mutation. Long-term anticoagulant therapy was initiated. Unexplained abdominal pain may be due to venous mesenteric ischemia, which can be associated with factor V Leiden mutation.