RESUMEN
BACKGROUND: Clinical decision support systems (CDSS) have been shown to reduce medication errors. However, they are underused because of different challenges. One approach to improve CDSS is to use ontologies instead of relational databases. The primary aim was to design and develop OntoPharma, an ontology based CDSS to reduce medication prescribing errors. Secondary aim was to implement OntoPharma in a hospital setting. METHODS: A four-step process was proposed. (1) Defining the ontology domain. The ontology scope was the medication domain. An advisory board selected four use cases: maximum dosage alert, drug-drug interaction checker, renal failure adjustment, and drug allergy checker. (2) Implementing the ontology in a formal representation. The implementation was conducted by Medical Informatics specialists and Clinical Pharmacists using Protégé-OWL. (3) Developing an ontology-driven alert module. Computerised Physician Order Entry (CPOE) integration was performed through a REST API. SPARQL was used to query ontologies. (4) Implementing OntoPharma in a hospital setting. Alerts generated between July 2020/ November 2021 were analysed. RESULTS: The three ontologies developed included 34,938 classes, 16,672 individuals and 82 properties. The domains addressed by ontologies were identification data of medicinal products, appropriateness drug data, and local concepts from CPOE. When a medication prescribing error is identified an alert is shown. OntoPharma generated 823 alerts in 1046 patients. 401 (48.7%) of them were accepted. CONCLUSIONS: OntoPharma is an ontology based CDSS implemented in clinical practice which generates alerts when a prescribing medication error is identified. To gain user acceptance OntoPharma has been designed and developed by a multidisciplinary team. Compared to CDSS based on relational databases, OntoPharma represents medication knowledge in a more intuitive, extensible and maintainable manner.
Asunto(s)
Sistemas de Apoyo a Decisiones Clínicas , Sistemas de Entrada de Órdenes Médicas , Interacciones Farmacológicas , Prescripciones de Medicamentos , Humanos , Errores de Medicación/prevención & controlAsunto(s)
COVID-19/terapia , Hospitales Públicos/organización & administración , Hospitales de Enseñanza/organización & administración , Hospitales Urbanos/organización & administración , Transferencia de Pacientes , Anciano , Femenino , Capacidad de Camas en Hospitales , Humanos , Masculino , Persona de Mediana Edad , Cuarentena , SARS-CoV-2 , Índice de Severidad de la Enfermedad , EspañaRESUMEN
GOALS: To describe the occurrence of malabsorption (MA) in hepatocellular carcinoma (HCC) patients under sorafenib, the potential relationship with pancreatic insufficiency (PI), and the role of pancreatic enzymes supplementation. BACKGROUND: With the increasing options of second-line systemic therapies for HCC, the recognition of drug intolerance using practical tools is crucial. It has been proposed that a MA syndrome could be due to sorafenib-induced pancreatic dysfunction. STUDY: All sorafenib-treated patients with suspicion of MA (defined as decreased stool consistency lasting >4 wk or presenting ≥10% body weight loss without HCC progression) were prospectively evaluated by serum markers, endoscopy, and imaging techniques. RESULTS: We evaluated 81 sorafenib-treated patients and 21 developed MA suspicion (85.7% male, 81.5% Child-Pugh A, 52.4% BCLC-B, and 47.6% BCLC-C) within a median 5.9 months after starting sorafenib. The median treatment duration, follow-up, and overall survival after MA suspicion were 5.9, 20.3, and 20.3 months, respectively. Nine of them (42.9%) presented hyperparathyroidism secondary to vitamin D deficiency and 8 with PI. A gradual decrease in pancreatic volume of up to 19% was observed among patients with PI. Six of the 8 patients with PI received pancreatic enzymes, with complete recovery from MA symptoms and stabilization of pancreatic volume. CONCLUSIONS: We validated the association between MA and PI in 10% of sorafenib-treated patients. Pancreatic enzymes supplementation successfully led to symptomatic recovery. Awareness of this adverse event can help in the management of sorafenib irrespective of cancer type and likely, of other tyrosine kinase inhibitors for HCC patients.
Asunto(s)
Antineoplásicos , Carcinoma Hepatocelular , Insuficiencia Pancreática Exocrina , Neoplasias Hepáticas , Antineoplásicos/efectos adversos , Carcinoma Hepatocelular/tratamiento farmacológico , Femenino , Humanos , Neoplasias Hepáticas/tratamiento farmacológico , Masculino , Niacinamida/efectos adversos , Compuestos de Fenilurea/efectos adversos , Sorafenib/efectos adversos , Resultado del TratamientoRESUMEN
Introduction: Cure of Helicobacter pylori infection in patients with gastric lymphoma of mucosa-associated lymphoid tissue (MALT) leads to long-term clinical remission in the initial stages. As it is a rare disease, its management in clinical practice remains largely unknown and heterogeneity of care remains a concern. The aim was to audit the management and evolution of a large series of low-grade gastric MALT lymphomas from thirteen Spanish hospitals. Materials and methods: Multicentre retrospective study including data on the diagnosis and follow-up of patients with gastric low-grade MALT lymphoma from January 1998 to December 2013. Clinical, biological and pathological data were analyzed and survival curves were drawn. Results: One-hundred and ninety-eight patients were included. Helicobacter pylori was present in 132 (69%) patients and 103 (82%) in tumors confined to the stomach (stage EI) and was eradicated in 92% of patients. Chemotherapy was given in 90 (45%) patients and 43 (33%) with stage EI. Marked heterogeneity in the use of diagnostic methods and chemotherapy was observed. Five-year overall survival was 86% (89% in EI). Survival was similar in EI patients receiving aggressive treatment and in those receiving only antibiotics (p=0.577). Discussion: Gastric MALT lymphoma has an excellent prognosis. We observed, however, a marked heterogeneity in the use of diagnostic methods or chemotherapy in early-stage patients
Introducción: La cura de la infección por Helicobacter pylori (H. pylori) en pacientes con linfoma gástrico de tejido linfoide asociado mucosas (mucosa-associated lymphoid tissue [MALT]) conduce a la remisión clínica a largo plazo en los estadios iniciales. Al tratarse de una enfermedad rara, su tratamiento en la práctica clínica en muchas ocasiones se desconoce y la heterogeneidad de la atención sigue siendo motivo de preocupación. El objetivo es auditar el tratamiento y la evolución de una gran serie de linfomas gástricos MALT de bajo grado procedentes de 13 hospitales españoles. Materiales y métodos: Estudio retrospectivo y multicéntrico que incluye datos sobre el diagnóstico y el seguimiento de pacientes con linfoma MALT gástrico de bajo grado desde enero de 1998 hasta diciembre del 2013. Se analizaron los datos clínicos, biológicos y patológicos, y se trazaron las curvas de supervivencia. Resultados: Se incluyó a 198 pacientes. El H. pylori estaba presente en 132 (69%) de los pacientes y en 103 (82%) tumores confinados al estómago (estadio EI) y se erradicó en el 92% de los pacientes. Se administró quimioterapia a 90 (45%) de los pacientes y a 43 (33%) en estadio EI. Se observó una marcada heterogeneidad en el uso de los métodos de diagnóstico y de la quimioterapia. La supervivencia global a los 5 años fue del 86% (89% en estadio EI). La supervivencia fue similar en los pacientes en estadio EI que recibieron tratamiento agresivo y en los que recibieron solo antibióticos (p=0,577). Discusión: El linfoma MALT gástrico presenta un pronóstico excelente. Sin embargo, se observó una marcada heterogeneidad en el uso de los métodos de diagnóstico o la quimioterapia en pacientes en estadio inicial
Asunto(s)
Humanos , Linfoma/patología , Tejido Linfoide/patología , Auditoría Clínica/métodos , Neoplasias Gástricas/tratamiento farmacológico , España , Estudios Retrospectivos , Supervivencia sin Progresión , Infecciones por Helicobacter/tratamiento farmacológico , Mucosa Gástrica/efectos de los fármacos , Mucosa Gástrica/patologíaRESUMEN
INTRODUCTION: Cure of Helicobacter pylori infection in patients with gastric lymphoma of mucosa-associated lymphoid tissue (MALT) leads to long-term clinical remission in the initial stages. As it is a rare disease, its management in clinical practice remains largely unknown and heterogeneity of care remains a concern. The aim was to audit the management and evolution of a large series of low-grade gastric MALT lymphomas from thirteen Spanish hospitals. MATERIALS AND METHODS: Multicentre retrospective study including data on the diagnosis and follow-up of patients with gastric low-grade MALT lymphoma from January 1998 to December 2013. Clinical, biological and pathological data were analyzed and survival curves were drawn. RESULTS: One-hundred and ninety-eight patients were included. Helicobacter pylori was present in 132 (69%) patients and 103 (82%) in tumors confined to the stomach (stage EI) and was eradicated in 92% of patients. Chemotherapy was given in 90 (45%) patients and 43 (33%) with stage EI. Marked heterogeneity in the use of diagnostic methods and chemotherapy was observed. Five-year overall survival was 86% (89% in EI). Survival was similar in EI patients receiving aggressive treatment and in those receiving only antibiotics (p=0.577). DISCUSSION: Gastric MALT lymphoma has an excellent prognosis. We observed, however, a marked heterogeneity in the use of diagnostic methods or chemotherapy in early-stage patients.
Asunto(s)
Linfoma de Células B de la Zona Marginal/diagnóstico , Linfoma de Células B de la Zona Marginal/terapia , Neoplasias Gástricas/diagnóstico , Neoplasias Gástricas/terapia , Anciano , Auditoría Clínica , Femenino , Helicobacter pylori/aislamiento & purificación , Humanos , Linfoma de Células B de la Zona Marginal/microbiología , Linfoma de Células B de la Zona Marginal/patología , Masculino , Persona de Mediana Edad , Clasificación del Tumor , Pautas de la Práctica en Medicina , Estudios Retrospectivos , España , Neoplasias Gástricas/microbiología , Neoplasias Gástricas/patologíaRESUMEN
No disponible
Asunto(s)
Humanos , Masculino , Persona de Mediana Edad , Oclusión Vascular Mesentérica/fisiopatología , Aneurisma Falso/diagnóstico por imagen , Melena/etiología , Arteria Mesentérica Superior , Fístula Intestinal/etiología , Endoscopía Capsular , Trasplante de Riñón/efectos adversos , Trasplante de Páncreas/efectos adversosAsunto(s)
Aneurisma Falso/diagnóstico por imagen , Endoscopía Capsular , Fístula Intestinal/etiología , Enfermedades del Yeyuno/etiología , Trasplante de Riñón , Arteria Mesentérica Superior , Trasplante de Páncreas , Complicaciones Posoperatorias/diagnóstico por imagen , Fístula Vascular/etiología , Anastomosis Quirúrgica , Aneurisma Falso/etiología , Aneurisma Falso/terapia , Diabetes Mellitus Tipo 1/cirugía , Embolización Terapéutica , Hemorragia Gastrointestinal/etiología , Humanos , Arteria Ilíaca/cirugía , Fístula Intestinal/diagnóstico por imagen , Enfermedades del Yeyuno/diagnóstico por imagen , Fallo Renal Crónico/cirugía , Masculino , Arteria Mesentérica Superior/cirugía , Persona de Mediana Edad , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/terapia , Ultrasonografía Doppler , Fístula Vascular/diagnóstico por imagenRESUMEN
BACKGROUND: Haematopoietic stem cell transplantation [HSCT] is considered a therapeutic option for patients with severe Crohn's disease [CD] unresponsive to currently available therapies. METHODS: Autologous HSCT was considered for CD patients with active disease, unresponsive or intolerant to approved medications and unsuitable for surgery. After HSCT, patients were closely followed up every 6 weeks during the first 2 years and every 6 months thereafter up to 5 years. Colonoscopy and/or magnetic resonance imaging were performed at Months 6, 12, 24, and 48 after HSCT. RESULTS: From December 1, 2007 to December 31, 2015, 37 CD patients were assessed for HSCT. Of these, 35 patients [13 within the ASTIC trial] underwent mobilisation. Six patients did not complete the transplant for various reasons and 29 patients were finally transplanted. Patients were followed up during a median of 12 months [6-60]. At 6 months, 70% of patients achieved drug-free clinical remission (Crohn's Disease Index of Severity [CDAI] < 150). The proportion of patients in drug-free remission (CDAI < 150, Simple Endoscopic activity Score [SES]-CD < 7] was 61% at 1 year, 52% at 2 years, 47% at 3 years, 39% at 4 years, and 15% at 5 years. Patients who relapsed were re-treated and 80% regained clinical remission. Six out of the 29 [21%] required surgery. One patient died due to systemic cytomegalovirus infection 2 months after transplant. CONCLUSIONS: HSCT is a salvage therapy for patients with extensive and refractory CD. Although relapse occurs in a majority of patients within 5 years after transplant, drug responsiveness is regained and clinical remission achieved in 80% of cases.
Asunto(s)
Enfermedad de Crohn/terapia , Trasplante de Células Madre Hematopoyéticas , Adolescente , Adulto , Colonoscopía , Enfermedad de Crohn/diagnóstico por imagen , Enfermedad de Crohn/patología , Femenino , Trasplante de Células Madre Hematopoyéticas/métodos , Humanos , Imagen por Resonancia Magnética , Masculino , Persona de Mediana Edad , Terapia Recuperativa/métodos , Resultado del Tratamiento , Adulto JovenRESUMEN
AIM: To evaluate the early and long-term efficacy of infliximab in ulcerative colitis and to determine predictors of response and colectomy. METHODS: This is an ambidirectional cohort study in a tertiary referral center including patients who started infliximab within 2005 and 2008 and monitored until 2014. Efficacy was evaluated by partial Mayo scores at weeks 2, 4, 8, 30, and 54. Long-term treatment maintenance with infliximab and colectomy requirements were recorded. RESULTS: Fifty-three patients were included with a median follow-up of 69.5 months. Clinical remission at the time point assessments was 40.8, 47.2, 54.7, 54.7, and 49.1 %. At the time of maximal follow-up, the proportion of patients under infliximab maintenance was 24.5 %. A higher level of albumin (OR 1.4, CI 95 % 1.06-1.8; p = 0.017) was predictive of a higher remission rate at week 8. Concomitant immunomodulators beyond 6 months were predictive of infliximab's long-term maintenance (OR 15.8, CI 95 % 1.8-135.4; p = 0.012). Colectomy was required in 41.5 %. Factors associated with a higher rate of colectomy at week 54 were previous treatment with cyclosporine (OR 3.4, CI 95 % 1.2-9.7; p = 0.012), absence of response at week 8 (OR 10.3, CI 95 % 3.3-31.7; p < 0.001), and not receiving concomitant immunomodulators (OR 4.1, CI 95 % 1.8-9; p = 0.002). Colectomy rates within the first 54 weeks were closely dependent on the number of variables present: none (0 %), 1 (26.3 %), 2 (71.4 %), or 3 (100 %) of them (log rank <0.0001). CONCLUSIONS: Low albumin, previous treatment with cyclosporine, absence of a concomitant immunomodulator, and lack of response at week 8 negatively affected the efficacy of infliximab in ulcerative colitis.
Asunto(s)
Colitis Ulcerosa/tratamiento farmacológico , Fármacos Gastrointestinales/uso terapéutico , Infliximab/uso terapéutico , Adulto , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Resultado del TratamientoRESUMEN
OBJECTIVE: To evaluate the feasibility and toxicity of autologous haematopoietic stem cell transplantation (HSCT) for the treatment of refractory Crohn's disease (CD). DESIGN: In this prospective study, patients with refractory CD suffering an aggressive disease course despite medical treatment, impaired quality of life and in whom surgery was not an acceptable option underwent HSCT. Toxicity and complications during the procedure and within the first year following transplantation were evaluated, along with the impact of the introduction of supportive measures on safety outcomes. RESULTS: 26 patients were enrolled. During mobilisation, 16 patients (62%) presented febrile neutropaenia, including one bacteraemia and two septic shocks. Neutropaenia median time after mobilisation was 5â days. 5 patients withdrew from the study after mobilisation and 21 patients entered the conditioning phase. Haematopoietic recovery median time for neutrophils (>0.5×10(9)/L) was 11â days and for platelets (>20×10(9)/L) 4â days. Twenty patients (95%) suffered febrile neutropaenia and three patients (27%) presented worsening of the perianal CD activity during conditioning. Among non-infectious complications, 6 patients (28.5%) presented antithymocyte globulin reaction, 12 patients (57%) developed mucositis and 2 patients (9.5%) had haemorrhagic complications. Changes in supportive measures over the study, particularly antibiotic prophylaxis regimes during mobilisation and conditioning, markedly diminished the incidence of severe complications. During the first 12-month follow-up, viral infections were the most commonly observed complications, and one patient died due to systemic cytomegalovirus infection. CONCLUSIONS: Autologous HSCT for patients with refractory CD is feasible, but extraordinary supportive measures need to be implemented. We suggest that this procedure should only be performed in highly experienced centres.
Asunto(s)
Profilaxis Antibiótica/métodos , Enfermedad de Crohn , Trasplante de Células Madre Hematopoyéticas , Complicaciones Posoperatorias , Calidad de Vida , Acondicionamiento Pretrasplante/métodos , Adolescente , Adulto , Enfermedad de Crohn/sangre , Enfermedad de Crohn/diagnóstico , Enfermedad de Crohn/psicología , Enfermedad de Crohn/terapia , Femenino , Trasplante de Células Madre Hematopoyéticas/efectos adversos , Trasplante de Células Madre Hematopoyéticas/métodos , Humanos , Masculino , Monitoreo Fisiológico/métodos , Gravedad del Paciente , Recuento de Plaquetas/métodos , Complicaciones Posoperatorias/diagnóstico , Complicaciones Posoperatorias/prevención & control , Estudios Prospectivos , Inducción de Remisión/métodos , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
Gastrointestinal bleeding of obscure origin or with an intractable cause is particularly common in patients with atrial fibrillation subject to oral anticoagulant therapy. This condition is highly recurrent and therefore gives rise to high morbidity and mortality rates, thus entailing a vicious cycle that is difficult to solve.Percutaneous left atrial appendage closure has become a therapeutic alternative for patients with atrial fibrillation and a contraindication for oral anticoagulation. This technique would allow the discontinuation of oral anticoagulants, thus helping to reduce the risk for gastrointestinal bleeding, and would also be protective against embolic events in this group of patients, thereby eventually breaking this vicious cycle.We report our experience with percutaneous left atrial appendage closure in the management of patients with atrial fibrillation who are subject to oral anticoagulation therapy and suffer from obscure or intractable gastrointestinal bleeding.
Asunto(s)
Anticoagulantes/efectos adversos , Fibrilación Atrial/complicaciones , Embolia/etiología , Embolia/prevención & control , Hemorragia Gastrointestinal/inducido químicamente , Hemorragia Gastrointestinal/terapia , Anciano , Anciano de 80 o más Años , Anticoagulantes/uso terapéutico , Apéndice Atrial/cirugía , Femenino , Humanos , Masculino , Dispositivo Oclusor SeptalRESUMEN
OBJECTIVE: To assess rates of further bleeding, surgery and mortality in patients hospitalized owing to peptic ulcer bleeding. MATERIALS AND METHODS: Consecutive patients hospitalized for peptic ulcer bleeding and treated with a proton pump inhibitor (PPI) (esomeprazole or pantoprazole) were identified retrospectively in 12 centers in Spain. Patients were included if they had high-risk stigmata (Forrest class Ia-IIb, underwent therapeutic endoscopy and received intravenous PPI ≥120 mg/day for ≥24 h) or low-risk stigmata (Forrest class IIc-III, underwent no therapeutic endoscopy and received intravenous or oral PPI [any dose]). RESULTS: Of 935 identified patients, 58.3% had high-risk stigmata and 41.7% had low-risk stigmata. After endoscopy, 88.3% of high-risk patients and 22.1% of low-risk patients received intravenous PPI therapy at doses of at least 160 mg/day. Further bleeding within 72 h occurred in 9.4% and 2.1% of high- and low-risk patients, respectively (p < 0.001). Surgery to stop bleeding was required within 30 days in 3.5% and 0.8% of high- and low-risk patients, respectively (p = 0.007). Mortality at 30 days was similar in both groups (3.3% in high-risk and 2.3% in low-risk patients). CONCLUSION: Among patients hospitalized owing to peptic ulcer bleeding and treated with PPIs, patients with high-risk stigmata have a higher risk of further bleeding and surgery, but not of death, than those with low-risk stigmata.
Asunto(s)
Úlcera Duodenal/complicaciones , Úlcera Péptica Hemorrágica/tratamiento farmacológico , Úlcera Péptica Hemorrágica/cirugía , Inhibidores de la Bomba de Protones/administración & dosificación , 2-Piridinilmetilsulfinilbencimidazoles/administración & dosificación , Administración Intravenosa , Administración Oral , Adulto , Anciano , Anciano de 80 o más Años , Úlcera Duodenal/tratamiento farmacológico , Úlcera Duodenal/cirugía , Endoscopía Gastrointestinal , Esomeprazol/administración & dosificación , Femenino , Hemostasis Endoscópica , Hospitalización , Humanos , Masculino , Persona de Mediana Edad , Pantoprazol , Úlcera Péptica Hemorrágica/mortalidad , Recurrencia , Retratamiento , Estudios Retrospectivos , Factores de Riesgo , Resultado del TratamientoRESUMEN
La hemorragia digestiva de origen oscuro o de causa no tratable es especialmente frecuente en los pacientes con fibrilación auricular subsidiarios de tratamiento con anticoagulantes orales. Esta condición conlleva una elevada recurrencia, la cual acarrea una elevada morbi-mortalidad, constituyendo un círculo vicioso de difícil solución. El cierre percutáneo de la orejuela de la aurícula izquierda se ha mostrado como una técnica terapéutica alternativa en los pacientes con fibrilación auricular y contraindicación para el tratamiento con anticoagulantes orales. Esta técnica posibilitaría la retirada de la anticoagulación oral, ayudando a disminuir el riesgo de sangrado digestivo, y protegería contra los eventos embólicos en este grupo de pacientes, pudiendo romper finalmente este círculo vicioso. Aquí describimos nuestra experiencia en el cierre percutáneo de la orejuela de la aurícula izquierda para el manejo de los pacientes con fibrilación auricular tributarios de tratamiento con anticoagulantes orales y hemorragia digestiva de origen oscuro o intratable (AU)
Gastrointestinal bleeding of obscure origin or with an intractable cause is particularly common in patients with atrial fibrillation subject to oral anticoagulant therapy. This condition is highly recurrent and therefore gives rise to high morbidity and mortality rates, thus entailing a vicious cycle that is difficult to solve. Percutaneous left atrial appendage closure has become a therapeutic alternative for patients with atrial fibrillation and a contraindication for oral anticoagulation. This technique would allow the discontinuation of oral anticoagulants, thus helping to reduce the risk for gastrointestinal bleeding, and would also be protective against embolic events in this group of patients, thereby eventually breaking this vicious cycle. We report our experience with percutaneous left atrial appendage closure in the management of patients with atrial fibrillation who are subject to oral anticoagulation therapy and suffer from obscure or intractable gastrointestinal bleeding (AU)
Asunto(s)
Humanos , Femenino , Anciano de 80 o más Años , Hemorragia Gastrointestinal/complicaciones , Hemorragia Gastrointestinal/diagnóstico , Fibrilación Atrial/complicaciones , Fibrilación Atrial/diagnóstico , Anticoagulantes/uso terapéutico , Hemorragia Gastrointestinal/tratamiento farmacológico , Hemorragia Gastrointestinal/fisiopatología , Fibrilación Atrial/tratamiento farmacológico , Fibrilación Atrial/fisiopatología , Fibrilación Atrial , Indicadores de Morbimortalidad , Apéndice Atrial/patología , Apéndice AtrialRESUMEN
OBJECTIVE: To assess clinical outcomes in patients treated with proton pump inhibitors (PPIs) after endoscopic hemostasis in routine clinical care, and to compare these outcomes to those seen in a randomized controlled trial (RCT) of i.v. esomeprazole. MATERIALS AND METHODS: Patients with peptic ulcer bleeding and endoscopic stigmata of recent hemorrhage, who were treated with i.v. esomeprazole or pantoprazole ≥120 mg/day following therapeutic endoscopy, were identified from 12 hospitals in Spain (n = 539). Outcomes assessed included further bleeding, all-cause mortality and surgery. The results were compared to those of the RCT. RESULTS: Overall, 9.1% (95% confidence interval [CI]: 6.7-11.5) of patients experienced further bleeding within 72 h following initial endoscopy, 14.3% (95% CI: 11.3-17.2) of patients had further bleeding within 30 days and 3.3% (95% CI: 1.8-4.9) of patients died within 30 days. In the RCT, the rate of rebleeding within 72 h was significantly lower in the esomeprazole arm (5.9%) than in the placebo arm (10.3%; p = 0.026). The further bleeding rate in patients treated with esomeprazole in routine clinical practice (7.8%; 95% CI: 4.6-11.1) was between these two values. Similar results were seen with the other outcomes studied. CONCLUSIONS: The proportion of patients treated with i.v. esomeprazole in routine clinical practice who experienced further bleeding following endoscopic treatment for peptic ulcer bleeding was between the rates observed in the esomeprazole group and the placebo group in the RCT.
Asunto(s)
2-Piridinilmetilsulfinilbencimidazoles/uso terapéutico , Esomeprazol/uso terapéutico , Úlcera Péptica Hemorrágica/tratamiento farmacológico , Inhibidores de la Bomba de Protones/uso terapéutico , Anciano , Intervalos de Confianza , Esomeprazol/administración & dosificación , Femenino , Hematemesis/etiología , Hemostasis Endoscópica , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Oportunidad Relativa , Pantoprazol , Úlcera Péptica Hemorrágica/mortalidad , Úlcera Péptica Hemorrágica/cirugía , Inhibidores de la Bomba de Protones/administración & dosificación , Ensayos Clínicos Controlados Aleatorios como Asunto , Recurrencia , Estudios Retrospectivos , Choque/etiología , España/epidemiologíaRESUMEN
BACKGROUND: In patients treated with TNF-antagonists, incident cases of tuberculosis (TB) after a negative screening have been reported, leading to the suggestion that improved TB testing is necessary. AIM: The aim of the current study is to establish the incidence of TB and its characteristics in patients with inflammatory bowel disease (IBD) under TNF antagonists to design improved prevention strategies. METHODS: IBD patients from a single center treated with anti-TNF therapy between January 2000 and September 2011 were identified through a database that prospectively records clinical data, treatments and adverse events. RESULTS: During the study period 423 patients received anti-TNF therapy. Screening for latent TB infection (LTBI) previous to anti-TNF treatment was positive in 30 patients (6.96%). Seven patients (1.65%) developed TB while under anti-TNF treatment. Six patients (five under immunosuppressant treatment) had a negative LTBI screening. TST was positive in one patient not receiving immunosuppressants, and was treated with isoniazid before starting anti-TNF therapy. In 4 patients TB was diagnosed within the first 16 weeks after starting anti-TNF therapy. Three cases had pulmonary TB and 4 extrapulmonary disease. CONCLUSIONS: In the IBD population under study, incidence of TB infection associated with anti-TNF therapy is higher than that reported in controlled trials and occurs early after treatment initiation. False negative results of LTBI despite appropriate measures may occur, suggesting that more effective screening strategies are needed.
Asunto(s)
Antiinflamatorios/efectos adversos , Anticuerpos Monoclonales Humanizados/efectos adversos , Anticuerpos Monoclonales/efectos adversos , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Tuberculosis/inducido químicamente , Adalimumab , Adulto , Antiinflamatorios/uso terapéutico , Anticuerpos Monoclonales/uso terapéutico , Anticuerpos Monoclonales Humanizados/uso terapéutico , Reacciones Falso Negativas , Femenino , Humanos , Incidencia , Enfermedades Inflamatorias del Intestino/complicaciones , Infliximab , Tuberculosis Latente/complicaciones , Tuberculosis Latente/diagnóstico , Tuberculosis Latente/epidemiología , Masculino , Persona de Mediana Edad , Factores de Riesgo , Resultado del Tratamiento , Prueba de Tuberculina , Tuberculosis/complicaciones , Tuberculosis/diagnóstico , Tuberculosis/epidemiologíaRESUMEN
OBJECTIVE: The aim of this study was to determine the diagnostic accuracy of magnetic resonance colonography (MRC) for the evaluation of disease activity and severity in patients with ulcerative colitis (UC) using endoscopy as the reference standard. METHODS: Fifty patients with UC underwent colonoscopy and MRC for the evaluation of disease activity. All patients were prospectively and consecutively included. Endoscopic activity was evaluated globally and on a segment basis using the modified Baron score (MBS), and also classified as absent, mild to moderate (inflammation without ulcers) or severe (presence of ulceration). MRC parameters evaluated in each segment were: wall thickness, pre- and post-contrast wall signal intensity, relative contrast enhancement (RCE), mural oedema, ulcers, enlarged lymph nodes and the comb sign. RESULTS: Independent predictors for endoscopic activity on a segment basis were RCE (p=0.006), presence of oedema (p=0.003), enlarged lymph nodes (p<0.001) and the comb sign (p<0.001). A segmental simplified MRC index (MRC-S) ≥ 1 detected endoscopic inflammation with high diagnostic accuracy (sensitivity 87%, specificity 88%, area under the curve (AUC) 0.95; p<0.001). MRC-S index ≥ 2 detected severe lesions with high sensitivity (83%) and specificity (82%) with an AUC of 0.91 (p<0.001). The MRC-S index strongly correlated with the MBS (r=0.81, p<0.001) and with the subjective assessment of the radiologists for the evaluation of disease severity (r=0.77, p<0.001). CONCLUSIONS: MRC has a high accuracy for the diagnosis of disease activity and severity in UC.
Asunto(s)
Colitis Ulcerosa/diagnóstico , Adulto , Colitis Ulcerosa/complicaciones , Colonoscopía/métodos , Edema/diagnóstico , Edema/etiología , Femenino , Humanos , Enfermedades Linfáticas/diagnóstico , Enfermedades Linfáticas/etiología , Imagen por Resonancia Magnética/métodos , Masculino , Persona de Mediana Edad , Variaciones Dependientes del Observador , Estudios Prospectivos , Reproducibilidad de los Resultados , Índice de Severidad de la EnfermedadRESUMEN
Introducción La mortalidad en la hemorragia digestiva alta no varicosa (HDA-NV) no ha variado. Se necesita conocer más información para mejorar las estrategias de tratamiento. Los objetivos de este estudio fueron: a) describir el perfil de presentación de los episodios de HDA-NV; b) el manejo clínico según práctica clínica habitual, y c) establecer cuáles son los resultados clínicos asociados a los tratamientos endoscópicos y médicos en España. Métodos ENERGIB fue un estudio retrospectivo de cohortes que recogió información del manejo y forma de presentación de HDA-NV en Europa. Presentamos los datos relativos a España. Los pacientes se trataron según la práctica clínica habitual. Para las variables cuantitativas se calculó la media y la desviación estándar y para las categóricas se calcularon frecuencias absolutas y relativas. Resultados Los pacientes (n = 403) fueron hombres (71%), con edad media 65 años, asociaron comorbilidad (62,5%). Los equipos encargados de su manejo fueron gastroenterólogos (57,1%) o médicos internistas (25,1%). Los inhibidores de la bomba de protones se usaron de forma empírica preendoscopia en un 80% de los casos. El 6,4% presentó persistencia y el 6,7% resangrado después de la endoscopia. La tasa de mortalidad en los 30 días posteriores fue del 3,5%.ConclusionesEste estudio permite conocer el perfil de presentación de los episodios de HDA-NV en España y el manejo en práctica clínica habitual. Este se ajusta a los estándares propuestos por las recientes guías de práctica clínica. Entre otros datos destaca que los pacientes con hemorragia son cada vez de edad más avanzada y presentan un mayor número de enfermedades asociadas, lo que podría explicar que la mortalidad se haya mantenido estable a pesar de los evidentes avances en el manejo de esta entidad (AU)
Background Mortality related to nonvariceal upper gastrointestinal bleeding (NVUGIB) has not changed. More information is needed to improve the management of this entity. The aims of this study were: a) to determine the characteristics of bleeding episodes, b) to describe the clinical approaches routinely used in NVUGIB, and c) to identify adverse outcomes related to endoscopic or medical treatments in Spain. Methods The European survey of nonvariceal upper GI bleeding (ENERGiB) was an observational, retrospective cohort study on NVUGIB with endoscopic evaluation carried out across Europe. The present study focused on Spanish patients in the ENERGiB study. The patients were managed according to routine care. The mean and standard deviation were calculated for quantitative variables and absolute and relative frequencies were calculated for categorical variables. Results Patients (n=403) were mostly men (71%), with a mean age of 65 years, and co-morbidities (62.5%). Most of the patients were managed by gastroenterologists (57.1%) or internal medicine teams (25.1%). A proton pump inhibitor was used empirically in 80% before endoscopy. Bleeding persistence occurred in 6.4% and recurrence in 6.7%. The mortality rate at 30 days was 3.5%.ConclusionsThis study contributes to the characterization of Spanish patients and NVUGIB episodes in a real clinical setting and identifies the routine management of this entity, which is in line with the standards proposed by recent clinical practice guidelines. A notable finding was that age and the number of comorbidities in NVUGIB patients were increasing. These factors could explain the persistent mortality rate, despite the evident advances in the management of this entity (AU)
Asunto(s)
Humanos , Hemorragia Gastrointestinal/diagnóstico , Hemorragia Gastrointestinal/terapia , Pautas de la Práctica en Medicina , Envejecimiento , Estudios Retrospectivos , Factores de RiesgoRESUMEN
BACKGROUND: Mortality related to nonvariceal upper gastrointestinal bleeding (NVUGIB) has not changed. More information is needed to improve the management of this entity. The aims of this study were: a) to determine the characteristics of bleeding episodes, b) to describe the clinical approaches routinely used in NVUGIB, and c) to identify adverse outcomes related to endoscopic or medical treatments in Spain. METHODS: The European survey of nonvariceal upper GI bleeding (ENERGiB) was an observational, retrospective cohort study on NVUGIB with endoscopic evaluation carried out across Europe. The present study focused on Spanish patients in the ENERGiB study. The patients were managed according to routine care. The mean and standard deviation were calculated for quantitative variables and absolute and relative frequencies were calculated for categorical variables. RESULTS: Patients (n=403) were mostly men (71%), with a mean age of 65 years, and co-morbidities (62.5%). Most of the patients were managed by gastroenterologists (57.1%) or internal medicine teams (25.1%). A proton pump inhibitor was used empirically in 80% before endoscopy. Bleeding persistence occurred in 6.4% and recurrence in 6.7%. The mortality rate at 30 days was 3.5%. CONCLUSIONS: This study contributes to the characterization of Spanish patients and NVUGIB episodes in a real clinical setting and identifies the routine management of this entity, which is in line with the standards proposed by recent clinical practice guidelines. A notable finding was that age and the number of comorbidities in NVUGIB patients were increasing. These factors could explain the persistent mortality rate, despite the evident advances in the management of this entity.