The Risk of Developing Disabling Crohn's Disease: Validation of a Clinical Prediction Rule to Improve Treatment Decision Making.

BACKGROUND: Crohn's disease (CD) is characterized by the development of complications over the course of the disease. It is crucial to identify predictive factors of disabling disease, in order to target patients for early intervention. We evaluated risk factors of disabling CD and developed a prognostic model. METHODS: In total, 511 CD patients were retrospectively analyzed. Univariate and multivariate logistic regression analyses were used to identify demographic, clinical, and biological risk factors. A predictive nomogram model was developed in a subgroup of patients with noncomplicated CD (inflammatory pattern and no perianal disease). RESULTS: The rate of disabling CD within 5 years after diagnosis was 74.6%. Disabling disease was associated with gender, location of disease, requirement of steroids for the first flare, and perianal lesions. In the subgroup of patients (310) with noncomplicated CD, the rate of disabling CD was 80%. In the multivariate analysis age at onset <40 years (OR = 3.46, 95% confidence interval [CI] = 1.52-7.90), extensive disease (L3/L4) (OR = 2.67, 95% CI = 1.18-6.06), smoking habit (OR = 2.09, 95% CI = 1.03-4.27), requirement of steroids at the first flare (OR = 2.20, 95% CI = 1.09-4.45), and albumin (OR = 0.59, 95% CI = 0.36-0.96) were associated with development of disabling disease. The developed predictive nomogram based on these factors presented good discrimination, with an area under the receiver operating characteristic curve of 0.723 (95% CI: 0.670-0.830). CONCLUSION: We identified predictive factors of disabling CD and developed an easy-to-use prognostic model that may be used in clinical practice to help identify patients at high risk and address treatment effectively.

Influencia de la puntuación MELD basal en la eficacia del tratamiento de la hepatitis C con sofosbuvir y simeprevir / Influence of baseline MELD score in the efficacy of treatment of hepatitis C with simeprevir and sofosbuvir

INTRODUCCIÓN: Hay pocos estudios publicados acerca de los factores predictivos de respuesta al tratamiento de la hepatitis C con sofosbuvir y simeprevir. OBJETIVO: Conocer qué factores influyen en la respuesta a simeprevir (SIM) y sofosbuvir (SOF) en pacientes infectados por los genotipos 1 o 4 de la hepatitis C. PACIENTES Y MÉTODOS: Estudio prospectivo observacional de cohortes en 12 hospitales. La efectividad se evaluó con respuesta virológica sostenida (RVS12). RESULTADOS: Se incluyeron 204 pacientes (62,3% varones, edad media 55 años). Ciento ochenta y seis (91,2%) genotipo 1 (60,3% 1b, 25% 1a) y 18 (8,8%) genotipo 4. Ciento treinta y dos (64,7%) cirróticos (87,9% Child A), 33 (16,2%) F3, 31 (15,2%) F2, 8 (3,9%) F0-1. Un 80,8% MELD < 10. Noventa y tres (45,6%) naive. Se asoció ribavirina en 68 (33,3%). Carga viral basal media 2.151.549 UI/ML (DE: 2.391.840). Duración tratamiento 12 semanas en 93,1%. Cuatro suspendieron tratamiento: suicidio, brote psicótico, hiperbilirrubinemia y recurrencia hepatocarcinoma. Ciento noventa (93,1%) alcanzaron RVS12. No hubo diferencias RVS12 en función del genotipo, duración tratamiento, empleo de ribavirina, tratamiento previo, CV y plaquetas basales. En análisis univariante, negatividad carga viral a las 4 semanas (p = 0,042), ausencia de cirrosis (p = 0,021), albúmina basal ≥ 4g/dl (p:0,001) y MELD<10 (p < 0,0001) se asociaron con mayor RVS12. En estudio multivariante solo hubo relación significativa entre puntuación MELD basal < 10 y mayor RVS12 (p < 0,001). CONCLUSIONES: La combinación de simeprevir y sofosbuvir es muy eficaz en pacientes infectados por los genotipos 1 y 4 de la hepatitis C. Es un tratamiento seguro, especialmente en pacientes sin ribavirina. Esta combinación es más efectiva en pacientes con puntuación MELD inferior a 10

INTRODUCTION: There are few published studies on predictors of response to treatment with sofosbuvir and simeprevir in HCV patients. OBJECTIVE: The objective of the study was to analyse possible predictors of response to simeprevir (SMV) and sofosbuvir (SOF) in patients infected with hepatitis C genotypes 1 or 4. PATIENTS AND METHODS: Prospective observational cohort study in 12 hospitals. The primary efficacy endpoint was SVR rate 12 weeks after end of treatment (SVR12). RESULTS: 204 patients (62.3% male, mean age 55 years) were included: 186 (91.2%) genotype 1 (60.3% 1b 25% 1a) and 18 (8.8%) genotype 4. 132 (64.7%) cirrhotic (87.9% Child A), 33 (16.2%) F3, 31 (15.2%) F2, 8 (3.9%) F0-1. 80.8% MELD<10. 93 (45.6%) naive. Ribavirin was added in 68 (33.3%). Mean baseline viral load 2,151,549 IU/ml (SD: 2,391,840). Treatment duration 12 weeks in 93.1%. 4 discontinued therapy: suicide, psychotic attack, hyperbilirubinaemia and liver cancer recurrence. 190 (93.1%) achieved SVR12. There were no differences in SVR12 depending on the genotype, treatment duration, ribavirin use, prior therapy, viral load (VL) or baseline platelets. In univariate analysis, undetectable VL at 4 weeks (p = 0.042), absence of cirrhosis (p = 0.021), baseline albumin ≥ 4g/dl (p = 0.001) and MELD < 10 (p < 0.0001) were associated with higher SVR12. In multivariate analysis, only baseline MELD score < 10 patients had higher SVR12 (p < 0.001). CONCLUSIONS: The combination of simeprevir and sofosbuvir in patients infected with genotype 1 and 4 hepatitis C is highly effective. It is a safe therapy, especially in patients without ribavirin. This combination was more effective in patients with a MELD score below 10

Influence of baseline MELD score in the efficacy of treatment of hepatitis C with simeprevir and sofosbuvir. / Influencia de la puntuación MELD basal en la eficacia del tratamiento de la hepatitis C con sofosbuvir y simeprevir.

INTRODUCTION: There are few published studies on predictors of response to treatment with sofosbuvir and simeprevir in HCV patients. OBJECTIVE: The objective of the study was to analyse possible predictors of response to simeprevir (SMV) and sofosbuvir (SOF) in patients infected with hepatitis C genotypes 1 or 4. PATIENTS AND METHODS: Prospective observational cohort study in 12 hospitals. The primary efficacy endpoint was SVR rate 12 weeks after end of treatment (SVR12). RESULTS: 204 patients (62.3% male, mean age 55 years) were included: 186 (91.2%) genotype 1 (60.3% 1b 25% 1a) and 18 (8.8%) genotype 4. 132 (64.7%) cirrhotic (87.9% Child A), 33 (16.2%) F3, 31 (15.2%) F2, 8 (3.9%) F0-1. 80.8% MELD<10. 93 (45.6%) naive. Ribavirin was added in 68 (33.3%). Mean baseline viral load 2,151,549 IU/ml (SD: 2,391,840). Treatment duration 12 weeks in 93.1%. 4 discontinued therapy: suicide, psychotic attack, hyperbilirubinaemia and liver cancer recurrence. 190 (93.1%) achieved SVR12. There were no differences in SVR12 depending on the genotype, treatment duration, ribavirin use, prior therapy, viral load (VL) or baseline platelets. In univariate analysis, undetectable VL at 4 weeks (p=0.042), absence of cirrhosis (p=0.021), baseline albumin ≥ 4g/dl (p=0.001) and MELD<10 (p<0.0001) were associated with higher SVR12. In multivariate analysis, only baseline MELD score <10 patients had higher SVR12 (p<0.001). CONCLUSIONS: The combination of simeprevir and sofosbuvir in patients infected with genotype 1 and 4 hepatitis C is highly effective. It is a safe therapy, especially in patients without ribavirin. This combination was more effective in patients with a MELD score below 10.

Spanish multicenter study to estimate the incidence of chronic pancreatitis.

OBJECTIVE: To estimate the incidence of chronic pancreatitis in Spain as diagnosed with endoscopic ultrasound (EUS), and to assess the risk factors and complications detected. MATERIAL AND METHOD: A descriptive, observational study of chronic pancreatitis cases diagnosed in Spanish health care centers with an EUS unit. A structured questionnaire was used to evaluate the incidence of the disease (cases identified over 18 months: from January 2011 to June 2012), risk factors, EUS criteria, Rosemont classification, and frequency of local complications. RESULTS: Twenty-three centers were selected serving a total reference area of 14,752,704 population. During the study period 1,031 chronic pancreatitis cases were diagnosed, with an incidence of 4.66 cases per 105 inhabitants/year (95% CI: 4.65-4.67). Tobacco and alcohol use appear as risk factors in 63.8% and 66.7% of cases, respectively. Of these, 53.3% met > 5 EUS criteria for chronic pancreatitis, and 69% had findings suggestive of or consistent with chronic pancreatitis according to the Rosemont classification. Most prevalent complications included calcifications (34.7%), pseudocysts (16%), and presence of an inflammatory pancreatic tumor (10.4%). CONCLUSIONS: The incidence of chronic pancreatitis in Spain is similar to that of other European countries. Given the widespread use of the technique, EUS units are key in detecting the disease, and their activity and results allow to estimate the incidence of chronic pancreatitis over wide, representative population areas.

[Eosinophilic esophagitis. Review of current clinical and physiopathological concepts]. / Esofagitis eosinofílica. Revisión de los conceptos fisiopatológicos y clínicos actuales.

Eosinophilc esophagitis (EE) is an emerging disease which is characterized by a dense infiltration of the esophagus by eosinophilic leukocytes. The main symptoms of this disease are dysphagia and frequent food impaction in esophagus, and they are due to a hypersentivity response to different foods or aeroallergens. Eosinophil accumulation in the esophageal epithelium is determined by local production of eosinophilotropic cytokines and chemokines, which have been well defined as a TH2-type hypersensitivity reaction in animal models of the disease. Esophageal epithelium, after T CD4+ lymphocytes stimulation, contains all the necessary cell types for the development of local immunoallergic responses. However, there is increasing data on the significant role that humoral immunity could play in the pathophysiology of EE, by means of the action of IgE over mast cells function. The high density of T CD8+ lymphocytes in inflammatory infiltrate suggests that a TH1-type reaction could also participate in the mechanism of the disease. Proteins contained in cytoplasmic granules of activated eosinophils and mast cells could act over neural and muscular components of the esophageal wall, triggering motor disturbances which can be measured by means of manometric recordings and justify the esophageal symptoms. This paper aims to review the newest clinical aspects of EE and the results of studies directed at investigating the pathophysiology of the disease. Furthermore, we carry out a critical review of available therapeutic options.

Esofagitis eosinofílica. Revisión de los conceptos fisiopatológicos y clínicos actuales / Eosinophilic esophagitis. Review of current clinical and physiopathological concepts

La esofagitis eosinofílica (EE) es una enfermedad emergente, caracterizada por una densa infiltración del esófago por leucocitos eosinófilos. Sus principales síntomas son la disfagia y las frecuentes impactaciones de alimento en el esófago, en respuesta a una reacción de hipersensibilidad frente a distintos alimentos o aeroalérgenos. La acumulación de eosinófilos en el epitelio esofágico, en respuesta a la producción local de citocinas y quimiocinas eosinofilotropas, se ha documentado en modelos animales, y se ha propuesto que responde a una reacción de hipersensibilidad de tipo TH2. El epitelio esofágico contiene todos los tipos celulares necesarios para desarrollar respuestas inmunoalérgicas locales, tras la estimulación de linfocitos T CD4+. Sin embargo, cada vez hay más pruebas del papel relevante que la inmunidad humoral desempeña en esta enfermedad, a través de la acción de la inmunoglobulina E, principalmente sobre los mastocitos. El predominio de linfocitos T CD8+ en el infiltrado inflamatorio también sugiere una posible reacción TH1 en el mecanismo de la enfermedad. Las proteínas contenidas en los gránulos citoplasmáticos de los eosinófilos y de los mastocitos activados podrían actuar sobre los componentes neuromusculares de la pared del esófago, desencadenando trastornos motores objetivables mediante manometría que justifican los síntomas esofágicos. En este trabajo se revisan los nuevos conceptos clínicos de la EE y los resultados de los estudios dirigidos a dilucidar la fisopatología del trastorno. Igualmente, se realiza una revisión crítica de las alternativas terapéuticas disponibles

Eosinophilc esophagitis (EE) is an emerging disease which is characterized by a dense infiltration of the esophagus by eosinophilic leukocytes. The main symptoms of this disease are dysphagia and frequent food impaction in esophagus, and they are due to a hypersentivity response to different foods or aeroallergens. Eosinophil accumulation in the esophageal epithelium is determined by local production of eosinophilotropic cytokines and chemokines, which have been well defined as a TH2-type hypersensitivity reaction in animal models of the disease. Esophageal epithelium, after T CD4+ lymphocytes stimulation, contains all the necessary cell types for the development of local immunoallergic responses. However, there is increasing data on the significant role that humoral immunity could play in the pathophysiology of EE, by means of the action of IgE over mast cells function. The high density of T CD8+ lymphocytes in inflammatory infiltrate suggests that a TH1-type reaction could also participate in the mechanism of the disease. Proteins contained in cytoplasmic granules of activated eosinophils and mast cells could act over neural and muscular components of the esophageal wall, triggering motor disturbances which can be measured by means of manometric recordings and justify the esophageal symptoms. This paper aims to review the newest clinical aspects of EE and the results of studies directed at investigating the pathophysiology of the disease. Furthermore, we carry out a critical review of available therapeutic options

Cuidados de enfermería en el paciente con cáncer de cabeza y cuello tratado con radioterapia / Nursing care of the patient with head and neck cancer treated with radiotherapy

La administración de radioterapia es un pilar fundamental en el tratamiento de la mitad de los pacientes oncológicos. El campo de administración de la radiación incluye, además del tumor, los ganglios linfáticos que drenan la zona y los tejidos sanos más próximos al tumor. Por este motivo, los efectos de la radioterapia aparecerán también sobre los tejidos sanos, resultando más sensibles los de rápida renovación, como la mucosa oral, faríngea o laríngea, los folículos pilosos y las células de la médula ósea. Este artículo revisa los efectos de la radioterapia sobre los órganos y tejidos sanos en el tratamiento de los tumores de cabeza y cuello, propone medidas de prevención o reducción de la toxicidad sobre estos, y analiza los cuidados de enfermería y las medidas de tratamiento frente a los efectos adversos locales de la radioterapia en el tratamiento de los cánceres de cabeza y cuello

Radiotherapy is one of the mainstays of the treatment of half of all oncological patients. The field of administration of radiation includes the tumoral volume, the lymph nodes that drain the area and the healthy tissues adjacent to the tumor. For this reason, the effects of radiotherapy also appear in healthy tissues and are more marked in those with a high cell turnover rate, such as the oral, pharyngeal and laryngeal mucosa and bone marrow. The present article aims to review the possible effects of radiotherapy on healthy tissues in the treatment of head and neck cancer and proposes measures to prevent or reduce toxicity. Aspects related to nursing care and treatment measures for the local adverse effects of radiotherapy are also discussed

Sobre la infusión de fármacos a través de infusores elastoméricos. Réplica de los autores / On drug infusions through elastometric techniques. Reply

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Infusores elastoméricos en la administración de fármacos / Elastomeric infusers in drug administration

El desarrollo de los sistemas de infusión elastoméricos, o infusores, ha supuesto un importante avance en la administración, tanto ambulatoria como hospitalaria, de fármacos en determinadas situaciones clínicas. El mantenimiento de valores plasmáticos de fármacos estables permite un mayor control de la enfermedad y de sus síntomas acompañantes, y supone una mejora en la calidad de vida de los pacientes, por lo que los infusores elastoméricos son una alternativa eficaz para la administración de tratamientos en pacientes oncológicos, con procesos terminales o con dolor agudo y/o crónico. En este artículo se lleva a cabo una revisión de las ventajas, el manejo y los cuidados de dichos infusores (AU)

El informe de alta de enfermería, un instrumento para la continuidad de los cuidados / The nursing discharge report, an instrument for contunuity of care

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Prevención y tratamiento de las extravasaciones de quimioterapia intravenosa / Prevention and treatment of extravasation of intravenous chemotherapy

La extravasación de quimioterapia intravenosa en el paciente oncológico es una grave complicación del tratamiento que puede provocar graves daños tisulares al paciente. Su prevención ha demostrado ser la mejor medida para evitar tales daños, pero hay múltiples alternativas de tratamiento que el profesional de enfermería debe conocer y aplicar ante tal complicación. Este artículo supone una revisión de la bibliografía y una síntesis de las medidas de tratamiento ante la extravasación de citostáticos (AU)

Administración de quimioterapia intravenosa en el paciente oncológico / Administration of Intravenous Chemotherapy in the Oncological Patient

La administración de fármacos antineoplásicos en ciclos repetidos por vía intravenosa es uno de los pilares fundamentales en el tratamiento del enfermo oncológico. Las diferencias entre el manejo de estas sustancias y el de otros fármacos y soluciones, y la necesidad de repetidas punciones determinan la importancia de la adecuada elección de la vía venosa de administración, central o periférica, y la localización de esta última. Durante la manipulación de fármacos antineoplásicos se requiere observar una serie de medidas, a fin de reducir las complicaciones para el paciente, asegurar el máximo beneficio del tratamiento y proteger al personal sanitario de los riesgos potenciales que poseen estas sustancias. El presente artículo supone una revisón de las distintas indicaciones, ventajas e inconvenientes de las distintas vías venosas para la administración de quimioterapia antitumoral, y de los diferentes aspectos en relación con las técnicas de perfusión (AU)