Monitorización terapéutica de los fármacos biológicos en la enfermedad inflamatoria intestinal. Documento de Posicionamiento del Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU) / Therapeutic drug monitoring in inflammatory bowel diseases. Position statement of the Spanish Working Group on Crohn's Disease and Ulcerative Colitis

El tratamiento de la enfermedad inflamatoria intestinal (EII) ha sufrido una gran transformación tras la introducción de los fármacos biológicos. Gracias a ellos, los objetivos del tratamiento han evolucionado desde la respuesta y remisión clínica a objetivos más ambiciosos, como la remisión endoscópica o radiológica. Sin embargo, aunque los biológicos son muy eficaces, un porcentaje importante de pacientes no obtendrá una respuesta inicial o la perderá a lo largo del tiempo. Sabemos que existe una relación directa entre las concentraciones valle del biológico y su eficacia terapéutica, que cuanto más exigente sea el objetivo terapéutico serán necesarios niveles superiores del fármaco y que es frecuente la exposición insuficiente al mismo. La monitorización terapéutica de medicamentos biológicos, así como los modelos farmacocinéticos, nos brindan la posibilidad de ofrecer un enfoque personalizado del abordaje en pacientes con EII. Durante los últimos años se ha acumulado información relevante respecto a su utilidad durante o después de la inducción, así como en el mantenimiento del tratamiento biológico, en estrategias reactivas o proactivas y antes de la retirada o desintensificación del esquema.El objetivo de este documento es establecer recomendaciones sobre la utilidad de la monitorización terapéutica de biológicos en pacientes con EII, en los diferentes escenarios de la práctica clínica e identificar las áreas donde su utilidad es evidente, prometedora o controvertida. (AU)

The treatment of inflammatory bowel disease has undergone a significant transformation following the introduction of biologic drugs. Thanks to these drugs, treatment goals have evolved from clinical response and remission to more ambitious objectives, such as endoscopic or radiologic remission. However, even though biologics are highly effective, a significant percentage of patients will not achieve an initial response or may lose it over time. We know that there is a direct relationship between the trough concentrations of the biologic and its therapeutic efficacy, with more demanding therapeutic goals requiring higher drug levels, and inadequate exposure being common.Therapeutic drug monitoring of biologic medications, along with pharmacokinetic models, provides us with the possibility of offering a personalized approach to treatment for patients with IBD. Over the past few years, relevant information has accumulated regarding its utility during or after induction, as well as in the maintenance of biologic treatment, in reactive or proactive strategies, and prior to withdrawal or treatment de-escalation.The aim of this document is to establish recommendations regarding the utility of therapeutic drug monitoring of biologics in patients with inflammatory bowel disease, in different clinical practice scenarios, and to identify areas where its utility is evident, promising, or controversial. (AU)

Undetectable circulating tumor DNA confirms the inability of pseudomyxoma peritonei to systemic dissemination.

The study of circulating tumor DNA (ctDNA) plays a pivotal role in advancing precision oncology, providing valuable information for individualized patient care and contributing to the ongoing effort to improve cancer diagnosis, treatment, and management. However, its applicability in pseudomyxoma peritonei (PMP) remains unexplored. In this multicenter retrospective study involving 21 PMP patients, we investigated ctDNA presence in peripheral blood using three distinct methodologies. Despite mucinous tumor tissues exhibiting KRAS and GNAS mutations, ctDNA for these mutations was undetectable in blood samples. In this pilot study, circulating tumor DNA was not detected in blood when the tumor harbored mutations of known significance. In the future, a study with a larger sample size is needed to confirm these findings and to determine whether ctDNA could identify patients at risk for early recurrence and/or systemic metastases.

Therapeutic drug monitoring in inflammatory bowel diseases. Position statement of the Spanish Working Group on Crohn's Disease and Ulcerative Colitis. / Monitorización terapéutica de los fármacos biológicos en la enfermedad inflamatoria intestinal. Documento de Posicionamiento del Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU).

The treatment of inflammatory bowel disease has undergone a significant transformation following the introduction of biologic drugs. Thanks to these drugs, treatment goals have evolved from clinical response and remission to more ambitious objectives, such as endoscopic or radiologic remission. However, even though biologics are highly effective, a significant percentage of patients will not achieve an initial response or may lose it over time. We know that there is a direct relationship between the trough concentrations of the biologic and its therapeutic efficacy, with more demanding therapeutic goals requiring higher drug levels, and inadequate exposure being common. Therapeutic drug monitoring of biologic medications, along with pharmacokinetic models, provides us with the possibility of offering a personalized approach to treatment for patients with IBD. Over the past few years, relevant information has accumulated regarding its utility during or after induction, as well as in the maintenance of biologic treatment, in reactive or proactive strategies, and prior to withdrawal or treatment de-escalation. The aim of this document is to establish recommendations regarding the utility of therapeutic drug monitoring of biologics in patients with inflammatory bowel disease, in different clinical practice scenarios, and to identify areas where its utility is evident, promising, or controversial.

Therapeutic effect of adipose-derived mesenchymal stem cells in a porcine model of abdominal sepsis.

BACKGROUND: The term sepsis refers to a complex and heterogeneous syndrome. Although great progress has been made in improving the diagnosis and treatment of this condition, it continues to have a huge impact on morbidity and mortality worldwide. Mesenchymal stem cells are a population of multipotent cells that have immunomodulatory properties, anti-apoptotic effects, and antimicrobial activity. We studied these capacities in a porcine model of peritoneal sepsis. METHODS: We infused human adipose-derived mesenchymal stem cells (ADSCs) into a porcine model of peritoneal sepsis. Twenty piglets were treated with antibiotics alone (control group) or antibiotics plus peritoneal infusion of ADSCs at a concentration of 2 × 106 cells/kg or 4 × 106 cells/kg (low- and high-dose experimental groups, respectively). The animals were evaluated at different time points to determine their clinical status, biochemical and hematologic parameters, presence of inflammatory cytokines and chemokines in blood and peritoneal fluid, and finally by histologic analysis of the organs of the peritoneal cavity. RESULTS: One day after sepsis induction, all animals presented peritonitis with bacterial infection as well as elevated C-reactive protein, haptoglobin, IL-1Ra, IL-6, and IL-1b. Xenogeneic ADSC infusion did not elicit an immune response, and peritoneal administration of the treatment was safe and feasible. One day after infusion, the two experimental groups showed a superior physical condition (e.g., mobility, feeding) and a significant increase of IL-10 and TGF-ß in blood and a decrease of IL-1Ra, IL-1b, and IL-6. After 7 days, all animals treated with ADSCs had better results concerning blood biomarkers, and histopathological analysis revealed a lower degree of inflammatory cell infiltration of the organs of the peritoneal cavity. CONCLUSIONS: Intraperitoneal administration of ADSCs as an adjuvant therapy for sepsis improves the outcome and diminishes the effects of peritonitis and associated organ damage by regulating the immune system and reducing intra-abdominal adhesions in a clinically relevant porcine model of abdominal sepsis.

Seroprevalence of ANTI-SARS-CoV-2 antibodies in patients with inflammatory bowel disease.

Patients with inflammatory bowel disease (IBD) treated with biologic and/or immunosuppressant drugs are at increased risk for opportunistic infections. Seroprevalence studies can confirm the diagnosis of SARS-CoV-2 infections as well as the associated risk factors. This is a descriptive study which primary endpoints were to highlight the prevalence of SARS-CoV-2 antibodies in a cohort of IBD patients in March 2021, and to analyze seroconversion in patients with known COVID-19 infection and its relationship with IBD treatments. Patients filled in a questionnaire about symptoms of COVID-19 infection and clinical information about their IBD. All included patients were tested for SARS-CoV-2 antibodies. 392 patients were included. Among patients with clinical infection, 69 patients (17,65%) were IgG-positive, 286 (73,15%) IgG-negative and 36 (9,21%) indeterminate. In relation to seroconversion among patients under biologic treatment, 13 patients of the 23 with a previous positive CRP developed antibodies (56.5%). However, when the influence of immunosuppressive treatment on the probability of developing antibodies was analyzed, no significant differences were seen between those patients with or without treatment (77.8% vs. 77.1%, p = 0.96). In our cohort of IBD patients, after one year of pandemic, there were 18.64% IgG positive patients, a higher prevalence than the general population (15.7%).

Factores estresantes en progenitores de neonatos ingresados en una Unidad de Cuidados Intensivos / Stress factors in parents of newborns admitted to an Intensive Care Unit

Introducción y objetivo. El estrés ocasionado por el ingreso de un recién nacido altera la dinámica y estructura de la unidad familiar. El objetivo de este estudio es analizar los factores estresantes percibidos por los padres/ madres de recién nacidos ingresados en una Unidad de Cuidados Intensivos Neonatales. Método. Estudio descriptivo transversal realizado en la Unidad de Neonatología del Hospital Universitario Río Hortega de Valladolid durante un periodo de un año. Se incluyeron a los padres/madres de recién nacidos ingresados en Unidad de Cuidados Intensivos durante más de 48 horas, obteniendo un total de 60 pacientes. Se recogieron variables sociodemográficas y clínicas de los progenitores y del recién nacido, y se aplicó la traducción y adaptación propia de la Escala de estrés parental. La participación en el estudio fue de manera voluntaria. Resultados. El nivel de estrés general obtenido para madres y padres fue entre moderado y extremadamente estresante (78,1%), siendo las madres las que mostraron niveles de estrés más elevados en los rangos superiores, con un 50% entre muy estresante y extremadamente estresante, mientras que los padres se mantuvieron en niveles moderados con un 42,4%. La subescala más afectada tras la evaluación de la Escala de estrés parental fue rol parental, concretamente el factor separación madre/padrerecién nacido (65,6% entre muy y extremadamente estresante). Encontramos significancia estadística (p< 0,021) al relacionar el nivel de estrés general con la distancia en kilómetros desde el hospital al domicilio. Conclusión. La hospitalización de un recién nacido genera estrés y ansiedad en los padres/madres alterando el vínculo afectivo (AU)

Introduction and objective. The stress caused by the admission of a newborn alters the dynamics and structure of the family unit. The objective of this study is to analyze to analyze the stressors perceived by parents of newborns admitted to a Neonatal Intensive Care Unit. Methods. Descriptive cross-sectional study carried out in the Neonatol Unit of Río Hortega University Hospital in Valladolid, during a one-year period. It included parents of newborns admitted to the Neonatal Intensive Care Unit for more than 48 hours, obtaining a total of 60 patients. Sociodemographic and clinical variables of the parents and newborns were collected and the translation and adaptation of the Parental Stressor Scale was applied. Participation in the study was voluntary. Results. The general stress level obtained for mothers and fathers was moderate to extremely stressful (78.1%), it is the mothers that show the highest stress levels in the upper ranges, with 50% of them between very stressful and extremely stressful; while fathers remained at moderate levels with 42.4%. The most affected subscale after the evaluation of the Parental Stressor Scale was the parental role, specifically the mother/father-newborn separation factor (65.6% between very and extremely stressful). The was a statistically significant association (p< 0.021) between general stress and distance from residency to hospital (AU)

Transforming a public university hospital and its area of influence into a comprehensive resource in response to the COVID-19 pandemic.

INTRODUCTION AND OBJECTIVES: The outbreak of COVID-19 has overwhelmed healthcare systems all over the world. The aim of this article is to describe the process of transforming the Vall d'Hebron University Hospital, the second largest hospital in Spain, into a COVID-19 centre coordinating response to the pandemic in its reference area. MATERIALS AND METHODS: The study draws on the experience of the authors in transforming the hospital into a comprehensive resource in response to the COVID-19 pandemic. The strategy is based on four central strategies: early planning, coordination of all healthcare agents in its reference area, definition of clear leadership roles, and the organisation of care based on multidisciplinary teams with minimal recruitment of new staff. RESULTS: The transformation strategy enabled the hospital to cope with the surge in patients without exceeding its capacity. During the response phases, which amounted to a period of 57 days, 3106 patients consulted the ER and 2054 were admitted, 346 of whom were treated at the ICU. To accommodate the number of adult COVID-19 patients, adult ICU availability was progressive increased by 371%, and ordinary beds increased by 240. A total of 671 staff members went on sick leave after testing positive for COVID-19. CONCLUSION: The transformation experience of the hospital provides insight into how effectively adapt the structures and functioning of large hospitals. The relevance of territorial coordination during the pandemic is stressed as an effective strategy that contributed coping the pandemic.

Proyecto revisa. ¿Sirve realmente para algo la revisión de la medicación? / Does medication review really do any good?

JUSTIFICACIÓN: la Revisión de la Medicación (RM) es una evaluación estructurada de la medicación del paciente con el objeto de optimizar su uso y mejorar los resultados en salud. “Pharmaceutical Care Network Europe” diferencia entre distintos tipos de RM en función del acceso a información clínica y a una entrevista con el paciente al margen. La Revisión del Uso de los Medicamentos (RUM), que podría encuadrarse en uno de estos subtipos, consiste en la realización junto con el paciente de una revisión estructurada del conocimiento que éste tiene de sus medicamentos y del uso que hace de los mismos, para ayudarle a emplear sus medicamentos con mayor eficacia. Ofreciéndole asesoramiento sobre su utilización, y asegurándose de que entiende por qué los tiene que tomar y sabe cómo utilizarlos, identificando los problemas observados y realizando las recomendaciones oportunas sobre los cambios necesarios. OBJETIVO: conocer la evidencia científica disponible sobre la efectividad de la RM y el RUM, llevado a cabo por farmacéuticos comunitarios, para mejorar resultados clínicos, económicos y humanísticos. MATERIAL Y MÉTODOS: se realizó una búsqueda bibliográfica en Pubmed de revisiones sistemáticas y metaanálisis con las palabras medication review y community pharmacist en el título o resumen y otra con medicine use review y community pharmacist. En el caso de RUM al no encontrar ninguna, se buscó también ensayos clínicos aleatorizados con las mismas palabras clave. (AU)

Proyecto Revisa. Medicamentos “alerta” a la hora de ofrecer el servicio RUM / Project Review. Medicines "alert" when it comes to offering the RUM service

JUSTIFICACIÓN: una clave para poder ayudar a los pacientes con el servicio de Revisión del Uso de los Medicamentos (RUM) es identificar a los pacientes que más se pueden beneficiar de él. Conocer los medicamentos que más incidencias generan en el RUM puede ayudar a los farmacéuticos a lograr ese objetivo. OBJETIVO: identificar los grupos terapéuticos que más incidencias generan en el RUM, con el fin de detectar pacientes “diana” del servicio y facilitar los medicamentos “clave” en los que prestar mayor atención durante este. MATERIAL Y MÉTODOS: estudio descriptivo, transversal, observacional retrospectivo sobre los grupos terapéuticos según la clasificación ATC, de los medicamentos implicados en diferentes incidencias detectadas en 564 RUM realizados por farmacéuticos capacitados por el proyecto Revisa® hasta el 15-02-2022 y registrados en la plataforma SEFAC e_XPERT. Para cada tipo de incidencia detectada se comparó la proporción de incidencia de cada grupo terapéutico con respecto al resto de grupos. Para el análisis estadístico se empleó el test Chi-cuadrado con la corrección de Yates, considerándose la diferencia significativa si p<0,05. El tratamiento informático de los datos se realizó con el programa Microsoft Excel. (AU)

Proyecto revisa. 6 años de RUM: repercusiones en la farmacia y el farmacéutico comunitario / Project revises. 6 years of RUM: impact on pharmacy and the community pharmacist

JUSTIFICACIÓN: el proyecto revisa®, que busca la implantación del servicio de Revisión del Uso del Medicamento (RUM) en la farmacia comunitaria española, cumple 6 años. Tras este periodo se han capacitado 275 farmacéuticos para la prestación del servicio. Desconocemos el nivel de implantación del servicio en la actualidad, así como los aspectos en los que se podría prestar un mayor apoyo desde SEFAC. OBJETIVO: conocer el grado de implantación del servicio RUM entre los farmacéuticos capacitados e identificar en que aspectos necesitan apoyo y cuál es su percepción sobre el servicio. MATERIAL Y MÉTODOS: se envió una encuesta a los farmacéuticos capacitados por SEFAC para el servicio RUM. Con 15 ítems, relativos a la puesta en práctica del servicio en sus farmacias, que tuvieron abierta para contestar desde el 25 de Febrero y el 7 de Marzo de 2022. La encuesta permanece abierta, por lo que los datos finales pueden diferir ligeramente de los expuestos aquí. RESULTADOS: el 15.2 % de los capacitados contestaron a la encuesta. El 29.3 % no hacen ningún RUM al año, el 51.2 % hacen menos de 5 RUMs al año, mientras que el 14.6 % hacen entre 5 y 10, y el 4.9 % hacen más de 10. Las principales dificultades que encuentran son el tiempo 52.8 % y la dificultad para promocionar el servicio 44.4 %, seguidos por el precio 36.1 % y dificultad para implementar el servicio 33.3 %. El 50 % cobra menos de 15€ por el RUM y un 47,2 % no cobra nada. El 83.9 % emplea menos de 40 minutos por RUM. En los pacientes que se ha hecho más de un RUM, el 88.9 % de los encuestados refiere haber apreciado cambios significativos en el uso de los medicamentos y el estado de salud. (AU)

Proyecto revisa. Servicio de Revisión del Uso de los Medicamentos (RUM) a un paciente polimedicado / Project reviews. Medication Use Review (MUR) service to a polymedicated patient

PRESENTACIÓN DEL CASO: varón de 69 años, despistado para su edad. Presenta varias patologías. Tratamiento actual y pauta prescrita:- Bisoprolol 2,5mg1-0-0- Omeprazol 20mg1-0-0 - Sertralina 50mg1-0-0- Ramipril 2,5mg1-0-0- Vidagliptina/Metformina 50/850mg1-0-1 - Empagliflozina 10mg1-0-0- Ácido acetilsalicílico 100mg0-1-0 - Rosuvastatina/Ezetimiba 20/10mg0-0-1- Flurazepam 30mg0-0-1- Colecalciferol 25.000UI1 cada 30 días- Hierro proteinsuccinilato 800mg1 ampolla diaria.Acude a la farmacia asustado, ha tomado el Flurazepam por la mañana por equivocación y se notaba muy atontado conduciendo. Confiesa tomar muchos medicamentos y no saber para qué son algunos de ellos. Le invitamos al servicio RUM. EVALUACIÓN: hacemos RUM y registramos con el programa SEFAC e_XPERT. Trae de casa también Atorvastatina 80mg y Ticagrelor 90mg, que no tiene prescritos actualmente. Ticagrelor no se lo toma pero lo tenía en casa “por si acaso” y Atorvastatina sí sigue tomándolo, no sabía que se lo habían sustituido por Rosuvastatina/Ezetimiba. Detectamos algunos Problemas Relacionados con los Medicamentos (PRM): Administración inadecuada, Falta adherencia parcial, Pauta inadecuada, Sospecha RAM… Por ejemplo, Flurazepam a veces no lo toma porque no le gusta el efecto somnífero que se prolonga por la mañana. Dice que suele tomarlo por la noche pero el otro día se despistó y la tomó por la mañana. INTERVENCIÓN: derivamos al servicio de adherencia, indicando la realización de un Sistema Personalizado de Dosificación (SPD) y al servicio de medida de la presión arterial y de la glucosa.Facilitamos Información Personalizada sobre los Medicamento (IPM) y solucionamos las faltas adherencia.Derivamos al Médico de Atención Primaria (MAP) con un Informe por el Flurazepam.Damos unas recomendaciones de estilo de vida saludable y le entregamos el Informe al paciente con las medidas que hemos acordada. (AU)

Proyecto revisa. Servicio Revisión del Uso del medicamento (RUM). En busca del inhalador perfecto / Project reviews. Review of Medicines Use (RUM) Service. In search of the perfect inhaler

PRESENTACIÓN DEL CASO: varón, 75 años, fumador, diagnosticado de EPOC por médico privado y con visita reciente al Sistema Nacional de Salud (SNS). Tratamiento:-Beclometasona 250mcg Inhalador Cartucho Presurizado (ICP) 1-0- 1 (médico privado)-Bromuro de ipratropio 20mcg ICP 1-1-1 (médico privado)-Salbutamol 100mcg ICP (a demanda) (médico privado)-Fluticasona/Umeclidinio/Vilanterol Ellipta® 92/55/22 (neumólogo SNS)-Prednisona 10mg, 5mg, 2.5mg. Pauta descendente (neumólogo SNS)-Omeprazol 20mg 1-0-0 (centro de salud)-Calcio Carbonato/Colecalciferol 1-0-0 (centro de salud)-Soludronate Semanal 70mg – 1 semanal (centro de salud). Utiliza el tratamiento del médico privado muchos años. Acude a la farmacia tras consulta con el neumólogo del SNS, posterior a varias visitas a urgencias por problemas respiratorios. Refiere confusión con los inhaladores. Le invitamos al servicio RUM. EVALUACIÓN: trae cuatro inhaladores, prescritos por distintos médicos. En su última visita con el neumólogo, éste sugirió dejar la Beclometasona y el Bromuro de ipratropio, y utilizar solamente Fluticasona/Umeclidinio/Vilanterol Ellipta® y Salbutamol. Confiesa no aclararse con el Fluticasona/Umeclidinio/Vilanterol Ellipta® y usar los tres inhaladores según cree conveniente, usando cada vez menos Fluticasona/Umeclidinio/Vilanterol Ellipta®. Comprobamos la técnica de inhalación con In-check Dial®, observando que su condición respiratoria no le permite hacer una inspiración adecuada para Fluticasona/Umeclidinio/Vilanterol Ellipta®. INTERVENCIÓN: considerando que la Beclometasona y el Bromuro de ipratropio no tenían el efecto deseado y que el paciente no podía usar correctamente Fluticasona/Umeclidinio/Vilanterol Ellipta®, derivamos al médico de familia, con informe para que el neumólogo reconsidere el tratamiento. Damos indicaciones sobre técnica inhalatoria, para intentar mejorar la adherencia al nuevo inhalador hasta la nueva revisión médica. (AU)

La contaminación citológica de la aguja de punción en ecobroncoscopia / Cytologic Contamination of the Sampling Needle in Endobronchial Ultrasound

No disponible

[Translated article] Cytologic Contamination of the Sampling Needle in Endobronchial Ultrasound / La contaminación citológica de la aguja de punción en ecobroncoscopia

No disponible

Toxicity study in a pig model of intraperitoneal collagenase as an "enzymatic scalpel" directed to break stroma in order to generate a new perspective for peritoneal carcinomatosis approach: an experimental research.

BACKGROUND: This study aimed to measure the toxicity resulting from collagenase administration to the peritoneal cavity in a pig model as a preliminary step to break down the stroma surrounding tumors. METHODS: Eight pigs were treated with 2 different collagenase concentrations previously tested in rats by our group. Time and temperature were controlled using a peritoneal lavage system (PRS System, Combat Medical Ltd.) identical to that used in human surgeries through hyperthermic intraperitoneal chemotherapy (HIPEC); 2 additional pigs were treated with peritoneal lavage only. Samples of blood and peritoneal fluid were collected pre-treatment, immediately after treatment, and 24 h postoperatively. In addition, histological studies and blood collagenase levels were measured. RESULTS: No complications were observed during the surgeries. Intraoperative images evidenced the release of peritoneal tissue during collagenase treatment. After surgery, the animals showed no signs of pain. Diet and mobility were normal at 4 h postoperatively, and there were no significant differences in hematologic or biochemical parameters. Quantification of MMP1 and MMP2 in all samples as measured by absorbance showed no differences in blood collagenase levels between pre-treatment, post-treatment, and 24 h postoperatively. None of the animals treated with collagenase showed peritoneal adhesions during the second surgery. Histologically, peritoneal organs and serous structures did not show any microscopic alterations associated with collagenase treatment in any group. CONCLUSION: Lavage of the peritoneal cavity with doses of up to 100,000 collagen digestion units/animal for 30 min is safe and removes connective tissue from the peritoneal cavity.

Risk of Immunomediated Adverse Events and Loss of Response to Infliximab in Elderly Patients with Inflammatory Bowel Disease: A Cohort Study of the ENEIDA Registry.

BACKGROUND AND AIMS: Immunomediated adverse events [IAEs] are the most frequently reported infliximab [IFX]-related adverse events. Combination therapy may reduce their incidence, although this strategy is not recommended in elderly patients. We aimed to compare the rates of IFX-related IAEs and loss of response [LOR] in elderly and younger patients. METHODS: Adult patients in the ENEIDA registry who had received a first course of IFX therapy were identified and grouped into two cohorts regarding age at the beginning of treatment [over 60 years and between 18 and 50 years]. The rates of IAEs and LOR were compared. RESULTS: In total, 939 patients [12%] who started IFX over 60 years of age and 6844 [88%] below 50 years of age were included. Elderly patients presented a higher proportion of AEs related to IFX [23.2% vs 19%; p = 0.002], infections [7.1% vs 4.3%; p < 0.001] and neoplasms [2.2% vs 0.5%; p < 0.001]. In contrast, the rates of IAEs [14.8% vs 14.8%; p = 0.999], infusion reactions [8.1% vs 8.1%; p = 0.989], late hypersensitivity [1.3% vs 1.2%; p = 0.895], paradoxical psoriasis [1% vs 1.5%; p = 0.187] and drug-induced lupus erythematosus [0.6% vs 0.7%; p = 0.947] were similar in elderly and younger patients. LOR rates were also similar between the two groups [20.5% vs 19.3%; p = 0.438]. In the logistic regression analysis, IFX monotherapy, extraintestinal manifestations and female gender were the only risk factors for IAEs, whereas IFX monotherapy, extraintestinal manifestations and Crohn's disease were risk factors for LOR. CONCLUSIONS: Elderly patients with inflammatory bowel disease have a similar risk of developing IFX-related IAEs and LOR to that of younger patients.

Características de la ventilación no invasiva prolongada en los servicios de urgencias hospitalarios y su impacto en la eficacia. Análisis del registro VNICat / Characteristics of prolonged noninvasive ventilation in emergency departments and impact upon effectiveness. Analysis of the VNICat registry

Objetivo: Analizar las características y variables asociadas con la ventilación no invasiva realizada completamente en los servicios de urgencias hospitalarios (VNI-SUH) de manera prolongada y su influencia en la eficacia de la técnica. Diseño Estudio multicéntrico observacional prospectivo de cohorte multipropósito. Ámbito Registro VNICat. Participantes Pacientes en los que se realiza VNI-SUH en 11 hospitales catalanes en los meses de febrero o marzo de 2015.IntervenciónNinguna.VariablesLa variable de estudio fue la VNI-SUH, que en función del tiempo se definió como prolongada o no prolongada. La variable de eficacia fue el éxito de la técnica por mejoría. Resultados Se incluyeron 125 pacientes con una mediana de tiempo de VNI-SUH de 12h, que fue el punto de corte para los 2 grupos comparados. En 60 (48%) la VNI-SUH fue no prolongada (<12h) y en 65 (52%) prolongada (≥12h). La VNI-SUH no prolongada se asoció con la indicación de insuficiencia cardiaca aguda y la prolongada con la presencia de diabetes. Entre la VNI-SUH no prolongada y la prolongada no hubo diferencias en la eficacia, éxito por mejoría del 68,3% y del 76,9%, respectivamente, con un odds ratio ajustado de 1,49 (intervalo de confianza del 95% de 0,61-3,60).Conclusiones La VNI-SUH prolongada es una situación frecuente, pero las variables estudiadas que se asocian a ella son escasas. Su presencia no influyo en el éxito de la VNI. (AU)

Objective: To analyze the characteristics and variables associated with prolonged noninvasive ventilation performed completely in Emergency Departments (NIV-ED) and its influence upon effectiveness. Design A prospective, multicenter, observational multipurpose cohort study was carried out. Setting VNICat Registry. Subjects Patients in which NIV-ED was performed in 11 Catalan hospitals in the months of February or March 2015. Intervention No. Variables The study variable was NIV-ED, which as a function of time was defined as prolonged or not prolonged. The efficacy variable was the success of the technique in terms of patient improvement. Results A total of 125 patients were included, with a median NIV-ED duration of 12hours, which was the cut-off point for the comparator groups. In 60 cases (48%) NIV-ED was not prolonged (<12hours), while in 65 cases (52%) ventilation was prolonged (≥12hours). Non-prolonged NIV-ED was associated to the indication of acute heart failure and prolonged ventilation to the presence of diabetes. There were no differences between non-prolonged and prolonged NIV-ED in terms of efficacy, and the success rate in terms of improvement was 68.3% and 76.9%, respectively, with an adjusted odds ratio of 1.49 (95%CI 0.61-3.60). Conclusions Prolonged NIV-ED is a frequent situation, but few variables associated to it have been studied. The presence of prolonged ventilation did not influence the success rate of NIV. (AU)

Characteristics of prolonged noninvasive ventilation in emergency departments and impact upon effectiveness. Analysis of the VNICat registry.

OBJECTIVE: To analyze the characteristics and variables associated with prolonged noninvasive ventilation performed completely in Emergency Departments (NIV-ED) and its influence upon effectiveness. DESIGN: A prospective, multicenter, observational multipurpose cohort study was carried out. SETTING: VNICAT Registry. SUBJECTS: Patients in which NIV-ED was performed in 11 Catalan hospitals in the months of February or March 2015. INTERVENTION: No. VARIABLES: The study variable was NIV-ED, which as a function of time was defined as prolonged or not prolonged. The efficacy variable was the success of the technique in terms of patient improvement. RESULTS: A total of 125 patients were included, with a median NIV-ED duration of 12 h, which was the cut-off point for the comparator groups. In 60 cases (48%) NIV-ED was not prolonged (<12 h), while in 65 cases (52%) ventilation was prolonged (≥12 h). Non-prolonged NIV-ED was associated to the indication of acute heart failure and prolonged ventilation to the presence of diabetes. There were no differences between non-prolonged and prolonged NIV-ED in terms of efficacy, and the success rate in terms of improvement was 68.3% and 76.9%, respectively, with an adjusted odds ratio of 1.49 (95%CI 0.61-3.60). CONCLUSIONS: Prolonged NIV-ED is a frequent situation, but few variables associated to it have been studied. The presence of prolonged ventilation did not influence the success rate of NIV.

Intraperitoneal collagenase as a novel therapeutic approach in an experimental model of colorectal peritoneal carcinomatosis.

The usefulness of local collagenase in therapeutic approaches to solid tumors has been tested recently. In this study, we evaluate the safety and efficacy of intraperitoneal collagenase associated or not to mitomycin for treatment of colorectal peritoneal metastases in an experimental rat model. Using a fixed-dose procedure, we found that a dose of collagenase of 37 IU/mL administered for 15 min with a hyperthermia pump at 37.5 °C, both in isolation or associated to sequential treatment with intraperitoneal mitomycin, led to a macroscopic decrease in tumor volume as evaluated by the modified peritoneal cancer index (mPCI). Concerning the safety of the procedure, the animals showed no physiological or behavioral disorders during 8 weeks of follow-up. Local treatment for peritoneal metastases of colorectal origin with intraperitoneal collagenase has proved safe and effective in an experimental murine model. Therefore, the stroma-first approach by enzymatic breakdown of collagen from the tumor's extracellular matrix provides a new therapeutic target for colorectal peritoneal metastases.