27 research outputs found

    Sobre el cálculo del tamaño muestral

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    Valoración de la adherencia y repercusión clínica de una estrategia para el manejo de la medicación antitrombótica en el perioperatorio de cirugía electiva no cardíaca

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    [ES]Introducción: Ante el aumento del número de pacientes que toman fármacos antitrobóticos que son sometidos a procedimientos quirúrgicos, previa elavoración de un protocolo de manejo en el perioperatorio, diseñamos un trabajo cuyo objetivo prinicipal fue la valoración de la adherencia al citado protocolo y secundario la repercusión clínica del mismo, así como su influencia en la estancia, para cirugías programadas no cardiacas. Material y métodos: Estudio descriptivo tranversal entre los años 2011 y 2014 en el Hospital Universitario de Salamanca. Seleccionamos pacientes en tratamiento antiagregante (AAP, n=445) ) o anticoagulante (AVK, n=304) que iban a ser sometidos a cirugía. Los datos los analizamos de forma separada en ambos grupos. Realizamos tanto un análisis univariante como multivariante teniendo como variables dependientes las consideradas objetivos del estudio Resultados: La adherencia al protocolo en el grupo AAP fue de 46% y en el grupo AVK del 74%. La adherencia en el grupo AAP se relacionó con la especialidad quirúrgica, del grupo de riesgo (hemorrágico/trombótico) al que pertenezca el paciente y del año de evaluación del protocolo. En el grupo AVK lo hizo con la edad y el riesgo de trombosis. Las complicaciones trombóticas y hemorrágicas se relacionaron con el no seguimiento al protocolo en el grupo AAP. Las complicaciones trombóticas, hemorrágicas, la muerte y la estancia se relacionaron con la no adherencia al protocolo en el grupo AVK. Conclusiones: La adherecia es más baja en el grupo AAP que en el AVK. Tanto para los pacientes en tratamiento con antiagregantes como en tratamiento con anticoagulantes el no seguimiento del protocolo perioperatorio aumenta el número de complicaciones hemorrágicas y trombóticas. La estancia y la muerte sólo se relacionaron con la adherencia en el grupo de anticoagulante

    Uncovering a Novel Functional Interaction Between Adult Hepatic Progenitor Cells, Inflammation and EGFR Signaling During Bile Acids-Induced Injury

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    Chronic cholestatic damage is associated to both accumulation of cytotoxic levels of bile acids and expansion of adult hepatic progenitor cells (HPC) as part of the ductular reaction contributing to the regenerative response. Here, we report a bile acid-specific cytotoxic response in mouse HPC, which is partially impaired by EGF signaling. Additionally, we show that EGF synergizes with bile acids to trigger inflammatory signaling and NLRP3 inflammasome activation in HPC. Aiming at understanding the impact of this HPC specific response on the liver microenvironment we run a proteomic analysis of HPC secretome. Data show an enrichment in immune and TGF-beta regulators, ECM components and remodeling proteins in HPC secretome. Consistently, HPC-derived conditioned medium promotes hepatic stellate cell (HSC) activation and macrophage M1-like polarization. Strikingly, EGF and bile acids co-treatment leads to profound changes in the secretome composition, illustrated by an abolishment of HSC activating effect and by promoting macrophage M2-like polarization. Collectively, we provide new specific mechanisms behind HPC regulatory action during cholestatic liver injury, with an active role in cellular interactome and inflammatory response regulation. Moreover, findings prove a key contribution for EGFR signaling jointly with bile acids in HPC-mediated actions

    LDL-cholesterol lowering effect of a generic product of simvastatin compared to simvastatin (Zocor™) in Thai hypercholesterolemic subjects – a randomized crossover study, the first report from Thailand

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    BACKGROUND: It is commonly agreed that people with a high blood LDL-cholesterol will have a higher risk of coronary artery disease (CAD) than people with low blood LDL-cholesterol. Due to the increasingly high costs of medication in Thailand, the government has set up several measures to combat the problem. One of such strategies is to promote the utilization of locally manufactured drug products, especially those contained in the National Drug List. Simvastatin, an HMG-CoA reductase inhibitor, is listed as an essential drug for the treatment of hypercholesterolemia. Here, we reported the study on the LDL-cholesterol-lowering effect of a generic simvastatin product in comparison with the Zocor(©), in 43 healthy thai volunteers. METHOD: The generic product tested was Eucor(©), locally manufactured by Greater Pharma Ltd., Part, Thailand, and the reference product was Zocor(©) (Merck Sharp & Dohme, USA). The two products were administered as 10-mg single oral doses in a two-period crossover design. After drug administration, serial blood samples were collected every 4 weeks for 16 weeks. The major parameter monitored in this study was blood LDL-cholesterol. RESULT: After taking the drugs for the first 8 weeks, no statistically significant difference was dedected in blood LDL-cholesterol between the first (Zocor(©)-treated) and the second (Eucor(©)-treated) groups. After crossover and taking drugs for further 8 weeks, a similar result was obtained, i.e., no significant difference in blood LDL-cholesterol between the first (Eucor(©)-treated) and the second (Zocor(©)-treated) groups was observed. Upon completion of the 16-week study, there was also no statisticaly significant difference in the changes of all tested blood parameters between the two products (randomized block ANOVA, N = 37). Only minor side effects, mainly dizziness and nausea, were observed in both products. CONCLUSION: Our study demonstrated no significant differences in the therapeutic effect and safety between the generic and original simvastatin products

    Endothelial dysfunction is an early indicator of sepsis and neutrophil degranulation of septic shock in surgical patients

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    Producción CientíficaBackground: Stratification of the severity of infection is currently based on the Sequential Organ Failure Assessment (SOFA) score, which is difficult to calculate outside the ICU. Biomarkers could help to stratify the severity of infection in surgical patients. Methods: Levels of ten biomarkers indicating endothelial dysfunction, 22 indicating emergency granulopoiesis, and six denoting neutrophil degranulation were compared in three groups of patients in the first 12 h after diagnosis at three Spanish hospitals. Results: There were 100 patients with infection, 95 with sepsis and 57 with septic shock. Seven biomarkers indicating endothelial dysfunction (mid-regional proadrenomedullin (MR-ProADM), syndecan 1, thrombomodulin, angiopoietin 2, endothelial cell-specific molecule 1, vascular cell adhesion molecule 1 and E-selectin) had stronger associations with sepsis than infection alone. MR-ProADM had the highest odds ratio (OR) in multivariable analysis (OR 11·53, 95 per cent c.i. 4·15 to 32·08; P = 0·006) and the best area under the curve (AUC) for detecting sepsis (0·86, 95 per cent c.i. 0·80 to 0·91; P < 0·001). In a comparison of sepsis with septic shock, two biomarkers of neutrophil degranulation, proteinase 3 (OR 8·09, 1·34 to 48·91; P = 0·028) and lipocalin 2 (OR 6·62, 2·47 to 17·77; P = 0·002), had the strongest association with septic shock, but lipocalin 2 exhibited the highest AUC (0·81, 0·73 to 0·90; P < 0·001). Conclusion: MR-ProADM and lipocalin 2 could be alternatives to the SOFA score in the detection of sepsis and septic shock respectively in surgical patients with infection.Instituto de Salud Carlos III (grants PI15/01959, PI15/01451 and PI16/01156

    The management of acute venous thromboembolism in clinical practice. Results from the European PREFER in VTE Registry

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    Venous thromboembolism (VTE) is a significant cause of morbidity and mortality in Europe. Data from real-world registries are necessary, as clinical trials do not represent the full spectrum of VTE patients seen in clinical practice. We aimed to document the epidemiology, management and outcomes of VTE using data from a large, observational database. PREFER in VTE was an international, non-interventional disease registry conducted between January 2013 and July 2015 in primary and secondary care across seven European countries. Consecutive patients with acute VTE were documented and followed up over 12 months. PREFER in VTE included 3,455 patients with a mean age of 60.8 ± 17.0 years. Overall, 53.0 % were male. The majority of patients were assessed in the hospital setting as inpatients or outpatients (78.5 %). The diagnosis was deep-vein thrombosis (DVT) in 59.5 % and pulmonary embolism (PE) in 40.5 %. The most common comorbidities were the various types of cardiovascular disease (excluding hypertension; 45.5 %), hypertension (42.3 %) and dyslipidaemia (21.1 %). Following the index VTE, a large proportion of patients received initial therapy with heparin (73.2 %), almost half received a vitamin K antagonist (48.7 %) and nearly a quarter received a DOAC (24.5 %). Almost a quarter of all presentations were for recurrent VTE, with &gt;80 % of previous episodes having occurred more than 12 months prior to baseline. In conclusion, PREFER in VTE has provided contemporary insights into VTE patients and their real-world management, including their baseline characteristics, risk factors, disease history, symptoms and signs, initial therapy and outcomes
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