BackgroundDelivery of therapeutic agents as erythropoietin (EPO) into Central Nervous System through intranasal route could benefit patients with neurological disorders. A new nasal formulation containing a non-hematopoietic recombinant EPO (NeuroEPO) has shown neuroprotective actions in preclinical models. In the current study, the safety of NeuroEPO was evaluated for the first time in humans.MethodsA phase I, randomized, parallel, open-label study was carried out in healthy volunteers. They received, intranasally, 1 mg of NeuroEPO every 8 h during 4 days (Group A) or 0.5 mg of NeuroEPO (Group B) with the same schedule. The working hypothesis was that intranasal NeuroEPO produce <10% of severe adverse reactions in the evaluated groups. Therefore, a rigorous assessment of possible adverse events was carried out, which included tolerance of the nasal mucosa and the effect on hematopoietic activity. Clinical safety evaluation was daily during treatment and laboratory tests were done before and on days 5 and 14 after starting treatment.ResultsTwenty-five volunteers, 56% women, with a mean age of 27 yrs. were included. Twelve of them received the highest NeuroEPO dose. Twenty types of adverse events occurred, with headache (20%) and increase of hepatic enzymes (20%) as the most reported ones. Nasopharyngeal itching was the most common local event but only observed in four patients (16%), all of them from the lowest dose group. About half of the events were very probably or probably caused by the studied product. Most of the events were mild (95.5%), did not require treatment (88.6%) and were completely resolved (81.8%). No severe adverse events were reported. During the study the hematopoietic variables were kept within reference values.ConclusionsNeuroEPO was a safe product, well tolerated at the nasal mucosa level and did not stimulate erythropoiesis in healthy volunteers.Trial registrationCuban Public Registry of Clinical Trials RPCEC00000157, June 10, 2013.
La insuficiencia cardiaca (IC) es un trastorno progresivo y letal que constituye la primera causa de ingreso hospitalario en las personas mayores de 65 años. Se ha demostrado la utilidad del NT-proBNP para su diagnóstico; sin embargo, los valores de estos marcadores difieren según las características de los pacientes y la severidad de la enfermedad. El objetivo de este estudio consistió en determinar la utilidad de la medición de NT-proBNP para diagnosticar el riesgo de padecer IC en adultos mayores. Se realizaron análisis de NT-proBNP, creatinina, urea, hemoglobina, glucosa y sodio en 47 muestras sanguíneas de pacientes de un centro gerontológico de Manabí en el periodo octubre a diciembre 2017. Se analizaron los valores y la posible asociación a otras enfermedades. Se compararon los valores de variables demográficas, analíticas y clínicas. Se analizaron las manifestaciones clínicas y antecedentes patológicos personales asociados al riesgo de IC. El valor NT-proBNP se asoció con la presencia de anemia, creatinina mayor de 2 mg/dL e hiponatremia. La edad media de los pacientes fue de 79 años, de predominio masculino, con comorbilidad asociada y cierto grado de dependencia, aunque la edad no fue un factor que influyó en la probabilidad de tener elevación en el valor plasmático de NT-proBNP y por lo tanto del riesgo latente de padecer o no IC. El valor de NT-proBNP mostró ser un analito complementario de gran importancia clínica para la evaluación y el cuidado integral de salud del anciano. Palabras clave: NT-proBNP, insuficiencia cardiaca, adultos mayores. Abstract Heart failure (HF) is a progressive and lethal disorder that constitutes the first cause of hospital admission in people over 65 years of age and represents just over 2% of national healthcare expenditure. The usefulness of NT-proBNP for its diagnosis has been demonstrated, however, the values of these markers differ according to the characteristics of the patients and the severity of the disease. The objective of this study is to determine the NT-proBNP usefullness to diagnose risk of HF in older adults. NT-proBNP, creatinine, urea, hemoglobin, glucose and sodium were analyzed in 47 blood samples of patients from the gerontological center from October to December 2017. The values and the possible association to other diseases were analyzed. The values of demographic, analytical and clinical variables were compared. The clinical manifestations and personal pathological background associated with the risk of HF were analyzed. The NT-proBNP value was associated with the presence of anemia, creatinine greater than 2 mg/dL and hyponatremia. The average age of the patients was 79 years, predominantly male, with associated comorbidity and a certain degree of dependence, although age was not a factor that influenced the probability of having an elevated plasma NT-proBNP value and therefore both of the latent risk of suffering or not IC. The value of NT-proBNP was shown to be a complementary analyte of great clinical importance for the evaluation and comprehensive health care of the elderly. Keywords: NT-proBNP, heart failure, elderly.
Este artículo debe citarse como Howland-Álvarez I, Cruz-Gómez Y, Zambrano-Mera JG. Daño renal asociado con componentes monoclonales débiles en pacientes cubanos con gammapatía monoclonal.
En este trabajo se caracterizaron los resultados patológicos de las electroforesis de proteínas (ELP) de pacientes atendidos en el Hospital Dr. Julio Villacreses Colmont (SOLCA-Manabí) entre 2015 y 2018. Se realizó un estudio retrospectivo, longitudinal y descriptivo de las características analíticas, clínicas y demográficas de los pacientes con resultados de ELP patológicas obtenidas en equipo Minicap (Sebia). La población estuvo conformada por 992 ELP y la muestra quedó constituida por 629 que resultaron patológicas (89 %). Se encontró que en el periodo evaluado se solicitaron ELP a menos del 1 % del total de pacientes atendidos a pesar de las facilidades diagnósticas que ofrece la prueba. En el estudio predominaron las mujeres y la edad media fue de 63 años, con mayor frecuencia de presentación entre la cuarta y octava décadas de vida. La mayoría de las electroforesis patológicas fueron gammapatías policlonales (GP), seguidas por gammapatías monoclonales (GM) lideradas por el mieloma múltiple. Se observaron componentes monoclonales débiles y componentes oligoclonales no relacionados a diagnóstico de GM. Se concluyó que un examen de proteínas totales no sería suficiente para poder diferenciar entre GM y GP; sin embargo, en caso de no disponer de un resultado inmediato de ELP, lo cual sería óptimo, una hiperproteinemia con hipoalbuminemia y una relación del coeficiente albúmina/globulinas disminuido, orientarían hacia el diagnóstico precoz del tipo de gammapatía. Palabras clave: Electroforesis capilar, electroforesis de proteínas, gammapatía, hipoproteinemia.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.