RESUMEN
INTRODUCTION: No neuroprotective treatment has been able to successfully halt the progression of Parkinson disease or prevent development of associated complications. Recombinant erythropoetin (EPO), an erythropoiesis-stimulating agent originally indicated in anemia, produced and manufactured in Cuba (iorEPOCIM, CIMAB S.A, Havana, Cuba) has neuroprotective properties. NeuroEPO is a new nasal formulation of recombinant EPO with a low content of sialic acid and without hematopoietic effects. It has neuroprotective effects in animal models. OBJECTIVE: Evaluate short-term tolerance of intranasal NeuroEPO in patients with Parkinson disease. METHODS: As part of a monocentric randomized placebo-controlled double-blind study (registered at www.clinicaltrials.gov number NCT04110678), 26 patients with Parkinson disease (stages 1 and 2 on Hoehn & Yahr Scale), were randomly divided into two groups: NeuroEPO (n = 15) and placebo (n = 11), both treated intranasally either with the drug (1 mL, at a concentration of 1 mg/mL of NeuroEPO) or placebo once a week for 5 weeks. At each application, we recorded any adverse events and blood pressure. To assess potential hematopoietic effects of the drug, hematological and biochemical variables were evaluated one week before and one week after the intervention. RESULTS: There were no significant differences (p = 0.22) between the two groups in terms of frequency of adverse events (20.0% in NeuroEPO and 9.1% in placebo groups). Three patients in NeuroEPO presented nausea, and one vomited (possibly due to the patient's positioning during drug application). One patient in placebo group reported polyuria and nasal irritation. In both groups, the adverse events were mild, brief, required no treatment and did not present sequelae. CONCLUSIONS: Nasally administered NeuroEPO for five weeks in patients with Parkinson disease stages 1 and 2 on Hoehn & Yahr Scale is well tolerated.
Asunto(s)
Eritropoyetina/administración & dosificación , Eritropoyetina/uso terapéutico , Enfermedad de Parkinson/tratamiento farmacológico , Administración Intranasal , Adulto , Anciano , Cuba , Método Doble Ciego , Eritropoyetina/efectos adversos , Humanos , Persona de Mediana Edad , Fármacos Neuroprotectores/administración & dosificación , Fármacos Neuroprotectores/efectos adversos , Fármacos Neuroprotectores/uso terapéutico , Proteínas Recombinantes/administración & dosificación , Proteínas Recombinantes/efectos adversos , Proteínas Recombinantes/uso terapéuticoRESUMEN
El buceo es una actividad deportivo - recreativa, segura, estudiada y con riesgos inherentes como cualquier otra actividad. Se presentan los resultados de una investigación descriptiva, observacional, y transversal, realizada con una muestra constituida por todos los buceadores que sufrieron algún accidente de buceo en el Centro Internacional de Buceo "María La Gorda" de Pinar del Río, durante los años 2007-2008. Se registró la información en una base de datos del sistema estadístico STATISTIC, lo cual permitió aplicar estimaciones puntuales de frecuencias relativas para el análisis estadístico descriptivo de los resultados. Se utilizaron la prueba de Ji cuadrado en su variante de tabla de contingencia y la prueba de hipótesis para la comparación de proporciones correspondientes a categoría mutuamente excluyentes. El mayor número de accidentes de buceo ocurrió en el sexo masculino y en el grupo de edad de 30 a 39. Los accidentes de buceo más frecuentes fueron los barotraumatismos de oído sin diferencias significativas en cuanto al sexo. La edad avanzada mayor de 45 años y el sexo femenino fueron los factores predisponentes que más incidieron en la muestra de estudio. La categoría de buceador más afectado fue la de los no profesionales, seguidos por los buceadores deportivos y los profesionales, sin diferencias estadísticamente significativas. La mayoría de los accidentes que se presentaron fueron no letales.
Diving is a sports, recreational, safe, and studied activity having risks of any other. The results of a descriptive, observation, and cross-sectional research was conducted with a sample comprised of all the divers that suffered any kind of diving accident at "Maria la Gorda" International Diving Center, Pinar del Rio, during 2007-2008. The information was recorded in a statistical database system (STATISTIC), which allowed applying detailed estimates of relative frequencies to the descriptive-statistical analysis of the results. Chi square test and its variants of contingency table, as well as the hypothesis to compare the corresponding ratios to the mutual exclusive category were used. Male sex and the age bracket of 30 to 39 prevailed. The most frequent diving accidents were: barotraumas of the ear having no significant differences regarding sex. Older ages than 45 and female sex were the most predisposing factors that affected the sample taken. The most affected category of divers was: nonprofessionals, followed by sports and professionals without significant statistical differences. The majority of the accidents were not fatal.