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2017, Número 1

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Biotecnol Apl 2017; 34 (1)


Interferón alfa-2b cubano. Treinta años como un medicamento eficaz y seguro

Nodarse-Cuní H, López-Saura PA

Idioma: Ingles.
Referencias bibliográficas: 72
Paginas: 1211-1217
Archivo PDF: 432.54 Kb.


RESUMEN

La producción por primera vez en 1986 del interferón alfa-2b humano recombinante cubano, comercializado como Heberon® Alfa R, dio inicio a la introducción y comercialización de diversos tipos y formulaciones de interferones por el Centro de Ingeniería Genética y Biotecnología, de La Habana, Cuba. El uso terapéutico de este producto fue evaluado en un gran número de investigaciones clínicas realizadas en el Sistema Nacional de Salud de Cuba. Para el análisis del perfil de seguridad del Heberon® Alfa R fueron revisados 28 años de reportes de eventos adversos en 5806 individuos entre niños y adultos, procedentes de un compendio de 147 investigaciones clínicas o usos asistenciales con el producto. Este trabajo contiene, además, una comparación de la seguridad entre las formulaciones liofilizada y líquida; Incluye también un análisis de la relación de ocurrencia de eventos adversos y las características demográficas de los pacientes; un análisis de inmunogenicidad y otro sobre la variación en la función tiroidea asociada al uso del Heberon® Alfa R. Por último, se muestra un análisis general de la eficacia del producto, a partir del número de pacientes tratados y los resultados clínicos obtenidos. Los principales eventos adversos observados fueron aquellos correspondientes con el síndrome pseudogripal, con mayor frecuencia en los pacientes masculinos blancos. El hipotiroidismo y la inmunogenicidad se comportaron inferiores respecto a los productos similares en el mercado farmacéutico internacional. Aproximadamente el 60 % de los pacientes tratados obtuvo una respuesta terapéutica relevante y la formulación líquida ofreció la mejor relación riesgo beneficio. La amplia información clínica evaluada reconoce al Heberon® Alfa R cubano como un medicamento efectivo y seguro, transcurridos 30 años desde su primera producción.


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