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2011, Número 1

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Rev Cubana Farm 2011; 45 (1)


Eficacia y seguridad del ior® LeukoCIM (FEC-G) en pacientes con neutropenia posquimioterapia

Pérez RL; Ramos CAM; Fernández ÁJD; Guerra AT; Cabrera ZM; Pascau ILJ

Idioma: Ingles.
Referencias bibliográficas: 52
Paginas: 19-33
Archivo PDF: 108.54 Kb.


RESUMEN

La neutropenia y las infecciones constituyen los eventos adversos más limitantes en la aplicación de quimioterapia. Los factores estimulantes de colonias de granulocitos activan los neutrófilos, acortan el periodo neutropénico y pueden ser efectivos contra los riesgos potenciales de infección. El propósito de este estudio fue evaluar la efectividad y seguridad del LeukoCIM® (CIMAB, La Habana). Se realizó un estudio retrospectivo, observacional con los datos de los pacientes incluidos en el ensayo clínico fase IV abierto, no aleatorizado y multicéntrico. Estos pacientes provenían del Hospital Gustavo Aldereguía Lima y se evaluaron durante un año. Se analizaron los datos demográficos, clínicos y de seguridad. Como profilaxis el fármaco fue administrado de 24-72 h después de la última dosis de quimioterapia y como tratamiento cuando la neutropenia había sido diagnosticada. En ambos casos la dosis única diaria fue de 300 μg por vía subcutánea. La administración del próximo ciclo de quimioterapia en tiempo resultó la variable principal de respuesta y la seguridad del producto se evaluó midiendo los eventos adversos. Se incluyeron 47 pacientes con 95 episodios neutropénicos. El 82,1 % de episodios recibió su próximo ciclo de quimioterapia en tiempo. Los eventos adversos más frecuentes fueron: dolor óseo y fiebre (11,22 % respectivamente), hiperuricemia (9,2 %), leucocitosis y neutrofilia (7,1 %) e incremento de LDH (6, 1%). LeukoCIM® resultó efectivo, pues aceleró la recuperación del número de neutrófilos, disminuyó la incidencia de neutropenia febril y permitió administrar las dosis de quimioterapia en tiempo según el protocolo. También se consideró seguro en la serie estudiada, pues solo reportó eventos adversos conocidos.


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