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Updated: Feb 9, 2026
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Administración de albúmina a largo plazo en cirrosis descompensada (ANSWER): ensayo aleatorizado abierto
Paolo Caraceni1, Oliviero Riggio2, Paolo Angeli3
1Department of Medical and Surgical Sciences, and Center for Applied Biomedical Research, University of Bologna, Bologna, Italy.
Lancet (London, England)
|June 5, 2018
Resumen
La administración a largo plazo de albúmina humana (AH) mejoró significativamente la supervivencia en pacientes con cirrosis descompensada. Este tratamiento puede modificar la progresión de la enfermedad, ofreciendo una nueva vía terapéutica para los pacientes con cirrosis hepática.
Área de la Ciencia:
- Hepatología
- Ensayos clínicos
- Médico interno
Sus antecedentes:
- Existen pruebas limitadas sobre la eficacia a largo plazo de la albúmina humana (AH) para la cirrosis descompensada.
- El objetivo del estudio ANSWER era abordar esta brecha de conocimiento.
Objetivo del estudio:
- Evaluar la eficacia de la administración a largo plazo de albúmina humana en pacientes con cirrosis descompensada.
- Evaluar el impacto de la HA en la supervivencia global y la modificación de la enfermedad.
Principales métodos:
- Un ensayo multicéntrico, aleatorizado, abierto y pragmático en el que participaron 440 pacientes con cirrosis y ascitis no complicada.
- Los pacientes recibieron tratamiento médico estándar (SMT) o SMT más albúmina humana (HA) durante un máximo de 18 meses.
- El objetivo primario fue la mortalidad a los 18 meses.
Principales resultados:
- La supervivencia a los 18 meses fue significativamente mayor en el grupo SMT más HA (77%) en comparación con el grupo SMT (66%), con una reducción del 38% en la proporción de riesgo de mortalidad (p=0,028).
- No se observaron diferencias significativas en los eventos adversos no relacionados con el hígado de grado 3- 4 entre los grupos.
Conclusiones:
- La administración a largo plazo de albúmina humana prolonga la supervivencia general en pacientes con cirrosis descompensada.
- El HA puede funcionar como un tratamiento modificador de la enfermedad en esta población de pacientes.
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