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Efecto de la hidrocortisona en la mortalidad de 21 días o el apoyo respiratorio entre pacientes críticos con
Pierre-François Dequin1,2,3, Nicholas Heming4,5, Ferhat Meziani6,7
1Médecine Intensive-Réanimation, CHU de Tours, Tours, France.
JAMA
|September 3, 2020
Resumen
La dosis baja de hidrocortisona no redujo significativamente el fracaso del tratamiento en pacientes críticos con COVID-19. El estudio se detuvo temprano, probablemente con poca potencia para detectar una diferencia significativa en los resultados de la infección por coronavirus 2 del síndrome respiratorio agudo severo (SARS-CoV-2).
Área de la Ciencia:
- Medicina para cuidados intensivos
- Enfermedades infecciosas
- Farmacología
Sus antecedentes:
- La enfermedad por coronavirus 2019 (COVID-19) puede causar daño pulmonar severo.
- Los corticosteroides se están investigando como un tratamiento potencial para la insuficiencia respiratoria aguda relacionada con el COVID-19.
Objetivo del estudio:
- Evaluar la eficacia de la dosis baja de hidrocortisona para reducir el fracaso del tratamiento al día 21 en pacientes en estado crítico con COVID-19 y insuficiencia respiratoria aguda.
Principales métodos:
- Se realizó un ensayo multicéntrico, aleatorizado, doble ciego, controlado con placebo.
- Los pacientes en estado crítico con insuficiencia respiratoria aguda relacionada con COVID-19 recibieron dosis bajas de hidrocortisona (n=76) o placebo (n=73).
- El resultado primario fue el fracaso del tratamiento al día 21, definido como muerte o necesidad persistente de ventilación mecánica o terapia de oxígeno de alto flujo.
Principales resultados:
- El estudio se interrumpió precozmente después de inscribir a 149 pacientes.
- El fracaso del tratamiento en el día 21 se produjo en el 42,1% del grupo de hidrocortisona frente al 50,7% del grupo de placebo (P=0,29).
- No se observaron diferencias significativas en el resultado primario ni en los resultados secundarios predefinidos entre los grupos. No se han notificado reacciones adversas graves.
Conclusiones:
- La dosis baja de hidrocortisona no redujo significativamente el fracaso del tratamiento en pacientes críticos con COVID-19 al día 21.
- El ensayo fue probablemente insuficiente debido a la terminación temprana para detectar una diferencia estadísticamente significativa.
- Es posible que se necesite más investigación para aclarar completamente el papel de los corticosteroides en el manejo de la COVID-19 grave.
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