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Peritonitis aséptica debida a la contaminación por peptidoglicanos de la solución de diálisis estándar de la
Leo Martis1, Mehul Patel, Joe Giertych
1Baxter Healthcare, McGraw Park, IL, USA.
Lancet (London, England)
|February 15, 2005
Resumen
La peritonitis aséptica en pacientes en diálisis fue causada por la contaminación bacteriana (Alicyclobacillus) en el dializado, a pesar de cumplir con las normas de seguridad. Las acciones correctivas resolvieron el problema, destacando las limitaciones en las pruebas actuales de la farmacopea para los productos parenterales.
Área de la Ciencia:
- Microbiología Microbiología.
- Inmunología Inmunología.
- Nefrología Nefrología.
Sus antecedentes:
- Las soluciones parenterales deben cumplir con las normas de la farmacopea para la seguridad y la esterilidad.
- En mayo de 2002 se produjo un retiro global del dialisato de icodextrina debido a casos de peritonitis aséptica.
- El estudio investigó la causa de la peritonitis aséptica en pacientes en diálisis peritoneal.
Objetivo del estudio:
- Para identificar el agente causante de la peritonitis aséptica en pacientes en diálisis peritoneal.
- Investigar por qué el dializado que cumple con las normas de la farmacopea causó eventos adversos.
Principales métodos:
- Análisis de 186 informes de peritonitis aséptica (septiembre de 2001 a enero de 2003).
- Investigación física, química y microbiológica del dializado retirado del mercado.
- Estudios de dosis-respuesta de la interleucina-6 inducida por peptidoglicano en células humanas y peritonitis estéril en ratas.
Principales resultados:
- El dializado desencadenó una respuesta a la interleucina-6 a pesar de cumplir con las especificaciones de endotoxina y químicos.
- El peptidoglicano de Alicyclobacillus acidocaldarius fue identificado como el contaminante.
- Se ha reportado una correlación positiva entre los niveles de peptidoglicano en diálisis y la peritonitis.
Conclusiones:
- La contaminación de peptidoglicano por Alicyclobacillus causó peritonitis aséptica en pacientes en diálisis peritoneal.
- El brote demostró que los productos seguros bajo las pruebas actuales de la farmacopea aún pueden causar efectos adversos.
- Las acciones correctivas redujeron con éxito las tasas de peritonitis, confirmando la causa identificada.
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