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Eventos adversos asociados con ciclofosfamida: un estudio de farmacovigilancia utilizando el sistema de notificación
Hui Zhang1, Minghao Lin1, Dexi Zhao1,2
1Changchun University of Chinese Medicine, Changchun, China.
PloS one
|January 6, 2026
Resumen
La quimioterapia con ciclofosfamida (CHOP) puede causar eventos adversos graves, particularmente trastornos de la sangre y del sistema linfático. Se recomienda precaución en pacientes de alto riesgo, especialmente cuando se combina con radioterapia, debido a un mayor riesgo de cistitis hemorrágica.
Área de la Ciencia:
- Oncología
- Farmacovigilancia
- Farmacología Clínica
Sus antecedentes:
- La ciclofosfamida (CHOP) es un agente alquilante ampliamente utilizado para diversos cánceres.
- Su mecanismo implica interferir con la replicación y transcripción del ADN para inhibir la proliferación de células tumorales.
- El análisis de datos del mundo real es crucial para comprender su perfil de seguridad.
Objetivo del estudio:
- Evaluar los eventos adversos (EA) asociados con la ciclofosfamida (CHOP) utilizando datos del mundo real.
- Identificar señales de seguridad potenciales y reacciones adversas inesperadas.
- Evaluar el impacto de CHOP en combinación con otras terapias.
Principales métodos:
- Análisis de 3.625 informes de eventos adversos de la base de datos FAERS (2004-2024).
- Inclusión de informes donde CHOP fue el fármaco sospechoso principal, presentados por profesionales de la salud.
- Se utilizaron cuatro métodos de detección de señales: ROR, PRR, BCPNN y MGPS.
Principales resultados:
- Se identificaron señales significativas en 25 clases de sistemas de órganos (SOC).
- El SOC con señal más prominente fueron los «trastornos de la sangre y del sistema linfático» (ROR = 6,64).
- Una señal significativa de término preferido (PT) fue «linfoma de células B de alto grado, linfoma tipo Burkitt recurrente» (ROR = 613,63).
Conclusiones:
- Se confirmaron preocupaciones de seguridad conocidas y se identificaron siete EA inesperados fuera de indicación.
- Se observó un mayor riesgo de EA graves como cistitis hemorrágica cuando CHOP se combina con radioterapia.
- Se enfatizó la necesidad de precaución en pacientes de alto riesgo con antecedentes médicos específicos.
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