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Datos del mundo real sobre reacciones cutáneas adversas graves a medicamentos
Sergey Zyryanov1, Elizaveta Terehina1,2, Olga Butranova1
1Department of General and Clinical Pharmacology, Peoples' Friendship University of Russia Named After Patrice Lumumba (RUDN University), 6 Miklukho-Maklaya St., 117198 Moscow, Russia.
Pharmaceuticals (Basel, Switzerland)
|January 28, 2026
Resumen
Este estudio identificó 907 desencadenantes de fármacos para reacciones cutáneas adversas graves (SCAR) utilizando datos de farmacovigilancia rusos. La linagliptina, la clindamicina y la piperacilina/inhibidores de la beta-lactamasa mostraron la asociación más fuerte con las SCAR.
Área de la Ciencia:
- Farmacovigilancia
- Seguridad de los medicamentos
- Epidemiolog'.'.a
Sus antecedentes:
- Las reacciones cut'.'.neas adversas a medicamentos (CADR) son alergias comunes inducidas por f'.'.rmacos.
- Las reacciones cut'.'.neas adversas graves (SCAR) son la forma m'.'.s grave de CADR.
- La identificaci'.'.n de los f'.'.rmacos causales es fundamental para el manejo de las SCAR.
Objetivo del estudio:
- Analizar las se'.'.ales de SCAR inducidas por f'.'.rmacos utilizando informes espont'.'.neos.
- Evaluar la estructura de los f'.'.rmacos asociados con SCAR.
- Identificar posibles desencadenantes de f'.'.rmacos para SCAR en la pr'.'.ctica cl'.'.nica.
Principales métodos:
- An'.'.lisis farmacoepidemiol'.'.gico descriptivo retrospectivo.
- Se utilizaron informes espont'.'.neos de la base de datos nacional de farmacovigilancia de Rusia (abril de 2019 - marzo de 2025).
- Se calcularon el cociente de probabilidades de notificaci'.'.n (ROR) y el cociente de notificaci'.'.n proporcional (PRR) para evaluar las se'.'.ales de f'.'.rmacos-SCAR.
Principales resultados:
- 7011 informes espont'.'.neos (SR) de SCAR identificados, con 907 desencadenantes de f'.'.rmacos asociados.
- Clases de f'.'.rmacos m'.'.s frecuentes: antibacterianos (22,8%), antineopl'.'.sicos (17,8%), antiepil'.'.pticos (6,0%).
- Se'.'.ales m'.'.s fuertes para linagliptina (PRR=15,37, ROR=17,24), clindamicina (PRR=12,44, ROR=13,62) e inhibidor de piperacilina/beta-lactamasa (PRR=10,02, ROR=10,81).
Conclusiones:
- Las bases de datos de farmacovigilancia identifican eficazmente los fenotipos de SCAR y los f'.'.rmacos causantes.
- Los hallazgos mejoran la comprensi'.'.n de las SCAR inducidas por f'.'.rmacos.
- Los datos respaldan la mejora de la pr'.'.ctica cl'.'.nica y la monitorizaci'.'.n de la seguridad de los medicamentos por parte de los profesionales de la salud.
Palabras clave:
síndrome de Stevens-Johnson (SJS)agentes antibacterianosreacción a fármacos con eosinofilia y síntomas sistémicos (DRESS)linagliptinafarmacovigilanciapiperacilinareacciones cutáneas adversas graves (SCAR)necrólisis epidérmica tóxica (TEN)Más Videos Relacionados
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