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Cladribina en el tratamiento de la esclerosis múltiple crónica progresiva
J C Sipe1, J S Romine, J A Koziol
1Department of Molecular and Experimental Medicine, Scripps Research Institute, La Jolla, California 92037.
Lancet (London, England)
|July 2, 1994
Resumen
El fármaco inmunosupresor cladribina influyó favorablemente en la esclerosis múltiple crónica progresiva (EM) al estabilizar las puntuaciones neurológicas y reducir la desmielinización. Este estudio encontró que la cladribina es una opción de tratamiento segura y efectiva para los pacientes con EM.
Área de la Ciencia:
- Neuroinmunología La neuroinmunología.
- Farmacología clínica Farmacología clínica.
Sus antecedentes:
- La esclerosis múltiple (EM) es una enfermedad desmielinizante crónica, progresiva y incapacitante.
- Se cree que los procesos autoinmunes juegan un papel importante en la patogénesis de la EM.
Objetivo del estudio:
- Evaluar la eficacia y seguridad del medicamento nucleósido cladribina en pacientes con esclerosis múltiple crónica progresiva.
- Evaluar el impacto de la cladribina en el estado neurológico, la desmielinización y los marcadores del líquido cefalorraquídeo.
Principales métodos:
- Un ensayo aleatorizado, doble ciego, en el que participaron 51 pacientes con EM crónicamente progresiva.
- Los pacientes recibieron cuatro ciclos mensuales de cladribina (0,7 mg/kg) o placebo, administrados a través de una línea central.
- Las evaluaciones neurológicas, el análisis del líquido cefalorraquídeo y la resonancia magnética cerebral se realizaron regularmente durante 12 meses.
Principales resultados:
- Los pacientes tratados con cladribina mostraron puntuaciones neurológicas estables o mejoradas y volúmenes desmielinizados reducidos en RM en comparación con el grupo placebo.
- Las concentraciones de las bandas oligoclonales del líquido cefalorraquídeo también se estabilizaron o mejoraron en el grupo de cladribina.
- La cladribina fue generalmente bien tolerada, con sólo un caso de toxicidad significativa (supresión de la médula).
Conclusiones:
- El fármaco inmunosupresor cladribina influye favorablemente en el curso de la esclerosis múltiple crónica progresiva.
- La cladribina demuestra eficacia en la estabilización de la progresión de la enfermedad y generalmente es bien tolerada.
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