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Terapia fotodinámica con metil-aminolevulinato en las onicomicosis: ensayo clínico controlado, aleatorizado y multicéntrico

  • Autores: Pilar Robres Guillén
  • Directores de la Tesis: Carmen Aspiroz Sancho (dir. tes.), Rosa Martínez Álvarez (dir. tes.), Yolanda Gilaberte Calzada (dir. tes.)
  • Lectura: En la Universidad de Zaragoza ( España ) en 2016
  • Idioma: español
  • Tribunal Calificador de la Tesis: María Isabel García Luque (presid.), Beatriz Boned Juliani (secret.), María Soledad Cuétara García (voc.)
  • Materias:
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  • Resumen
    • INTRODUCCIÓN: Onicomicosis es la infección de la lámina ungueal causada por hongos. Su tratamiento es prolongado en el tiempo, tiene una alta tasa de fracasos y no está exento de efectos secundarios e interacciones. La terapia fotodinámica (TFD) ha demostrado ser útil en el tratamiento de determinadas infecciones cutáneas superficiales, entre las que se encuentran las onicomicosis.

      OBJETIVO: Evaluar la eficacia de la TFD con metilaminolevulinato (MAL) al 16% (Metvix®) en el tratamiento de las onicomicosis.

      PACIENTES Y MÉTODOS: Tipo de Estudio: Ensayo clínico aleatorizado, controlado con placebo.

      Población de estudio: Pacientes incluidos en el “Ensayo clínico abierto, aleatorizado y multicéntrico comparando tres sesiones de terapia fotodinámica con metilaminolevulinato 16% (Metvix®) frente a placebo en el tratamiento de la onicomicosis”. (FAEDV-2012-01).

      Intervención: Tres sesiones de TFD, separadas entre sí por una semana. La sesión de TFD consiste en la aplicación de la crema de MAL al 16% (Metvix®) seguida de 3 horas de incubación y posterior iluminación con Aktilite® (fluencia de 37 J/cm2) durante 7-9 minutos. El grupo control es tratado con tres sesiones de iluminación con las mismas características que el grupo intervención pero sin aplicación de Metvix®.

      Seguimiento: A las 12, 24 y 36 semanas tras finalización del tratamiento, para comprobar la curación clínica y microbiológica.

      Plan de análisis: • Resultado principal: Valoración del porcentaje global de pacientes clínica y microbiológicamente curados.

      • Resultados secundarios: Reducción en el índice de gravedad de la onicomicosis (Onychomycosis Severity Index, OSI). Efectos adversos y modificación de la calidad de vida.

      RESULTADOS: Inicialmente un total de 60 pacientes fueron randomizados a recibir el tratamiento previsto, pero solo 40 fueron incluidos en el análisis final porque el comité científico del ensayo decidió excluir los datos de los 20 pacientes incluidos en un centro participante, al no considerarlos fiables por observar durante la monitorización irregularidades en la recogida de datos. Veintidós pacientes fueron aleatorizados al grupo de tratamiento (TFD-MAL) y 18 al grupo control (placebo). Cuatro pacientes (18,18%) en el primero y uno (5,56%) en el segundo presentaron curación clínica (NNT: 7,92, IC95% 2,98, -9,69. p=0,23). Las onicomicosis no distróficas presentaron mejor respuesta clínica (OSI>75%: 53,85% vs. 18,75% (p=0,048) y microbiológica (41,56% vs. 7,14% (p=0,037) con TFD-MAL que las distróficas. No se observaron efectos adversos significativos.

      Finalizado el periodo de seguimiento del ensayo, a aquellos pacientes que no presentaron curación clínica ni microbiológica, se les ofreció la posibilidad de recibir un nuevo tratamiento basado en TFD-MAL combinada o no con terbinafina, en función de las caracterIsticas de la onicomicosis, del tipo de hongo causal y del grupo de tratamiento durante el ensayo. Los pacientes que han completado o continúan en seguimiento tras finalizar el segundo tratamiento, presentan buena evolución clínica y microbiológica, independientemente de la etiología basal.

      CONCLUSIÓN: La TFD con MAL precedida del uso de urea al 40% fue más eficaz en términos de curación clínica y microbiológica que la aplicación de urea al 40% y luz roja en las onicomicosis, aunque las diferencias encontradas no alcanzaron la significación estadística. Los subgrupos de pacientes con uñas no distróficas y aquellos en los que el agente causal fue un moho no dermatofito fueron los más beneficiados por el uso de la TFD con MAL.

      Ante la presencia de onicomicosis por dermatofitos la combinación de terbinafina y TFD-MAL parece ofrecer altas tasas de efectividad.

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