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Ensayos de aumento controlados distribuidos al azar en pacientes esquizofrénicos resistentes a la clozapina: una revisión crítica
Published online by Cambridge University Press: 12 May 2020
Resumen
El 40-70% aproximadamente de los pacientes esquizofrénicos resistentes al tratamiento no se benefician de la monoterapia de clozapine o responden parcialmente. Durante los últimos años, se ha introducido varios agentes complementarios a la clozapina en la práctica clínica. Este estudio pretende revisar críticamente todos los ensayos clínicos doble ciego distribuidos al azar controlados con placebo (EDAC) publicados acerca de la eficacia y seguridad de los agentes complementarios en pacientes esquizofrénicos o esquizoafectivos resistentes a la clozapina. Se realizó una búsqueda en Medline de los EDAC sobre agentes complementarios a la clozapina publicados desde enero de 1980 hasta febrero de 2004. Se revisó críticamente todos los artículos identificados y se los examinó con respecto a varios rasgos metodológicos, así como parámetros clínicos y farmacológicos. Once ensayos que incluían a 270 pacientes con respuesta parcial o inexistente a la clozapina evaluaban la eficacia de la sulpirida, el litio, la lamotrigina, la fluoxetina, la glicina, la D-serina, la D-cicloserina y el etil-eicosapentanoato (E-EPA) como tratamiento complementario de la clozapina. Había ocho ensayos de grupos paralelos y tres cruzados. Los criterios de inclusión variaban mucho. La duración y la dosis de monoterapia de clozapina comunicadas eran adecuadas en un solo ensayo. Las concentraciones de clozapina en plasma se evaluaron sólo en tres ensayos. Los efectos secundarios principals comunicados fueron: hipersalivación, sedatión, diarrea, náuseas e hiperprolactinemia. La evolutión favoreció al aumento de clozapina con sulpirida, lamotrigina y E-EPA. Se mostró que el litio beneficiaba sólo a los pacientes esquizoafectivos. Sin embargo, las limitaciones metodológicas de los ensayos analizados limitan las repercusiones de los datos proporcionados.
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- Copyright © European Psychiatric Association 2006
Footnotes
Kontaxakis VP, Ferentinos PP, Havaki-Kontaxaki BJ, Roukas DK. Randomized controlled augmentation trials in clozapine-resistant schizophrenic patients: a critical review. Eur Psychiatry 2005;20:409-415.
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