Pharmacovigilance de NeuroEPO chez les sujets participant à des essais cliniques
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Pharmacovigilance de NeuroEPO chez les sujets participant à des essais cliniques

Pharmacovigilance de NeuroEPO chez les sujets participant à des essais cliniques


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About the Book

Introduction: NeuroEPO est une variante de l'érythropoïétine humaine recombinante à faible teneur en acide sialique, formulée pour une administration intranasale. Objectif: évaluer la sécurité de NeuroEPO pendant son utilisation chez les sujets inclus dans les essais cliniques menés à Cuba entre 2013 et 2020. Matériels et méthodes: une étude rétrospective a été menée, basée sur les données de sécurité de 356 sujets inclus dans cinq essais cliniques terminés (25 volontaires sains, 34 patients avec un diagnostic d'Ataxie Spinocérébelleuse de type 2, 127 avec un diagnostic de maladie de Parkinson et 170 avec un diagnostic clinique de maladie d'Alzheimer à un stade léger-modéré). Les événements ont été classés en fonction de leur gravité, de leur intensité, de l'attitude à l'égard du médicament, de l'issue et de la causalité. Résultats: 137 (38,48 %) patients présentant des EI ont été signalés, répartis en 63 types avec une fréquence de 162 événements. Parmi ceux-ci, 18 (28,6 %) types avec une fréquence de 44 (27,2 %) étaient liés au médicament de l'étude. Tous ont été classés comme non graves, d'intensité légère et 41 (93,2 %) ont eu une issue réversible. Conclusions: Le traitement par NeuroEPO intranasal était sûr.


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Product Details
  • ISBN-13: 9786206105282
  • Publisher: KS Omniscriptum Publishing
  • Binding: Paperback
  • Language: French
  • Returnable: N
  • Weight: 145 gr
  • ISBN-10: 6206105288
  • Publisher Date: 19 Jul 2023
  • Height: 229 mm
  • No of Pages: 56
  • Spine Width: 3 mm
  • Width: 152 mm


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