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Farmacovigilância da NeuroEPO em indivíduos envolvidos em ensaios clínicos

Farmacovigilância da NeuroEPO em indivíduos envolvidos em ensaios clínicos


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About the Book

Introdução: A NeuroEPO é uma variante da eritropoietina humana recombinante com baixo teor de ácido siálico, formulada para administração intranasal. Objetivo: Avaliar a segurança da NeuroEPO durante a sua utilização em indivíduos incluídos em ensaios clínicos realizados em Cuba entre 2013 e 2020. Materiais e métodos: Foi realizado um estudo retrospetivo, com base nos dados de segurança de 356 indivíduos incluídos em cinco ensaios clínicos concluídos (25 voluntários saudáveis, 34 doentes com um diagnóstico de Ataxia Espinocerebelosa tipo 2, 127 com um diagnóstico de doença de Parkinson e 170 com um diagnóstico clínico de doença de Alzheimer ligeira-moderada). Os eventos foram classificados de acordo com a gravidade, intensidade, atitude medicamentosa, desfecho e causalidade. Resultados: Foram notificados 137 (38,48%) doentes com EAs, distribuídos em 63 tipos com uma frequência de 162 eventos. Destes, 18 (28,6 %) tipos com uma frequência de 44 (27,2 %) estavam relacionados com o medicamento em estudo. Todos foram classificados como não graves, de intensidade leve e 41 (93,2 %) com desfecho reversível. Conclusões: O tratamento com NeuroEPO intranasal foi seguro.


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Product Details
  • ISBN-13: 9786206105299
  • Publisher: KS Omniscriptum Publishing
  • Binding: Paperback
  • Language: Portuguese
  • Returnable: N
  • Weight: 141 gr
  • ISBN-10: 6206105296
  • Publisher Date: 19 Jul 2023
  • Height: 229 mm
  • No of Pages: 52
  • Spine Width: 3 mm
  • Width: 152 mm


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