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Interpretação do "Guia de farmacovigilância para a aplicação clínica de medicamentos orais de Medicina Tradicional Chinesa"

  • role： First author第一作者
  • Affiliation：

    Institute of Basic Research in Clinical Medicine，China Academy of Chinese Medical Sciences，Beijing 100700，China

  • Email：pengwenxi@163.com
  • Introduction：彭文茜，在读硕士，从事中药上市后评价研究，E-mail：pengwenxi@163.com
PENG Wenxi1,  
  • Affiliation：

    Institute of Basic Research in Clinical Medicine，China Academy of Chinese Medical Sciences，Beijing 100700，China

QIAO Meng1,  
  • Affiliation：

    Institute of Basic Research in Clinical Medicine，China Academy of Chinese Medical Sciences，Beijing 100700，China

WANG Lianxin1,  
  • Affiliation：

    Institute of Basic Research in Clinical Medicine，China Academy of Chinese Medical Sciences，Beijing 100700，China

LI Yuanyuan1,  
  • Affiliation：

    Beijing You'an Hospital，Capital Medical University，Beijing 100069，China

LI Xiuhui2,  
  • Affiliation：

    Institute of Basic Research in Clinical Medicine，China Academy of Chinese Medical Sciences，Beijing 100700，China

CUI Xin1,  
  • Affiliation：

    Xiyuan Hospital，China Academy of Chinese Medical Science，Beijing 100091，China

CHEN Zijia3,  
  • Affiliation：

    Institute of Basic Research in Clinical Medicine，China Academy of Chinese Medical Sciences，Beijing 100700，China

CHEN Xinyi1,  
  • Affiliation：

    Institute of Basic Research in Clinical Medicine，China Academy of Chinese Medical Sciences，Beijing 100700，China

DENG Yi1,  
  • role： Corresponding author通信作者
  • Affiliation：

    Institute of Basic Research in Clinical Medicine，China Academy of Chinese Medical Sciences，Beijing 100700，China

  • Email：ktzu2018@163.com
  • Introduction：谢雁鸣，首席研究员，博士生导师，从事中药上市后评价研究，E-mail：ktzu2018@163.com
XIE Yanming1*,  
  • role： Corresponding author通信作者
  • Affiliation：

    Institute of Basic Research in Clinical Medicine，China Academy of Chinese Medical Sciences，Beijing 100700，China

  • Email：wzhftcm@163.com
  • Introduction：王志飞，研究员，博士生导师，从事中药上市后评价研究，E-mail：wzhftcm@163.com；
WANG Zhifei1*

Resumo

O "Guia de farmacovigilância para a aplicação clínica de medicamentos orais de Medicina Tradicional Chinesa" (doravante "Guia") é o primeiro guia especializado no campo da farmacovigilância de medicamentos orais de Medicina Tradicional Chinesa na China. Baseia-se nas condições nacionais da China, focando nas características de uso e manifestações de risco dos medicamentos orais chineses, preenchendo uma lacuna regulatória nesse campo. Para garantir a compreensão correta e a implementação eficaz do Guia, e promover a padronização do trabalho de farmacovigilância dos medicamentos orais chineses, este artigo realiza uma interpretação sistemática em torno de três aspectos centrais do Guia. No que tange à monitorização e relatório, este artigo analisa os motivos práticos para a integração de informação de risco provenientes de múltiplos canais, ao mesmo tempo que esclarece as bases para o estabelecimento de variedades e populações-chave de monitorização; na avaliação de risco, analisa-se o quadro de avaliação de risco a partir de três perspetivas — componentes, comportamento e populações — para responder aos riscos complexos causados pela composição do medicamento, riscos comportamentais e diferenças populacionais; no controlo de riscos, foca-se no conceito de intervenção em cenários de risco e no caminho de gestão dinâmica de ciclo fechado, explorando como realizar a transição da resposta passiva para a intervenção ativa na prática. Além disso, o artigo analisa o valor da aplicação do Guia e propõe caminhos de otimização que incluem o aperfeiçoamento do mecanismo de atualização dinâmica, o fortalecimento da formação básica, e o incentivo à capacitação da farmacovigilância através da inteligência artificial, para superar dificuldades atuais como a fragilidade técnica na base e a insuficiência da infraestrutura informática. Este artigo visa fornecer referência para tomada de decisões e suporte à implementação para titulares de autorizações de comercialização (incluindo empresas farmacêuticas), empresas de distribuição, instituições médicas, institutos de pesquisa e outras organizações relacionadas, promovendo o estabelecimento e a otimização do sistema de farmacovigilância ao longo de todo o ciclo de vida dos medicamentos orais chineses.

Palavras-chave

medicamentos orais chineses;aplicação clínica;farmacovigilância;interpretação do guia

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