张力,杨晓晖.在中药安全性监测和评价过程中充分引入药物警戒理念[J].,2009,(9):843-846 |
在中药安全性监测和评价过程中充分引入药物警戒理念 |
Pharmacovigilance Idea Should Be Introduced Sufficiently into the Safety Monitoring and Evaluation Process of Chinese Drugs |
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DOI: |
中文关键词: 中药 安全性 不良反应 监测 评价 药物警戒 |
英文关键词:Chinese drug safety adverse reaction monitoring evaluation pharmacovigilance |
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中文摘要: |
随着公众安全用药意识的普遍提升和中药新剂型的研制及使用,有关中药安全性的问题也日益受到重视。如何客观认识、分析和评价中药的安全性问题,不仅关系到保障公众用药安全的科学决策,也关系到中医药产业的健康发展。本文从药物警戒理念入手阐述"中药不良反应"及"中药不良事件"的不同涵义,从药物警戒角度客观分析影响中药安全性的相关因素,提出"中药安全性监测与评价"概念更符合实际工作需要,并认为在中药安全性监测与评价过程中充分引入药物警戒理念是全面评价、有效控制中药风险的基础。 |
英文摘要: |
Along with the general improving of public consciousness on drugs′ safety and the increasing of new Chinese drugs′ manufacture and application,the safety of Chinese drugs has become a more prominent concern and a focus of attention.The scientific identification,analysis and evaluation of this affairs greatly impacts the scientific decision-making for ensuring the public use of drugs in security,also influences the healthy development of Chinese medicine industry.In this paper,the different meanings of "adverse reaction" and "adverse events" of Chinese drugs were introduced from pharmacovigilance idealistic view,and the influencing factors on safety of Chinese drugs were analyzed from the perspective of pharmacovigilance.The authors proposed that "Chinese medicine safety monitoring and evaluation" is a much more practical concept in consistence with the current situation.They pointed out that introducing sufficiently the concept of pharmaco vigilance idea into the safety monitoring and evaluation process is the basis for overall evaluation and effective risk controlling of Chinese drugs. |
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