| 摘要: |
| 药品的安全性一直是全球热议的话题,评价药品安全性的基础在于对药品不良反应术语的标准化,这可以为药品监管机构提供评估药品安全性的依据。本文通过文献检索和网页查询等方法,对国际上现有的不良反应术语集《监管活动医学词典》(MedDRA)、《WHO不良反应术语集》(WHOART)、不良事件通用术语标准(CTCAE)、风湿病常见毒性标准(OMERACT)的词表概括、层级结构和应用特点进行了总结和介绍。同时,还分析了中国现有的不良反应术语集在使用中所遇到的实际问题。本文结合中医药安全性评价的特点,对建立中医药不良反应术语集进行了深入讨论。 |
| 关键词: 药品不良反应术语集 中医药 安全性评价 监管活动医学词典 |
| DOI：10.11656/j.issn.1673-9043.2023.06.16 |
| 分类号:R2-03 |
| 基金项目:国家自然科学基金项目（82274682）；天津市中医药重点领域科技项目（C0101）。 |
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| Inspiration from the international terminology of adverse reaction to the establishment of the terminology of adverse reaction of traditional Chinese medicine |
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WANG Chunyang, DU Xuechen, ZHUANG Ming, AN Jiali, ZHONG Mengyuan, ZHENG Wenke
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Centre for Evidence-Based Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China
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| Abstract: |
| Drug safety has always been a hot topic in the world. The basis of evaluating drug safety lies in the standardization of terms of adverse drug reactions,which can provide a basis for drug regulators to evaluate drug safety. By means of literature search and web search,this paper summarized and introduced the summary,hierarchical structure and application characteristics of the existing international glossary of adverse reaction terms MedDRA,WHO-ART,CTCAE and OMERACT. At the same time,it also analyzes the practical problems encountered in the use of the existing adverse reaction term set. Based on the characteristics of safety evaluation of traditional Chinese medicine (TCM),this paper discussed the establishment of a glossary of adverse reactions of TCM. |
| Key words: glossary of adverse drug reactions traditional Chinese medicine safety evaluation MedDRA |
