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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 |
Hits 777 Download times 770 Received:August 01, 2023 |
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DOI
10.11656/j.issn.1673-9043.2023.06.16 |
Key Words
glossary of adverse drug reactions;traditional Chinese medicine;safety evaluation;MedDRA |
Author Name | Affiliation | E-mail | WANG Chunyang | Centre for Evidence-Based Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | DU Xuechen | Centre for Evidence-Based Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | ZHUANG Ming | Centre for Evidence-Based Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | AN Jiali | Centre for Evidence-Based Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | ZHONG Mengyuan | Centre for Evidence-Based Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | ZHENG Wenke | Centre for Evidence-Based Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | zhengwk@tice.com.cn |
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Abstract
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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. |
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