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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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DOI   10.11656/j.issn.1673-9043.2023.06.16
Key Words   glossary of adverse drug reactions;traditional Chinese medicine;safety evaluation;MedDRA
Author NameAffiliationE-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 
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.

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