Development of coding terminologies on adverse drug reactions for traditional Chinese medicine_Chinese Journal of Evidence-Based Medicine

Authors：

LI Qingna , LU Fang , ZHAO Yang , LI Rui , ZHAO Yingpan , ZI Mingjie ,  TANG Xudong ,  GAO Rui

Institute of Clinical Pharmacology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing, 100091, P.R.China;

Corresponding author：

TANG Xudong, Email: txdly@sina.com; GAO Rui, Email: ruigao@126.com

Keywords：

Traditional Chinese medicine; Adverse drug reaction; MedDRA

DOI：

10.7507/1672-2531.201804073

Video：

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Adverse drug reactions (ADR) are one important type of safety data for investigational products and post-market drugs. Standardized coding is beneficial to normative ADR analysis and reporting. However, terms peculiar to traditional Chinese medicine (TCM) are not included in the widely used international adverse reaction terminologies. This paper briefly introduced the differences of World Health Organization adverse reaction terminology (WHOART) and medical dictionary for regulatory activities (MedDRA) which was developed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). Based on the existing development of TCM terminologies for coding ADRs, basic path for developing internationally recognized TCM terminologies was proposed in this paper.

Citation： LI Qingna, LU Fang, ZHAO Yang, LI Rui, ZHAO Yingpan, ZI Mingjie, TANG Xudong, GAO Rui. Development of coding terminologies on adverse drug reactions for traditional Chinese medicine. Chinese Journal of Evidence-Based Medicine, 2018, 18(11): 1169-1172. doi: 10.7507/1672-2531.201804073 Copy

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2. Anna ZW. MedDRA and MSSO Updates. Available at: https://www.meddra.org/user-groups.
3. 马丹华. MedDRA应用于药品安全性监测与评价的可行性研究. Available at: https://www.meddra.org/user-groups.
4. 李庆娜, 陆芳, 赵阳, 等. 构建基于MedDRA术语的中医临床试验编码术语集初探. 中国药物警戒, 2015, 12(1): 53-55.
5. 李溪. 基于MedDRA的中药新药临床安全性评价术语编码数据库研究. 北京: 北京中医药大学, 2012.
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7. 中华人民共和国国家标准. 中医临床诊疗术语疾病部分(GB/T 16751.1-1997). 北京: 中国标准出版社, 1997.
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Chinese Journal of Evidence-Based Medicine

Development of coding terminologies on adverse drug reactions for traditional Chinese medicine

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