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[中国中药不良反应监测的现状与发展]

[Current status and development of monitoring on adverse reaction of traditional Chinese medicine in China].

作者信息

Zhang Li, Yang Xiao-hui, Cao Li-ya, Ji Shaoliang

机构信息

Food and Drug Administration, Beijing.

出版信息

Zhongguo Zhong Xi Yi Jie He Za Zhi. 2005 Jul;25(7):581-4.

PMID:16089130
Abstract

With the wide usage of traditional Chinese medicine (TCM) and the diversity of its dosage-forms, the reports about adverse reaction (ADR) caused by TCM were gradually increased. As the cradle of TCM with tremendous manufacturing enterprise engaged for this purpose, to establish and perfect the TCM ADR monitoring is the problem that TCM industry should face to. In this paper, the key point of TCM ADR monitoring was made clear by analysing the current situation and the problems presented in TCM ADR monitoring in China, and indicated that the nowday developing goals of TCM ADR monitoring are to establish and perfect the technologic system for TCM ADR monitoring, strengthen the related basic research and enhance international communication and cooperation in this field.

摘要

随着中药的广泛应用及其剂型的多样化,有关中药引起不良反应(ADR)的报道逐渐增多。作为中药的发源地且有众多企业致力于此,建立和完善中药不良反应监测是中药行业应面对的问题。本文通过分析我国中药不良反应监测的现状及存在的问题,明确了中药不良反应监测的要点,并指出当前中药不良反应监测的发展目标是建立和完善中药不良反应监测技术体系,加强相关基础研究,加强该领域的国际交流与合作。

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[Current status and development of monitoring on adverse reaction of traditional Chinese medicine in China].[中国中药不良反应监测的现状与发展]
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Safety evaluation of chinese medicine injections with a cell imaging-based multiparametric assay revealed a critical involvement of mitochondrial function in hepatotoxicity.基于细胞成像的多参数分析的中药注射液安全性评价显示,线粒体功能在肝毒性中起关键作用。
Evid Based Complement Alternat Med. 2015;2015:379586. doi: 10.1155/2015/379586. Epub 2015 Feb 22.
2
Pharmacovigilance in China: current situation, successes and challenges.中国的药物警戒:现状、成就与挑战
Drug Saf. 2014 Oct;37(10):765-70. doi: 10.1007/s40264-014-0222-3.
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Spontaneous reporting of adverse drug reactions through electronic submission from regional society healthcare professionals in Korea.
韩国地区学会医护人员通过电子提交报告的药物不良反应自发报告。
Yonsei Med J. 2012 Sep;53(5):1022-7. doi: 10.3349/ymj.2012.53.5.1022.