To establish a body of evidence on safety for postmarketing Chinese medicine: A new research paradigm

Xing Liao; Yan-ming Xie; Nicola Robinson; Yong-yan Wang

doi:10.1007/s11655-016-2534-x

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To establish a body of evidence on safety for postmarketing Chinese medicine: A new research paradigm

OriginalPaper | Updated：2021-08-27

- To establish a body of evidence on safety for postmarketing Chinese medicine: A new research paradigm
- To establish a body of evidence on safety for postmarketing Chinese medicine: A new research paradigm
- 中国结合医学杂志（英文版） 2017年23卷第3期页码：226-232
- Affiliations：
  
  Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences,Beijing,China
- Author bio：
- Funds：
  
  Supported by the Ninth-Science Foundation of Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences (No. Z0406), the Seventh Science Foundation of China Academy of Chinese Medical Sciences (No. ZZ070817), National Natural Science Foundation of China (General Program, No. 81202776) and China Postdoctoral Science Foundation project (No. 2014T70202)
- DOI：10.1007/s11655-016-2534-x
  中图分类号：
- 纸质出版日期：2017，
  
  网络出版日期：2016-11-29，
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Liao, X., Xie, Ym., Robinson, N. et al. To establish a body of evidence on safety for postmarketing Chinese medicine: A new research paradigm., Chin. J. Integr. Med. 23, 226–232 (2017). https://doi.org/10.1007/s11655-016-2534-x

Xing Liao, Yan-ming Xie, Nicola Robinson, et al. To establish a body of evidence on safety for postmarketing Chinese medicine: A new research paradigm[J]. Chinese Journal of Integrative Medicine, 2017,23(3):226-232.
Liao, X., Xie, Ym., Robinson, N. et al. To establish a body of evidence on safety for postmarketing Chinese medicine: A new research paradigm., Chin. J. Integr. Med. 23, 226–232 (2017). https://doi.org/10.1007/s11655-016-2534-x DOI：

Xing Liao, Yan-ming Xie, Nicola Robinson, et al. To establish a body of evidence on safety for postmarketing Chinese medicine: A new research paradigm[J]. Chinese Journal of Integrative Medicine, 2017,23(3):226-232. DOI： 10.1007/s11655-016-2534-x.

摘要

The issue of safety evaluation on postmarketing Chinese medicines has become a hot topic in mainland China recently. Researchers and decision-makers can obtain a variety of evidence resources about safety in order to evaluate the safety profile for postmarketing Chinese medicines. A registry study on ten Chinese medicine injections for postmarketing surveillance has come to the end. From such a study observing more than 300

000 patients for more than 4 years

a theoretical research question emerges

that is

how to identify and evaluate safety evidence systematically. We put forward a brand new research paradigm on the theory level

which is to establish a body of evidence on safety evaluation for postmarketing Chinese medicine. Therefore

multiple information sources were explored and extracted from preclinical experiments for toxicity

postmarketing clinical trials for effificacy and safety evaluation

registry study for surveillance

retrospective data analysis from hospital information system and spontaneous response system

and case reports and systematic review from literature. Greater efforts for this idea and cooperation with experts in this fifield both in China and abroad are urgently needed.

Abstract

000 patients for more than 4 years

a theoretical research question emerges

that is

how to identify and evaluate safety evidence systematically. We put forward a brand new research paradigm on the theory level

which is to establish a body of evidence on safety evaluation for postmarketing Chinese medicine. Therefore

multiple information sources were explored and extracted from preclinical experiments for toxicity

postmarketing clinical trials for effificacy and safety evaluation

registry study for surveillance

retrospective data analysis from hospital information system and spontaneous response system

and case reports and systematic review from literature. Greater efforts for this idea and cooperation with experts in this fifield both in China and abroad are urgently needed.

关键词

postmarketing Chinese medicinesafety researchKudiezi Injectionbody of evidence

Keywords

postmarketing Chinese medicinesafety researchKudiezi Injectionbody of evidence

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