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To establish a body of evidence on safety for postmarketing Chinese medicine: A new research paradigm
- Chinese Journal of Integrative Medicine Vol. 23, Issue 3, Pages: 226-232(2017)
- 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
CLC：Published：2017，
Published Online：29 November 2016，
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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 23(3):226-232(2017)
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 23(3):226-232(2017) 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
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.
关键词
postmarketing Chinese medicinesafety researchKudiezi Injectionbody of evidence
Keywords
postmarketing Chinese medicinesafety researchKudiezi Injectionbody of evidence
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