title: To establish a body of evidence on safety for postmarketing Chinese medicine: A new research paradigm.
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.
authors.affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, 100700, China.
authors.forename: Xing
authors.initials: X
authors.lastname: Liao
authors.affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, 100700, China. datmamining5288@163.com.
authors.forename: Yan-Ming
authors.initials: YM
authors.lastname: Xie
authors.affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, 100700, China.
authors.forename: Nicola
authors.initials: N
authors.lastname: Robinson
authors.affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, 100700, China.
authors.forename: Yong-Yan
authors.initials: YY
authors.lastname: Wang
mesh_terms: D002986:Clinical Trials as Topic; D004353:Drug Evaluation, Preclinical; D064420:Drug-Related Side Effects and Adverse Reactions; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use; D006751:Hospital Information Systems; D006801:Humans; D008516:Medicine, Chinese Traditional; D011358:Product Surveillance, Postmarketing; D012042:Registries; D012106:Research; D058028:Research Report
chemical_list: D004365:Drugs, Chinese Herbal
keywords: Kudiezi Injection; body of evidence; postmarketing Chinese medicine; safety research