Protocol of intensive hospital monitoring with long follow up and large sample: Diemailing Kudiezi injection as example
Liao, X.; Xie, Y-Ming.; Wang, G-Qian.
Zhongguo Zhong Yao Za Zhi 41(24): 4494-4499
2016
ISSN/ISBN: 1001-5302 PMID: 28936829 Document Number: 688579
This is a protocol of intensive hospital monitoring with long follow up and large sample of Diemailing Kudiezi injection, which aims to identify adverse drug reactions(ADRs) of Diemailing Kudiezi injection, including known incidence of adverse reactions, the incidence of new adverse reactions, the incidence of various ADR symptoms and the incidence of ADR among the sub populations; clarify the clinical features of ADRs of Diemailing Kudiezi injection; explore risk factors for ADRs; and analyze their usage in real world. After all, no existing experience about active surveillance on safety issues for postmarkeing traditional Chinese medicine injections could be used for us to learn. On the basis of references to related domestic policies and regulations as well as the design points for observational studies, we extensively solicited opinions from experts in the industry to develop this implementation protocol on monitoring research.