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Protocol of intensive hospital monitoring with long follow up and large sample: Diemailing Kudiezi injection as example / 中国中药杂志
China Journal of Chinese Materia Medica ; (24): 4494-4499, 2016.
Article in Chinese | WPRIM | ID: wpr-231029
ABSTRACT
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.

Full text: Available Index: WPRIM (Western Pacific) Type of study: Practice guideline / Observational study / Prognostic study / Risk factors Language: Chinese Journal: China Journal of Chinese Materia Medica Year: 2016 Type: Article

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Full text: Available Index: WPRIM (Western Pacific) Type of study: Practice guideline / Observational study / Prognostic study / Risk factors Language: Chinese Journal: China Journal of Chinese Materia Medica Year: 2016 Type: Article