Security revaluation study based on nested case-control method of Danhong injection

To explore security revaluation of Danhong injection and study correlative influencing factor of ADR/ADE.The retrospective nested case-control study was carried out in hospitalized patients of the first affiliated hospital of Henan university of traditional Chinese medicine (TCM). The 8 452 cases of participation Danhong injection adverse reaction scentralized monitoring were defined as the study cohort. Adverse reactions occurred in patients with data as the case group, according to choose control group by methods of group design and individual matching in accordance with the ratio of 1:4 (The case group 52 cases and 208 patients in control group), to estimate the correlative fluencing factor of ADR/ADE.The univariate analysis indicated that factors which OR value of group design reaching significance level were gender, personal allergichistory and medication days (P<0.05), factors of individual matching OR value reaching significance level were just only medication days (P<0.05). Multivariate logistic regression analysis showed that factors screened into equation were gender and personal allergic history.The correlative in fluencing factor of Danhong injection adverse reactions have more correlation with taking medicine population. We should pay special attention to female and the population which have personal allergic history.