Abstract

This study aims to assess if adverse drug reactions (ADRs) to parenterally administered salvianolate are allergic in origin. Hospital information system (HIS) data from 20 hospitals in China were used to carry out a retrospective nested case control design study. Included were patients who received dexamethasone for suspected allergic reactions after receiving parenterally administered salvianolate. These were compared with non-allergic reaction people. Single factor logistic regression and multiple factor logistic regression were used to analyze data. Condition on admission, allergic history, dosage, disease status and drug combinations were taken into account in cases of suspected allergic reactions. After analysis in two subgroups we found that the condition on admission had a significant effect, P values was < 0.000 1 on suspected cases of allergic reactions in the first subgroup analysis. For the second subgroup analysis, we found condition on solvents had a significant effects, P values was 0.005 1 on suspected cases of allergic reactions. We also found that using other four injections at the same time as parenterally administered salvianolate could be risky factors in suspected cases of allergic reactions. For the second subgroup analysis combining using three injections could increase risks. However, further research for verification is required. This study can provide guidance for safe clinical practice in using parenterally administered salvianolate.

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