Abstract: Objective To investigate the influencing factors of severe anaphylactic reactions (SAR) of Yanhuning injections in children, and to provide reference for clinical rational drug use. Methods A retrospective study was performed. The medical records of 7 320 children who had received Yanhuning injections in two hospitals from October 1, 2017 to October 31, 2020 were collected. SAR patients and non-SAR patients were selected by the diagnostic criteria of SAR. The SAR patients were included into the SAR group (n=57). Propensity score matching was used to match the control group from non-SAR patients at a ratio of 1:4 (n=228). The general data, primary diseases, drug combinations, and usage of Yanhuning injections were compared between the two groups. Univariate analysis and multivariate logistic analysis were used to analyze the factors that affected SARs of Yanhuning injections. Results The incidence of SAR in children who had used Yanhuning injections in our hospital was 0.78% (57/7 320). Univariate analysis showed that there was statistically significant difference between the two groups in the incidence of renal insufficiency, number of combined drugs, rate of overdose, infusion concentrations and ways of pretreatment. More logistic regression analysis showed that a creatinine clearance rate less than 30 mL/min(OR= 2.336, 95% CI: 1.227 to 4.362, P=0.009), more than 3 types of combined drugs (OR= 2.147, 95% CI: 1.189 to 3.878, P= 0.015), and overdose (OR= 3.708, 95%CI: 1.942 to 7.014, P= 0.000) were independent risk factors for SARs induced by Yanhuning injections in children, while pretreatment (OR= 0.473, 95% CI: 0.248 to 0.887, P= 0.043) was a protective factor. Conclusion Renal dysfunction, overdose of drugs, and drug combinations can increase the risk of SAR in children using Yanhuning injections, while tube flushing before and after infusion can reduce the incidence of SAR.

Key words: Yanhuning injection, children, severe anaphylactic reactions, risk factors