Risk Factors for Severity of Adverse Events Associated with Xuebijing Injection: A Propensity Score-Matched Analysis

To determine risk factors associated with the severity of Xuebijing Injection (XBJ)-related adverse events (AEs).

Totally 16,031 cases reported XBJ-related AEs were retrospectively analyzed from China national spontaneous reporting system (SRS) from its inception to 2022. Factors including age, gender, weight, ethnicity, family history, and allergic history were examined. Univariate and multivariate logistic regression analyses were performed, followed by propensity score matching (PSM) to control for confounding factors.

A total of 11,131 XBJ-related AE cases were identified after excluding duplicates and incomplete reports, including 9,771 general and 1,360 serious AEs. Serious AEs were mainly distributed among respiratory, thoracic and mediastinal disorders (27.00%). Univariate analysis identified gender, age, history of allergies, and previous AE history, XBJ-other β-lactam antimicrobials combination and XBJ-aminoglycoside antimicrobials combination were potential risk factors of serious AEs (P<0.05 or P<0.01). Multivariate analysis identified age, gender, history of allergies, and XBJ-other β-lactam antimicrobials combination as significant risk factors of AE severity (P<0.05 or P<0.01). PSM further confirmed that patients receiving XBJ combined with β-lactam antibiotics had a significantly higher risk of severe AEs (odds ratio=1.913, P=0.019).

The risk factors influencing the severity of XBJ include age, gender, history of allergies, and its combination with other β-lactam antimicrobials. Among them, PSM further proved that the XBJ-other β-lactam antimicrobials combination needs to be given attention in clinical practice.