Objective:

2

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

Methods:

2

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.

Results:

2

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).

Conclusions:

2

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.