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

Rui Zheng¹, Zhuo Chen¹, Xiao-Ying Zhong¹

¹Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, China.

Chinese Journal of Integrative Medicine

|November 18, 2025

Summary

Age, gender, allergies, and combining Xuebijing Injection (XBJ) with other β-lactam antimicrobials are key risk factors for severe adverse events (AEs). Careful clinical consideration of these factors, especially XBJ-β-lactam combinations, is crucial for patient safety.

Keywords:

Xuebijing Injection adverse event other β-lactam antimicrobials propensity score-matched analysis risk factor safety

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Area of Science:

Pharmacovigilance
Drug Safety
Clinical Pharmacology

Background:

Xuebijing Injection (XBJ) is a widely used traditional Chinese medicine injection.
Understanding risk factors for XBJ-related adverse events (AEs) is crucial for safe clinical practice.

Purpose of the Study:

To identify and analyze risk factors associated with the severity of XBJ-related adverse events (AEs).

Main Methods:

Retrospective analysis of 16,031 XBJ-related AE cases from China's spontaneous reporting system (2004-2022).
Examination of factors including age, gender, weight, ethnicity, family history, and allergic history.
Application of univariate, multivariate logistic regression, and propensity score matching (PSM) for robust analysis.

Main Results:

11,131 valid XBJ-related AE cases were analyzed, with 1,360 classified as serious.
Serious AEs predominantly affected the respiratory, thoracic, and mediastinal systems (27%).
Age, gender, allergy history, and combination with β-lactam antimicrobials were identified as significant risk factors for severe AEs, with PSM confirming a higher risk (OR=1.913) for XBJ-β-lactam combinations.

Conclusions:

Age, gender, allergy history, and concurrent use of XBJ with β-lactam antimicrobials are significant risk factors for severe AEs.
The combination of XBJ with other β-lactam antimicrobials warrants particular attention in clinical settings due to increased risk of severe adverse events.