Chinese Journal of Pharmacovigilance ›› 2025, Vol. 22 ›› Issue (12): 1404-1409.
DOI: 10.19803/j.1672-8629.20250464

• Orginal Article • Previous Articles     Next Articles

Clinical Profiles and Risk Factors of 400 Cases of Drug-Induced Liver Injury

YANG Chuang1,2, ZHOU Ying, ZHU Xiang1, LI Na1, QUAN Mingxia2, WAN Jiangju2, SHEN Hong2, CHEN Jie1*   

  1. 1 Department of Pharmacy, Kunming Third People’s Hospital, Kunming Yunnan 650000, China;
    2School of Pharmacy, Dali University, Dali Yunnan 671000, China;
    3Department of Pharmacy, Xichang People’s Hospital, Xichang Sichuan 615000, China
  • Received:2025-07-14 Published:2025-12-19

Abstract: Objective To analyze the current incidence of and risk factors for drug-induced liver injury (DILI), and to investigate the differences in risk factor profiles between non-ATB-DILI and ATB-DILI. Methods A retrospective study was conducted to collect medical records of patients diagnosed with drug-induced liver injury (DILI) in 2024 at the Third People's Hospital of Kunming. Patients in the DILI group (n=400) were assigned to the case group while those in the abnormal liver biochemistry group (n=500) served as controls. A multivariate logistic regression model was used to identify potential risk factors associated with DILI. Based on the suspected causative agents, DILI cases were subsequently classified into non-ATB-DILI and ATB-DILI subgroups that were then compared with the overall abnormal liver biochemistry group as well as their corresponding subgroups (non-ATB abnormal liver biochemistry and ATB abnormal liver biochemistry) in order to explore differences in risk factor profiles between the two types of DILI. Results Among the suspected drugs causing DILI, anti-tuberculosis agents accounted for the highest proportion (64.54%), followed by anti-infective agents (23.52%) and traditional Chinese medicines/dietary supplements (TCM/DS) (4.12%). DILI and its subgroups (non-ATB-DILI and ATB-DILI) were mostly hepatocellular in type, with most cases classified as mild (Grade 1). Multivariate logistic regression analysis indicated that female sex, liver disease, HIV infection, and coagulation dysfunction might be potential risk factors for DILI, with notable differences between non-ATB-DILI and ATB-DILI. For non-ATB-DILI, risk factors included female sex, liver disease, HIV infection, and coagulation dysfunction, whereas for ATB-DILI, only coagulation dysfunction was identified as a risk factor. In addition, patients with coagulation dysfunction were more vulnerable to non-ATB-DILI (OR=2.595>1.847). Conclusion Female sex, liver disease, HIV infection, and coagulation dysfunction are identified as potential risk factors for DILI. Differences in risk factor profiles between non-ATB-DILI and ATB-DILI are of statistically significant. Therefore, differentiated risk assessment and monitoring strategies should be implemented in clinical practice according to the types of patients in order to enable early identification and precise interventions among high-risk populations, thereby reducing the risk of DILI.

Key words: Drug-Induced Liver Injury, Anti-Tuberculosis Drugs, Anti-Infective Agents, Traditional Chinese Medicine(TCM)/Herbal and Dietary Supplements(HDS), Risk Factors, Female, Liver Diseases, HIV Infection, Abnormal Coagulation Function

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