Clinical Features of Anti-Tuberculosis Drug-Induced Liver Injury and Risk Factors for Severe Cases: A Retrospective Study in China

Shuang Zhang,1 Ningning Dong,1 Lu Wang,1 Yu Lu,1 Xiaoyou Chen2 1Department of Pharmacology, Beijing Key Laboratory of Drug Resistance Tuberculosis Research, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing, People’s Republic of China; 2Infectious Diseases Department, Beijing Ditan Hospital, Capital Medical University, Beijing, People’s Republic of ChinaCorrespondence: Yu Lu, Department of Pharmacology, Beijing Key Laboratory of Drug Resistance Tuberculosis Research, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing, People’s Republic of China, Email [email protected] Xiaoyou Chen, Infectious Diseases Department, Beijing Ditan Hospital, Capital Medical University, Beijing, People’s Republic of China, Email [email protected]: Anti-tuberculosis drug-induced liver injury (ATB-DILI) is a common adverse reaction associated with tuberculosis (TB) treatment, significantly impacting treatment adherence and therapeutic outcomes. However, large-scale studies on hospitalized patients in China remain limited.Purpose: To characterize the clinical features and liver injury patterns in hospitalized TB patients with ATB-DILI and to identify risk factors associated with severe ATB-DILI.Methods: We retrospectively reviewed 28,753 hospitalized TB patients at Beijing Chest Hospital from 2014 to 2023. ATB-DILI was diagnosed in 567 patients (2.0%) based on serum biochemical criteria and causality assessment. Demographic, clinical, and laboratory data were analyzed to characterize liver injury types and identify risk factors for severe cases. Subgroup analyses based on liver injury patterns were performed to further evaluate the association between age and severe ATB-DILI.Results: Overall, 567 cases with ATB-DILI (2.0%) were analyzed. Hepatocellular injury was the most common type (71.4%), followed by cholestatic (13.8%) and mixed (14.8%) injury patterns. Most patients (68.4%) were asymptomatic and diagnosed via routine biochemical monitoring; jaundice occurred in 18.2%. Patients with hepatocellular damage were significantly younger, while those with cholestatic injury were older (p < 0.001). Severe ATB-DILI occurred in 46 patients (8.1%), with advanced age (≥ 60 years) identified as an independent risk factor (OR = 2.45, 95% CI: 1.33– 4.52, p = 0.004). Subgroup analysis showed that this association between age and severe ATB-DILI was significant in the hepatocellular injury type (unadjusted OR = 3.59, 95% CI: 1.61– 8.02, p = 0.002), while no statistically significant association was observed in cholestatic or mixed types, which may reflect limited statistical power in these subgroups.Conclusion: Routine liver function monitoring and age-specific risk assessment are essential for early identification and management of ATB-DILI in hospitalized TB patients.Keywords: anti-tuberculosis drugs, drug-induced liver injury, hepatotoxicity, severe liver injury, risk factors