Abstract: Objective The purpose of this study was to investigate the diagnostic efficacy of serum cytokeratin (CK)18-M30, heme oxygenase-1(HO-1), hypoxia-inducible factor 1-alpha (HIF-1α) and nuclear factor erythroid 2-related factor 2(Nrf2) levels in patients with drug-induced liver injury (DILI). Methods 83 patients with DILI and 80 healthy individuals who underwent physical examinations were enrolled in our hospital between March 2021 and March 2024, and serum CK18-M30, HO-1, HIF-1α and Nrf2 levels were detected by using ELISA. Receiver operating characteristic (ROC) curve was constructed to evaluate the diagnostic performance. Results Serum ALT, AST, ALP, GGT and bilirubin levels in patients with DILI were(118.5±36.1)U/L, (91.4±40.3)U/L, (193.5±46.7)U/L, (377.8±86.2)U/L and (49.8±7.3)μmol/L, all significantly higher than in healthy persons (P<0.05); serum CK18-M30 level in healthy control was (4.9±0.2)ng/L, much higher than in those with DILI (P<0.05), while serum HO-1, HIF-1α and Nrf2 levels were (11.8±1.9)U/L, (55.4±16.3)ng/mL and (165.5±31.4)U/L, much lower than in those with DILI(P<0.05); ROC analysis showed that the AUC was 0.978(95%CI:0.952-1.000), with sensitivity of 97.6% and specificity of 93.2%, when any two parameters of the four serum markers reached to diagnostic threshold (cut-off-value:CK18-M30=4.08 ng/L, HO-1=15.40 U/L, HIF-1α=90.53 ng/mL and Nrf2=501.23 U/L) for DILI. Conclusion The detection of serum CK18-M30, HO-1, HIF-1α and Nrf2 levels might help make diagnosis of DILI, which needs further clinical investigation.

Key words: Drug-induced liver injury, Cytokeratin 18-M30, Heme oxygenase-1, Hypoxia-inducible factor 1-alpha, Nuclear factor erythroid 2-related factor 2, Diagnosis