Abstract: Objective To explore the risk factors and prognosis of drug-induced liver injury(DILI) and liver failure(DILF). Methods Between January 2015 and December 2022, hospitalized patients in Nantong Cancer Hospital who were diagnosed with DILI or DILF were enrolled. There were 221 patients with DILI[97 males, 124 females; age=46 (37, 60) years] and 32 cases of DILF[17 males, 15 females, age=47 (40, 58) years]. The clinical data of DILI, DILF and DILF patients with different clinical outcomes were compared. Multivariate analysis was used to explore the risk factors and poor prognosis of liver failure. Results The drug use of DILI patients included 120 cases of traditional Chinese medicines/proprietary Chinese medicines (54.3 %), 37 cases of anti-tuberculosis drugs (16.7 %), 29 cases of cold drugs (13.1 %), 11 cases of anti-tumor drugs (5.0 %), 7 cases of hypolipidemic drugs (3.2 %), 5 cases of antithyroid drugs (2.3 %) and neuropsychiatric drugs. The drug use of DILF patients included 14 cases of anti-tuberculosis drugs (43.7 %), 12 cases of traditional Chinese medicine/proprietary Chinese medicine (37.5 %), 2 cases of cold drugs (6.2 %), and 1 case of anti-tumor drugs, immunomodulators, psychotropic drugs and antihypertensive drugs (3.1 %). Univariate analysis showed that the scores of HBV infection, anti-tuberculosis drugs, WBC, AST, TBil, blood ammonia, INR and MELD in patients with DILI were significantly lower than those in patients with DILF, while PLT and PTA in patients with DILI were significantly higher than those in patients with DILF(P<0.05). Excluding indicators that reflect the severity of liver injury such as liver function, coagulation function and other indicators, multivariate analysis showed that HBV infection, increased WBC and decreased PLT were independent risk factors for DILF(P<0.05). After systemic treatment, 14 patients with DILF improved and 18 patients deteriorated. Univariate analysis indicated that the differences in ALT, TBil, Scr, PTA, INR and MELD scores between patients with DILF who improved and those who deteriorated were statistically significant (P<0.05). Multivariate analysis showed that low PTA was an independent risk factor for poor prognosis of DILF patients (P<0.05). Conclusion There are many risk factors for patients with DILF, including increased WBC and decreased PLT. When HBV-infected patients take anti-tuberculosis drugs, traditional Chinese medicine/Chinese patent medicine and other high-risk drugs causing liver injury, they need to be alert to the occurrence of AILF. In addition, patients with AILF often have poor prognoses when they have abnormal coagulation function.

Key words: Drug-induced liver injury, Liver failure, Anti-tuberculosis drugs, HBV infection, Prothrombin time activity