Abstract: Objective To evaluate the applicability of 2 different diagnostic criteria for chronic drug-induced liver injury (DILI) in China and the predictive value of total bilirubin (TBil) and alkaline phosphatase (ALP) at the second month after the onset of DILI.Methods A total of 73 cases of chronic DILI admitted to our hospital from January 2015 to June 2018 were enrolled. The patients were assessed by 6-month and 12-month diagnostic criteria, respectively. The diagnostic results of the 2 criteria were compared. The predictive value of TBil and ALP at the second month after the onset of DILI was analyzed.Results According to the 6-month diagnostic criterion, 65 cases were in accordance with the diagnosis of chronic DILI, and 8 cases were not. The best predictive threshold of TBil at the second month was 33.65 umol/L, with a sensitivity of 88% and a specificity of 61%. The level of ALP at the second month had no predictive value. According to the 12-month diagnostic criterion, 51 cases were in accordance with the diagnosis of chronic DILI, 22 cases were not. The levels of TBil and ALP at the second month both had no predictive value. Between the 2 criteria, there were significant differences (P<0.05). The detection rate of 6-month criterion was higher than that of 12-month criterion, and 43 patients met the 2 criteria at the same time.Conclusion At the second month after the onset of DILI, the predictive value of TBil was higher than that of ALP. According to the standard definition of chronic DILI, in consideration of diagnostic efficacy and the situation of DILI in China, it is suggested to refer to the 6-month diagnostic criterion for treatment and 12-month diagnostic criterion for diagnosis.

Key words: Chronic drug-induced liver injury, Diagnose, Clinical study