Assessment of cholestasis in drug-induced liver injury by different methods

Cholestasis in drug-induced liver injury (DILI) can be assessed by biochemical and pathologic methods, but the agreement between the 2 methods remains unclear. The aim of this study was to identify the accurate method for assessment of cholestasis in DILI. The DILI standard established and revised by the Council for International Organizations of Medical Sciences (CIOMS) (R values were calculated by liver function at different time points), cholestatic liver disease guideline (European Association for the Study of the Liver, EASL), and liver pathology were used to assess, compare, and analyze the cholestasis in 133 patients with DILI. The R values at different time points in CIOMS standard had no statistical difference for the assessment of cholestatic DILI (a = 0.05, χ(2) = 1.51, P = .679). There were statistical differences among the results of CIOMS, EASL, and pathology (a = 0.05, χ(2) = 99.97, P < .001). EASL standard had no statistical difference with pathology (a = 0.003, χ(2) = 8.00, P = .005). CIOMS and EASL standards based on biochemical parameters underestimated cholestatic DILI, as compared to liver pathology.