Abstract: Objective To investigate the diagnostic value of serum total bile acid (TBA) in drug-induced cholestasis(DRIC). Methods Clinical and pathological data of patients with drug-induced liver injury who were hospitalized in Beijing You'an Hospital, Capital Medical University from July 2013 to August 2019 were collected. Based on pathological manifestations, the enrolled patients were grouped as having cholestasis or no cholestasis, and the TBA levels of the two groups were compared. Results A total of 281 DILI patients were enrolled, including 127 (45.20%) in the non-cholestatic group(group A) and 154 (54.80%) in the cholestatic group(group B). Hepatocellular cholestasis (61.04%) was the main pathological manifestation of cholestasis according to the pathological changes. There were no significant differences in gender, age and clinical symptoms between the two groups. The serum TBA, TBil and DBil levels in group B were significantly higher compared to group A (all P<0.05), and the hospital stay was longer (P<0.05). Univariate analysis showed that the serum TBA, TBil and DBil levels in group B were significantly higher than those in group A. Multivariate analysis showed that TBA was an independent predictor of cholestasis in patients with DILI. With 99.70 μmol/L as the critical value, the area under curve (AUC) of TBA for predicting hepatic histological cholestasis was 0.603 (0.536-0.671) (P=0.003), and its sensitivity and specificity were 52.6% and 74.0%, respectively. When the serum TBA level≥20.1 μmol/L, the probability of cholestasis could be considered as 75%, and the sensitivity was greater than 76.6%. Conclusion Serum TBA, TBil and DBil are sensitive indexes for DRIC. Moreover, serum TBA can be diagnostically useful.

Key words: Drug-induced liver injury, Cholestasis, Bile acid, Pathology