Abstract
Background Drug-induced liver injury(DILI) is difficult in diagnose, criteria used now are mostly based on history review. We tried to evaluate the value of these criteria and histopathology features in DILI to perform a method diagnosing DILI more definitely.Methods We enrolled 458 consecutive hospitalized DILI patients from 1st January 2012 to 31st December 2018, using Roussel-Uclaf Causality Assessment Method(RUCAM), Maria&Victorino scale (M&V) and Digestive Disease Week-Japan criterion(DDW-J) to perform the evaluation. A refined pathological scale was calculated and combined with those criteria using logistic regression analysis. Area under receiver operating characteristics(AUROC) were used to estimate diagnostic accuracy.Results The AUROC of the three clinical diagnostic criteria were 0.730 (95%CI:0.667-0.793), 0.793(95%CI:0.740-0.847) and 0.764(95%CI:0.702-0.826) respectively. The AUROC of the refined pathological scale combined with the three criteria were 0.843(95%CI:0.747-0.914), 0.907(95%CI:0.822-0.960) and 0.881(95%CI:0.790-0.942) respectively. In hepatocellular type, the AUROCs were 0.894(95%CI:0.787-0.959), 0.960(95%CI:0.857-0.994) and 0.940(95%CI:0.847-0.985); In cholestatic type, the AUROCs were 0.750(95%CI:0.466-0.931), 0.500(95%CI:0.239-0.761) and 0.500(95%CI:0.239-0.761); In mixed type, the AUROCs were 0.786(95%CI: 0.524-0.943), 0.869(95%CI:0.619-0.981) and 0.762(95%CI: 0.498 -0.930).Conclusion Combined with pathological scale can significantly improve the accuracy of clinical diagnostic criteria, no matter in alone or combined condition, M&V might be more accurate in diagnosing DILI from suspected patients.