Abstract

Background: Drug-induced liver injury (DILI) is a complex disease and could lead to death. The clinical characteristics of DILI vary in China and western countries. This study analyzed the causes, clinical features and outcomes of DILI from China. Methods: All 2035 cases with DILI were retrospectively collected from the 96857 hospitalized patients due to liver injury in the 302 Military Hospital between January 2009 and January 2014. Results: Chinese herbal medicine (CHM) was implicated in 595 patients (29.2%), whereas Western medicine (WM) and a combination of WM and CHM were implicated in 875 cases (43.0%) and the other patients (27.8%), respectively. The major classes of implicated WM were antibiotics and antituberculotics and the most commonly implicated antibiotic was azithromycin. In patients with DILI caused by CHM, 52.4% were caused by herbal decoction and the major implicated herb were Polygonum multiflorum. Compared to WM, there were more female patients, less alcohol use, and higher proportion of hepatocellular injury pattern in cases with caused by CHM, but no differences in outcomes was found. The outcomes of the entire DILI cases were generally good, whereas 345 cases got poor prognosis, in which 13.3% developed into chronic DILI, 3.1% died due to liver injury, and 0.5% underwent liver transplantation. A model for prediction about prognosis of DILI, involving alanine transaminase (ALT), alkaline phosphatase (ALP), total bilirubin (TB) and international normalized ratio (INR), was established and achieved sensitivity and specificity both over 0.90. Conclusions: The clinical characteristics of DILI in China are different from those in western countries and the features of cases with DILI caused by CHM differ from those by WM. The established prognosis model was ready-to-use to give prediction of outcome by biochemical indices. Table 1. Characteristics of patients with DILI caused by Chinese herbal medicine as compared with Western medicine.

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