Drug-induced liver injury (DILI) can lead to potentially fatal complications, such as acute liver failure and even death. In clinical practice, glucocorticoids have been considered in some cases of DILI, especially patients with hyperbilirubinemia. However, the available evidence remains controversial and its quality is also very limited. Herein, a multicenter randomized controlled trial (RCT) has been designed to explore the efficacy and safety of glucocorticoids in patients with acute DILI and hyperbilirubinemia.
A definite diagnosis of acute DILI;
5×ULN ≤ TBIL level at baseline ≤ 20×ULN;
Age 18-80 years old;
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Other causes of liver injury, including viral hepatitis, cytomegalovirus infection, Epstein-Barr virus infection, Herpes virus infection, autoimmune liver disease, alcoholic liver disease, hypoxic/ischemic liver disease, Budd-Chiari syndrome, biliary tract disease, Wilson's disease, hemochromatosis, and α1-antitrypsin deficiency;
Immune checkpoint inhibitors or gynura segetum induced DILI;
Absolute contraindications to glucocorticoids, such as systemic mold infections or allergies;
A history of glucocorticoid therapy within 3 months before enrollment;