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;
Parallel
Methylprednisolone
DrugInitially, an intravenous dose of 1 mg/kg/day of methylprednisolone will be administered for one week, with the possibility of extending treatment to two weeks if necessary. Following this, participants will receive oral methylprednisolone tablets, starting at a dose of 40 mg/day. The oral dosage will be gradually tapered based on the participants' condition over a period of 1 to 3 months.
Magnesium isoglycyrrhizinate
DrugIt is suitable for patients with hepatocellular or mixed DILI. A daily dose of 0.15g to 0.2g
Glutathione
DrugIt is suitable for patients with hepatocellular or mixed DILI. A daily dose of 1.2g to 1.8g
Silymarin
DrugIt is suitable for patients with hepatocellular or mixed DILI. The dosage is 140 mg, taken 2 to 3 times per day.
Polyene Phosphatidylcholine
DrugIt is suitable for patients with hepatocellular or mixed DILI. The dosage is 228mg-456mg, taken 3 times per day.
Ursodeoxycholic acid capsules
DrugIt is suitable for patients with cholestatic or mixed DILI. A daily dose of 10mg-15mg/kg/day.
Ademetionine 1,4-Butanedisulfonate
DrugIt is suitable for patients with cholestatic or mixed DILI. A daily dose of 0.5g to 1g.
Plaslna exchange
Procedure/SurgeryIt is suitable for patients whose condition continues to worsen or even develop to liver failure.
Liver transplantation
Procedure/SurgeryIt is suitable for patients whose condition continues to worsen or even develop to liver failure.
Improvement of DILI on the second week
TBIL level decreases by 50% as compared to the baseline level.
Improvement of DILI on the fourth week
TBIL level decreases by 50% as compared to the baseline level.
Progressive liver injury on the second week
TBIL level increases as compared to the baseline level.
Progressive liver injury on the fourth week
TBIL level increases as compared to the baseline level.
Improvement of liver enzymes on the second week
Proportion of 50% reduction from baseline in ALT, AST, ALP, and GGT levels.
Population who will be more suitable for glucocorticoids treatment
Characteristics of patients with DILI in whom glucocorticoids treatment is more beneficial.
Changes of inflammatory factors
Changes of IL-6 and TNF-α levels.
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