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Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia
Sponsor: General Hospital of Shenyang Military Region
Summary
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.
Official title: Efficacy and Safety of Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia: A Multicenter Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
232
Start Date
2025-06-24
Completion Date
2027-09-30
Last Updated
2025-12-18
Healthy Volunteers
No
Conditions
Interventions
Methylprednisolone
Initially, 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
It is suitable for patients with hepatocellular or mixed DILI. A daily dose of 0.15g to 0.2g
Glutathione
It is suitable for patients with hepatocellular or mixed DILI. A daily dose of 1.2g to 1.8g
Silymarin
It is suitable for patients with hepatocellular or mixed DILI. The dosage is 140 mg, taken 2 to 3 times per day.
Polyene Phosphatidylcholine
It is suitable for patients with hepatocellular or mixed DILI. The dosage is 228mg-456mg, taken 3 times per day.
Ursodeoxycholic acid capsules
It is suitable for patients with cholestatic or mixed DILI. A daily dose of 10mg-15mg/kg/day.
Ademetionine 1,4-Butanedisulfonate
It is suitable for patients with cholestatic or mixed DILI. A daily dose of 0.5g to 1g.
Plaslna exchange
It is suitable for patients whose condition continues to worsen or even develop to liver failure.
Liver transplantation
It is suitable for patients whose condition continues to worsen or even develop to liver failure.
Locations (1)
Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
Shenyang, Liaoning, China