Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia

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.

Timeline

Start

2025-06-24

Primary completion

2027-03-31

Completion

2027-09-30

Publications

• Results Hou FQ, Zeng Z, Wang GQ. Hospital admissions for drug-induced liver injury: clinical features, therapy, and outcomes. Cell Biochem Biophys. 2012 Nov;64(2):77-83. doi: 10.1007/s12013-012-9373-y.
• Results Hu PF, Wang PQ, Chen H, Hu XF, Xie QP, Shi J, Lin L, Xie WF. Beneficial effect of corticosteroids for patients with severe drug-induced liver injury. J Dig Dis. 2016 Sep;17(9):618-627. doi: 10.1111/1751-2980.12383.
• Results Chai L, Wang R, Teschke R, Jin S, Deng J, Qi X. Successful corticosteroid therapy for severe liver injury secondary to herbal traditional Chinese medicine, Mega Defends X, assessed for causality by the updated RUCAM: A case report. Medicine (Baltimore). 2024 Aug 23;103(34):e39439. doi: 10.1097/MD.0000000000039439.
• Results Mao Y, Ma S, Liu C, Liu X, Su M, Li D, Li Y, Chen G, Chen J, Chen J, Zhao J, Guo X, Tang J, Zhuge Y, Xie Q, Xie W, Lai R, Cai D, Cai Q, Zhi Y, Li X; Technology Committee on DILI Prevention, Management, Chinese Medical Biotechnology Association; Study Group on Drug-Induced Liver Disease, Chinese Society of Hepatology, Chinese Medical Association. Chinese guideline for the diagnosis and treatment of drug-induced liver injury: an update. Hepatol Int. 2024 Apr;18(2):384-419. doi: 10.1007/s12072-023-10633-7. Epub 2024 Feb 24.
• Li Q, Lin Y, Zeng X, Zhou L, Wang F, Ye Q, Gao Y, Guo L, Zhu J, Li J, Li Y, Shao L, Hu Y, Xiao J, Jia A, Wang D, Chang L, Wang J, Zhang J, Wang R, Gao F, Wu Q, Hu P, Zhu C, Cai L, Ran Y, Li Y, Zhang J, Ran Y, Wang C, Wang N, Zhang J, Zhang X, Li J, Sun J, Chu Y, Ma Y, Wang T, Zheng Z, Shen Y, Qi X, Xie W. Efficacy and safety of glucocorticoids for acute drug-induced liver injury with hyperbilirubinemia: protocol of a multicenter randomized controlled trial. Ther Adv Gastroenterol. 2026 Apr 26;19:17562848261440777. doi: 10.1177/17562848261440777. eCollection 2026.

Drugs

Indications