The efficacy and safety of methylprednisolone in hepatitis B virus-related acute-on-chronic liver failure: a prospective multi-center clinical trial.

Abstract

BACKGROUND:

Hepatitis B virus-related acute-on-chronic liver failure (HBV-ACLF) is a severe condition with high mortality due to lack of efficient therapy. Until now, the use of methylprednisolone (MP) in HBV-ACLF is still controversial. We aimed to evaluate the efficacy and safety of MP in HBV-ACLF.

METHODS:

Totally 171 HBV-ACLF patients from three medical centers were randomly allocated into MP group (83 patients treated with MP intravenously guttae for 7 days plus standard treatment: 1.5 mg/kg/day [day 1-3], 1 mg/kg/day [day 4-5], and 0.5 mg/kg/day [day 6-7]) and control group (88 patients treated with standard treatment). The primary endpoints were 6-month mortality and prognostic factors for 6-month survival. The survival time, cause of death, adverse events, liver function, and HBV DNA replication were analyzed.

RESULTS:

The 6-month mortality was significantly lower in MP group than control group [32.4% vs. 42.5%, P = 0.0037]. MP treatment was an independent prognostic factor for 6-month survival [HR (95% CI) 0.547(0.308-0.973); P = 0.040]. Factors associated with reduced 6-month mortality in MP group included HBV DNA and lymphocyte/monocyte ratio (LMR) (P < 0.05). Based on ROC curve, LMR+MELD had a better predictive value for prognosis of HBV-ACLF under MP treatment. No significant difference in HBV DNA replication was observed between groups (P > 0.05).

CONCLUSIONS:

MP therapy is an effective and safe clinical strategy in HBV-ACLF, increasing the 6-month survival rate. Clinical trials registered at http://www.chictr.org.cn as ChiCTR-TRC-13003113 registered on 16 March 2013.

• Authors: Lin Jia, Ran Xue, Yueke Zhu, Juan Zhao, Juan Li, Wei-Ping He, Xiao-Mei Wang, Zhong-Hui Duan, Mei-Xin Ren, Hai-Xia Liu, Hui-Chun Xing, Qing-Hua Meng
• Journal: BMC medicine (BMC Med) Vol. 18 Issue 1 Pg. 383 (12 08 2020) ISSN: 1741-7015 [Electronic] England
• PMID: 33287816 (Publication Type: Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Methylprednisolone

Topics

• Acute-On-Chronic Liver Failure (drug therapy, mortality)
• Adult
• Female
• Hepatitis B virus (drug effects)
• Humans
• Male
• Methylprednisolone (pharmacology, therapeutic use)
• Middle Aged
• Prognosis
• Prospective Studies