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The efficacy and safety of methylprednisolone in hepatitis B virus-related acute-on-chronic liver failure: a prospective multi-center clinical trial
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The efficacy and safety of methylprednisolone in hepatitis B virus-related acute-on-chronic liver failure: a prospective multi-center clinical trial
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The efficacy and safety of methylprednisolone in hepatitis B virus-related acute-on-chronic liver failure: a prospective multi-center clinical trial
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Journal Article
The efficacy and safety of methylprednisolone in hepatitis B virus-related acute-on-chronic liver failure: a prospective multi-center clinical trial
2020
Overview
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.
Publisher
BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
Subject
Acute-on-chronic liver failure
/ Acute-On-Chronic Liver Failure - drug therapy
/ Acute-On-Chronic Liver Failure - mortality
/ Adult
/ Ascites
/ Blood
/ Complications and side effects
/ DNA
/ Female
/ Hepatitis B virus - drug effects
/ Humans
/ Liver
/ Male
/ Medicine
/ Methylprednisolone - pharmacology
/ Methylprednisolone - therapeutic use
/ Patients
/ Plasma
/ Proteins
/ Safety
/ Survival
/ Viruses
