1. Adding methylprednisolone to standard treatment in hepatitis B virus-related acute-on-chronic liver failure was associated with an increase in 6-month survival rate.
Evidence Rating Level: 1 (Excellent)
Hepatitis B virus-related acute-on-chronic liver failure (HVB-ACLF), accounting for 70% of all ACLF cases in Asia, is a severe exacerbation of liver function leading to high mortality rates. WIth liver transplantation as the only curative treatment, there is a lack of efficacious treatment options for these patients. As systemic inflammation secondary to a cytokine storm is a key feature of ACLF, methylprednisolone (MP) has been theorized to play a role in its treatment; particularly when combined with nucleoside analogs (NAs), this combination may reverse potential HBV-related liver deterioration. However, the use of MP in HBV-ACLF remains uncertain and controversial. In this multicentre, prospective randomized controlled clinical trial, 171 patients (mean age 45.2 years, 88.9% men) with HBV-ACLF were recruited from three medical centres in Beijing. They were randomized in a 1:1 ratio to receive either MP (1.5mg/kg/day IV for 3 days, 1mg/kg/day IV for 2 days, then 0.5mg/kg/day IV for 2 days) plus standard treatment or standard treatment only (the control group). At 6 months, the mortality rate of the MP group was lower than the control group (32.4% vs 42.5%, p=0.0037), while there was no significant difference in liver transplants between the groups. The univariate analysis and collinearity diagnosis showed that MP was an independent predictor for mortality among HBV-ACLF patients (HR 0.547, p=0.040). Cox analysis identified HBV DNA and lymphocyte/monocyte ratios (LMRs) as predictors of mortality, in the MP group. In terms of adverse events, incidence of hypoalbuminemia (56.6% vs 37.5%, p=0.012), fungal infection, ascites, hepatic encephalopathy, and new onset infection (41.1% vs 31.8%, p=0.214) were higher in the MP group. While the timing of MP administration plays a major role in treatment efficacy, most patients were transferred to the medical centres after spending a median of 16 days and 20 days in primary care, in the MP and control groups respectively. As this study could not determine the significance of MP onset time, future studies should explore this factor when evaluating the potential efficacy of MP therapy in HBV-ACLF.
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