The efficacy and safety of methylprednisolone in hepatitis B virus-related acute-on-chronic liver failure: a prospective
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RESEARCH ARTICLE
Open Access
The efficacy and safety of methylprednisolone in hepatitis B virusrelated acute-on-chronic liver failure: a prospective multi-center clinical trial Lin Jia1†, Ran Xue1,2†, Yueke Zhu1, Juan Zhao1, Juan Li1, Wei-Ping He3, Xiao-Mei Wang4, Zhong-Hui Duan1, Mei-Xin Ren1, Hai-Xia Liu1, Hui-Chun Xing4* and Qing-Hua Meng1*
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. Keywords: Hepatitis B, Acute-on-chronic liver failure, Methylprednisolone
* Correspondence: [email protected]; [email protected] † Lin Jia and Ran Xue contributed equally to this work. 4 Institute of Infectious Diseases, Beijing Di Tan Hospital, Capital Medical University, No. 8 Jing Shun Dong Street, Chao yang District, Beijing 100015, China 1 Department of Critical Care Medicine of Liver Disease, Beijing You-An Hospital, Capital Medical University, Beijing, China Full list of author information is available at the end of the article
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