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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.


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).

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.

SUBMITTER: Jia L 

PROVIDER: S-EPMC7722342 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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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.

Jia Lin L   Xue Ran R   Zhu Yueke Y   Zhao Juan J   Li Juan J   He Wei-Ping WP   Wang Xiao-Mei XM   Duan Zhong-Hui ZH   Ren Mei-Xin MX   Liu Hai-Xia HX   Xing Hui-Chun HC   Meng Qing-Hua QH  

BMC medicine 20201208 1


<h4>Background</h4>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.<h4>Methods</h4>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 treatm  ...[more]

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