Department of Critical Care Medicine of Liver Disease, Beijing You-An Hospital, Capital Medical University, Beijing, China.
Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of phase I clinical trial, Peking University Cancer Hospital & Institute, Fucheng Road 52, Haidian District, Beijing, 100142, China.
BMC Med. 2020 Dec 8;18(1):383. doi: 10.1186/s12916-020-01814-4.
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.
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.
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).
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.
乙型肝炎病毒相关慢加急性肝衰竭（HBV-ACLF）是一种死亡率很高的严重疾病，由于缺乏有效的治疗方法。到目前为止，甲基强的松龙（MP）在 HBV-ACLF 中的应用仍存在争议。我们旨在评估 MP 在 HBV-ACLF 中的疗效和安全性。
来自三个医疗中心的 171 例 HBV-ACLF 患者被随机分为 MP 组（83 例患者静脉滴注 MP 7 天，加标准治疗：1.5mg/kg/天[第 1-3 天]，1mg/kg/天[第 4-5 天]，0.5mg/kg/天[第 6-7 天]）和对照组（88 例患者接受标准治疗）。主要终点是 6 个月死亡率和 6 个月生存率的预后因素。分析了生存时间、死亡原因、不良事件、肝功能和 HBV DNA 复制情况。
MP 组的 6 个月死亡率明显低于对照组[32.4%比 42.5%，P=0.0037]。MP 治疗是 6 个月生存的独立预后因素[HR（95%CI）0.547（0.308-0.973）；P=0.040]。MP 组 6 个月死亡率降低的相关因素包括 HBV DNA 和淋巴细胞/单核细胞比值（LMR）（P<0.05）。基于 ROC 曲线，LMR+MELD 对 MP 治疗的 HBV-ACLF 预后具有更好的预测价值。两组 HBV DNA 复制无明显差异（P>0.05）。
MP 治疗是 HBV-ACLF 的一种有效、安全的临床策略，可提高 6 个月生存率。临床试验注册于 http://www.chictr.org.cn，注册号为 ChiCTR-TRC-13003113，于 2013 年 3 月 16 日注册。
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