Lin Bingliang, Pan Calvin Q, Xie Dongying, Xie Junqiang, Xie Shibin, Zhang Xiaohong, Wu Biao, Lin Chaoshuang, Gao Zhiliang
Department of Infectious Diseases, Third Affiliated Hospital of Sun Yet-Sen University, 600 Tianhe Road, Tianhe Area, Guangzhou, 510060, People's Republic of China.
Division of Liver Diseases, Department of Medicine, Mount Sinai Medical Center, Mount Sinai School of Medicine, New York, NY, USA.
Hepatol Int. 2013 Jun;7(2):460-7. doi: 10.1007/s12072-012-9415-y. Epub 2013 Feb 11.
The mortality of acute-on-chronic hepatitis B liver failure (ACHBLF) from acute exacerbation of chronic hepatitis B is 30-70 % without liver transplant.
We conducted an open-label, prospective, 48-week study to evaluate the efficacy of entecavir (ETV) in ACHBLF with 110 patients who received either ETV or no treatment. Primary measurements were survival and improvement in disease severity scores.
Of the 110 patients enrolled, 2 withdrew consent, 108 were treated with 53 ETV, and 55 were untreated. When compared to the patients in the untreated group at week 48, a lower cumulative mortality rate in ETV-treated patients was observed [54.7 % (29/53) vs. 78.2 % (43/55), p < 0.01). ETV treatment significantly improved disease severity scores including Child-Turcotte-Pugh (CTP), model for end-stage liver disease (MELD), and MELD sodium (MELD-Na). All ETV-treated subjects achieved an undetectable HBV DNA level (<500 copies/mL; 100 % vs. 7.9 %, p < 0.001). In univariate analysis, predictors of survival at week 48 included baseline age, total bilirubin, international normalized ratio of prothrombin time, albumin, cholesterol, receiving ETV therapy, CTP, MELD, MELD-Na, and sequential organ failure assessment (SOFA) scores. In multivariate analysis, baseline age, total bilirubin, untreated (with ETV), CTP, and SOFA scores were the independent risk factors for mortality.
Entecavir treatment for patients with ACHBLF significantly improves disease severity scores with a marked reduction in mortality and suppression in HBV DNA to undetectable levels at week 48. Patients' age, total bilirubin, CTP, and SOFA scores at baseline are independent risk factors for higher mortality without liver transplantation.
慢性乙型肝炎急性加重所致的慢加急性乙型肝炎肝衰竭（ACHBLF），在未进行肝移植的情况下，死亡率为30% - 70%。
我们开展了一项开放标签、前瞻性、为期48周的研究，以评估恩替卡韦（ETV）对110例接受ETV治疗或未接受治疗的ACHBLF患者的疗效。主要测量指标为生存率和疾病严重程度评分的改善情况。
在纳入的110例患者中，2例撤回同意书，108例接受治疗，其中53例接受ETV治疗，55例未接受治疗。与48周时未治疗组的患者相比，ETV治疗组患者的累积死亡率更低[54.7%（29/53） vs. 78.2%（43/55），p < 0.01]。ETV治疗显著改善了疾病严重程度评分，包括Child - Turcotte - Pugh（CTP）评分、终末期肝病模型（MELD）评分和MELD钠评分（MELD - Na）。所有接受ETV治疗的受试者HBV DNA水平均低于检测下限（<500拷贝/毫升；100% vs. 7.9%，p < 0.001）。在单因素分析中，48周时生存的预测因素包括基线年龄、总胆红素、凝血酶原时间国际标准化比值、白蛋白、胆固醇、接受ETV治疗、CTP评分、MELD评分、MELD - Na评分和序贯器官衰竭评估（SOFA）评分。在多因素分析中，基线年龄、总胆红素、未治疗（与ETV治疗相比）、CTP评分和SOFA评分是死亡的独立危险因素。
对ACHBLF患者进行恩替卡韦治疗可显著改善疾病严重程度评分，在48周时死亡率显著降低，且HBV DNA被抑制至检测不到的水平。患者的年龄、总胆红素、基线CTP评分和SOFA评分是未进行肝移植时较高死亡率的独立危险因素。
