两种恩替卡韦制剂治疗慢加急性乙型肝炎肝衰竭患者疗效对比研究

目的 对比研究两种恩替卡韦制剂治疗慢加急性乙型肝炎肝衰竭患者的疗效差异。方法 2011年7月~2016年4月我院诊治的慢加急性乙型肝炎肝衰竭患者105例,其中54例接受恩替卡韦分散片（润众）抗病毒治疗的患者为观察组,51例服用恩替卡韦片（博路定）抗病毒治疗的患者为对照组,对比分析两组患者治疗前和治疗12周后血清HBV DNA、肝功能变化的差异,以及12周病死率。结果 两组患者治疗后HBV DNA载量均显著下降,其中,观察组第12周HBV DNA载量<500 copies/ml的比例为72.22%（39/54）,对照组为72.55%（37/51）,组间差异无统计学意义（x²=0.03,P=0.86）;与治疗前比,观察组患者治疗12周后血清总胆红素、丙氨酸氨基转移酶、天冬氨酸氨基转移酶水平下降至（66.59±10.78）μmol/L、（68.32±11.57）U/L和（46.77±18.82）U/L,血清白蛋白上升至（37.18±4.29） g/L,PT缩短至（15.34±1.28）s,对照组上述指标变为（65.32±9.18）μmol/L、（67.07±9.62）U/L、（44.17±14.18） U/L、（37.51±4.30） g/L和（15.68±1.27）s,组间差异无统计学意义（P>0.05）;在第12周末,两组患者病死率分别为31.48%（17/54）和31.37%（16/51）,差异无统计学意义（x²=0.04,P=0.84）。治疗期间两组患者均未发生严重不良反应。结论 恩替卡韦分散片与恩替卡韦在治疗慢加急性肝衰竭患者的疗效无显著性差异。

Comparison of efficacy of domestic and imported entecavir on patients with hepatitis B-induced acute-on-chronic liver failure

Objective To compare the efficacy of domestic and imported entecavir on patients with hepatitis B-induced acute-on-chronic liver failure. Methods 105 patients with hepatitis B-induced acute-on-chronic liver failure between July 2011 and April 2016 in our hospital were included in this clinical trial,and 54 of them were treated with domestic entecavir as observation group,and another 51 patients were treated with imported entecavir as control group. Serum HBV DNA,liver function index,the mortality rate after 12 week treatment were compared between the two groups. Results At the end of 12 weeks,serum HBV DNA levels in the two groups were significantly decreased and the negative rate in the observation group was 72.22% （39/54）,no significant difference as compared to 72.55%（37/51） in the control grou（x²=0.03,P=0.86）;total serum bilirubin,alanine aminotransferase,aspartate aminotransferase levels decreased to（66.59±10.78）μmol/L,（68.32±11.57）U/L,（46.77±18.82）U/L,the serum albumin levels increased to（37.18±4.29）g/L,and PT decreased to（15.34±1.28） s,all of which were not significantly different to those in the control group （65.32±9.18）μmol/L,（67.07±9.62）U/L,（44.17±14.18）U/L,（37.51±4.30）g/L,（15.68±1.27）,P>0.05];the mortality in the two groups were 31.48%（17/54） and 31.37%（16/51）,and there was no significant difference between the two groups（x²=0.04,P=0.84）. No serious adverse event occurred in the two groups. Conclusions The domestic is equally effective as the imported entecavir in the treatment of patients with hepatitis B-induced acute-on-chronic liver failure.