恩替卡韦治疗失代偿期乙型肝炎肝硬化的疗效观察

Antiviral effects of entecavir in patients with hepatitis B virus-induced decompensated liver cirrhosis

目的观察恩替卡韦治疗失代偿期乙型肝炎肝硬化患者48周的安全性和疗效。方法 80例患者随机分为恩替卡韦(ETV)组和阿德福韦酯(ADV)组各40例,疗程48周,观察治疗前、后生化指标、Child-Pugh评分、HBV DNA标志物及HBV DNA。结果治疗4周时,ETV组HBV DNA下降幅度、HBV DNA不可测率、ALT复常率分别为2.26lgIU/ml、50.0%、30.0%,均分别高于ADV组(0.91lgIU/ml、10.0%、10.0%),P<0.05。在12、24、48周时,ETV组HBV DNA下降幅度、HBV DNA不可测率、ALT复常率仍然分别高于ADV组,P<0.05。ETV组24、48周HBeAg阴转率、HBeAg血清学转换率均高于ADV组(P<0.05)。ETV组Child-Pugh分级均明显改善,Child A级患者比例增加,高于ADV组(χ2=17.248,P<0.05),ETV组出现疾病进展的比例低于ADV组(χ2=3.922,P<0.05)。48周内两组无耐药发生。结论 ETV治疗失代偿期乙肝肝硬化,强效、快速抑制HBVDNA复制,改善肝功能,延缓病情进展,耐药率低,耐受性好。

Objective To analyse antiviral effects of entecavir （ETV） in patients with HBV-induced decompensated cirrhosis. Methods 80 cases were randomly divided into enteeavir group （n=40） and adefovir group （n=40） for 48 weeks. HBV DNA, liver function and Child-Pugh scores were observed at different time points. Results At week 4, mean reduction of HBV DNA was 2.26 lgIU/ml, 50.0% of the patients achieved undetectable HBV DNA and 30.0% achieved ALT normalization in ETV group. At week 4, 12, 24, 48, the differences of mean reduction of HBV DNA, undeteetable HBV DNA and ALT normalization were statiseally significant between the two groups, respectively. The difference of HBeAg negative conversion rates and the HBeAg seroeonversion at week 24, 48 were significance between the two groups, respectively. The differences of the improvement of Child-Pugh scores were statistically significance between the two groups. Conclusion Entecavir therapy can delay the progression of cirrhosis and has low drug-resistance rates and the safety.