恩替卡韦治疗乙型肝炎肝硬化失代偿期患者96周临床观察

Clinical Observation of Entecavir in the Treatment of Decompensated Cirrhotic Patient with HBV for 96 Weeks

目的研究恩替卡韦治疗乙型肝炎肝硬化失代偿期患者96周疗效、YMDD变异和安全性。方法 57例乙型肝炎肝硬化失代偿期患者随机分为两组,A组28例予拉米夫定100mg/d;B组29例恩替卡韦0.5mg/d治疗。以上两组的疗程为96周。均给予常规护肝及支持、对症治疗。观察两组患者HBVDNA定量、Child-Pugh评分变化、YMDD变异及药物不良反应情况。结果两组患者治疗后均有明显的HBVDNA转阴率和Child-Pugh评分改善,但两组之间进行这两项比较时差异无统计学意义(P>0.05)。拉米夫定组治疗48周时发生YMDD变异,随着时间延长,变异数增加,而恩替卡韦组未发生变异。72周后两组比较差异有统计学意义(P<0.05)。拉米夫定组有2例死亡,恩替卡韦组1例死亡,未发生与药物相关的严重不良反应。结论恩替卡韦治疗乙型肝炎肝硬化失代偿期患者96周,其疗效与安全性与拉米夫定相似,但能显著减少YMDD变异的发生,是一种有效且理想的治疗乙型肝炎肝硬化失代偿期的药物。

Objective To observe the curative efficacy, YMDD mutation and safety of entecavir treated Hepatitis B patients with decompensated cirrhosis. Methods 57 patients from our hospital from March 2006 to June 2009, were randomLy divided into two groups. 28 patients in group A were treated with lamivudine 100mg/d, and 29 patients in group B were treated with entecavir 0.5mg/d. They also received living-protecting, and the other symptomatic treatments. The total treatment in these two groups was 96 weeks. The level of HBV DNA, Child-Pugh score, YMDD mutation and adverse drug reactions were detected detailed. Results After the treatment, there were obvious undetectable rate of HBV DNA and improved Child Pugh score in the two groups. But the comparisons have no statistical difference（P0.05）. YMDD mutation would appear at 48 weeks in group A which used lamivudine 100mg/d for treatment. And the greater variation would come out as the time become longer. There was no YMDD mutation in group B at the total treatment. YMDD variation had significant differences between the two groups at 72 weeks （P0.05）. Two groups have no medicine related serious untoward effect occurred. Conclusion Entecavir treatments in patients with decompensate hepatitis B cirrhosis 96 weeks, its efficacy and safety of lamivudine were similar, but significantly reduced the incidence of YMDD mutation. Entecavir is an effective and ideal treatment of decompensate liver cirrhosis drug.