恩替卡韦分散片与恩替卡韦片治疗乙型肝炎肝硬化的对比研究

摘要

OBJECTIVE:To evaluate the efficacy and safety of entecavir dispersible tablet for hepatitis B cirrhosis. METHODS:A double blind randomized controlled trial was carried out on a total of 100 patients with hepatitis B liver cirrhosis,according to the proportion of 1∶1 draw randomly into observation group and control group, with 50 cases assigned to the observation group ( taking entecavir dispersible tablet ) and another 50 to the control group ( taking entecavir tablet) .The negative-return of HBV-DNA and Child-Pugh grading scores in the two groups were followed. RESULTS:After 12-months’ treatment, the logarithm value of HBV-DNA and liver Child-Pugh grading scores in both of the two groups were significantly reduced as compared before treatment, and the differences were statistically significant ( P 0.05 );the two groups were no serious adverse reaction.CONCLUSIONS:Entecavir dispersible tablet has remarkable antiviral effect in the treatment of hepatitis B liver cirrhosis.%目的：观察恩替卡韦分散片治疗乙型肝炎肝硬化的效果和安全性。方法：对100例乙型肝炎肝硬化患者进行随机对照试验，按1∶1的比例抽签分为观察组和对照组，观察组50例患者服用恩替卡韦分散片，对照组50例患者服用恩替卡韦片，观察治疗前后患者乙型肝炎病毒脱氧核糖核酸（ HBV-DNA）阴转情况及Child-Pugh评分的改变。结果：治疗12个月后，2组患者HBV-DNA对数值及肝脏Child-Pugh评分均较治疗前明显下降，差异均有统计学意义（P＜0.05），但组间差异无统计学意义（P＞0.05）；2组均未发现严重不良反应。结论：恩替卡韦分散片在治疗乙型肝炎肝硬化方面具有显著的抗病毒作用，疗效与恩替卡韦片相当。