拉米夫定初始联合阿德福韦酯治疗失代偿期乙型肝炎肝硬化疗效观察

Efficacy of combination therapy of lamivudine and adefovir dipivoxyl for patients with hepatitis B-induced decompensated liver cirrhosis

目的:观察拉米夫定(lamivudine,LAM)初始联合阿德福韦酯(adefovir dipivoxyl,ADV)治疗失代偿期乙型肝炎肝硬化48周的临床疗效和安全性。方法:乙型肝炎肝硬化失代偿期患者81例随机分为2组,均给予护肝、对症支持治疗,联合组给予LAM 100 mg/d+ADV 10 mg/d,ADV组给予ADV 10 mg/d,疗程48周。观察治疗前、后HBV DNA水平、肝功能、Child-Pugh评分和HBV DNA标志物。结果:治疗4周时,HBV DNA下降幅度、HBV DNA阴转率、ALT复常率,联合组分别为1.83lgIU/mL,17.9%,28.2%,ADV组分别为0.96lgIU/mL,5.3%,10.5%,联合组均高于ADV组(P<0.05)。在12,24,48周时,联合组HBV DNA下降幅度、HBV DNA阴转率、ALT复常率均高于ADV组(P<0.05)。24,48周时两组HBeAg阴转率比较差异无统计学意义(P>0.05);24,48周时两组HBeAg血清学转换率差异无统计学意义(P>0.05)。两组Child-Pugh分级均明显改善,联合组ChildA级患者比例高于ADV组(P<0.05),48周两组出现疾病进展的比例相似(P>0.05)。48周内两组均无耐药发生。结论:LAM和ADV初始联合治疗失代偿期乙型肝炎肝硬化能显著抑制HBVDNA复制,改善肝功能,优于单独使用ADV,且耐药率低,耐受性好。

Objective： To evaluate the efficacy of combination therapy of lamivudine（LAM） and adefovir dipivoxyl（ADV） for patients with hepatitis B-induced decompensated cirrhosis.Methods： A total of 81 patients were randomly divided into a combination group and an ADV group over 48 week treatment course.The combination group were treated with LAM（100 mg/d） plus ADV（10 mg/d）,and the ADV group with ADV（10 mg/d） for 48 weeks.All patients received hepatic function support and symptomatic treatment.The levels of HBV DNA,liver function,Child-Pugh scores and HBV DNA indicators were observed before and after the treatment.Results： At week 4,the mean reduction of HBV DNA was 1.83 lgIU/mL,17.9% of the patients achieved undetectable HBV DNA and 28.2% showed normal ALT in the combination group.The counterpart in the ADV group was 0.96 lgIU/mL,5.3% and 10.5%.At week 4,12,24 and 48,the differences in the mean reduction of HBV DNA,undetectable HBV DNA and ALT normalization were statiscally significant between the 2 groups.The difference in HBeAg negative conversion rates and HBeAg seroconversion at week 24 and 48 was not significant.Conclusion： The combination therapy results in HBV suppression and improved liver function and Child-Pugh score.The combination treatment has an advantage over ADV due to low drugresistance rate and good tolerance.