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拉米夫定联合阿德福韦酯与恩替卡韦单药治疗失代偿期乙型肝炎肝硬化二年疗效比较

De novo combination with lamivudine and adefovir dipivoxil versus entecavir monotherapy for naive patients with hepatitis B virus-related decompensated cirrhosis: a 2-year study

摘要:

目的 比较拉米夫定( LAM)与阿德福韦酯(ADV)初始联合与恩替卡韦(ETV)单药治疗失代偿期乙型肝炎肝硬化2年的疗效.方法 选取2007年1月-2008年4月浙江省上虞市人民医院和浙江大学医学院附属第一医院120例失代偿期乙型肝炎肝硬化患者作为研究对象,其中60例接受LAM联合ADV初始抗病毒治疗,60例接受ETV单药抗病毒治疗.每1~3个月检测患者肝功能、肾功能、甲胎蛋白、HBV血清学标志物、HBV DNA、凝血酶原时间(PT)、肝脏超声波或CT.采用重复测量方差分析和x2检验比较两组在治疗12和24个月时的疗效、不良反应和累计生存率.结果 LAM和ADV初始联合治疗组和ETV单药治疗组各有45例至随访结束.两组HBV DNA转阴率和ALT复常率在治疗12个月(x2=2.12和2.88,P>0.05)和24个月时(X2=3.21和3.24,P>0.05)差异均无统计学意义;治疗24个月时HBeAg血清学转换率分别为43.5% (10/23)和36.4%( 8/22),差异有统计学意义(x2=4.09,P<0.05).治疗12个月和24个月后,LAM和ADV初始联合组分别有2例(4.4%)和3例(6.7%)发生病毒学突破,但均未检测到病毒学变异;ETV单药组分别有1例(2.2%)和2例(4.4%)发生病毒学突破,并在24个月检测到1例(2.2%)发生病毒变异.LAM+ADV初始联合组和ETV组治疗24个月后分别与治疗前(基线)相比,Alb水平上升(F=18.9和17.3,P<0.05),TBil和ALT下降(F=16.5、17.1和23.7、24.8,P<0.05),PT缩短(F=22.7和24.5,P<0.05),CTP评分和MELD评分下降(F=18.5、17.8和24.2、23.8,P<0.05).LAM和ADV初始联合治疗组累计病死率(或肝移植)为16.7% (10/60),ETV单药组累计病死率(或肝移植)为18.3% (11/60).两组均未发现有血清肌酐超过正常值上限的病例.结论 LAM与ADV初始联合或ETV单药治疗失代偿期乙型肝炎肝硬化患者均能明显抑制HBV复制,改善肝功能,降低病死率,且耐药变异率低;联合组HBeAg血清学转换率在24个月时高于单药组,两种方案在临床上均可使用.

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abstracts:

Objective To compare the 2-year efficacy of de novo combination therapy with lamivudine (LAM) and adefovir dipivoxil (ADV) to that of entecavir (ETV) monotherapy in treatment of patients with hepatitis B virus ( HBV )-related decompensated cirrhosis.Methods A total of 120 naive patients with HBV-related decompensated cirrhosis admitted to Shangyu People's Hospital and the First Affiliated Hospital of Zhejiang University from January 2007 to April 2008 were enrolled,in which 60 were treated with LAM and ADV combination therapy,and other 60 patients were treated with ETV monotherapy.Tests for liver and kidney function,alpha-fetoprotein,HBV serum markers,HBV DNA load,prothrombin time (PT),and ultrasonography or CT scan of liver were performed every 1-3 months.Repeated measure ANOVA and x2test were used to compare the efficacy,side effects and accumulated survival rates at 12 and 24 month in two groups.Results Forty-five patients in each group were followed-up for 24 months.There was no significant difference in HBV DNA negative rates and ALT normalization rates at month 12 (x2 =2.12 and 2.88,P >0.05 ) and month 24 between two groups (x2 =3.21 and 3.24,P > 0.05); while HBeAg seroconversion rate in LAM + ADV group at month 24 was significantly higher than that in ETV group (43.5% vs.36.4%,x2 =4.09,P<0.05).Viral breakthrough occurred in 2 cases (4.4%) by month 12 and 3 cases (6.7%) by month 24 in LAM + ADV group,and no viral mutation was observed; while in ETV group,viral breakthrough occurred in 1 case ( 2.2% ) by month 12 and 2 cases (4.4%) by month 24,and viral mutation was observed in 1 case (2.2%) by month 24.At the end of month 24,increase of AIb (F=18.9 and 17.3,P<0.05),decrease of TBil and ALT (F=16.5,17.1 and 23.7,24.8,P <0.05 ),shortening of PT ( F =22.7 and 24.5,P < 0.05 ),and the improvements of CTP and MELD scores (F=18.5,17.8 and 24.2,23.8,P<0.05) were observed in both groups.The accumulative rates of mortality or liver transplantation were 16.7% ( 10/60 ) and 18.3% ( 11/60 ) in LAM + ADV and ETV groups,respectively.No blood creatinine increased above the normal upper limit was observed in both groups.Conclusion Both LAM + ADV combination therapy and ETV monotherapy can effectively inhibit HBV replication,improve liver function,decrease mortality and viral resistance,but the 24-month HBeAg seroconversion rate in combination therapy group is higher than that in monotherapy group.

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作者: 宋伟泉 [1] 徐尧江 [1] 张要栋 [1] 吕国才 [2] 郑临 [3] 杨益大 [3]
分类号: R51
栏目名称: 论著
DOI: 10.3760/cma.j.issn.1674-2397.2012.03.003
发布时间: 2012-10-22
基金项目:
国家病毒性肝炎及艾滋病的诊治"十一·五"重大专项 浙江医药卫生科学研究基金计划 中管局浙江省中医药科学研究基金计划
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