ETV或ADV初治CHB患者的2年疗效观察

Efficacy of entecavir or adefovir dipivoxil in treatment of chronic hepatitis B patients at the first time in two years

目的随机、对照、开放比较恩替卡韦(ETV)或阿德福韦酯(ADV)初治慢性乙型肝炎(CHB)患者2年的疗效。方法选取2007年8月-2007年12月在沈阳市第六人民医院住院的CHB患者60例,按1∶1的比例随机分成2组,分别接受ETV 0.5 mg/d或ADV 10 mg/d口服,疗程至少104周。评价患者96周HBV DNA下降幅度、HBV DNA阴转率、ALT复常率、HBeAg血清转换率、病毒学突破率及应答不佳率。结果 96周时,ETV组HBV DNA水平较基线平均降幅为(6.05±1.99)lg拷贝/ml,高于ADV组的(4.03±3.24)lg拷贝/ml(t=2.192,P=0.005)。ETV组HBV DNA阴转率高于ADV组(80%vs 40%,χ2=10.000,P=0.002)。ALT复常率、HBeAg阳性患者HBeAg血清转换率两组比较差异无统计学意义。ETV组无病毒学突破,应答不佳率为23.3%。ADV组病毒学突破率为13.3%,应答不佳率为73.3%(χ2=-2.053、15.017,P=0.04、<0.001)。结论 ETV相对于ADV可早期快速抑制病毒。不论是ETV还是ADV,24周评估原发性无应答及48周评估部分病毒学应答是优化治疗中应关注的截点。

Objective To compare the therapeutic effects between ETV and ADV on CHB patients at the first time. Methods 60 patients with CHB in our hospital from Aug. 2007 to Dec. 2007 were collected. They were randomly di- vided into 2 groups and treated with 0.5 mg ETV or 10 mg ADV daily for at least 104 weeks. Reduction of HBV DNA, undetectable HBV DNA, ALT normalization, HBeAg seroconversion, viral breakthrough and poor antiviral response were evaluated. Results At 96 th week, mean reduction of HBV DNA level and undeteetable HBV DNA rate were sig- nificant higher in ETV group than those in ADV group. There were no differences in the rates of ALT normalization and HBeAg seroconversion in HBeAg-positive patients between the ETV and ADV group. The rates of viral breakthrough and poor antiviral response were significant lower in ETV group. Conclusion Compared with ADV, ETV appeared to inhib- it HBV early and rapidly. During optimal therapy with ETV or ADV, evaluation of primary nonresponse at 24th week and partial response at 48th week are important cut-off.