恩替卡韦对核苷初治HBeAg阳性慢性乙型肝炎患者的疗效

Efficacy of entecavir in nucleoside-nave patients with hepatitis B e antigen-positive chronic hepatitis B

目的:探讨恩替卡韦对核苷初治HBeAg阳性慢性乙型肝炎患者的疗效.方法:101例慢性乙型肝炎患者被随机分配到恩替卡韦(ETV)组和阿德福韦酯(ADV)组,分别给予0.5mg/d恩替卡韦和10mg/d阿德福韦酯治疗.疗效的主要观测指标有:血清HBV DNA水平,HBeAg转阴或丙氨酸氨基转移酶(ALT)复常.结果:48wk时,ETV组与ADV组HBV DNA均下降,且>103copies/mL的比率有统计学差异(95.83%vs60.38%,P<0.001);ALT复常率2组亦有显著差别(52.08%vs28.30%,P=0.015);2组均无HBeAg转阴;不良事件发生率分别为77.08%与71.69%(P=0.536),两组差异没有统计学意义.结论:在核苷初治HBeAg阳性慢性乙型肝炎的治疗中,恩替卡韦比阿德福韦酯有更强的病毒学与生物化学应答率,但HBeAg转阴率不高,还需进一步观测.

AIM：To investigate the efficacy and safety of entecavir in nucleoside-nave patients with hepatitis B e antigen （HBeAg）-positive chronic hepatitis B. METHODS：One hundred and one nucleoside-nave patients with chronic hepatitis B were randomly divided into two groups. The entecavir （ENT） treatment group was given 0.5 mg of ENT once daily,while the adefovir dipivoxil （AD） treatment group was given 10 mg of AD once daily. The primary outcome measures assessed included serum hepatitis B virus （HBV） DNA level,HBeAg seroconversion or normalization of alanine aminotransferase （ALT） level. RESULTS：At week 48 after the treatment,serum HBV DNA levels decreased in both theENT and AD treatment groups. The percentage of patients showing a reduction greater than 103 copies/mL in HBV DNA titer was significantly higher in the ENT treatment group than in the AD treatment group （95.83% vs 60.38%,P〈0.001）. The percentage of patients achieving normalization of ALT level was also significantly higher in the ENT treatment group than in the AD treatment group （52.08% vs 28.30%,P = 0.015）. No signif icant difference was observed in the incidence rate of adverse events （77.08% vs 71.69%,P = 0.536） between the two groups. No HBeAg seroconversion was noted in both groups. CONCLUSION：In nucleoside-nave patients with HBeAg-positive chronic hepatitis B,entecavir is superior to adefovir dipivoxil in the suppression of serum HBV DNA level. Both two drugs have poor effects on HBeAg seroconversion.