目的 观察国产恩替卡韦治疗慢性乙型肝炎的临床疗效并评估影响疗效的因素.方法 应用国产恩替卡韦治疗浙江省绍兴市第六人民医院2010年12月至2012年12月门诊或住院200例慢性乙型肝炎患者,分别于12、24、48周进行病毒学、血清学及生化学指标的检测,并将包括乙型肝炎e抗原(HBeAg)阳性或阴性、基线丙氨酸转氨酶(ALT)水平、乙型肝炎病毒脱氧核糖核酸(HBV DNA)转阴时间、基线HBV DNA水平及肝组织病理特征等因素对疗效的影响进行评估.结果 国产恩替卡韦治疗48周,ALT复常率为78.5% (157/200),HBV DNA转阴率为84.5%(169/200),HBeAg血清转换率23.4%(33/141,耐药率为0%;基线ALT >5倍正常值上限(ULN)患者的HBeAg血清学转换率高于2~5 ULN的患者[分别为35.4% (19/54)和16.1%(14/87),P<0.05];治疗24周后HBV DNA阴转的患者与未阴转的患者相比,其48周HBV DNA阴转、ALT复常和HBeAg血清学转换的比例明显增高[分别为92.4%(134/145)、86.2%(125/145)、20.7% (30/145)和63.6% (35/55)、58.2%(32/55)、5.5%(3/55),均P<0.05];炎症活动分级(G)>2,HBeAg血清转换率高于G≤2[分别为37.5%(12/32)和15.0%(3/20),P<0.05];基线病毒载量高低与48周疗效差异无统计学意义(P>0.05).在治疗48周过程中8例发生一过性ALT升高,无患者因发生不良事件而停药.结论 国产恩替卡韦能明显抑制HBV DNA复制,促进ALT复常及HBeAg血清转换,有效改善肝功能,耐药率低,安全性良好.且基线ALT>5 ULN、炎症活动分级G>2及治疗24周后HBV DNA阴转的患者在48周时有更好的疗效.
Objective To investigate the effect of domestic entecavir on chronic hepatitis B.Methods The virology,serology and biochemical indicators of 200 patients who received entecavir for the treatment of chronic hepatitis B were analyzed before treatment and 12,24 and 48 weeks after treatment.Results After 48 weeks of treatment,hepatitis B virus(HBV) DNA negative rate was 84.5% (169/200) ; hepatitis B e antigen(HBeAg) seroconversion rate was 23.4% (33/141) ; alanime transaminase (ALT) normolization rate was 78.5% (157/200)and drug resistant rate was 0.The rate of HBeAg seroconversion in patients with baseline ALT > 5 ULN was significantly higher than tht in patients with 2 to 5 ULN[35.4% (19/54) vs 16.1% (14/87),P <0.05].Compared with patients with no HBV DNA negative conversion at 24 weeks,ratio of HBV DNA negative conversion,ALT normalization and HBeAg seroconversion were significantly higher in patients with HBV DNA negative 48 weeks after treatment [92.4% (134/145) vs 6