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目的评价恩替卡韦(ETV)对拉米夫定(LVD)失效的慢性乙型肝炎(CHB)患者治疗1年的疗效和安全性。方法选择LVD治疗失效的CHB患者145例,按4：1比例随机分为ETV组(1．0mg/d)116例和安慰剂组29例,治疗12周后,所有患者进入36周的开放用药阶段(ETV 1．0 mg/d)。观察血清HBV DNA水平、乙型肝炎e抗原(HBeAg)、肝生化功能的变化和不良事件的发生率。结果经12周的治疗,ETV组患者血清HBV DNA平均下降4．30 log_(10)拷贝/ml(聚合酶链反应法),安慰剂组下降0．15 log_(10)拷贝/ml(P＜0．01)。第12周时,在基线丙氨酸转氨酶(ALT)异常的患者中,ETV组的ALT复常率明显高于安慰剂组(分别为68%与6%,P＜0．01)。两组间不良事件的总发生率相当(33%与28%)。经48周的治疗,服用ETV 48周患者HBV DNA的下降幅度为5．08 log_(10)拷贝/ml；服用ETV 36周患者HBV DNA的下降幅度为4．86 log_(10)拷贝/ml；在治疗前ALT异常的患者中,上述两组ALT的复常率分别是85%和90%。治疗结束时,在基线HBeAg阳性的患者中,有6．2%(8/129)出现血清学转换。在治疗期间,未发生与耐药相关的变异。每天服用ETV 1．0mg,持续48周的安全性和耐受性良好。结论ETV(1．0 mg/d)治疗LVD失效的CHB患者具有显著的抗病毒和临床疗效。
Objective To evaluate the efficacy and safety of entecavir (ETV) for 1 year in patients with lamivudine (LVD) failure of chronic hepatitis B (CHB). Methods One hundred and sixty-five patients with CHB who failed LVD treatment were randomly divided into ETV group (1.0mg / d), 116 cases and placebo group according to the ratio of 4: 1. After 12 weeks of treatment, all patients were enrolled into the study for 36 weeks Stage (ETV 1.0 mg / d). Serum HBV DNA levels, hepatitis B e antigen (HBeAg), changes in liver biochemical function and incidence of adverse events were observed. Results After 12 weeks of treatment, serum HBV DNA in ETV group decreased by an average of 4.30 log 10 copies / ml (polymerase chain reaction) and 0.15 log 10 copies / ml in placebo group (P < 0.01). At week 12, patients with abnormal ALT in the baseline ETV group had significantly higher rates of ALT abnormalities than those in the placebo group (68% vs 6%, respectively; P <0.01). The overall incidence of adverse events was comparable between the two groups (33% and 28%). After 48 weeks of treatment, the decrease of HBV DNA in 48-week ETV patients was 5.08 log_ (10) copies / ml. The decrease of HBV DNA in ETV patients was 4.86 log_ (10) copies / Among patients with pre-treatment ALT abnormalities, the rates of normobaric reversion in the two groups were 85% and 90%, respectively. At the end of treatment, seroconversion occurred in 6.2% (8/129) of baseline HBeAg-positive patients. During treatment, no resistance-related mutations occurred. Taking ETV 1.0mg daily for 48 weeks is safe and well tolerated. Conclusions ETV (1.0 mg / d) has significant antiviral and clinical efficacy in CHB patients with LVD failure.