对拉米夫定(LAM)初治耐药后,LAM联合阿德福韦酯(ADV)应答不佳的慢性乙型肝炎患者,分别采用恩替卡韦(ETV)单药或ETV联合ADV进行补救治疗,比较两种补救方案的疗效. 对LAM初治耐药后应用LAM联合ADV应答不佳的40例患者,分别应用ETV 1.0 mg/d(14例)及ETV 联合ADV (26例)两种方案进行补救治疗,至少观察48周,定期监测HBV DNA、肝肾功能、HBV标志物等指标.两组患者采用补救治疗前的基线情况差异无统计学意义. 恩替卡韦1.0mg组，HBV DNA的基线值为(5.768 ± 0.709) log10 copies/ml ，在4周、12周、24周及48周时，分别降至(4.712 ± 0.846) log10 copies/ml, (3.914 ± 0.996) log10 copies/ml, (3.702 ± 0.934) log10 copies/ml, (3.879 ± 0.913) log10 copies/ml and (3.855 ± 1.070) log10 copies/ml 。在ETV 联合ADV 组，HBV DNA的基线值为(5.703 ± 0.845) log10 copies/ml ，在4周、12周、24周及48周时，分别降至(4.712 ± 0.846) log10 copies/ml, (4.476 ± 0.905) log10 copies/ml, (3.590 ± 0.884) log10 copies/ml, (2.987 ± 0.673 ) log10 copies/ml , (2.933 ± 0.535) log10 copies/ml 。在24周时，恩替卡韦1.0mg组，有28.6%的患者HBV DNA < 500 copies/ml ，而ETV + ADV 组有80.8%的患者达到此水平。在48周时，恩替卡韦1.0mg组，另有4例患者HBV DNA < 500 copies/ml ，但是ETV + ADV 组所有患者均达到此水平。在24周时，恩替卡韦1.0mg组，42.9%的ALT水平恢复正常，但是ETV + ADV 组92.3%的患者均达到此水平。差距有统计学意义。在48周时，恩替卡韦1.0mg组，57.1%的ALT水平恢复正常，而ETV + ADV 组所有患者均达到此水平。差距有统计学意义。在48周时，恩替卡韦1.0mg组，有1例患者e抗原血清学转换，而ETV + ADV 组4例患者e抗原血清学转换。对于LAM耐药后LAM联合ADV应答不佳的慢性乙型肝炎患者,采用ETV联合ADV的补救方案较ETV单药1.0mg的方案更为有效,可以实现更好的病毒学及生物化学应答.



To evaluate the efficacy of entecavir (ETV) 1.0 mg/d or ETV plus adefovir dipivoxil (ADV) in adults with chronic hepatitis B virus (HBV) infection who had previously resisted lamivudine (LAM) and failed with rescue treatment of LAM + ADV.
40 patients were enrolled. 14 patients were treated with ETV 1.0 mg/d monotherapy while 26 patients were treated with ETV + ADV. The HBV DNA level, liver function, HBV serology and renal function were observed.There was no statistically significant difference with baseline situation between group ETV 1.0 mg and group ETV + ADV. HBV DNA level in group ETV 1.0 mg was (5.768 ± 0.709) log10 copies/ml on baseline, and it declined to (4.712 ± 0.846) log10 copies/ml, (3.914 ± 0.996) log10 copies/ml, (3.702 ± 0.934) log10 copies/ml, (3.879 ± 0.913) log10 copies/ml and (3.855 ± 1.070) log10 copies/ml at 4, 8, 12, 24 and 48 weeks. HBV DNA level in group ETV + ADV was (5.703 ± 0.845) log10 copies/ml on baseline, and it declined to (4.476 ± 0.905) log10 copies/ml, (3.590 ± 0.884) log10 copies/ml, (2.987 ± 0.673) log10 copies/ml and (2.933 ± 0.535) log10 copies/ml at 4, 8, 12 and 24 weeks. At 24 weeks, there were 28.6% patients achieved HBV DNA < 500 copies/ml in group ETV 1.0 mg, but there were 80.8% patients in group ETV + ADV achieved this level. At 48 weeks, there were still 4 patients achieved HBV DNA < 500 copies/ml in group ETV 1.0 mg, but patients in group ETV + ADV all achieved it. At 24 weeks, ALT levels of 42.9% patients in group ETV 1.0 mg were back to normal, but there were 92.3% patients‘ ALT levels back to normal in group ETV + ADV. There was statistically significant difference . At 48 weeks, ALT levels of 57.1% patients in group ETV 1.0 mg were back to normal, but all patients' ALT levels were back to normal in group ETV + ADV. At 48 weeks, there was 1 patient with HBeAg seroconversion in group ETV 1.0 mg while there were 4 patients in group ETV + ADV.As rescue treatment for patients with chronic hepatitis B who had previously resisted LAM and failed with treatment of LAM + ADV, ETV + ADV was more efficient than ETV 1.0 mg monotherapy, and it can achieve better virological and biochemical response.

点击下载 恩替卡韦1.0mg或其联合阿德福韦酯补救治疗拉米夫定联合阿德福韦酯应答不佳的慢性乙型肝炎