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摘要: 目的探讨阿德福韦酯（ADV）联合拉米夫定（LAM）治疗LAM耐药慢性乙型肝炎（CHB）患者的临床疗效及安全性。方法选择LAM耐药的HBeAg阳性CHB患者102例随机分为3组,ADV+LAM组（A组）38例,给予ADV10mg/d联合LAM100 mg/d口服;ADV组（B组）42例,ADV10mg/d口服;LAM组（C组）22例,LAM 100mg/d口服,分别于完成24、48和72周治疗时,观察血清HBV DNA水平、HBV血清学标志、肝功能及不良反应。结果治疗24、48、72周A、B组HBV DNA水平较C组均显著下降（P<0.01）,HBV DNA阴转率较C组显著升高（P<0.05,P<0.01）,治疗24、48、72周A组和72周B组ALT复常率较C组均显著升高（P<0.05,P<0.01）;治疗48、72周A组HBV DNA水平较B组显著下降（P<0.05）,治疗72周HBV DNA阴转率和ALT复常率较B组显著升高（P<0.05,P<0.01）。三组血清HBeAg阴转率及血清转换率间差异无统计学意义（P>0.05）。治...Abstract: Objective To study the therapeutic effect and safety of adefovir dipivoxil (ADV) combined with lamivudine (LAM) for chronic hepatitis B (CHB) patients with lamivudine-resistant.Methods 102 cases of HBeAg positive CHB patients with LAM resistant were randomly divided into three groups, ADV combined with LAM group (group A, n=38) was treated with ADV10mg and LAM100 mg once daily by orally taken, ADV group (group B, n=42) was given ADV10mg/d and LAM group (group C, n=22) was given LAM100 mg/d.After 24, 48 and 72-weeks of treatment, serum HBV DNA levels, HBV serology and liver function tests were measured re spectively, and safety assessments were also conducted.Results At 24, 48 and 72 weeks, the mean reduction and negative rate of HBV DNA were significantly greater in group A and B compared with that in group C (P<0.05, P<0.01) .The ALT normalization of group A at 24, 48 and 72 weeks and group B at 72 weeks were significantly higher than that of group C (P<0.05, P<0.01) .The mean reduction of HBV DNA at 48 and 72 weeks, HBV DNA negative rate and ALT normalization at 72 weeks were significantly greater in group A than group B (P<0.05, P<0.01) , there were no significant different between the three groups in the portion of HBeAg loss and HBeAg seroconversion (P>0.05) .During the treatment, the new resistance mutation rate was lower in group A than group C (P<0.05) , there was no severe adverse event related to the investigational product.Conclusion ADVcombined with LAM is effective and safe for CHB patients with lamivudine-resistant.
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Key words:
- Hepatitis B /
- chronic /
- Adefovir dipivoxil /
- Lamivudine /
- Drug resistant
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