摘要目的 研究阿德福韦酯(ADV)治疗拉米夫定(LAM)耐药的慢性乙型肝炎(CHB)患者的疗效和安全性.方法 治疗组32例,为LAM耐药的CHB患者采用ADV 10 mg/d联合LAM 100 mg/d治疗,疗程为48周;历史对照组24例,为LAM耐药的CHB患者继续服用LAM 100 mg/d治疗,疗程为48周.服药后定期检测ALT、HBV DNA和HBeAg,并观察不良反应.结果 治疗第24周和48周时,ADV组HBV DNA水平较用药前分别下降256 log10拷贝/ml和2.93 log10拷贝/ml,病毒学应答率分别为50.0%和75.0%,ALT复常率分别为53.1%和68.8%;在48周时肝组织学改善率为65.6%,都显著高于安慰剂组(P<0.05).经统计,HBeAg阴转率及血清学转换率两组比较差异无统计学意义.两组均未发现明显不良反应.结论 ADV治疗LAM耐药的CHB安全有效.

abstractsObjective To investigate the efficacy and safety of adefovir dipivoxil (ADV) in treatment of chronic hepatitis B (CHB) patients with lamivudine (LAM) resistance. Methods There were treatment group (32 CHB patients with LAM resistance) and historical control group (24 CHB patients with LAM resistance) in this study. The treatment group received ADV 10 mg/d and LAM 100 mg/d for 48 weeks; the historical control group continued to use LAM monotherapy. During the treatment causes, serum HBV DNA levels, liver function and HBV serology were monitored regularly, and safety assessments were also conducted. Results In treatment group, mean HBV DNA levels decreased by 2.56 log10 eopies/ml and 2.93 log10 copies/ml, virus response rates were 50. 0% and 75.0%, ALT normalization rates were 53.1% and 68.8% after 24 and 48 weeks of treatment, respectively. The histological improvement rate was 65.6% after 48 weeks. Comparing with those in control group, the differences were statistically significant ( P <0. 05), while there was no significant statistical differences in HBeAg loss rate and HBeAg seroconversion rate between two groups. There was no severe adverse event during the treatment. Conclusion ADV is effective and safe in treatment of lamivudine-resistant CHB.