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目的观察阿德福韦酯治疗HBeAg阳性慢性乙型肝炎和拉米夫定治疗无效的慢性乙型肝炎患者,单药连续144周治疗,停药后监测96周疗效和药物安全性。方法初始治疗69例,拉米夫定治疗无效再治疗32例共101例,采用单药阿德福韦酯(ADV)10mg,每日1次口服,连续治疗144周,疗程结束继续监测到240周。结果阿德福韦酯初治组和复治组经144周连续治疗和停药后监测至240周血清ALT累积复常率分别为91.3%和90.6%,血清HBV DNA转阴率分别为88.4%和84.3%,HBeAg转阴率分别为34.7%和28.1%,HBeAg/HB-eAb血清转换率分别为55.0%和53.1%,HBsAg/HBsAb血清学转换均在停药后不同时间段发生,初治组为7.2%,复治组为6.3%。经144周连续治疗和停药后随访期间血、尿常规和肾功能,均无与治疗相关的异常发现。结论阿德福韦酯单药10mg每日1次口服治疗HBeAg阳性慢性乙型肝炎患者,有显著抑制HBV DNA复制,对拉米夫定治疗无效患者,可获得同样疗效,长期服药无明显耐药性,安全性好。
Objective To observe the adefovir dipivoxil treatment in patients with HBeAg-positive chronic hepatitis B and lamivudine ineffective treatment of chronic hepatitis B, single-drug treatment for 144 consecutive weeks, monitoring the efficacy of 96 weeks after drug withdrawal and drug safety. Methods Initial treatment of 69 cases, lamivudine ineffective re-treatment of 32 cases a total of 101 cases with single-agent adefovir dipivoxil (ADV) 10mg, once daily oral administration, continuous treatment of 144 weeks, the end of treatment continued to monitor 240 week. Results The cumulative ALT cumulative rates of serum adefovir dipivoxil-treated group and re-treatment group after continuous treatment and discontinuation of drug for 144 weeks after reperfusion were 91.3% and 90.6%, respectively, and the serum HBV DNA negative rates were 88.4% And 84.3% respectively. The HBeAg negative rates were 34.7% and 28.1% respectively. The seroconversion rates of HBeAg / HB-eAb were 55.0% and 53.1% respectively. The seroconversion of HBsAg / HBsAb occurred at different time points after discontinuation. 7.2% in the group and 6.3% in the retreatment group. After 144 weeks of continuous treatment and withdrawal after follow-up of blood, urine and renal function, no treatment-related abnormalities found. Conclusion Adefovir dipivoxil 10mg once daily oral administration of HBeAg-positive chronic hepatitis B patients, significantly inhibited HBV DNA replication, lamivudine ineffective treatment of patients with the same effect, long-term medication without significant resistance Sexual, safety is good.