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目的:评价国产阿德福韦酯胶囊治疗HBeAg阳性的中国慢性乙型病毒性肝炎患者48周的疗效和安全性。方法:采用多中心、随机、双盲、安慰剂平行对照的研究设计。前12周双盲阶段,240例患者按2∶1的比例随机进入阿德福韦酯10 mg.d-1组(160例,B组)或安慰剂组(80例,A组);12~48周,所有患者均接受开放的阿德福韦酯治疗。主要疗效指标为血清HBV DNA的变化情况,次要疗效指标包括:丙氨酸转氨酶(ALT)的复常率、48周HBeAg阴转率和HBeAg的血清转换率等。结果:治疗12周时,B组HBVDNA对数值下降(3.01±1.34),高于A组(P<0.05)。治疗48周时,A、B两组HBVDNA对数值分别下降(2.73±1.56),(3.02±1.55),HBVDNA转阴率分别为27.5%和31.6%,HBeAg阴转率分别为27.5%和41.2%,HBeAg/抗-HBe转换率分别为8.7%和8.8%,ALT复常率分别为81.2%和82.4%。研究期间无严重不良事件,且各组血清肌酐水平同基线相比无变化。结论:阿德福韦酯胶囊10 mg.d-1剂量治疗HBeAg阳性的中国慢性乙型肝炎患者48周有效,且安全性良好。
OBJECTIVE: To evaluate the efficacy and safety of domestic adefovir dipivoxil capsules in the treatment of 48-week patients with HBeAg-positive chronic hepatitis B in China. METHODS: A multicenter, randomized, double-blind, placebo-controlled study design was used. In the first 12 weeks of the double-blind phase, 240 patients were randomized to either adefovir dipivoxil 10 mg.d-1 (n = 160, group B) or placebo (n = 80, group A) ~ 48 weeks, all patients received open adefovir dipivoxil treatment. The main efficacy indicators for changes in serum HBV DNA, the secondary efficacy indicators include: alanine aminotransferase (ALT) normalization rate, 48 weeks HBeAg negative conversion rate and HBeAg seroconversion rate. Results: At 12 weeks, the logarithm of HBVDNA in group B was decreased (3.01 ± 1.34), which was higher than that in group A (P <0.05). After 48 weeks of treatment, the logarithm of HBVDNA in group A and group B were decreased (2.73 ± 1.56) and (3.02 ± 1.55) respectively, the negative conversion rates of HBVDNA were 27.5% and 31.6%, and the negative conversion rates of HBeAg were 27.5% and 41.2% , HBeAg / anti-HBe conversion rates were 8.7% and 8.8%, ALT normalization rates were 81.2% and 82.4%. There were no serious adverse events during the study, and serum creatinine levels in each group were unchanged from baseline. Conclusion: Adefovir dipivoxil capsule at a dose of 10 mg.d-1 for 48 weeks in Chinese patients with HBeAg-positive chronic hepatitis B is effective and safe.