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目的评价阿德福韦酯(ADV)治疗HBeAg阳性慢性乙型肝炎患者48周的疗效和安全性。方法试验按两个阶段进行。第一阶段患者随机进人安慰剂组(A组,20例)或ADV组(B组,34例)双盲治疗12周;第二阶段患者均接受开放的ADV治疗36周。结果治疗12周时,A组和B组HBVDNA总有效率分别为33.3%、76.5%;12周后,随着疗程延长,HBVDNA转阴率、HBeAg转阴率、HBeAg血清转换率、ALT复常率均增加。结论ADV(10mg,1/d,48周)能安全有效地治疗HBeAg阳性慢性乙型肝炎。
Objective To evaluate the efficacy and safety of adefovir dipivoxil (ADV) for 48 weeks in patients with HBeAg-positive chronic hepatitis B. The method test is conducted in two stages. Patients in the first phase were randomized to placebo (group A, n = 20) or ADV (group B, n = 34) for 12 weeks. Patients in phase two received open ADV for 36 weeks. Results After 12 weeks of treatment, the total effective rates of HBVDNA in group A and group B were 33.3% and 76.5% respectively. After 12 weeks, the HBVDNA negative rate, HBeAg negative rate, HBeAg seroconversion rate and ALT normalization Rates are increased. Conclusion ADV (10mg, 1 / d, 48 weeks) can safely and effectively treat HBeAg-positive chronic hepatitis B patients.