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[目的]评价国产阿德福韦酯(代丁)片10mg/d治疗HBeAg阳性慢性乙型肝炎患者48周的疗效和安全性。[方法]采用随机分组的方法,将111例HBeAg阳性的慢乙肝患者随机分为A、B两组。A组63例,口服国产阿德福韦酯(代丁)10mg/d,48周;B组48例,口服葛兰素史克公司阿德福韦酯(贺维力)10mg/d,48周。观察两组治疗前后血清ALT和HBV-DNA水平,HBV-DNA阴转率、ALT复常率、HBeAg阴转率、HBeAg血清转换率及药物不良反应。[结果]两组患者ALT、血清HBV-DNA下降水平及HBV-DNA阴转率、ALT复常率、HBeAg阴转率、HBeAg血清转换率均随着治疗疗程的延长而增加,但两组比较,差异无统计学意义(P﹥0.05)。两组患者均未发现药物相关的肾功能损害,两组共有9例患者出现轻度药物不良反应,但均能耐受。[结论]国产阿德福韦酯(代丁)治疗HBeAg阳性慢性乙型肝炎的有效性和安全性与国外同类药物相似。
[Objective] To evaluate the efficacy and safety of domestic adefovir dipivoxil (DingDing) tablet at 10 mg / d for 48 weeks in patients with HBeAg-positive chronic hepatitis B. [Methods] A total of 111 HBeAg-positive chronic hepatitis B patients were randomly divided into A and B groups. A group of 63 cases, oral made of adefovir dipivoxil (generation D) 10mg / d, 48 weeks; B group 48 cases, oral GSK Adefovir dipivoxil (He Weili) 10mg / d, 48 weeks. Serum ALT and HBV-DNA levels, HBV-DNA negative conversion rate, ALT normalization rate, HBeAg negative conversion rate, HBeAg seroconversion rate and adverse drug reactions were observed before and after treatment. [Results] The levels of ALT, serum HBV-DNA and HBV-DNA negative rate, ALT normalization rate, HBeAg negative rate and HBeAg seroconversion rate increased with the prolongation of treatment course in both groups , The difference was not statistically significant (P> 0.05). No drug-related renal impairment was found in either group, with a total of 9 patients in the two groups presenting with mild adverse drug reactions, but both were tolerated. [Conclusion] The efficacy and safety of domestic adefovir dipivoxil in treating HBeAg-positive chronic hepatitis B are similar to that of foreign similar drugs.