阿德福韦酯片治疗HBeAg阳性慢性乙型肝炎多中心临床研究  

Multi-center clinical trial on effect of adefovir dipivoxii in treating chronic hepatitis B with e antigenpositive

作　　者：臧红 丁晋彪 李进 柳芳芳[2] 李晨[2] 朱冰[2] 刘婉姝[2] 游绍莉[2] 辛绍杰[2] 

机构地区：[1]解放军医学院,北京100853 [2]解放军第三0二医院肝衰竭诊疗与研究中心 [3]医务部

出　　处：《中华实验和临床病毒学杂志》2013年第6期440-442,共3页Chinese Journal of Experimental and Clinical Virology

摘　　要：目的评价国产阿德福韦酯片治疗成人HBeAg阳性慢性乙型肝炎的有效性和安全性。方法采用多中心、开放试验方法，入选1930例患者服用阿德福韦酯片10mg／d。随访观察采用标准操作规程（SOP），观察12周、24周、36周、52周的生化、病毒学指标及不良反应。结果1930例患者治疗12周、24周、36周、52周，HBVDNA阴转率分别为16．42％、28．55％、37．25％、43．32％，ALT复常率分别为29．69％、49．02％、56．42％、62．95％。治疗24周、52周HBeAg阴转率分别为12．59％、19．38％。随着疗程延长，HBVDNA阴转率、ALT复常率、HBeAg阴转率越高。治疗52周时耐药率为0．17％。不良反应率0．72％，极少数病例出现尿常规轻微异常，未发现肾功或生殖系统受损。结论国产阿德福韦酯片治疗HBeAg阳性慢性乙型肝炎具有良好的有效性及安全性。Objective To evaluate the efficacy and safety of domestic adefovir dipivoxil in the treatment of chronic hepatitis B with e antigen-positive. Methods The multicenter open clinical trial was conducted,the 1930 patients received oral adefovir dipivoxil 10 mg/d. Follow-up observations by standard operating procedures（SOP）. The changes in biochemical, virological parameters and adverse reactions were observed after treatment on 12 weeks, 24 weeks, 36 weeks and 52 weeks. Results After 12 weeks, 24 weeks, 36 weeks and 52 weeks of treatment, the rates of the serum HBV DNA negative-conversion and alanine aminotransferase（ALT） renormalization were 16.42% ,28.55% ,37.25% ,43.32% and 29.69% , 49.02% ,56.42% ,62.95% respectively. After 24 weeks and 52 weeks of treatment, the rates of HBeAg negative-conversion were 12.59% , 19.38% respectively. After that, as the treatment duration prolonged, there was an increase in the serum HBV DNA negative-conversion, ALT renormalization and HBeAg negative-conversion rate resistance rate was 0.17% during the treatment of 52 weeks period. The adverse reaction rate of 0. 72% , very few cases of urine routine showed mild abnormality, no impairments of renal function or reproductive system were emerge. Conclusions Domestic adefovir dipivoxil for treating chronic hepatitis B with e antigen-positive is safe and effective.

关 键 词：阿德福韦酯 肝炎 乙型 慢性 

分 类 号：R512.62[医药卫生—内科学]