阿德福韦酯(阿迪仙)治疗慢性乙型肝炎患者4年临床疗效观察  

Four-year Efficacy and Safety of Adefovir Dipivoxil for the Treatment of Chronic Hepatitis B

作　　者：欧晓娟[1] 王晓明[1] 尤红[1] 贾继东[1] 王宇[1] 段维佳[1] 李忆梅[1] 李佳[1] 王宝恩[1] 

机构地区：[1]首都医科大学附属北京友谊医院肝病中心

出　　处：《首都医科大学学报》2010年第5期570-572,共3页Journal of Capital Medical University

基　　金：北京市科委病毒性肝炎重大项目(H020920020730);北京市优秀人才(20061D0300100062)资助项目~~

摘　　要：目的观察阿德福韦酯(阿迪仙)片10 mg/d治疗慢性乙型病毒性肝炎患者4年的疗效和安全性。方法对240例慢性乙型病毒性肝炎患者,采用随机、双盲、对照的研究设计,按1∶1的比例分为阿德福韦酯(阿迪仙)治疗组(120例)或对照组(120例);观察阿德福韦酯(阿迪仙)长期治疗的临床疗效。评价指标包括:丙氨酸氨基转移酶(ALT)复常率、HBV DNA转阴率及药物安全性。结果治疗组在各时间点ALT的复常率均高于对照组,2组间比较差异有统计学意义(P<0.01)。1年时达76.8%;2年后维持在58%左右。HBV DNA转阴率4年分别为48.3%,38.3%,44.2%,43.3%,2组差异有统计学意义(P<0.01)。4年观察期间2组均无明显不良反应。结论阿德福韦酯(阿迪仙)10 mg/d剂量治疗慢性乙型肝炎患者4年安全、有效。Objective To assess the long-term efficacy and safety of generic adefovir dipivoxil（ADV） for the treatment of Chinese patients with chronic hepatitis B.Methods This four-year random,double-blind,controlled study included 240 patients with chronic hepatitis B virus（HBV） infection,120 received ADV monotherapy.Alanine aminotransferase（ALT） normalization,HBV DNA loss and safety were evaluated every 6 months.Results ALT normalization rate was significantly higher in the ADV group than that in the control group.After 1 year ADV treatment the ALT normalization rate was 76.8% and sustained at 58% for the following 3 years.Complete virological response（HBV DNA 500 IU/L） was observed in 48.3%,38.3%,44.2% and 43.3% of the cases during the four years of ADV treatment respectively.The safety profiles showed no significant difference between the ADV and control group,except that only 4 patients had slightly increased（less than 0.5 fold higher than baseline level） creatinine.Conclusion Generic ADV showed the good anti-HBV efficacy and safety during the four years treatment.

关 键 词：阿德福韦酯 慢性乙型肝炎 治疗 HBVDNA 

分 类 号：R575.1[医药卫生—消化系统]