首都医科大学学报 ›› 2010, Vol. 31 ›› Issue (5): 570-572.

• 慢性乙肝临床转归个体化治疗预测模型研究 • 上一篇    下一篇

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

欧晓娟, 王晓明, 尤红, 贾继东, 王宇, 段维佳, 李忆梅, 李佳, 王宝恩*   

  1. 首都医科大学附属北京友谊医院肝病中心
  • 收稿日期:1900-01-01 修回日期:1900-01-01 出版日期:2010-10-21 发布日期:2010-10-21
  • 通讯作者: 王宝恩

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

OU Xiao-juan, WANG Xiao-ming, YOU Hong, JIA Ji-dong, WANG Yu, DUAN Wei-jia, LI Yi-mei, LI Jia, WANG Bao-en*   

  1. Liver Research Center, Beijing Friendship Hospital, Capital Medical University
  • Received:1900-01-01 Revised:1900-01-01 Online:2010-10-21 Published:2010-10-21
  • Contact: WANG Bao-en

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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。

关键词: 阿德福韦酯, 慢性乙型肝炎, 治疗, HBV DNA

Abstract: 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<'b> 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.

Key words: adefovir dipivoxil, chronic hepatitis B, treatment, HBV DNA

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