阿德福韦酯片治疗慢性乙型肝炎的临床研究  

Clinical study on adefovir dipivoxil in the treatment of chronic hepatitis B

作　　者：刘锐[1] 高卫真[1] 徐道振[2] 皇甫玉珊[3] 胡大荣[4] 唐美芳[5] 龚作炯[6] 潘晨[7] 姚晨[8] 

机构地区：[1]天津医科大学药理学教研室 [2]北京地坛医院 [3]中国人民解放军第三○二医院 [4]北京军区总医院 [5]上海市传染病医院 [6]武汉大学人民医院 [7]福州市传染病医院 [8]北京大学第一医院医学统计室

出　　处：《天津医科大学学报》2008年第1期38-40,57,共4页Journal of Tianjin Medical University

摘　　要：目的:评价阿德福韦酯片对慢性乙型肝炎患者的临床疗效及安全性。方法:采用随机、双盲、安慰剂平行对照、多中心临床试验,试验分两个阶段,持续48周。将病人随机分为阿德福韦酯组(A组)和安慰剂组(B组),第一阶段A组服用阿德福韦酯片10mg,每日1次。B组服用安慰剂,每日1次,双盲治疗12周;第二阶段A组和B组都服用阿德福韦酯片10mg,每日1次,开放治疗36周。分别在治疗的4、8、12、24、36、48周末进行疗效和安全性评价。结果:两组治疗至12周,血清HBV-DNA水平(对数值)分别下降2.27、0.48,较基线水平相比两组差异有统计学意义(P<0.05),即阿德福韦酯与安慰剂相比,可显著降低HBV-DNA水平。治疗至48周时,两组可使血清HBV-DNA(对数值)的含量较基线时分别下降3.30和3.40,两组数值较基线数值差异有统计学意义(P<0.05);分别有73.89%和74.68%的患者血清HBV-DNA的含量较基线时下降≥21og10,两组数值较基线数值差异无统计学意义(P≥0.05)。结论:阿德福韦酯片抑制乙肝病毒复制安全有效,是可以治疗慢性乙型肝炎的药物。Objective： To evaluate the efficacy and safety of adefovir dipivoxil （ADV） for chronic hepatitis B patients. Methods：Patients with chronic hepatitis B were randomly divided into A or B group. During the first trial period, patients in group A and B received 10 mg of ADV and a placebo once a day for 12 weeks respectively. During the second trial period, all patients in group A and group B received 10 mg of ADV successively for 36 weeks. After 4, 8, 12, 24, 36, 48week, all trial indicators were measured and assessed. Results：At 12 week, the serum HBVDNA levels of two groups were reduced 2.27 and 0.48, Compared with group B, group A could significantly lower the HBVDNA level （P〈0.05）. At week 48, the serum HBVDNA levels of two groups were reduced 3.30 and 3.40 compared with basic level（P〈0.05）.In73.89% and 74.68% of two group patients , HBV-DNA level lowered over 21og10, There was no significance in two group （P=0.895〉0.05）. Conclusion：ADV is safe and effective to inhibit the copy of hepatitis B virus, which can be used to treat chronic hepatitis B.

关 键 词：慢性乙型肝炎 阿德福韦酯 随机对照试验 

分 类 号：R512.62[医药卫生—内科学] R743.330.5[医药卫生—临床医学]