Adefovir dipivoxil for the treatment of hepatitis B e antigen-negative chronic hepatitis B
Adefovir dipivoxil for the treatment of hepatitis B e antigen-negative chronic hepatitis B
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DOI：
10.1056/nejmoa021812
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发表时间：
2003-02-27
影响因子：
158.5
通讯作者：
Brosgart, CL
中科院分区：
文献类型：
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作者：
Hadziyannis, SJ;Tassopoulos, NC;Brosgart, CL
dadefovir dipivoxil是一种核苷酸类似物，在1期和2期临床试验中对慢性乙型肝炎患者显示出显著的临床抗病毒活性。方法：我们随机分配185例乙型肝炎e抗原（HBeAg）阴性的慢性乙型肝炎患者，按照2:1的比例和双盲方式，每天1次接受10mg阿德福韦酯或安慰剂治疗，持续48周。主要终点为组织学改善。结果：在第48周，阿德福韦酯组有64%的基线肝活检标本的患者（121人中有77人）的组织学肝脏异常有所改善，而安慰剂组只有33%的患者(57人中有19人，P
BACKGROUNDAdefovir dipivoxil, a nucleotide analogue, demonstrated clinically significant antiviral activity in patients with chronic hepatitis B in phase 1 and 2 clinical trials.METHODSWe randomly assigned 185 patients with chronic hepatitis B who were negative for hepatitis B e antigen (HBeAg) to receive either 10 mg of adefovir dipivoxil or placebo once daily for 48 weeks in a 2:1 ratio and a double-blind manner. The primary end point was histologic improvement.RESULTSAt week 48, 64 percent of patients who had base-line liver-biopsy specimens available in the adefovir dipivoxil group had improvement in histologic liver abnormalities (77 of 121), as compared with 33 percent of patients in the placebo group (19 of 57, P