Four years of lamivudine treatment in Chinese patients with chronic hepatitis B
Four years of lamivudine treatment in Chinese patients with chronic hepatitis B
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DOI：
10.1111/j.1440-1746.2004.03428.x
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发表时间：
2004-11-01
影响因子：
4.1
通讯作者：
Leung, NW
中科院分区：
文献类型：
--
作者：
Chang, TT;Lai, CL;Leung, NW
背景和目标：本研究评估了长达4年的拉米夫定治疗的有效性和安全性以及YMDD变异型B型肝炎病毒（HBV）出现的临床相关性。58例中国成人慢性B肝炎（CHB）患者随机接受拉米夫定100 mg/d治疗长达5年，并监测YMDD变异型HBV，乙型肝炎B e抗原（HBeAg）血清转换（HBeAg和可检测到的HBeAg抗体的丧失）和血清丙氨酸氨基转移酶（ALT）浓度。结果：HBeAg血清转换率随着治疗时间的延长和ALT水平的升高而升高。67%（39/58）的患者在治疗期间的某个时间点检测到YMDD变异型HBV。4年后，共有47%（27/58）的患者实现HBeAg血清转换。33%（13/39）的YMDD变异型HBV患者实现了HBeAg血清转换;在治疗前ALT浓度中度升高（>2-5倍正常上限）的患者中，这一比例增加至57%（8/14）。达到正常血清ALT的患者比例从基线时的29%（17/58）增加至治疗4年后的69%（31/45）。其中包括68%（23/34）的YMDD变异型HBV患者和73%（8/11）的无变异型HBV患者。所有接受拉米夫定治疗的患者血清HBV-DNA浓度较基线水平均降低，尽管39例患者出现YMDD变异型HBV。拉米夫定的耐受性普遍良好，在第四年的研究中，药物相关不良事件的数量或类型变化不大。结论：尽管出现了YMDD变异HBV，但中国患者表现出HBeAg血清转换增加，ALT水平改善，拉米夫定治疗持续时间增加。(C)2004年Blackwell Publishing Asia Pty Ltd.
Background and Aims: This study assessed the efficacy and safety of up to 4 years of lamivudine treatment and the clinical relevance of the emergence of YMDD-variant hepatitis B virus (HBV).Methods: Fifty-eight Chinese adult patients with chronic hepatitis B (CHB) were randomized to lamivudine 100 mg/day for up to 5 years and were monitored for YMDD-variant HBV, hepatitis B e antigen (HBeAg) seroconversion (loss of HBeAg and detectable antibody to HBeAg) and serum alanine aminotransferase (ALT) concentrations. Four-year data are reported here.Results: The rate of HBeAg seroconversion increased with extended therapy and also with higher baseline ALT concentrations. YMDD-variant HBV was detected in 67% (39/58) of patients at some point during treatment. After 4 years, a total of 47% (27/58) of patients achieved HBeAg seroconversion. Thirty-three per cent (13/39) of patients with YMDD-variant HBV achieved HBeAg seroconversion; this increased to 57% (8/14) in patients with moderately elevated (>2-5 x upper limit of normal) pre-treatment ALT concentrations. The proportion of patients that achieved normal serum ALT increased from 29% (17/58) at baseline to 69% (31/45) following 4 years of treatment. That included 68% (23/34) of patients with YMDD-variant HBV and 73% (8/11) of those without the variant. All patients receiving lamivudine had reduced serum concentrations of HBV-DNA compared with baseline, despite the emergence of YMDD-variant HBV in 39 patients. Lamivudine was generally well tolerated; there was little change in the number or type of drug-related adverse events in the fourth year of the study.Conclusions: Despite the emergence of YMDD-variant HBV, Chinese patients showed increased HBeAg seroconversion and improvement in ALT levels with an increased duration of treatment with lamivudine. (C) 2004 Blackwell Publishing Asia Pty Ltd.