Xijing Hospital of Digestive Diseases, State Key Laboratory of Cancer Biology, Fourth Military Medical University, Xi'an, China.
J Viral Hepat. 2013 Apr;20 Suppl 1:58-64. doi: 10.1111/jvh.12065.
The aim of this study was to evaluate the efficacy and safety of telbivudine 600 mg/day compared with lamivudine 100 mg/day for 48 weeks of treatment in patients with hepatitis B-related cirrhosis. Data were reviewed retrospectively from 165 hepatitis B-related cirrhotic patients (55 compensated patients and 110 decompensated) who received antiviral therapy with telbivudine or lamivudine. Serum alanine aminotransferase (ALT) and hepatitis B virus (HBV) DNA levels, hepatitis B e antigen (HBeAg) loss and seroconversion, histological improvement and various adverse events (AEs) were evaluated. Baseline characteristics were comparable. ALT levels declined but showed no significant difference in treatment with telbivudine or lamivudine (P > 0.05). Reduction in serum HBV DNA levels was evident by week 4 in compensated HBV-related cirrhosis patients (telbivudine, 2.34 log10 copies/mL; lamivudine, 2.07 log10 copies/mL; P = 0.02) and persisted by week 8. Patients administrated with telbivudine had slightly greater HBeAg loss and seroconversion than patients with lamivudine, but the difference was not statistically significant (P > 0.05). Accumulative HBeAg loss was seen at week 48 (25.0% vs 25.0% and 13.3% vs 10.0% for telbivudine vs lamivudine in compensated and decompensated cirrhotic groups, respectively), as well as HBeAg seroconversion (15.0% vs 8.3% and 8.9% vs 6.7%). Mean Knodell Histologic Activity Index scores decreased in both compensated and decompensated cirrhotic patients (3.92 vs 3.64, 3.85 vs 3.73, for telbivudine vs lamivudine). Telbivudine and lamivudine were both well tolerated with minor AEs. The results of this study support telbivudine as an effective therapy for patients with both compensated and decompensated HBV-related cirrhosis.
本研究旨在评估替比夫定 600mg/天与拉米夫定 100mg/天治疗乙型肝炎相关肝硬化患者 48 周的疗效和安全性。我们回顾性分析了 165 例接受替比夫定或拉米夫定抗病毒治疗的乙型肝炎相关肝硬化患者（55 例代偿期患者和 110 例失代偿期患者）的数据。评估血清丙氨酸氨基转移酶（ALT）和乙型肝炎病毒（HBV）DNA 水平、乙型肝炎 e 抗原（HBeAg）丢失和血清学转换、组织学改善和各种不良事件（AE）。两组基线特征具有可比性。替比夫定或拉米夫定治疗后 ALT 水平均有下降，但差异无统计学意义（P>0.05）。代偿性乙型肝炎相关肝硬化患者治疗第 4 周时 HBV DNA 水平明显下降（替比夫定，2.34log10 拷贝/ml；拉米夫定，2.07log10 拷贝/ml；P=0.02），第 8 周时持续下降。与拉米夫定相比，替比夫定组患者 HBeAg 丢失和血清学转换率稍高，但差异无统计学意义（P>0.05）。代偿性和失代偿性肝硬化组患者分别在第 48 周时出现累积 HBeAg 丢失（替比夫定组 25.0%、25.0%和 13.3%、10.0%，拉米夫定组 25.0%、10.0%和 8.3%、6.7%）和 HBeAg 血清学转换（替比夫定组 15.0%、8.3%和 8.9%、6.7%）。代偿性和失代偿性肝硬化患者的 Knodell 组织学活动指数评分均降低（替比夫定组 3.92、3.64，拉米夫定组 3.85、3.73）。替比夫定和拉米夫定均耐受良好，仅有轻微的不良反应。本研究结果支持替比夫定为治疗代偿性和失代偿性乙型肝炎相关肝硬化患者的有效治疗药物。
