Department of Infectious Diseases, Third Affiliated Hospital to Wenzhou Medical College, Ruian, Zhejiang, P.R. China.
Med Sci Monit. 2013 Sep 9;19:751-6. doi: 10.12659/MSM.889443.
The aim of this study was to compare the effect of combination lamivudine (LAM) and adefovir dipivoxil (ADV) versus entecavir (ETV) monotherapy for naïve HBeAg-positive chronic hepatitis B (CHB) patients.
MATERIAL/METHODS: Fifty enrolled patients with CHB were evenly divided into 2 groups: a group treated with of lamivudine (LAM) (100 mg/day) plus adefovir (ADV) (10 mg/day) combination, and a group treated with entecavir (ETV) (0.5 mg/day). Serum levels of ALT, AST, creatinine, bilirubin, HBsAg, HBeAg and HBV viral load, and genotypic resistance were analyzed at 0, 12, 24, 52, and 104 weeks. HBV DNA levels were determined by real-time PCR and HBsAg and HBeAg by chemiluminescence. Serum levels of ALT, AST, creatinine, and bilirubin were measured by an automatic biochemical analyzer. Data analysis was performed with SPSS 12.0 software.
There were no significant differences in the virological response (VR) rates between LAM+ADV and ETV cohorts at 24, 52, and 104 weeks (P>0.05). The HBeAg seroconversion rates were 28% and 20%, and the biochemical response (BR) rates were 88% and 84% at week 104 in the LAM+ADV and ETV groups, respectively. The rates of undetectable HBV DNA, HBeAg seroconversion, and ALT normalization rates were similar in both cohorts. No virological breakthrough or serious adverse effects were noted for any patient during the study period.
Both LAM+ADV combination therapy and ETV monotherapy were effective and safe in the treatment of -naïve HBeAg-positive CHB patients. However, further studies are needed to obtain long-term results.
本研究旨在比较拉米夫定（LAM）和阿德福韦酯（ADV）联合与恩替卡韦（ETV）单药治疗初治 HBeAg 阳性慢性乙型肝炎（CHB）患者的疗效。
材料/方法：将 50 例 CHB 患者等分为 2 组：LAM（100mg/天）+ADV（10mg/天）联合治疗组和 ETV（0.5mg/天）治疗组。分别于 0、12、24、52 和 104 周检测血清 ALT、AST、肌酐、胆红素、HBsAg、HBeAg 和 HBV 病毒载量及基因型耐药情况。采用实时 PCR 法检测 HBV DNA 水平，化学发光法检测 HBsAg 和 HBeAg。采用自动生化分析仪检测血清 ALT、AST、肌酐和胆红素水平。采用 SPSS 12.0 软件进行数据分析。
LAM+ADV 组和 ETV 组在 24、52 和 104 周时的病毒学应答（VR）率无显著差异（P＞0.05）。LAM+ADV 组和 ETV 组在 104 周时的 HBeAg 血清学转换率分别为 28%和 20%，生化学应答率分别为 88%和 84%。两组患者的 HBV DNA 不可检测率、HBeAg 血清学转换率和 ALT 正常化率相似。研究期间，两组患者均未出现病毒学突破或严重不良反应。
LAM+ADV 联合治疗和 ETV 单药治疗初治 HBeAg 阳性 CHB 患者均有效且安全，但仍需进一步研究以获得长期结果。
