马来酸恩替卡韦与恩替卡韦治疗HBeAg阴性慢性乙型肝炎的随机、双盲、双模拟、对照、多中心研究：48周结果

[A randomized, double-blind, double-dummy, controlled, multicenter study of entecavir maleate versus entecavir for treatment of HBeAg-negative chronic hepatitis B: results at week 48].

作者信息

Xu Jing-hang, Yu Yan-yan, Si Chong-wen, Zeng Zheng, Zhang Da-zhi

机构信息

Department of Infectious Diseases, Peking University First Hospital, Beijing, China.

出版信息

Zhonghua Gan Zang Bing Za Zhi. 2012 Jul;20(7):512-6. doi: 10.3760/cma.j.issn.1007-3418.2012.07.007.

DOI:10.3760/cma.j.issn.1007-3418.2012.07.007

PMID:23044236

Abstract

OBJECTIVE

To evaluate the efficacy and safety of entecavir (ETV) maleate versus ETV in Chinese patients with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B (CHB).

METHODS

This was a randomized, double-blind, double-dummy, controlled, multicenter study. Patients were randomly assigned to receive 48 weeks of treatment with 0.5 mg/day ETV (group A; n = 26) or 0.5 mg/day ETV maleate (n = 31). Hepatitis B virus (HBV) DNA levels were measured at weeks 12, 24, and 48 by the Roche Cobas Ampliprep/Taqman PCR assay. Adverse events (AE) were recorded.

RESULTS

Baseline characteristics were similar between the two groups. At weeks 12, 24, and 48, the mean HBV DNA level had similarly decreased from baseline in both groups (A: by 4.24, 4.61 and 4.88 log10 IU/mL vs. B: 4.01, 4.50 and 4.99 log10 IU/mL, respectively; all P more than 0.05). Patients who achieved undetectable levels of serum HBV DNA (less than 20 IU/mL) at week 48 were similar in the two groups (A: 69.23% vs. B: 80.65%; P more than 0.05). Both groups achieved similar normalization of ALT at week 48 (A: 96.00% vs. B: 83.87%; P more than 0.05). The overall AE incidence was similar for the two groups (A: 22.22% vs. B: 9.38%; P more than 0.05).

CONCLUSION

Entecavir maleate and entecavir showed similar efficacy and safety in patients with HBeAg-negative CHB.

摘要

目的

评估马来酸恩替卡韦（ETV）与恩替卡韦在中国乙肝e抗原（HBeAg）阴性慢性乙型肝炎（CHB）患者中的疗效和安全性。

方法

这是一项随机、双盲、双模拟、对照、多中心研究。患者被随机分配接受为期48周的治疗，其中一组每天服用0.5mg恩替卡韦（A组；n = 26），另一组每天服用0.5mg马来酸恩替卡韦（n = 31）。在第12、24和48周时，采用罗氏Cobas Ampliprep/Taqman PCR检测法测量乙肝病毒（HBV）DNA水平。记录不良事件（AE）。

结果

两组的基线特征相似。在第12、24和48周时，两组的平均HBV DNA水平均较基线有相似程度的下降（A组分别下降4.24、4.61和4.88 log10 IU/mL，B组分别下降4.01、4.50和4.99 log10 IU/mL；所有P值均大于0.05）。在第48周时，两组中血清HBV DNA水平低于检测下限（低于20 IU/mL）的患者比例相似（A组为69.23%，B组为80.65%；P值大于0.05）。两组在第48周时ALT复常率相似（A组为96.00%，B组为83.87%；P值大于0.05）。两组的总体不良事件发生率相似（A组为22.22%，B组为9.38%；P值大于0.05）。