一项随机、双盲、双模拟、对照、多中心研究的分析证实，马来酸恩替卡韦与恩替卡韦治疗HBeAg阳性慢性乙型肝炎的疗效相似。

[Analysis of a randomized, double-blind, double-dummy, controlled, multicenter study confirmed the similar therapeutic efficacies of entecavir maleate and entecavir for treatment of HBeAg-positive chronic hepatitis B].

作者信息

Xu Jing-hang, Yu Yan-yan, Si Chong-wen, Zeng Zheng, Li Jun, Mao Qing, Zhang Da-zhi, Tang Hong, Sheng Ji-fang, Chen Xin-yue, Ning Qin, Shi Guang-feng, Xie Qing, Zhang Xi-quan, Dai Jun, Xu Zhong-nan

机构信息

Department of Infectious Diseases, Peking University First Hospital, Beijing 100034, China.

出版信息

Zhonghua Gan Zang Bing Za Zhi. 2013 Dec;21(12):881-5. doi: 10.3760/cma.j.issn.1007-3418.2013.12.001.

DOI:10.3760/cma.j.issn.1007-3418.2013.12.001

PMID:24636286

Abstract

OBJECTIVE

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

METHODS

The patient population of this previously published randomized, double-blind, double-dummy, controlled, multicenter study was expanded by patients in the 0.5 mg/day ETV maleate group (total n = 110) and patients in the 0.5 mg/day ETV group (total n = 108). At treatment weeks 12, 24 and 48, hepatitis B virus (HBV) DNA levels were measured by the Roche Cobas Ampliprep/Cobas Taqman PCR assay. Adverse events (AE) were recorded.

RESULTS

As in the original analysis, the two treatment groups showed similar characteristics at baseline. In addition, the results for the all therapeutic effects showed identical trends to the results obtained in the original analysis, including the statistically similar effects of ETV and ETV maleate treatment-induced decreases in mean HBV DNA level at weeks 12, 24, and 48 (ETV: by 4.28, 5.00, and 5.53 log10 IU/ml vs. ETV maleate: by 4.46, 4.99, and 5.51 log10 IU/ml, respectively; all vs. baseline P more than 0.05), achievement of undetectable levels of serum HBV DNA ( less than 20 IU/ml) at week 48 (ETV: 38.18% vs. ETV maleate: 35.19%; P more than 0.05), HBeAg loss rates at week 48 (ETV: 10.91% vs. ETV maleate: 12.96%; P more than 0.05), HBeAg seroconversion rates at week 48 (ETV: 7.77% vs. ETV maleate: 10.38%; P more than 0.05), normalization of alanine aminotransferase at week 48 (ETV: 75.47% vs. ETV maleate: 82.86%; P more than 0.05), and overall incidence of AE (ETV: 18.02% vs. ETV maleate: 17.43%; P more than 0.05).

CONCLUSION

Performing analysis of the therapeutic efficacies of entecavir maleate versus entecavir with a larger study population confirmed our original findings of similar efficacy and safety profiles for these two drugs in patients with HBeAg-positive CHB.

摘要

目的

评估马来酸恩替卡韦（ETV）与恩替卡韦治疗乙肝e抗原（HBeAg）阳性慢性乙型肝炎（CHB）中国患者的疗效和安全性。

方法

这项先前发表的随机、双盲、双模拟、对照、多中心研究的患者群体，通过纳入每日0.5mg马来酸恩替卡韦组患者（共110例）和每日0.5mg恩替卡韦组患者（共108例）进行了扩充。在治疗第12、24和48周时，采用罗氏Cobas Ampliprep/Cobas Taqman PCR检测法测定乙肝病毒（HBV）DNA水平。记录不良事件（AE）。

结果

与原分析一样，两个治疗组在基线时表现出相似特征。此外，所有治疗效果的结果与原分析结果显示出相同趋势，包括恩替卡韦和马来酸恩替卡韦治疗在第12、24和48周时导致平均HBV DNA水平下降的统计学相似效果（恩替卡韦：分别下降4.28、5.00和5.53 log10 IU/ml，而马来酸恩替卡韦：分别下降4.46、4.99和5.51 log10 IU/ml；所有与基线相比P均大于0.05），第48周时血清HBV DNA达到不可检测水平（低于20 IU/ml）的比例（恩替卡韦：38.18%，而马来酸恩替卡韦：35.19%；P大于0.05），第48周时HBeAg消失率（恩替卡韦：10.91%，而马来酸恩替卡韦：12.96%；P大于0.05），第48周时HBeAg血清学转换率（恩替卡韦：7.77%，而马来酸恩替卡韦：10.38%；P大于0.05），第48周时丙氨酸氨基转移酶正常化比例（恩替卡韦：75.47%，而马来酸恩替卡韦：82.86%；P大于0.05），以及AE的总体发生率（恩替卡韦：18.02%，而马来酸恩替卡韦：17.43%；P大于0.05）。