A comparison of telbivudine and entecavir in the treatment of hepatitis B e antigen-positive patients: a prospective cohort study in China
A comparison of telbivudine and entecavir in the treatment of hepatitis B e antigen-positive patients: a prospective cohort study in China
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替比夫定和恩替卡韦治疗乙型肝炎e抗原阳性患者的比较：中国的一项前瞻性队列研究。
DOI：
10.1016/j.cmi.2015.10.024
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发表时间：
2016-03-01
影响因子：
14.2
通讯作者：
Zhang, J. -M.
中科院分区：
文献类型：
--
作者：
Zhang, Y.;Hu, P.;Zhang, J. -M.
很少有研究直接比较替比夫定和恩替卡韦的疗效和安全性。本前瞻性队列研究旨在评价这些化合物在196例B e抗原（HBeAg）阳性慢性B型肝炎患者中的长期疗效和安全性，中位随访期为172周; 97例接受替比夫定治疗，99例接受恩替卡韦治疗。表现出次优反应的患者也可以在24-48周服用阿德福韦，所有病毒突破的患者都开始服用阿德福韦。两个研究组中240周累积的显示检测不到B型肝炎DNA水平和血清丙氨酸转氨酶（ALT）正常化的患者比例相似。替比夫定组14%和恩替卡韦组2%出现病毒突破（p 0.002）。有趣的是，恩替卡韦和替比夫定治疗48周时HBeAg血清转换的累积比例分别为12%和21（p 0.041），96周时为15% vs 38%（p 0.001），144周时分别为24%与50%（p 0.001），192周时分别为33%与53%（p 0.004），240周时分别为36%与53%（p 0.005）。因此，与接受恩替卡韦治疗的患者相比，接受替比夫定治疗的患者更可能出现HBeAg血清转换，并且在年龄、血清ALT和HBV DNA水平匹配的研究亚组中观察到相似的结果。一项安全性分析发现，研究组中3/4级肌酸激酶升高之间没有差异，只有替比夫定与肾功能改善相关。临床微生物学和感染（C）2015年欧洲临床微生物学和传染病学会。由爱思唯尔有限公司出版。保留所有权利。
There are few studies directly comparing the efficacy and safety of telbivudine and entecavir. The present prospective cohort study aimed to evaluate the long-term efficacy and safety of these compounds in 196 hepatitis B e antigen (HBeAg)-positive patients with chronic hepatitis B for a median follow-up period of 172 weeks; 97 were treated with telbivudine and 99 were treated with entecavir. Patients showing suboptimal responses could also take adefovir at 24-48 weeks and all patients with viral breakthrough were started on adefovir. The 240-week cumulative proportions of patients showing undetectable hepatitis B DNA levels and serum alanine transaminase (ALT) normalization were similar in the two study groups. Viral breakthrough developed in 14% of the telbivudine group and in 2% of the entecavir group (p 0.002). Interestingly, the cumulative proportions of patients treated with entecavir and telbivudine showing HBeAg seroconversion were 12% versus 21% at 48 weeks (p 0.041), 15% versus 38% at 96 weeks (p 0.001), 24% versus 50% at 144 weeks (p 0.001), 33% versus 53% at 192 weeks (p 0.004) and 36% versus 53% at 240 weeks (p 0.005), respectively. Patients treated with telbivudine were therefore significantly more likely to show HBeAg seroconversion than those receiving entecavir and similar results were observed in study sub-groups matched for age, serum ALT, and HBV DNA levels. A safety analysis identified no differences between grade 3/4 creatine kinase elevations in the study groups and only telbivudine was associated with improved kidney function. Clinical Microbiology and Infection (C) 2015 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.