Zuo Shan-Ru, Zuo Xiao-Cong, Wang Chun-Jiang, Ma Yu-Tao, Zhang Hao-Ye, Li Zuo-Jun, Song Li-Ying, Deng Zhen-Zhen, Liu Shi-Kun
Center of Clinical Pharmacology and Pharmacy Department, The Third Xiangya Hospital, Central South University, Changsha, China.
School of Pharmaceutical Science, Central South University, Changsha, China.
J Clin Pharmacol. 2015 Mar;55(3):288-97. doi: 10.1002/jcph.409. Epub 2014 Nov 20.
The efficacy of entecavir and tenofovir in patients with chronic hepatitis B virus (HBV) is inconsistent. To address this issue, we conducted a meta-analysis based on a current review of the literature addressing the efficacy and safety of entecavir and tenofovir. Electronic databases were searched through June 2014 for relevant clinical trials. We included 2 randomized controlled trials, 2 prospective cohort studies, and 7 case-control studies that included 1,656 patients. In the entecavir group, 842 of 992 were nucleos(t)ide-naïve chronic HBV patients, and in the tenofovir group 481 of 664 were nucleos(t)ide-naïve. The virological response to tenofovir was superior to entecavir (RR: 0.82; 95%CI: 0.72-0.93), especially in nucleos(t)ide-naïve chronic HBV patients at 48 weeks (RR: 0.78; 95%CI: 0.65-0.92). Additionally, there was no difference between entecavir and tenofovir for virological response at 24 weeks (RR: 0.87, 95%CI: 0.71-1.05). The alanine aminotransferase normalization rate, serological response, and adverse event rate were also not significantly different between entecavir and tenofovir at 24 or 48 weeks after treatment. These results suggest that tenofovir is a better choice to treat chronic HBV patients than entecavir as it is better able to suppress HBV viral load and has a similar safety profile.
恩替卡韦和替诺福韦对慢性乙型肝炎病毒（HBV）患者的疗效并不一致。为解决这一问题，我们基于当前对恩替卡韦和替诺福韦疗效及安全性的文献综述进行了一项荟萃分析。检索电子数据库至2014年6月以查找相关临床试验。我们纳入了2项随机对照试验、2项前瞻性队列研究和7项病例对照研究，共1656例患者。在恩替卡韦组中，992例患者中有842例为核苷（酸）初治慢性HBV患者，在替诺福韦组中，664例患者中有481例为核苷（酸）初治患者。替诺福韦的病毒学应答优于恩替卡韦（RR：0.82；95%CI：0.72 - 0.93），尤其是在核苷（酸）初治慢性HBV患者中，治疗48周时（RR：0.78；95%CI：0.65 - 0.92）。此外，在24周时，恩替卡韦和替诺福韦的病毒学应答无差异（RR：0.87，95%CI：0.71 - 1.05）。治疗24周或48周后，恩替卡韦和替诺福韦在谷丙转氨酶正常化率、血清学应答及不良事件发生率方面也无显著差异。这些结果表明，与恩替卡韦相比，替诺福韦是治疗慢性HBV患者的更好选择，因为它能更好地抑制HBV病毒载量且安全性相似。
