替诺福韦与恩替卡韦初始治疗慢性乙型肝炎患者长期疗效比较  

Efficacy Comparison of Tenofovir and Entecavir for Nucleoside-analogues Naive Chronic Hepatitis B Patients for 60 Weeks

作　　者：黄明星[1,2] 时红[1] 林国莉[1] 陈淑如[1] 揭育胜[1] 李新华[1] 吴元凯[1] 崇雨田[1] 

机构地区：[1]中山大学附属第三医院感染科,广东广州510630 [2]中山大学附属第五医院感染科,广东珠海519000

出　　处：《中山大学学报（医学科学版）》2015年第5期693-698,共6页Journal of Sun Yat-Sen University:Medical Sciences

基　　金："十一.五"国家科技重大专项(2012ZX10004-902)

摘　　要：【目的】比较一线抗乙肝病毒药物替诺福韦(TDF)与恩替卡韦(ETV)初始治疗慢性乙型肝炎(CHB)患者中疗效及安全性。【方法】回顾性比较TDF组33例及ETV组65例的CHB初治患者,具体为两组治疗前后第4、12、24、36、48、60周HBV DNA水平、不可检测率和累积不可检测率,ALT水平和累积复常率,不良事件发生率等。【结果】两组患者HBV DNA的对数水平(IU/m L)在第4周时ETV组明显低于TDF组(TDF:4.26±1.37 VS ETV:3.47±1.06,P=0.005),其余时间点差异无统计学意义。HBV DNA累积不可检测率、ALT累积复常率比较差异均无统计学意义(P分别为:0.114;0.656)。两组中各时间点CK超过2倍正常上限的比例差异无统计学意义(P均>0.05)。而两组内前后比较显示,HBV DNA水平进行性下降、HBV DNA不可检测率进行性上升,且在24周之前差异有统计学意义(P均<0.05),两组内ALT复常率也在12周之前差异有统计学意义(P均<0.05)。【结论】中国大陆NA初治的CHB,TDF或ETV治疗均能快速抑制HBV DNA复制,且ALT复常率高,不良事件发生率低,为指导抗病毒治疗方案选择有良好的参考价值。【Objective】 To compare the clinical efficacy and safety of Tenofovir Disoproxil Fumarate（TDF） and Entecavir（ETV） in the Nucleoside-Analogues（NA） for NA na觙ve chronic hepatitis B patients（CHB）. 【Methods】 33 NA-naived CHB patients treated with TDF（TDF group） and 65 with ETV（ETV group） in our follow-up clinic were retrospectively investigated. HBV DNA levels, the cumulative rate of undetectable HBV DNA and ALT normalization,incidences of adverse events were evaluated at week 0,4, 12, 24, 36, 48, 60. 【Results】 At 4th week, HBV DNA level was significantly lower in ETV group than in TDF group（TDF：4.26± 1.37 vs ETV： 3.47 ± 1.06 log10 IU / m L, P = 0.005）, while no difference was found in other time. The differences between the two groups in the cumulative rate of undetectable HBV DNA, ALT normalization rate were not statistically significant（P = 0.114, P =0.656）. HBV DNA levels persistent declined and the rate of undetectable HBV DNA continued rise in each group and the differences were statistically significant before in the first 24 weeks（all P〈0.05）, the same as ALT normalization rate in the first 12 weeks treatment（all P〈0.05）. There was no significant differences in the incidences of CK more than 2ULN in TDF and ETV.【Conclusions】 For NA naive CHB patients in Mailand China, both TDF and ETV can suppress HBV DNA replication very quickly,with a high rate of ALT normalization and lower rate of adverse events.

关 键 词：肝炎 乙型 肝炎病毒 慢性 替诺福韦 恩替卡韦 

分 类 号：R512.62[医药卫生—内科学]