核苷（酸）类似物初始治疗慢性乙型肝炎患者疗效和安全性的网络Meta分析

doi:10.3969/j.issn.1672-5069.2017.01.009

摘要/Abstract

摘要： 目的比较核苷（酸）类似物单药初始治疗慢性乙型肝炎患者的疗效和安全性。方法计算机检索阿德福韦酯（ADV）、恩替卡韦（ETV）、拉米夫定（LAM）、替比夫定（LdT）和富马酸替诺福韦酯（TDF）初始治疗慢性乙型肝炎患者的随机对照试验。应用Stata13进行网络Meta分析。采用固定效应模型和效应指标相对危险度（RR)及其95%可信区间（CI）进行分析。结果纳入14篇RCTs,总计5720例患者,其中ETV 治疗1396例,LdT 治疗982例,LAM 治疗2015例,TDF 治疗783例,ADV 治疗544例。经1年治疗,在HBV DNA低于检测下限方面, TDF为88.5%,ETV为79.9%,LdT为55.4%,LAM为19.9%,ADV为6.2%;在ALT复常方面, ETV为95.9%,TDF为56.6%,LdT为44.6%,ADV为34.1%,LAM为18.8%;在HBeAg消失方面, LdT为80.2%,TDF为76.2%,ETV为42.5%,LAM为27.4%,ADV为23.7%;在HBeAg血清学转换方面,LdT为79.9%,TDF为66.5%,ETV为39.1%,LAM为35.5%,ADV为29.0%。结论 TDF在HBV DNA低于检测下限方面疗效最好,ETV在ALT复常方面疗效最好,LdT在HBeAg消失/HBeAg血清学转换方面疗效最好。

关键词: 慢性乙型肝炎, 核苷（酸）类似物, 网络Meta分析, 疗效

Abstract: Objective To compare the efficacy and safety of nucleos（t）ide analogue monotherapy for treatment of naive patients with chronic hepatitis B. Methods A systematic review of related databases was conducted to evaluate the efficacy and safety of nucleos（t）ides in adult patients with chronic hepatitis B （CHB）. Only randomized controlled trials were included. The evaluated outcomes included undetectable HBV DNA,ALT normalization,HBeAg loss and HBeAg seroconversion at the end of 1 year treatment. Stata13 was applied to perform this network Meta-analysis. Results In 14 RCTs included,a total of 5720 patients with CHB were recruited,and out of them,1396 cases were treated with ETV,982 with LdT,2015 with LAM,783 with TDF,and 544 with ADV. As respect to undetectable serum HBV DNA,the sucra values of five agents were as follows：TDF（88.5%）,ETV（79.9%）,LdT（55.4%）,LAM（19.9%） and ADV（6.2%）;As for ALT normalization,the sucra values were as follows：ETV（95.9%）,TDF（56.6%）,LdT（44.6%）,ADV（34.1%）and LAM（18.8%）;for HBeAg loss,the sucra values were as follows：LdT（80.2%）,TDF（76.2%）,ETV（42.5%）,LAM（27.4%） and ADV（23.7%）;for HBeAg seroconversion,the sucra values were as follows：LdT（79.9%）,TDF（66.5%）,ETV（39.1%）,LAM（35.5%）and ADV（29.0%）. Conclusion TDF is the best in undectable serum HBV DNA,ETV is the best in ALT normalization and LdT is the best in HBeAg loss and/or HBeAg seroconversion。

Key words: Hepatitis B, Nucleos（t）ides, Network Meta analysis, Efficacy

潘静, 陆伦根. 核苷（酸）类似物初始治疗慢性乙型肝炎患者疗效和安全性的网络Meta分析[J]. 实用肝脏病杂志, 2017, 20(1): 29-33.

Pan Jing, Lu Lungen.. Efficacy and safety of nucleos（t)ides for the treatment of naive patients with chronic hepatitis B:A network Meta-analysis[J]. JOURNAL OF PRACTICAL HEPATOLOGY, 2017, 20(1): 29-33.

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