替诺福韦酯和恩替卡韦对慢性乙型肝炎初治患者疗效的荟萃分析

目的评价替诺福韦酯(TDF)和恩替卡韦(ETV)对慢性乙型肝炎(CHB)初治患者抗病毒的疗效及安全性。方法对2006年1月至2016年10月在国际生物医学期刊有关TDF和ETV治疗CHB的临床研究进行质量评价,并对相关文献进行荟萃分析。结果共纳入6篇文献。荟萃分析结果显示ETV和TDF抗病毒治疗的HBV DNA转阴率差异无统计学意义48周时的RR=1.19,95%CI=1.09~1.30;96周时的RR=1.08,95%CI=1.02~1.14];两种药物的ALT复常率及HBeAg血清学转换率同样差异无统计学意义;且两种药物长期使用安全性良好,未观察到严重不良反应。结论 ETV和TDF对CHB核苷(酸)类药物初治患者抗病毒疗效相似,但仍需进一步观察远期治疗的安全性。

A meta-analysis of comparison of efficacy of tenofovir or entecavir in nucleos(t)ide analogue-naive patients with chronic hepatitis B

Objective To compare treatment efficacy and safety of tenofovir (TDF) or entecavir (ETV) in nucleoside-nave chronic hepatitis B (CHB) patients using meta-analysis.Methods Published data relevant to TDF or ETV treated CHB patients from January 2006 to October 2016 was enrolled and meta-analyzed.The rate of Hepatitis B virus (HBV) DNA suppression, alanine transaminase (ALT) normalization, and hepatitis B e antigen (HBeAg) seroconversion at week 48 and 96 were reviewed, respectively.Drug safety and resistance were also discussed.Results There were 6 articles involved.The meta-analysis showed no significant differences in HBV DNA suppression rate between the two drugs in nave treated CHB patients (TDF vs.ETV: RR=1.19, 95% CI =1.09~1.30 and RR=1.08, 95% CI=1.02~1.14 for week 48 and week 96, respectively).Moreover, there were also no differences in ALT normalization rate (4 studies for 48 weeks), HBeAg seroconversion rate (3 studies for 96 weeks) and long-term safety between TDF and ETV, respectively.Conclusion TDF and ETV show similar efficacy in treating nucleoside-nave chronic HBV patients.Nevertheless, the long-term efficacy and safety should be monitored in prolonged therapy.