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拉米到恩替的转换疗法的随机临床实验
Recommendation of lamivudine-to-entecavir switching treatment in chronic hepatitis B responders: Randomized controlled trial
[肝胆速递]： 从2年的观察来看，在3年拉米治疗的慢性乙肝患者中（DNA小于10的2.6次方），转换到恩替治疗效果优于持续拉米治疗
http://onlinelibrary.wiley.com/doi/10.1111/j.1872-034X.2011.00807.x/abstract
Hepatology Research
Volume 41, Issue 6, pages 505–511, June 2011
Aim:
In the 2007–2008 guidelines of the study group (Ministry of Health, Labor and Welfare of Japan), lamivudine (LAM)-continuous treatment was recommended in patients treated with LAM for more than 3 years who maintained hepatitis B virus (HBV) DNA less than 2.6 log copies/mL, because in these patients LAM resistance might exist and switching treatment to entecavir (ETV) might cause ETV resistance. However, there was no evidence on whether switching treatment to ETV- or LAM-continuous treatment was better in those patients. In the present study, we performed a randomized controlled trial of LAM-to-ETV switching treatment.
Methods:
Twenty-seven patients treated with LAM for more than 3 years whose HBV DNA levels were less than 2.6 log copies/mL were enrolled and randomly divided into two groups, LAM-continued group or switching to ETV group. Then, we examined incidence of virological breakthrough (VBT) and breakthrough hepatitis (BTH) in each group.
Results:
There was no BTH in any of the patients. VBT was observed in six patients of the LAM group (6/15, 40%), and no patient of the ETV group (0/11, 0%) (P = 0.02). The differences of the proportion of cumulated VBT using a log–rank test with Kaplan–Meier analysis were significant between the LAM and ETV groups (P = 0.025).
Conclusion:
In patients treated with LAM for more than 3 years maintaining HBV DNA less than 2.6 log copies/mL, switching treatment to ETV is recommended at least during the 2 years' follow-up period.
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发表于 2011-5-30 03:50
