恩替卡韦与拉米夫定初次治疗慢性乙肝的效果和安全性比较

Comparison of effect and safety of entecavir and lamivudine in initial treatment of chronic hepatitis B

目的探讨恩替卡韦（ETV）与拉米夫定（LAM）初次治疗慢性乙型肝炎（CHB）的效果和安全性。方法选择2012年7月-2013年6月在本院确诊为CHB的患者,共212例,将其随机分为ETV组（n=102,4例中途退出）和LAM组（n=105,1例中途退出）。ETV组患者口服ETV,0.5 mg/d,LAM组患者口服LAM,100 mg/d,疗程均为48周。比较治疗期间两种药物对HBV DNA载量、ALT复常和HBe Ag转阴的作用及其不良反应情况。结果治疗48周后,ETV组患者的HBV DNA转阴率（82.4%vs 44.8%）和ALT复常率（86.3%vs 73.3%）均高于LAM组（P〈0.05）。ETV组患者的病毒学突破率（1.0%vs 17.1%）和耐药突变率（0%vs 15.2%）均低于LAM组（P〈0.01）。两组患者的HBe Ag转阴率、HBe Ag/HBe Ab血清学转换率和不良反应的发生率差异无统计学意义（P〉0.05）。结论与LAM相比,ETV能更有效地抑制HBV DNA复制,减少耐药发生率,且安全性与LAM相当,是初次治疗CHB的选择。

Objective To investigate effect and safety of entecavir（ETV） and lamivudine（LAM） in initial treatment of chronic hepatitis B（CHB）. Methods 122 patients with CHB in our hospital from July 2012 to 2013 June were selected,and were randomly divided into ETV group（n =102,4 cases were dropped out） and LAM group（n =105,1 case was dropped out）.ETV group was reated with ETV,0.5 mg/d,LAM group was reated with LAM,100 mg/d,course of treatment was 48 weeks.Effect of two drugs on HBV DNA load, ALT normalization,HBe Ag negative and adverse effects was compared during treatment period. Results After treatment 48 weeks,HBV DNA conversion negative rate（82.4% vs 44.8%）and ALT recovery rate（86.3% vs 73.3%） in ETV group was higher than that of LAM group（P〈0.05）.Virologic breakthrough rate（1.0% vs 17.1%） and drug resistance mutation rate（0% vs 15.2%） in ETV group was lower than that of LAM group（P〈0.01）.There was no statistical difference of HBe Ag negative rate,HBe Ag/HBe Ab seroconversion rate,incidence of adverse reaction between two groups（P 0.05）. Conclusion Compared with LAM,ETV can effectively inhibit HBV DNA replication and reduce drug resistance rate,the safety of ETV is equivalent to LAM,ETV is the first choice for the treatment of CHB.