阿德福韦酯及恩替卡韦治疗慢性乙型肝炎2年临床随机对照研究

Efficacy of adefovir dipivoxil and entecavir in chronic hepatitis B:a 2-year randomized controlled study

目的比较阿德福韦酯(ADV)与恩替卡韦对慢性乙型肝炎(CHB)的抗病毒作用,并探讨乙型肝炎病毒e抗原(HBeAg)、生化水平等对核苷类抗病毒药物作用的影响。方法收集2007年3月至2008年8月我院门诊CHB患者85例,随机分为2组,抗病毒治疗2年。采用多因素重复测量方差分析。结果 2种药物对乙型肝炎病毒(HBV)DNA的抑制作用比较差异有统计学意义(P=0.044);HBeAg(+/-)之间抗病毒效果比较差异有统计学意义(P<0.01);丙氨酸转氨酶(ALT)分组比较,差异无统计学意义(P=0.597)。结论①恩替卡韦抗病毒快速平稳,优于ADV;②HBeAg(+/-)组患者均出现明显的病毒抑制,2年时阴性组HBVDNA水平低于阳性组;③ALT水平不影响核苷类似物的抗病毒作用。

Objective To compare the anti-viral effects of adefovir dipivoxil（ADV） and entecavir（ETV） in chronic hepatitis B（CHB）,and to study the impact of HBeAg and patient biochemistry on anti-viral effects of nucleoside agents.Methods Eighty-five CHB patients registered to our hospital clinics between March 2007 to August 2008 were randomly divided into two groups and underwent antiviral therapy for two years.Results Significant difference in HBV DNA inhibition by ADV and ETV was noted（P=0.044）.The anti-viral effects were significantly different between HBeAg positive and negative subjects（P0.01）,but not between patients with varied levels of ALT（P=0.597）.Conclusion ①ETV appeared fast-and stable-acting as compared with adefovir.②Significant viral suppression was revealed in patients with positive or negative HBeAg.However,at the end of 2-year treatment,patients with negative HBeAg showed lower level of HBV DNA.③ALT level has no effect on the anti-viral activity of nucleoside analogues.