恩替卡韦和阿德福韦酯治疗慢性乙型肝炎的真实世界效果评价

目的 基于真实世界临床数据,比较恩替卡韦(ETV)和阿德福韦酯(ADV)治疗慢性乙型肝炎(慢乙肝)的疗效.方法 回顾性收集2008年1月—2015年12月于广州市第八人民医院门诊就诊且初始治疗使用ETV或ADV治疗的慢乙肝患者427例,收集两组患者基线及治疗期间的HBV DNA、HBeAg、ALT的改善情况,计算两组患者HBV DNA阴转率、HBeAg血清学转换率、ALT复常率,使用生存分析方法比较两组药物的治疗效果.结果 在HBeAg阳性及阴性组中,使用ETV治疗患者的HBV DNA阴转率均高于ADV组;HBeAg(+)患者中ETV组的HBeAg血清学转换率高于ADV组;HBeAg(+)患者中,ETV组的ALT复常率在第3个月和第18个月的ALT复常率与ADV组差异有统计学意义(P<0.05),其余时点差异无统计学意义(P>0.05);HBeAg(-)患者中,各个时点两组患者的ALT复常率差异无统计学意义(P>0.05);COX多因素分析结果显示,HBeAg阳性和阴性的患者中,两种抗病毒药物组的HBV DNA应答率的差异均有统计学意义(P<0.05).结论 无论HBeAg阳性或阴性的慢乙肝患者,使用ETV进行抗病毒治疗的效果优于ADV,ETV是慢乙肝患者初始治疗的理想抗病毒药物.

Evaluation of the efficacy of entecavir and adefovir dipivoxil in the treatment of chronic hepatitis B based the real world study

Objective To study the efficacy of entecavir ( ETV ) and adefovir dipivoxil ( ADV ) in the treatment of chronic hepatitis B based on the real world study. Methods A total of 427 patients with chronic hepatitis B treated with ETV or ADV were retrospectively collected from January 2008 to December 2015 at Guangzhou Eighth People's Hospital. HBV DNA, HBeAg and ALT in patients were measured before and after ADV or ETV treatment. Meantime, HBV DNA negative conversion rate, HBeAg seroconversion rate and ALT normal rate were analyzed. The survival analysis method was used to compare the efficacy of ADV and ETV treatment. Results Both in HBeAg positive and negative groups, the HBV DNA negative conversion rate in patients was higher in the ETV group than that in the ADV group. In HBeAg (+) subgroup, the HBeAg seroconversion rate was also higher in the ETV group. The ALT normalization rate in the ETV group was different from that in the ADV group at the 3rd and 18th months. In HBeAg (-) subgroup, there was no significant difference in ALT normalization rate between two treatment groups. The HBV DNA response rates in both HBeAg positive and negative patients were different between two treatment groups by COX multivariate analysis. Conclusion ETV is superior to ADV in the treatment of chronic hepatitis B patients with HBeAg positive or negative condition.