拉米夫定联用阿德福韦酯与恩替卡韦单药治疗乙型肝炎肝硬化的疗效与安全性比较

Comparison of Efficacy and Safety of Lamivudine Combined with Adefovir Dipivoxil and Entecavir Monotherapy in the Treatment of Hepatitis B Cirrhosis

目的 研究拉米夫定（LAM）联用阿德福韦酯（ADV）与恩替卡韦（ETV）单药抗病毒方案治疗乙型肝炎肝硬化的疗效与安全性.方法 纳入乙肝肝硬化患者300例：单用ETV组（对照组）和LAM联合ADV组（观察组）,随访96周,收集两组疗效和安全性指标.结果 治疗96周后：两组肝功能和Child-Pugh评分与治疗前比较,差异均有统计学意义（P〈0.05）;两组间肝功能和Child-Pugh评分比较,差异无统计学意义（P〉0.05）;对照组与观察组比较：HBV-DNA转阴率、HBeAg血清转换率、病毒学突破率、肝硬化失代偿发生率、耐药变异发生率、不良反应发生率、肝细胞癌（HCC）发生率、病死率的差异均无统计学意义（P〉0.05）.结论 LAM联用ADV与ETV单药治疗乙肝肝硬化患者的疗效和安全性相似,均能有效抗HBV.

Objective To study the efficacy and safety of lamivudine （LAM）combined with adefovir dipivoxil （ADV） and entecavir（ETV） monotherapy in the treatment of hepatitis B cirrhosis. Methods A total of 300 patients with hepatitis B cirrhosis were divided into two groups：ETV group（ control group）and LAM combined with ADV group （observation group）. All patients were followed up for 96 weeks. Therapeutic effects and safety indexes were collect- ed. Results There were significant differences on liver function and Child - Pugh score before and after treatment be- tween the two groups（ P 〈 0.05 ）. There were no significant differences on liver function and Child - Pugh score be- tween the two groups after treatment（ P 〉 0.05 ）. There were no significant differences on HBV - DNA negative con- version rate, HBeAg seroconversion rate, virological breakthrough rate, cirrhosis decompensation rate, drug resistance mutation rate, adverse reaction rate, HCC occurrence rate and mortality rate between the two groups（P 〉 0.05）. Con- clusion The efficacy and safety of LAM combined with ADV and ETV monotherapy are similar for patients with hepatitis B cirrhosis.