拉米夫定与阿德福韦酯治疗乙型肝炎肝硬化患者96周的临床观察

Clinical efficacy of lamivudine and adefovir dipivoxil therapy in patients with liver cirrhosis resulting from hepatitis B

目的观察拉米夫定(LAM)和阿德福韦酯(ADV)治疗乙型肝炎后肝硬化患者的长期疗效。方法采用随机、双盲对照的入组方法,选择慢性乙型肝炎肝硬化代偿期和失代偿期患者随机分组,分别给予LAM100mg/d(LAM治疗组)或ADV10mg/d治疗(ADV治疗组),比较二者的疗效。结果两种药物治疗48周后对病毒抑制效果相似,均能显著改善乙型肝炎肝硬化患者的肝功能。二者联合治疗的疗效显著优于单药治疗。单药治疗48周和联合治疗48周期间均无药物相关的不良反应发生。结论 LAM与ADV治疗乙型肝炎肝硬化患者安全且有效,联合治疗后95.5%患者达到完全病毒学应答,患者的肝功能得以改善,生活质量也相应提高。

Objective To observe the long antiviral efficacy of lamivudine （LAM） versus adefovir dipivoxil （ADV） in treatment of patients with liver cirrhosis resulting from hepatitis B. Methods Double-blind and randomized recruitment was applied in compensated and decompensated liver cirrhosis paitients with chronic hepatitis B （LAM treatment group and ADV treatment group, with the number of cases as 21 and 23, respectively）. The dose were 100 mg/d of LAM and 10 mg/d of ADV, and the efficacy were evaluated, respectively. Results The virus suppressive efficacy were similar between LAM and ADV at the end of 48th week and both could significantly improve liver function in liver cirrhosis patients with chronic hepatitis B. The combination treatment of LAM and ADV exhibited significantly superior efficacy compared to either single LAM or single ADV treatment. There were no drug-related adverse reactions identified during either single therapy period or combination therapy period of the two drugs for 48 weeks. Conclusions The safety and efficacy profiles of LAM and ADV were confirmed in treatment of liver cirrhosis patients with chronic hepatitis B. Complete viral response was demonstrated among 95.5% patients with combination therapy, which also proved improvement in liver function and life quality.