索非布韦联合达卡他韦治疗代偿期丙型肝炎肝硬化的疗效及安全性分析

Efficacy and safety of sofosbuvir combined with daclatasvir in the treatment of compensated hepatitis C cirrhosis

目的探讨索非布韦联合达卡他韦治疗代偿期丙型肝炎肝硬化的疗效和不良反应。方法160例代偿期丙型肝炎肝硬化患者按治疗方案不同分为A组(索非布韦+达卡他韦)87例和B组(干扰素α-2a+利巴韦林)73例;连续治疗24 w后,观察并对比两组治疗前和治疗后的肝功能、病毒载量、病毒学应答率及治疗期间的不良反应。结果两组患者治疗24 w的TBiL、ALT、AST及HCV-RNA水平均较治疗前显著降低,且A组低于B组,差异均有统计学意义(P<0.05)。A组的RVR率、EVR率、ETVR率及SVR率均高于B组,治疗期间头痛、头晕、乏力、肌肉关节痛、轻度抑郁、血小板减少及白细胞减少发生率均低于B组;差异均有统计学意义(P<0.05)。结论索非布韦联合达卡他韦治疗代偿期丙型肝炎肝硬化具有较好的临床疗效和安全性,与干扰素α-2a联合利巴韦林治疗方案相比,可获得更高的病毒学应答率,明显改善肝功能,减少不良反应。

Objective To evaluate the efficacy and safety of sofosbuvir combined with daclatasvir as a therapy for the treatment of compensated hepatitis C cirrhosis.Methods Firstly,160 patients with hepatitis C cirrhosis were divided into two groups,namely,group A(n=87,subjected to treatment with sofosbuvir+daclatasvir),and group B(n=73,subjected to treatment with interferonα-2a+ribavirin).Secondly,the liver function,the viral load,the virological response rate,and the rate of adverse reactions of the two groups as observed before and after 24 w treatment were compared.Results The levels of TBiL,ALT,AST and HCV-RNA of the two groups as observed 24 w after treatment were significantly lower than those before treatment,with the decrease of those levels in group A being even greater than that in group B.The differences were statistically significant(P<0.05).The RVR rate,the EVR rate,the ETVR rate and the SVR rate of group A were higher than those of group B.The rates of incidence of headache,dizziness,fatigue,muscle and joint pain,mild depression,thrombocytopenia or leukopenia of group A were lower than those of group B.The differences were statistically significant(P<0.05).Conclusions Sofosbuvir combined with daclatasvir as a therapy warrants better clinical efficacy and safety than interferonα-2a plus ribavirin for the treatment of compensated hepatitis C cirrhosis in that it can obtain a higher virology response rate and significantly improve the liver function and reduce adverse reactions.