阿德福韦酯联合拉米夫定治疗乙型肝炎肝硬化失代偿期的疗效及安全性研究

目的：观察联合使用阿德福韦酯与拉米夫定抗病毒治疗乙型肝炎肝硬化失代偿期患者的安全性及疗效,从而找到更有效更安全的治疗方法。方法：将120例HBV-DNA阳性肝硬化失代偿期患者随机分为联合用药组和单独用药组,在保肝、利尿、支持等基础治疗的同时,联合用药组服用阿德福韦酯及拉米夫定,单独用药组服用拉米夫定。观察期为96周,观察两组患者的肝功能、肾功能、出凝血时间、HBV-DNA定量的变化。结果：肝功能、出凝血时间均明显改善,HBV-DNA定量显著下降,而联合用药组在肝脏生化指标改善及存活率方面均优于单独用药组,差异有统计学意义（P〈0.01）。两组均未发现严重的不良反应。结论：阿德福韦酯、拉米夫定联合应用在治疗乙肝肝硬化失代偿期的患者时发挥优势互补作用,能迅速控制病情,改善生化指标,降低病毒载量,不宜产生耐药性,患者可以长期而安全地服用。

The safty reseach on the effect of adefovir dipivoxil and lamivudine to treat hepatitis B and liver cirrhosis patients at decompensation stage

Objective： To observe the combination of adefovir dipivoxil and lamivudine to the patients with hepatitis B in decompensation of liver cirrhosis （LC）, in order to get the data of safety and effects, so that the more effective and reliable therapy can be obtained. Methods： One hundred and twenty cases in the decompensation of LC with HBV-DNA were divided into two groups randomly. Under the same basic supporting therapy of diuretic and liver-protecting, one group was given the drug combination of adefovir dipivoxil and lamivudine, and the other was given lamivudine singly. In the 96 weeks of observation, got the data of hepatic function, renal function, bleeding-time and clotting-time, and HBV-DNA quantification of both groups. Results： For both, improvements could be seen in the hepatic function and bleeding-time and clotting-time, while the HBV-DNA quantification got lower. The group with drug combination performs was better than the other one with lamivudine in the aspects of hepatic biochemistry and survival rate, and there was difference （P〈0.01）. Severe adverse reaction did not occur in both groups. Conclusion： The drug combination of adefovir dipivoxil and lamivudine to the patients with hepatitis B in decompensation of liver cirrhosis （LC） has superior and complementary effect. It can quickly control the condition, improve the biochemistry indicator, and decrease the viruses without getting drug resistance easily; as a result, the patients can have it safely in the long course of treatment.