恩替卡韦长期治疗乙肝相关肝硬化疗效及影响因素研究

Clinical efficacy of long-term treatment with entecavir in patients with hepatic cirrhosis caused by hepatitis B virus

目的研究恩替卡韦长期治疗乙型肝炎相关性肝硬化(乙肝相关肝硬化)患者的疗效和安全性,探讨预后影响因素。方法 120例乙肝相关肝硬化抗病毒初治患者,按1∶1原则随机分为恩替卡韦治疗组60例和拉米夫定对照组60例,进行144周治疗。结果 120例患者在48周内共死亡7例(5.83%),均为50岁以上的失代偿期Child-Pugh C级患者。治疗组死亡3例。对照组死亡4例,1例患者因肝细胞癌(HCC)接受肝移植。治疗组57例、对照组55例完成144周随访。治疗组血清谷丙转氨酶(ALT)、总胆红素(TBi L)、Alb复常率高于拉米夫定对照组,Child-Pugh评分改善优于拉米夫定对照组(P<0.05),治疗组病毒学应答率高于拉米夫定对照组(100%vs 85.4%,χ~2=4.46,P<0.05)。治疗组血清学应答率、不良反应发生率、终点不良事件发生率均与对照组相近(P>0.05)。对照组耐药率高于治疗组(14.5%vs 0%,χ~2=5.72,P<0.05)。结论恩替卡韦长期治疗乙肝相关肝硬化比拉米夫定具有更优异的抗病毒效力,其疗效优于拉米夫定;年龄、Child-Pugh评分与乙肝相关肝硬化患者终点不良事件发生相关。

Objective To evaluate the clinical efficacy, safety and the prognostic factors of the long-term therapy with entecavir in the patients with hepatic cirrhosis caused by hepatitis B virus. Methods A total of 120 patients were randomly divided into the treatment group （n = 60） and the control group （n = 60 ）. The treatment group received entecavir, and the control group received lamivudin. Results Of the 120 patients, 7 cases died within 48 weeks, and all the dead cases were over 50 years old with Child-Pugh C. 3 cases died in the treatment group, and 4 cases died in the control group, 1 case received liver transplantation because of hepatocellular carcinoma （HCC）. 57 cases in the treatment group and 55 cases in the control group were followed up for 144 weeks. The improvement rates of ALT, TBil, ALB, Child-Pugh score in the treatment group were significantly higher than those in the control group （P 〈 0. 05 ）. The virological response rate of the treatment group was significantly higher than that of the control group （ 100% vs 85.4% , χ2 = 4. 46, P 〈 0. 05 ）. There were no singnificant differences between the two groups in the rates of serological response, adverse reactions and the terminal adverse events（ P 〉 0.05 ）. The rate of drug resistance in the treatment group was significantly higher than that in the control group（ 14. 5% vs 0%, ,1,2 =5.72, P 〈 0.05）. Conclusion Entecavir has a better effect on antivirus than lamivudin in the treatment of hepatic cirrhosis caused by hepatitis B virus. Age and Child-Pugh score are correlative with the terminal adverse events.