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目的:探讨乙肝(CHB)肝硬化失代偿期患者应用恩替卡韦抗病毒治疗的临床效果及安全性。方法:采用随机数字表法将我院2010年1月至2013年7月收治的200例CHB失代偿期患者分为研究组和对照组各100例,两组均采用综合治疗作为基础疗法,对照组在此基础上加用阿德福韦酯,研究组在此基础上加用恩替卡韦治疗,比较两组患者治疗前、治疗12个月、治疗24个月的肝功能指标、凝血相关指标、HBV—DNA变化情况,治疗前后的Child—Pugh分级评分及生活质量变化情况。结果:研究组和对照组的ALT、AST、TBiL治疗后较治疗前均显著的下降,ALB较治疗前显著的升高(P<0.05);治疗前后两组间的ALT、AST、T BiL、ALB比较差异均不显著(P>0.05)。治疗前后两组患者间的PT、PTA、Child—Pugh评分、生活质量评分差异均不显著(P>0.05);治疗前两组间HBV—DNA水平差异不显著(P>0.05);治疗后研究组的HBV—DNA水平显著低于对照组(P<0.05)。治疗后研究组和对照组的血清肝纤维化指标:透明质酸、层粘连蛋白、Ⅲ型前胶原、Ⅳ型前肢原较治疗前均显著的下降(P<0.05)。两组间HBeAg转阴率比较差异不显著(X~2=0.323,P=0.570)。两组患者的不良反应发生率比较差异不显著(X~2=1.087,P=0.297)。结论:乙肝肝硬化失代偿期患者应用恩替卡韦抗病毒治疗能够改善患者肝功能、提高患者生活质量外,对抑制病毒复制的作用更加显著较阿德福韦酯。
Objective: To investigate the clinical efficacy and safety of entecavir antiviral therapy in patients with decompensated hepatitis B (CHB). Methods: 200 CHB patients with decompensated CHB admitted from January 2010 to July 2013 in our hospital were randomly divided into study group (100 cases) and control group (100 cases). The two groups were treated with combination therapy as basic therapy, In the control group, adefovir dipivoxil was added on the basis of this study. On the basis of this study, the study group added entecavir, and compared the two groups of patients before treatment, 12 months of treatment, 24 months of treatment of liver function indicators, coagulation related indicators, HBV-DNA changes, Child-Pugh grading before and after treatment and quality of life changes. Results: The levels of ALT, AST and TBiL in study group and control group decreased significantly after treatment compared with that before treatment (P <0.05). ALT, AST, T BiL, ALB difference was not significant (P> 0.05). There were no significant differences in PT, PTA, Child-Pugh scores and quality of life scores between the two groups before and after treatment (P> 0.05). There was no significant difference between the two groups before and after treatment (P> 0.05) The level of HBV-DNA in the group was significantly lower than that in the control group (P <0.05). After treatment, the indexes of serum liver fibrosis, such as hyaluronic acid, laminin, type Ⅲ procollagen and type Ⅳ forelimb in serum of the study group and the control group were significantly decreased (P <0.05). There was no significant difference in the negative rate of HBeAg between the two groups (X ~ 2 = 0.323, P = 0.570). There was no significant difference in adverse reactions between the two groups (X ~ 2 = 1.087, P = 0.297). Conclusion: Entecavir anti-retroviral therapy in patients with decompensated hepatitis B can improve liver function and improve quality of life of patients, and inhibit the virus replication more significantly than adefovir dipivoxil.