替诺福韦酯单药治疗慢性乙肝后肝硬化失代偿期的长期疗效随机对照研究

Randomized controlled study of long-term efficacy of tenofovir disoproxil monotherapy in the treatment of decompensated cirrhosis after chronic hepatitis B

目的探讨替诺福韦酯单药治疗在慢性乙型肝炎(CHB)后肝硬化失代偿期(DCC)治疗中的长期应用价值。方法随机将84例CHB后DCC患者分为对照组及观察组,每组42例。对照组接受拉米夫定联合阿德福韦酯治疗,观察组接受替诺福韦酯治疗。对比两组12个月内治疗时间内的死亡率及肝癌发生率,并分析两组肝功能、肝硬化指标及Child-Pugh评分变化趋势,同时对比两组治疗过程中HBeAg转阴率、HBV-DNA转阴率及失代偿好转率。此外,对比两组治疗不良反应的发生率。结果在12个月的治疗时间内,两组死亡率及肝癌发生率比较,差异无统计学意义(P>0.05)。而两组治疗过程中ALT、AST、HA、LN、PCⅢ及Child-Pugh评分呈降低趋势,ALB呈升高趋势(P<0.05);治疗6个月及12个月时,治疗组ALT、AST、HA、LN、PCⅢ及Child-Pugh评分低于对照组,ALB高于对照组(P<0.05)。而两组12个月治疗完成后,HBeAg转阴率比较差异无统计学意义,但观察组HBV-DNA转阴率高于对照组(P<0.05)。此外,两组治疗不良反应发生率比较差异无统计学意义(P>0.05)。结论在CHB后DCC的治疗中,替诺福韦酯单药治疗方案具有良好的长期治疗效果。

Objective To evaluate the long-term value of tenofovir disoproxil monotherapy in the decompensated cirrhosis(DCC)after chronic hepatitis B(CHB).Methods Eighty-four patients with DCC after CHB were randomly divided into control group and observation group,42 cases in each group.The control group received lamivudine combined with adefovir dipivoxil,and the observation group received tenofovir disoproxil.Mortality and incidence of liver cancer within 12 months of treatment between the two groups were compared,and the change trend of liver function,liver fibrosis index and child-pugh score in the two groups were analyzed.At the same time,we compared the conversion rate of HBeAg,HBV-DNA and decompensated positive rate between the two groups.In addition,the incidence of adverse reactions were compared between the two groups.Results Within 12 months of treatment,there were no statistically significant differences in mortality and liver cancer incidence between the two groups(P>0.05).And during the treatment,the ALT,AST,HA,LN,PCⅢand Child-Pugh score showed a decrease trend,ALB showed a increase trend(P<0.05).After 6-month and 12-month treatment,ALT,AST,HA,LN,PCⅢChild-Pugh score of treatment group were lower than that of control group,ALB was higher than that of control group(P<0.05).After 12 months of treatment,the negative conversion rate of HBV-DNA in the observation group was higher than that of control group(P<0.05).In addition,there was no statistically difference in the incidence of adverse reactions between the two groups(P>0.05).Conclusion Tenofovir disoproxil monotherapy has a good long-term therapeutic effect in the treatment of DCC after CHB.