国产阿德福韦酯治疗乙型肝炎肝硬化的安全性与疗效观察

Clinical observation on effects and safety of domestic adefovir dipivoxil in treatment of compensated cirrhosis following chronic hepatitis B

目的:观察国产阿德福韦酯(亿来芬)治疗代偿期乙型肝炎肝硬化的安全性与临床效果。方法:70例乙型肝炎肝硬化失代偿期患者随机分成两组,分别给予国产与合资企业产阿德福韦酯治疗72周,观察生化学指标、HBV DNA阴转、HBeAg阴转、抗-HBe阳转以及组织学指标炎症活动度(G)分级和纤维化程度(S)分期的差异。结果:两组患者生化指标均有明显改善,两组HBeAg血清转换率分别为26.09%和27.27%,HBV DNA阴转率两组分别为42.86%和45.71%,两组G分级和S分期均有明显改善,以上各项指标两组比较均无统计学意义(P>0.05)。结论:国产和合资企业产阿德福韦酯治疗乙型肝炎肝硬化有相同的安全性和疗效。

Objective：To study the clinical therapeutic effects and safety of domestic adefovir on compensated cirrhosis secondary to chronic hepatitis B.Methods：70 cases of patients with compensated cirrhosis secondary to chronic hepatitis B were randomly assigned into 2 groups.Patients in group A and B were treated with domestic adefovir and joint adefovir for 72 weeks,respectively.Clinical biochemical indicators,HBV DNA loads,HBeAg and anti-HBe situations,and histological indices were recorded.Results：After anti-viral treatment for 72 weeks,the patients with compensated cirrhosis were significantly improved in liver functions and histological indices.HBeAg seroconversion rates of the two groups were not statistically significant（26.09% and 27.27%,P0.05）.Similarly,no significant difference of HBV DNA negative conversion rate in the two groups（42.86% and 45.71%,P0.05） was found.Conclusion：Teatments of domestic adefovir and joint adefovir on hepatitis B patients with cirrhosis are not significantly different,and both drugs are safe and effective.