国产阿德福韦酯联合中药治疗乙型肝炎失代偿期肝硬化近期疗效观察

Recent efficacy of home-made adefovir dipivoxil in combinative Traditional Chinese Medicine treatment of hepatitis B patients with decompensated cirrhosis

目的观察国产阿德福韦酯联合中药扶正化瘀胶囊治疗乙型肝炎失代偿期肝硬化近期疗效及安全性。方法采用随机分组的方法,将64例e抗原阳性的乙型肝炎病毒脱氧核糖核酸(HBV DNA)复制活跃的失代偿期肝硬化患者随机分为两组。治疗组32例,给予国产阿德福韦酯联合中药扶正化瘀胶囊治疗;对照组32例,单用国产阿德福韦酯治疗,疗程均为48周。分别观察两组治疗前后血清肝功能指标、HBV DNA水平、血清病毒标志物变化,并进行Child-Pugh评分。结果疗程结束后,两组血清肝功能指标较治疗前均有明显改善(P<0.01),但治疗组优于对照组,其中丙氨酸转氨酶(36.6±15.2)U/L vs(47.8±19.6)U/L、天冬氨酸转氨酶(31.4±12.7)U/L vs(40.3±17.0)U/L、总胆红素(22.6±9.1)μmol/L vs(32.1±10.0)μmol/L、白蛋白(36.1±1.8)g/L vs(32.3±1.8)g/L(P<0.05或P<0.01);两组Child-Pugh分级评分均有下降,但治疗组优于对照组(6.9±2.1)分vs(8.8±1.8)分(P<0.01);两组均有良好的病原学应答,其差异无统计学意义(P>0.05)。结论国产阿德福韦酯联合中药扶正化瘀胶囊治疗乙型肝炎失代偿期肝硬化近期疗效肯定,优于单用抗病毒药阿德福韦酯,而且安全性良好。

Objective To observe the recent efficacy and safety of combination therapy with home-made adefovir dipivoxil（ADV） and Fuzhenghuayu capsule to hepatitis B patients with decompensated cirrhosis. Methods Sixty-four eases of decompensated cirrhosis patients with hepatitis B e antigen（HBeAg）-positive HBV-DNA active replication were randomly divided into treatment group （ n = 32） and control group （ n = 32）. Treatment group received combination therapy with home-made ADV and Fuzhenghuayu capsule, while control group received treatment only home-made ADV. The patients in both groups were observed before and after treatment for their serum liver function, HBV DNA level and serum virus markers. Simultaneously their Child-Pugh was scored. Results After a course of treatment, both groups had a good response to the pathogen（ P 〈0.01）. Serum biochemical indicators, treatment group was much better than control group,including alanine aminotransferase （36.6 ±15.2） U/L vs （47.8±19.6） U/L （P 〈 0.05） ,aspartate aminotransferase （31.4±12.7） U/L vs （40.3±17.0） U/L（ P 〈0.05） ,total bilirubin （22.6± 9.1） μmol/L vs （32.1±10.0） μmol/L（P〈0.01） ,albumin （36.1±.8） g/L vs （32.3±1.8） g/L（P〈0.01）. Child- Pugh scores of two groups declined and treatment group was much better than group B, （6.9±2.1） scores vs （8.8±1.8） scores （ P 〈 0.01）. Conclusion Combination therapy with home-made ADV and Fuzhenghuayu capsule to hepatitis B patients with decompensated cirrhosis has a good recent effect and security.