抗纤软肝胶囊联合西药治疗乙型肝炎肝硬化随机平行对照研究

The Soft Liver Capsules of the Kangxian Combined with Western Medicine in the Treatment of Hepatitis B Cirrhosis Randomized and Controlled Study

[目的]观察抗纤软肝胶囊联合西药治疗乙型肝炎肝硬化疗效。[方法]使用随机平行对照方法,将74例住院患者按随机数字表分为两组,治疗前2周均停用其他相关药物,常规保肝、护肝治疗。对照组31例阿德福韦10mg/d口服。治疗组43例抗纤软肝胶囊(茵陈蒿20g,丹参30g,鳖甲10g,三七6g,桃仁10g,当归10g,莪术10g,炮山甲6g,土鳖虫10g,白术10g,薏苡仁20g,黄芪10g)5g/次,3次/d,口服;西药同对照组。连续治疗48周为1疗程。观测临床症状、体征、肝功能TBil、ALT、AST、白蛋白/球蛋白(A/G)、HBV DNA,、乙型肝炎病毒标志物(HBV-M)、清肝纤维化指标。连续治疗2疗程,判定疗效。[结果]两组TBil,ALT,AST,A/G指标均有改善,治疗组优于对照组(P>0.05)。两组的HBeAg阴转率、HBeAg/HBeAb血清转换率及HBV DNA阴转率比较差异不明显(P>0.05)。治疗组血清肝纤维化指标有改善,治疗组优于对照组(P<0.05)。[结论]抗纤软肝胶囊联合西药能有效地控制肝硬化进展,提高生存质量,未见明显不良反应,值得推广。

[ Objective ] To investigate the hepatitis B cirrhosis using A Duff Vee joint of Kangxian Ruangan Capsule in the treatment of clinical effect. [ Methods ] Randomized controlled method, 74 cases of referral for hospitalized patients, patients were divided into two groups by random number table, disable other drugs 2 weeks before treatment. Were given conventional Liver, Liver treatment. The control group, 31 patients with adefovir 10mg/ d orally. Treatment group of 43 cases Kangxian Ruangan capsules （Artemisia capillaries 20g, Salvia 30g, turtle shell 10g, thirty - seven 6g, peach kernel 10g, angelica 10g, Curcuma 10g, guns Shan Jia 6g Eupolyphaga 10g, Atractylodes 10g, Coix seed 20g , Astragalus 10g） of 5g/time, 3 times/d, orally, Western medicine with the control group. 48 weeks of continuous treatment for a course of treatment. Observation of clinical symptoms and signs, liver function TBil, ALT, AST, albumin/ globulin （A/G） , HBV DNA markers of hepatitis B virus （ HBV - M） , Liver fibrosis markers. Continuous treatment course, to determine efficacy. [ Results ] Two groups TBil, ALT, AST, A / G indicators have improved, the treatment group than the control group （P 〉 0.05）. HBeAg negative rate of the two groups, HBeAg / HBeAb the serum of conversion rate and HBV DNA negative rate was not significantly different （ P 〉 0.05 ）. The treatment group serum fibrosis markers to improve the treatment group than the control group （P 〈 0.05 ）. [ Conclusion ] The combination therapy can effectively control the progression to cirrhosis.