疏肝健脾化瘀汤联合恩替卡韦治疗乙型肝炎肝硬化临床研究

Clinical effect of Shugan-Jianpi-Huayu decoction combined with entecavir for the patients with hepatic cirrhosis of hepatitis B

目的 评价舒肝健脾化瘀汤联合恩替卡韦治疗乙型肝炎肝硬化的疗效.方法 将将符合入选标准的乙型肝炎肝硬化患者150例,采用随机数字表法分为2组,每组75例.对照组采用恩替卡韦治疗,观察组在对照组治疗基础上加用舒肝健脾化瘀汤治疗.观察、比较2组患者治疗前后肝功能指标、肝纤维化指标及症状变化,评价临床疗效.结果 治疗后,观察组肝功能指标AST[（42.88±12.57）U/L比（56.94±14.83）U/L,t=6.263]、ALT[（41.10±10.61）U/L比（53.12±16.78）U/L,t=5.243]、TBiL[（20.15±9.76）μmol/L比（28.35±12.20）μmol/L,t=4.545],以及肝纤维化指标Ⅲ型前胶原[（103.65±22.84）μg/L比（162.44±38.90）μg/L,t=11.287]、Ⅳ型胶原[（106.72±23.41）μg/L比（152.94±30.01）μg/L,t=10.518]、层黏连蛋白[（92.75±25.32）μg/L比（156.64±38.79）μg/L,t=11.945]、透明质酸[（105.58±18.07）μg/L比（159.74±35.50）μg/L,t=11.775]均低于对照组（P〈0.05或P〈0.01）;ALB[（42.67±8.93）g/L比（38.08±8.85）g/L,t=3.221]高于对照组.观察组总有效率为85.33%（64/75）,对照组为64.00%（48/75）,2组比较差异有统计学意义（χ2=9.023,P=0.003）.结论 舒肝健脾化瘀汤联合恩替卡韦治疗乙型肝炎肝硬化疗效优于单纯应用恩替卡韦,且随访的远期效果好.

Objective To explore the clinical effect and safety of Shugan-Jianpi-Huayu decoction combined with entecavir for the patients with hepatic cirrhosis of hepatitis B.Methods A total of 150 patients with hepatic cirrhosis of hepatitis B visiting our hospital from Jan. 2013 to Jan. 2015 were enrolled and randomly divided into the observation group and control group, 75 in each group. The control group received entecavir, while the observation group received Shugan-Jianpi-Huayu decoction additionally. The index of liver fuction and liver fibrosis, clinical efficacy and adverse reactions were observed and compared after the treatment.Results After treatment, the AST （42.88 ± 12.57U/Lvs.56.94 ± 14.83U/L,t=6.263）, ALT （41.10 ± 10.61U/L vs.53.12 ± 16.78U/L,t=5.243）, TBIL （20.15 ± 9.76μmol/Lvs.28.35 ± 12.20μmol/L, t=4.545）, PC Ⅲ （103.65 ± 22.84μg/Lvs. 162.44 ± 38.90μg/L,t=11.287）,Ⅳ-C （106.72 ± 23.41μg/Lvs.152.94 ± 30.01μg/L, t=10.518）, LN （92.75 ± 25.32μg/Lvs.156.64 ± 38.79μg/L,t=11.945）, HA （105.58 ± 18.07μg/L vs.159.74 ± 35.50μg/L,t=11.775） of the observation group were significantly better than those of the control group （allP〈0.05）. The total efficacy rate of the observation group were 85.33% （64/75）, which were significantly higher than 64.00% （48/75） of control group （χ2=9.023,P=0.003）.Conclusions The Shugan-Jianpi-Huayu decoction combined with entecavir showed efficacy and safey for the patients with hepatic cirrhosis of hepatitis B.