安络化纤丸联合恩替卡韦治疗乙肝肝硬化的临床疗效研究

Clinical Efficacy of Anluo Huaxian Pills Combined with Entecavir in the Treatment of Hepatitis B Cirrhosis

目的探讨安络化纤丸联合恩替卡韦治疗乙肝肝硬化的临床疗效。方法将384例乙肝肝硬化活动期患者随机分为对照组和观察组,每组192例。在常规对症支持治疗基础上,对照组予以恩替卡韦分散片口服治疗,观察组在对照组基础上予以安络化纤丸口服治疗。2组治疗时间均为1年,并进行6个月的随访。观察2组治疗后乙肝病毒(HBV)DNA、乙肝e抗原(HBeAg)转阴率;比较2组治疗前后Child-Pugh评分、血清肝功能指标、肝纤维化指标、肝脾影像学的改善情况;统计2组不良反应发生情况。结果与对照组比较,治疗后及随访6个月观察组Child-Pugh评分显著下降(P<0.05),HBeAg转阴率显著升高(P<0.05),治疗后HBV-DNA转阴率比较,差异无统计学意义(P>0.05)。治疗后,2组血清肝纤维化指标、肝功能指标均有明显改善;与对照组比较,观察组在治疗后及随访6个月后的改善程度更为显著(P<0.05)。与对照组比较,观察组治疗后脾静脉内径缩小、脾长径缩小、门静脉主干内径缩小的患者比例明显提高(P<0.05)。治疗期间所有患者均未出现不良反应。结论安络化纤丸联合恩替卡韦治疗乙肝肝硬化疗效显著,可阻止甚至逆转肝纤维化的发展,改善肝功能,提高生存质量并延长生存周期。

Objective To investigate the clinical effect of Anluo Huaxian pills combined with entecavir in the treatment of hepatitis B cirrhosis.Methods A total of 384 patients with active hepatitis B cirrhosis were randomly divided into control group and observation group with 192 cases in each group.On the basis of routine symptomatic support therapy,the control group was treated with entecavir dispersible tablets orally,and the observation group with Anluo Huaxian pills on the basis of the control group.The treatment time of both groups was 1 year,and the follow-up was 6 months.The negative rate of hepatitis B virus(HBV)DNA and hepatitis B e antigen(HBeAg)were observed after treatment in two groups.The Child-Pugh score,serum liver function index,hepatic fibrosis index and the improvement of liver and spleen imaging were compared before and after treatment.The incidence of adverse reactions in the two groups were analyzed.Results Compared with the control group,the Child-Pugh score of the observation group decreased significantly after treatment and 6 months follow-up(P<0.05).The negative rate of HBeAg was significantly increased(P<0.05),the negative rate of HBV-DNA after treatment was not statistically significant(P>0.05).After treatment,the indexes of serum hepatic fibrosis and liver function were significantly improved in both groups.The improvement of the above indexes in the observation group were more significant than those in the control group after treatment and 6 months follow-up(P<0.05).The diameter of the splenic vein,the length of the spleen and the internal diameter of the main portal vein were decreased after treatment in the observation group(P<0.05).No adverse reactions occurred in all patients during treatment.Conclusion Anluo Huaxian pills combined with entecavir is effective in the treatment of hepatitis B cirrhosis,which can prevent or even reverse the development of liver fibrosis,enhance liver function,improve the quality of life and prolong the life cycle.