培土化癥汤辅助治疗乙型肝炎肝硬化代偿期临床研究

Clinical Study on Peitu Huazheng Tang Assisted for Hepatitis B in Decompensated Cirrhosis

目的:观察培土化癥汤辅助抗病毒治疗乙型肝炎(简称乙肝)肝硬化代偿期患者的临床疗效。方法:将102例乙肝肝硬化代偿期患者随机分为抗病毒组与联合组,每组各51例,抗病毒组给予恩替卡韦常规抗病毒治疗,联合组在抗病毒组的基础上加用培土化癥汤治疗,疗程均为6个月;观察比较2组疗效、中医证候积分、肝纤维化指标[透明质酸(HA)、层黏蛋白(LN)、Ⅲ型前胶原N端肽(PⅢNP)、Ⅳ-C型前胶原(Col-Ⅳ)]、肝功能指标[丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、白蛋白(Alb)、总胆红素(TBil)]、乙肝病毒脱氧核糖核酸(HBV-DNA)定量及肝脏瞬时弹性探测(Fibroscan)与肝脏B超影像学检查结果的变化,并观察2组不良反应发生情况。结果:总有效率联合组为82.35%,抗病毒组为64.71%,2组比较,差异有统计学意义(P<0.05)。治疗后,2组食少纳差、胸胁胀痛、面色晦暗、胃脘胀满、倦怠乏力等中医证候积分均较治疗前降低(P<0.05),且联合组各项积分均明显低于抗病毒组(P<0.05)治疗后,2组HA、LN、PⅢNP、Col-Ⅳ水平均较治疗前降低(P<0.05);且联合组上述各项指标明显低于抗病毒组(P<0.05)。治疗后,2组ALT、AST、TBil及HBV-DNA定量均较治疗前降低(P<0.05),Alb较治疗前上升(P<0.05);且联合组上述各项指标改善较对照组更显著(P<0.05)。病毒学应答率联合组为80.39%;抗病毒为60.78%,2组比较,差异有统计学意义(P<0.05)。治疗后,2组门脉宽度、脾脏厚度、脾脏长度、Fibroscan弹性值均较治疗前降低(P<0.05);且联合组各指标明显低于抗病毒组(P<0.05)。不良反应发生率联合组为7.84%;抗病毒组为9.80%。2组比较,差异无统计学意义(P>0.05)。结论:培土化癥汤辅助抗病毒治疗乙肝肝硬化代偿期整体疗效肯定,可改善患者中医证候及肝功能,减轻肝硬化程度。

Objective:To observe the clinical effect of Peitu Huazheng tang combined with antivirus for patients with hepatitis B(HB for short)in decompensated cirrhosis.Methods:Divided 102 cases of patients with HB in decompensated cirrhosis into the antivirus group and the combination group randomly,51 cases in each group.The antivirus group received routine antiviral therapy with entecavir,while the combination group additionally received Peitu Huazheng tang.The course of treatment in both groups lasted for 6 months.Observed and compared the changes of therapeutic effect,Chinese medicine syndrome scores,indexes of hepatic fibrosis[hyaluronic acid(HA),laminin(LN),pro-collagen type IIIN-terminal peptide(PIIINP),type C pro-collagen-IV(Col-IV)],indexes of liver function[alanine aminotransferase(ALT),aspartate aminotransferase(AST),albumin(Alb),total bilirubin(TBil)],and the quantification of hepatitis B virus-deoxyribonucleic acid(HBV-DNA),transient elastic imaging(Fibroscan)of liver and B-ultrasonic imaging examination in liver,and observed adverse reactions in both groups.Results:The total effective rate was 82.35%in the combination group and 64.71%in the antivirus group,difference being significant(P<0.05).After treatment,Chinese medicine syndrome scores ofless food intake and poor appetite,distending pain in chest and hypochondrium,dim complexion,gastric fullness,lassitude and fatigue in both groups were lower than those before treatment,and each score above in the combination group was obviously lower than that in the antivirus group(P<0.05).After treatment,the levels of HA,LN,PIIINP and Col-Ⅳin both groups were lower than those before treatment(P<0.05),and each score above in the combination group was obviously lower than that in the antivirus group(P<0.05).After treatment,the levels of ALT,AST and TBil and quantification of HBV-DNA were lower than those before treatment(P<0.05),and the level of Alb was higher than that before treatment(P<0.05);each score above in the combination group was improved more significant than those in the control group(P<0.05).The rate of virological response was 80.39%in the combination group and 60.78%in the antivirus group,difference being significant(P<0.05).After treatment,the width of portal vein,thickness of spleen,length of spleen,and liver stiffness in Fibroscan in both groups were lower than those before treatment,and each index above in the combination group was obviously lower than that in the antivirus group(P<0.05).The incidence of adverse reactions was 7.84%in the combination group and 9.80%in the antivirus group,difference being insignificant(P>0.05).Conclusion:The application of Peitu Huazheng tang combined with antivirus has definite overall therapeutic effect in treating HB in decompensated cirrhosis.It can relieve Chinese medicine syndrome,improve liver function and alleviate hepatic cirrhosis.