鳖甲煎丸联合替诺福韦酯治疗乙型肝炎肝硬化失代偿期临床研究

Clinical Study on Biejiajian Pills Combined with Tenofovir for Hepatitis B Cirrhosis in Decompensated Period

目的:观察鳖甲煎丸联合替诺福韦酯治疗乙型肝炎肝硬化失代偿期气滞血瘀证的临床疗效。方法:选择98例乙型肝炎肝硬化失代偿期气滞血瘀证患者,按照随机数字表法分为鳖甲煎丸组、对照组各49例。鳖甲煎丸组剔除6例,对照组剔除7例,最终纳入研究鳖甲煎丸组43例、对照组42例。2组均给予保肝、退黄、降低门静脉压力等对症治疗,对照组在此基础上给予富马酸替诺福韦二吡呋酯片治疗,鳖甲煎丸组在对照组基础上给予鳖甲煎丸治疗。2组均治疗6个月。比较2组临床疗效,肝功能指标、肝纤维化指标水平,趋化因子受体(CCR)阳性表达率及不良反应发生率。结果:治疗后,总有效率鳖甲煎丸组95.35%,高于对照组78.57%,差异有统计学意义(P<0.05)。2组谷草转氨酶(AST)、谷丙转氨酶(ALT)、总胆红素(TBil)水平均较治疗前降低(P<0.05),鳖甲煎丸组AST、 ALT、 TBil水平均低于对照组(P<0.05)。2组透明质酸(HA)、层粘连蛋白(LN)、Ⅲ型前胶原(PCⅢ)、Ⅳ型胶原(Ⅳ-C)水平均较治疗前降低(P<0.05),鳖甲煎丸组HA、LN、PCⅢ、Ⅳ-C水平均低于对照组(P<0.05)。2组CCR4、CCR6阳性表达率均较治疗前降低(P<0.05),鳖甲煎丸组CCR4、CCR6阳性表达率均低于对照组(P<0.05)。对照组不良反应发生率7.14%,鳖甲煎丸组不良反应发生率9.30%,2组比较,差异无统计学意义(P>0.05)。结论:鳖甲煎丸联合替诺福韦酯治疗乙型肝炎肝硬化失代偿期气滞血瘀证临床疗效显著,可有效改善患者的肝功能及肝纤维化指标,其作用机制可能与降低CCR表达有关,且治疗安全性好。

Objective:To observe the clinical effect of Biejiajian Pills combined with Tenofovir for hepatitis B cirrhosis in decompensated period with qi stagnation and blood stasis syndrome.Methods:A total of 98 cases of patients with hepatitis B cirrhosis in decompensated period with qi stagnation and blood stasis syndrome were selected and divided into the Biejiajian Pills group and the control group according to the random number table method,with 49 cases in each group.Six cases were excluded from the Biejiajian Pills group and seven cases were excluded from the control group.Finally,43 cases in the Biejiajian Pills group and 42 cases in the control group were included.Both groups were given symptomatic treatments such as protecting the liver,reducing jaundice,and reducing portal vein pressure.On this basis,the control group was treated with Tenofovir Disoproxil Fumarate Tablets,and the Biejiajian Pills group was treated with Biejiajian Pills on the basis of the control group.Both groups were treated for six months.The clinical efficacy,levels of liver function indicators and liver fibrosis indicators,and chemokine receptor(CCR)positive expression rate were compared between the two groups,and the incidence of adverse reactions were recorded.Results:After treatment,the total effective rate was 95.35%in the Biejiajian Pills group,which was higher than that of 78.57%in the control group,the difference being significant(P<0.05).The levels of aspartate aminotransferase(AST),alanine aminotransferase(ALT),and total bilirubin(TBil)in the two groups were decreased when compared with those before treatment(P<0.05),and the levels of AST,ALT,and TBil in the Biejiajian Pills group were lower than those in the control group(P<0.05).The levels of fibrosis indicators including hyaluronic acid(HA),laminin(LN),typeⅢprocollagen(PCⅢ),and typeⅣcollagen(Ⅳ-C)in the two groups were decreased when compared with those before treatment(P<0.05),and the levels of HA,LN,PCⅢ,andⅣ-C in the Biejiajian Pills group were lower than those in the control group(P<0.05).The positive expression rate of CCR4 and CCR6 in the two groups were decreased when compared with those before treatment(P<0.05),and the positive expression rate of CCR4 and CCR6 in the Biejiajian Pills group were lower than those in the control group(P<0.05).The incidence of adverse reactions was 7.14%in the control group,and 9.30%in the Biejiajian Pills group,and there was no significant difference between the two groups(P>0.05).Conclusion:Biejiajian Pills combined with Tenofovir has significant clinical efficacy in the treatment of hepatitis B cirrhosis in decompensated period with qi stagnation and blood stasis syndrome,which can effectively improve liver function and liver fibrosis indicators in patients.Its mechanism of action may be related to reducing CCR expression,and the treatment is safe.