鳖甲煎丸联合替比夫定治疗乙型肝炎肝硬化的临床研究

Clinical study on Biejiajian Pills combined with telbivudine in treatment of hepatitis B cirrhosis

目的 探讨鳖甲煎丸联合替比夫定治疗乙型肝炎肝硬化的临床效果。方法 选取2018年3月-2021年3月渭南市中心医院收治的116例乙型肝炎肝硬化患者,随机分成对照组和治疗组,每组各58例。对照组口服替比夫定片,600mg/次,1次/d。在对照组基础上,治疗组餐后口服鳖甲煎丸,3 g/次,3次/d。两组均连续治疗6个月。观察两组患者临床疗效,比较治疗前后两组患者乙型肝炎病毒脱氧核糖核酸(HBV DNA)水平,肝脏硬度值(LSM)和36项健康调查简表(SF-36)总分,血清丙氨酸氨基转移酶(ALT)、总胆红素(TBil)、白蛋白(Alb)、透明质酸(HA)、层黏连蛋白(LN)、Ⅲ型前胶原(PC-Ⅲ)、Ⅳ型胶原(IV-C)、肿瘤坏死因子-α(TNF-α)、转化生长因子-β1(TGF-β1)和丙二醛(MDA)水平。结果 治疗后,治疗组临床有效率为82.76%,显著高于对照组(65.52%,P<0.05)。治疗后,两组血清ALT、TBil及HBV DNA水平均较治疗前显著降低(P<0.05),血清Alb水平均较治疗前显著升高(P<0.05),且均以治疗组的改善更显著(P<0.05)。与治疗前对比,两组治疗后LSM显著减小,SF-36总分显著增加(P<0.05),且均以治疗组的改善更显著(P<0.05)。两组治疗后血清肝纤维化四项(HA、LN、PC-Ⅲ、Ⅳ-C)水平均较治疗前显著下降(P<0.05),且治疗组对血清肝纤维化四项水平的降低作用显著优于对照组(P<0.05)。与治疗前比较,两组治疗后血清TNF-α、TGF-β1和MDA水平均显著降低(P<0.05),且治疗组显著低于对照组(P<0.05)。结论 鳖甲煎丸联合替比夫定治疗乙型肝炎肝硬化的整体疗效确切,能有效抑制患者体内HBV的复制,改善肝功能与肝纤维化,并可一定程度上逆转肝硬化,提高患者生活质量,且安全性较好。

Objective To investigate the clinical effect of Biejiajian Pills combined with telbivudine in treatment of hepatitis B cirrhosis.Methods Patients(116 cases)with hepatitis B cirrhosis in Weinan Central Hospital from March 2018 to March 2021 were randomly divided into control and treatment group,and each had 58 cases.Patients in the control group were po administered with Telbivudine Tablets,600 mg/time,once daily.Patients in the treatment group were po administered with Biejiajian Pills on the basis of the control group,3 g/time,three times daily.Patients in two groups were treated for 6 months.After treatment,the clinical evaluation was evaluated,the HBV DNA levels,the scores of LSM and SF-36,the levels of serum ALT,TBil,Alb,HA,LN,PC-Ⅲ,Ⅳ-C,TNF-α,TGF-β1 and MDA in two groups before and after treatment were compared.Results After treatment,the clinical effective rate of the treatment group was 82.76%(48/58),which was significantly higher than that of the control group[65.52%(38/58),P<0.05].After treatment,the levels of serum ALT,TBil and HBV DNA in two groups were significantly lower than those before treatment,while the levels of serum Alb in two groups were significantly higher than those before treatment(P<0.05),and the improvement in the treatment group was more significant(P<0.05).Compared with those before treatment,the LSM of the two groups were significantly decreased and the total score of SF-36 were significantly increased after treatment(P<0.05),and the improvement in the treatment group was more significant(P<0.05).The serum levels of four hepatic fibrosis items(HA,LN,PC-Ⅲ,Ⅳ-C)in two groups after treatment were significantly lower than those before treatment(P<0.05),and the effect of the treatment group was significantly better than that of the control group(P<0.05).Compared with those before treatment,the levels of serum TNF-α,TGF-β1 and MDA in two groups were significantly decreased(P<0.05),which in the treatment group were significantly lower than those in the control group(P<0.05).Conclusion The overall curative effect of Biejiajian Pills combined with telbivudine in treatment of hepatitis B cirrhosis is definite,which can effectively inhibit the replication of HBV in patients,improve liver function and liver fibrosis,reverse liver cirrhosis to a certain extent,improve the quality of life of patients,and is safe.