富马酸丙酚替诺福韦联合复方鳖甲软肝片治疗乙型肝炎肝硬化患者疗效和安全性评估  

Anti-fibrotic efficacy of tenofovir disoproxil fumarate and Compound Fufang Biejia Ruangan tablet in the treatment of patients with hepatitis B-induced liver cirrhosis

作　　者：连作勤 王世明 张甲 李付平 Lian Zuoqin;Wang Shiming;Zhang Jia(Department of Pharmacy,People's Hospital,Jinchang 737100,Gansu Province,China)

机构地区：[1]甘肃省金昌市人民医院药剂科,737100 [2]甘肃省金昌市人民医院肝病科,737100 [3]甘肃中医药大学附属医院药剂科

出　　处：《实用肝脏病杂志》2024年第5期753-756,共4页Journal of Practical Hepatology

基　　金：甘肃省自然科学基金资助项目(编号:22JR5RA1000)。

摘　　要：目的观察富马酸丙酚替诺福韦(TAF)联合复方鳖甲软肝片治疗乙型肝炎肝硬化患者的效果。方法2021年6月~2023年6月我院收治的乙型肝炎肝硬化患者116例,被随机分为两组,每组58例。给予对照组患者口服TAF治疗,给予观察组TAF联合复方鳖甲软肝片治疗,两组均治疗观察6个月。常规检测血清HBV标记物和HBV DNA载量,采用放射免疫分析法检测血清透明质酸(HA)、层粘连蛋白(LN)、Ⅲ型前胶原(PIIIP)和Ⅳ型胶原(CIV),使用超声检测肝脏剪切波弹性成像(SWE)和门脉指标。结果在治疗6个月末,观察组血清ALT水平为(43.1±6.2)U/L,显著低于对照组【(62.6±7.8)U/L,P<0.05】,而两组血清TBIL、ALB和INR比较,无显著性差异(P>0.05);两组血清HBV DNA均转阴,但血清HBsAg和HBeAg水平均无变化;观察组血清透明质酸、Ⅲ型前胶原和Ⅳ型胶原水平分别为(82.2±10.3)ng/L、(94.8±11.5)ng/mL和(61.3±7.5)ng/mL,均显著低于对照组【分别为(123.1±11.9)ng/L、(132.1±13.8)ng/mL和(89.7±9.1)ng/mL,P<0.05】;观察组SWE为(11.2±2.0)kPa,显著低于对照组【(14.1±2.5)kPa,P<0.05】,而两组门静脉内径和脾静脉内径比较,无显著性差异(P>0.05)。结论应用TAF联合复方鳖甲软肝片治疗乙型肝炎肝硬化患者可加速肝功能指标的恢复,抗肝纤维化作用明显,其长期疗效还有待于进一步观察。Objective The purpose of this study was to investigate anti-fibrotic efficacy of tenofovir disoproxil fumarate(TAF)and Fufang Biejia Ruangan tablet,an herbal Compound,in the treatment of patients with hepatitis B-induced liver cirrhosis(LC).Methods 116 patients with hepatitis B-induce LC were encountered in our hospital between June 2021 and June 2023,and we randomly assigned them to receive TAF(control,n=58)or TAF and herbal Compound combination(observation,n=58)for treatment of six months.Serum HBV DNA loads,and HBsAg and HBeAg levels were routinely assayed.Serumhyaluronic acid(HA),laminin(LN),procollagen type III(PIIIP)and collagen type IV(CIV)levels were detected by radioimmunoassay,and portal vein diameter(PVD),splenic vein diameter(SVD),splenic thickness(ST)and splenic length(SL)were detected by ultrasonography.Results By end of six month treatment,serum ALT level in the observation group were(43.1±6.2)U/L,much lower than[(62.6±7.8)U/L,P<0.05]in the control,and there were no significant differences as respect to total serum bilirubin,serum albumin and INR(P>0.05)between the two groups;serum HBV DNA returned to negative,and serum HBsAg and HBeAg levels didn’t change in all patients in the two groups;serum HA,PIIIP and CIV levels in the observation were(82.2±10.3)ng/L,(94.8±11.5)ng/mL and(61.3±7.5)ng/mL,all significantly lower than[(123.1±11.9)ng/L,(132.1±13.8)ng/mLand(89.7±9.1)ng/mL,respectively,P<0.05]in the control;SWE was(11.2±2.0)kPa,much lower than[(14.1±2.5)kPa,P<0.05]in the control,and there were no significant differences respect to portal vein diameters and splenic vein diameters(P>0.05)between the two groups.Conclusion Administration of tenofovir disoproxil fumarate and Compound Fufang Biejia Ruangan tablets combination in the treatment of patients with hepatitis Binduced LC could improve liver function tests normal and have anti-fibrotic efficacy,which needs long-term investigation.

关 键 词：肝硬化 乙型肝炎 富马酸丙酚替诺福韦 复方鳖甲软肝片 肝纤维化 治疗 

分 类 号：R512.62[医药卫生—内科学] R575.2[医药卫生—临床医学]