目的 使用瞬时弹性成像系统(FibroScan)评价复方鳖甲软肝片联合恩替卡韦治疗慢性乙型肝炎(CHB)肝纤维化的临床疗效.方法 将120例CHB肝纤维化患者随机分为2组.对照组60例(最终完成试验59例)予恩替卡韦治疗,治疗组60例(最终完成试验58例)予复方鳖甲软肝片联合恩替卡韦治疗,疗程均为12个月.观察2组患者治疗前后肝功能[丙氨酸氨基转移酶(ALT)、天冬氨酸氨基转移酶(AST)、γ-谷氨酰转肽酶(γ-GT)、碱性磷酸酶(ALP)、总胆红素(TBiL)、血清白蛋白(Alb)]及血常规中白细胞计数(WBC)、血小板计数(PLT),门静脉主干(MPV)内径、肝脏弹力硬度值(LSM)变化.结果 治疗后2组患者肝功能指标ALT、AST、γ-GT、ALP水平均较本组治疗前显著下降(P＜0.05),PLT显著升高(P＜0.05),TBiL、Alb、WBC无明显变化(P＞0.05);2组治疗前后差值比较显示,治疗组PLT明显高于对照组(P＜0.05).2组治疗后MPV内径与本组治疗前比较差异无统计学意义(P＞0.05),2组治疗前后差值比较差异亦无统计学意义(P＞0.05).2组治疗后LSM均较本组治疗前明显下降(P＜0.05);2组治疗前后差值比较显示,治疗组LSM降低程度明显高于对照组(P＜0.05).结论 复方鳖甲软肝片可有效提高恩替卡韦抗病毒治疗的效果,降低CHB肝纤维化患者LSM,减轻肝纤维化程度,在临床中值得推广应用.%Objective To evaluate the anti-hepatic fibrosis effect of compound Biejia-ruangan tablets combined with entecavir on chronic hepatitis B (CHB) by transient elastography (FibroScan).Methods 120 CHB patients were randomly divided into two groups.60 cases (59 finished cases finally) in the control group were treated by entecavir.60 cases (59 cases finished finally) in the treatment group were treated by compound Biejia-ruangan tablets combined with entecavir.The treatment course was 12 months in two groups.The changes of liver function including alanine aminotransferase(ALT),aspartate aminotransferase(AST),γ-glutamyl transpeptidase (γ-GT),alkaline phosphatase (ALP),total bilirubin (TBiL),serum albumin (Alb),and the changes of blood routine including white blood cell (WBC) count and platelet (PLT) count,and the changes of inner diameter of main portal vein (MVP) and liver stiffness value (LSM) before and after treatment were observed in two groups.Results The levels of ALT,AST,γ-GT and ALP after treatment significantly reduced in two groups (P ＜ 0.05),and PLT count significantly increased (P ＜ 0.05),the TBiL,Alb and WBC count had no obvious changes (P ＞ 0.05).The difference between before and after treatment in two groups showed that the rise of PLT count in treatment group was significantly higher than that in control group (P ＜ 0.05).There was no statistical difference on the inner diameter of MVP between before and after treatment in two groups (P ＞ 0.05).The LSM after treatment significantly reduced in two groups (P ＜ 0.05),and the difference between before and after treatment in two groups showed that the reduction of LSM in treatment group was significantly higher than that in control group (P ＜ 0.05).Conclusion Compound Biejia-ruangan tablets can effectively improve the effect of antiviral treatment of entecavir,reduce the Stiffness of LSM in CHB patients with liver fibrosis and reduce the degree of liver fibrosis,which is worthy of popularization and application in clinic.
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