复方鳖甲软肝片联合恩替卡韦治疗慢性乙型肝炎纤维化的长期疗效探究

Study on the Long-term Efficacy of Compound Biejiaruangan Tablet Combined with Entecavir in the Treatment Patients with Chronic Hepatitis B Fibrosis

目的探究复方鳖甲软肝片联合恩替卡韦治疗慢性乙型肝炎纤维化的长期疗效。方法将2013年2月~2014年2月于某院接受治疗的慢性乙肝肝纤维化的129例患者随机分为联合组(65例)和对照组(64例)。联合组给予恩替卡韦联合复方鳖甲软肝片,对照组单用恩替卡韦。观察两组患者功能指标、肝纤维化情况、乙型肝炎病毒(HBV) DNA定量以及不良反应。结果治疗3年后,两组谷草转氨酶(AST)、总胆红素(TBIL)、谷丙转氨酶(ALT)均明显低于治疗前(P<0.05),两组白蛋白(ALB)治疗2年和3年后均显著高于治疗前(P<0.05);两组患者肝纤维化指标均较治疗前明显下降(P<0. 05);治疗3年后联合组的C反应蛋白(CRP)、层粘连蛋白(LN)、Ⅲ型前胶原氨基端肽(PIIINP)、透明质酸酶(HA)明显低于对照组(P<0.05)。治疗后3年联合组的门静脉主干内径(cm)、门静脉血流量(m L·min-1)明显小于对照组(P<0.05),门静脉平均血流速度(cm·s-1)明显大于对照组,差异有统计学意义(P<0.05)。联合组以及对照组治疗后均未出现乙肝表面抗原(HBs Ag)阴转,血清学转换率联合组明显高于对照组(P<0.05)。治疗后两组HBV DNA定量检测达到正常水平的占比发生率与对照组相似,差异无统计学意义(P>0. 05)。两组不良反应发生率无显著差异,无严重不良反应。结论复方鳖甲软肝片联合恩替卡韦能够有效地降低患者的血清肝纤维化指标,长期疗效较为显著。

OBJECTIVE To study the long-term efficacy of compound Biejiaruangan tablet combined with entecavir in the treatment patients with chronic hepatitis B fibrosis. METHODS 129 patients with chronic hepatitis B fibrosis treatment in a hospital from February 2013 to February 2014 were randomly divided into combination group ( 65 cases) and control group ( 64 cases). The combination group was treated with entecavir combined with compound Biejiaruangan tablet, and the control group was treated with entecavir alone. Functional parameters, hepatic fibrosis, hepatitis B virus ( HBV ) DNA quantification and adverse reactions were observed in the two groups. RESULTS After 3 years of treatment, the levels of aspartic transaminase (AST),total bilirubin ( TBIL) and alanine ami notransferase ( ALT) in the two groups were significantly lower than before treatment (P<0.05), however, the levels of ALB in both groups were significantly higher than before treatment ( P<0.05). The hepatic fibrosis indexes of the two groups were significantly lower than those before treatment (P<0.05). After 3 years of treatment, the levels of C-reactive protein ( CRP), laminin (LN),procollagen III N-termi peptide( PIIINP) and hyaluronidase( HA) in combination group were significantly lower than the control group (P<0.05). The portal vein diameter (cm) and portal vein blood flow ( mL·min^-1 ) in the combination group were significantly lower than those in the control group (P<0.05). The mean portal blood flow velocity (cm·s^-1 ) was significantly greater than that of the control group(P<0.05). There was no hepatitis B surface antigen( HBsAg) negative conversion after treatment both in the two groups, and the serological conversion rate was significantly higher in the combined group than in the control group (P<0.05). After treatment, the incidence of HBV DNA quantitative detection reached the normal level in the two groups was similar to the control group, the difference was not statistically significant (P>0.05). There was no significant difference in the incidence of adverse reactions between the two groups, and there were no serious adverse reactions. CONCLUSION Compound Biejiaruangan tablet combined with entecavir can effectively reduce the serum hepatic fibrosis index, and the long-term curative effect is more remarkable.