Evaluation of anti- fibrosis effect of compound Biejia Ruangan tablets with transient elastography
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摘要:
目的使用瞬时弹性成像的方法,评价在恩替卡韦抗病毒治疗基础上,复方鳖甲软肝片治疗代偿期乙型肝炎肝硬化的疗效。方法以代偿期乙型肝炎肝硬化为研究对象,开展前瞻性随机对照试验,对照组50例,使用恩替卡韦抗病毒治疗,试验组50例,在使用恩替卡韦抗病毒基础上联合复方鳖甲软肝片抗纤维化治疗,观察时间节点为6和12个月,比较两组治疗后以及各组自身治疗前后瞬时弹性数值的变化情况。计量资料采用t检验,计数资料及率的比较采用χ2检验。结果复方鳖甲软肝片治疗后,在降低瞬时弹性数值方面,治疗6、12个月均优于对照组(t=2.963、2.239;P=0.004、0.027)。瞬时弹性程度在治疗6、12个月与治疗前比较均有显著下降,对照组治疗6个月与治疗前相比,t=4.295,治疗12个月与治疗前相比,t=6.109,治疗12个月与治疗6个月相比,t=5.394,上述P均<0.001。试验组治疗6个月与治疗前相比,t=8.505,治疗12个月与治疗前相比,t=9.882,治疗12个月与治疗6个月相比,t=7.930,上述P均<0.001。治疗12个月后试验组肝硬化的比例明显低于对照组(χ2=4.058,...
Abstract:Objective To evaluate the clinical efficacy of compound Biejia Ruangan tablets using transient elastography in patients with hepatitis B- induced compensated liver cirrhosis who are concurrently treated with entecavir. Methods In this prospective, randomized, and controlled study, 100 patients with hepatitis B- induced compensated liver cirrhosis were randomly assigned to the control group and the experimental group in a ratio of 1: 1. The patients in the control group were treated with the anti- virus drug entecavir alone, whereas the patients in the experimental group were treated with entecavir and compound Biejia Ruangan tablets for anti- fibrosis therapy. The patients were followed up at 6 and 12months. After treatment, the changes in transient elasticity values were evaluated, and the transient elasticity values were compared between the two groups. Continuous variables were compared with the t test and categorical data as well as rates were compared with the chi- square test. Results Treatment with compound Biejia Ruangan tablets led to significantly lower transient elasticity values in the experimental group than in the control group at 6 and 12 months ( t = 2. 963, P = 0. 004; t = 2. 239, P = 0. 027) . Transient elasticity values at 6 and 12 months were significantly lower than their respective baseline levels in the control group ( t = 4. 295, P < 0. 001 for comparison between values at baseline and 6months; t = 6. 109, P < 0. 001 for comparison between values at baseline and 12 months; t = 5. 394, P < 0. 001 for comparison between values at 6 and 12 months) and the experimental group ( t = 8. 505, P < 0. 001 for comparison between values at baseline and 6 months; t = 9. 882, P<0. 001 for comparison between values at baseline and 12 months; t = 7. 930, P < 0. 001 for comparison between values at 6 months and 12months) . At 12 months, the proportion of patients with liver cirrhosis in the experimental group was significantly lower than that in the control group ( χ2= 4. 058, P = 0. 044) . Conclusion Entecavir can relieve liver fibrosis to some extent. Moreover, entecavir combined with compound Biejia Ruangan tablets can lead to further improvement in liver fibrosis at 6 and 12 months.
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Key words:
- liver cirrhosis /
- hepatitis B /
- elasticity imaging techniques /
- treatment outcome
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