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目的:观察肝苏胶囊联合恩替卡韦片治疗湿热中阻证慢性乙型病毒性肝炎的临床疗效。方法:将130例湿热中阻证慢性乙型病毒性肝炎患者随机分为观察组和对照组各65例。对照组给予恩替卡韦片治疗,观察组在对照组的用药基础上联合肝苏胶囊治疗,3月为1疗程,2组均连续治疗4疗程。观察2组临床症状的改善情况及治疗前、治疗6、12月和停药3月时的肝功能指标[谷丙转氨酶(ALT)、谷草转氨酶(AST)、总胆红素(TBil)]、乙肝病毒基因(HBV-DNA)、肝纤维化指标[透明质酸(HA)、Ⅲ型前胶原(PC-Ⅲ)、Ⅳ型胶原(CIV)、层粘连蛋白(LN)]含量的变化;观察2组治疗前后的不良反应发生情况。结果:观察组总有效率为86.15%,对照组总有效率为66.16%(P<0.05)。治疗前,2组ALT、AST、TBil、HA、PC-Ⅲ、CIV、LN及HBVDNA含量比较,差异均无统计学意义(P>0.05)。治疗6、12月和停药3月后,2组ALT、AST、TBil、HA、PC-Ⅲ、CIV、LN及HBV-DNA含量均较治疗前下降(P<0.05);观察组的3项肝功能、4项肝纤维化指标及HBV-DNA含量均低于同期对照组(P<0.05),HBV-DNA含量虽低于同期对照组,但差异均无统计学意义(P>0.05)。停药3月后,2组3项肝功能、4项肝纤维化指标和HBV-DNA含量与治疗12月后比较,差异均无统计学意义(P>0.05)。结论:肝苏胶囊联合恩替卡韦片治疗湿热中阻证慢性乙型病毒性肝炎疗效显著,能有效改善患者的肝功能及肝纤维化指标,且不良反应少。
Objective: To observe the clinical efficacy of Gan Su capsule combined with entecavir tablets in treating chronic hepatitis B with damp-heat resistance syndrome. Methods: One hundred and thirty cases of chronic hepatitis B with damp-heat resistance syndrome were randomly divided into observation group and control group with 65 cases each. The control group was treated with entecavir tablets. The observation group was treated with Gansu Capsule on the basis of the control group. March was 1 course of treatment. Both groups were treated for 4 courses continuously. The improvement of clinical symptoms and the changes of liver function indexes (ALT, AST, TBil) before treatment, 6, 12 months and 3 months after treatment were observed, HBV-DNA and the indexes of liver fibrosis (HA, PC-Ⅲ, CIV, LN) were observed. 2 groups before and after treatment of adverse reactions occurred. Results: The total effective rate was 86.15% in observation group and 66.16% in control group (P <0.05). Before treatment, there was no significant difference in the levels of ALT, AST, TBil, HA, PC-Ⅲ, CIV, LN and HBVDNA between the two groups (P> 0.05). The levels of ALT, AST, TBil, HA, PC-Ⅲ, CIV, LN and HBV-DNA in the two groups after treatment were lower than those before treatment (P <0.05) Liver function, liver fibrosis index and HBV-DNA content were lower than the control group (P <0.05), HBV-DNA content was lower than the control group, but the difference was not statistically significant (P> 0.05). Three months after discontinuation, there were no significant differences in the three groups of liver function, four indexes of liver fibrosis and HBV-DNA in two groups after 12 months of treatment (P> 0.05). Conclusion: Gan Su Capsule combined with entecavir tablets in the treatment of damp-heat resistance syndrome has significant curative effect on chronic hepatitis B, can effectively improve the liver function and liver fibrosis in patients with less adverse reactions.