参芪肝康片对慢性乙型肝炎患者的疗效及免疫功能的影响

Impact of Shenqi Gankang tablets on clinical efficacy and immune function in the treatment of chronic hepatitis B

目的 探讨参芪肝康片对慢性乙型肝炎(chronic hepatitis B,CHB)患者的疗效及免疫功能的影响。方法 选取2017年1月至2019年12月于新乡医学院第一附属医院感染科住院治疗的182例CHB患者作研究对象,随机分为对照组(n=91)和观察组(n=91)。对照组给予马来酸恩替卡韦片,一日1次,每次0.5 mg;观察组在对照组的基础上给予口服参芪肝康片,一日3次,每次2.1 g。两组患者均治疗6个月。比较两组患者临床疗效、肝功能[谷草酸氨酶(aspartate aminotransferase,AST)、谷丙转氨酶(alanine aminotransferanse,ALT)、肝纤维化[层粘连蛋白(laminin,LN)、透明质酸(hualuronic acid,HA)、Ⅲ型前胶原(Ⅲprocollagen,PCⅢ)、Ⅳ型胶原(Ⅳcollagen,Ⅳ-C)、T淋巴细胞亚群(CD4^(+)、CD8^(+)、CD4^(+)/CD8^(+))、细胞因子水平[干扰素(interferon,IFN)-γ、白介素(interleukin,IL)-2、IL-4、IL-10]及不良反应发生率的差异。结果 与对照组比较,观察组总有效率显著升高,差异具有统计学意义(P=0.014)。治疗后,两组ALT、AST、LN、HA、PCⅢ、Ⅳ-C、CD8^(+)细胞、IL-4和IL-10水平均显著降低(P<0.05),而CD4^(+)细胞、CD4^(+)/CD8^(+)比值、IFN-γ和IL-2均显著升高(P<0.05),且与对照组相比,观察组ALT、AST、LN、HA、PCⅢ、Ⅳ-C、CD8^(+)细胞、IL-4和IL-10水平降低更为显著(P<0.05),而CD4^(+)细胞、CD4^(+)/CD8^(+)比值、IFN-γ及IL-2升高更为显著(P<0.05)。两组治疗期间不良反应发生率分别为13.19%和12.08%,差异无统计学意义(P=0.823)。结论 参芪肝康片辅助治疗CHB安全有效,能显著改善患者的肝功能并减轻肝纤维化,促进辅助性T1细胞免疫应答及增强免疫功能。

Objective To investigate the impact of Shenqi Gankang tablets on clinical efficacy and immune function in the treatment of chronic hepatitis B(CHB).Methods A total of 182 patients with CHB from Department of Infectious Diseases,the First Affiliated Hospital of Xinxiang Medical University between January 2017 to December 2019 were collected.All patients were randomly divided into control group(n=91) and observation group(n=91).The control group was given entecavir maleate tablets,0.5 mg/time,one time/d and the observation group was additional given Shenqi Gankang tablets,2.1 g/time,3 times/d on the basis of the control group.Two groups were treated for 6 months.The differences of clinical efficacy,liver function index(AST、ALT),liver fibrosis index(LN、HA、PCⅢ,Ⅳ-C),T lymphocyte subsets index(CD4^(+),CD8^(+),CD4^(+)/CD8^(+)),cytokine levels index(IFN-,IL-2,IL-4,IL-10) and incidence of adverse reactions between two groups were compared after treatment.Results The total effective rates in the observation group was significantly higher than control group(P=0.014).After treatment,the ALT,AST,LN,HA,PCⅢ,Ⅳ-C,CD8^(+)cells,IL-4,IL-10 of two groups were significantly reduced,while CD4^(+)cells,CD4^(+)/CD8^(+)ratio value,IFN-,IL-2 were significantly increased,with statistically significant differences between two groups before and after treatment(P<0.05).After treatment,the ALT,AST,LN,HA,PCⅢ,Ⅳ-C,CD8^(+)cells,IL-4,IL-10 of the observation group were significantly lower than that of the control group,while CD4^(+)cells,CD4^(+)/CD8^(+)ratio value,IFN-,IL-2 were higher than that of the control group,with statistically significant differences(P<0.05).The incidence of adverse reactions in control and observation group was 13.19% and 12.08%,respectively.There was no significant difference between the two groups(P=0.823).Conclusion Shenqi Gankang tablet is safe and effective in the treatment of CHB,and it could significantly improve liver function and alleviate the degree of liver fibrosis.Shenqi Gankang tablet can also promote Th1 cell immune response and enhance immune function.