柔肝化纤颗粒治疗肝肾阴虚型乙肝后肝纤维化的疗效及作用机制

Efficacy and Mechanism of Rougan Huaxian Granules(柔肝化纤颗粒)in Liver Fibrosis after Hepatitis B with Liver and Kidney Yin Deficiency

目的:观察柔肝化纤颗粒治疗肝肾阴虚型乙肝后肝纤维化的临床疗效,探讨其作用机制。方法:将90例乙肝后肝纤维化患者随机分为对照组和治疗组,每组45例,对照组采用恩替卡韦分散片治疗,治疗组在对照组基础上加用柔肝化纤颗粒治疗,均连续治疗12周。治疗结束后比较两组患者中医证候积分、肝功能、肝纤四项、乙型肝炎病毒(HBV)转阴率、肝脏硬度值、血清白介素-6(IL-6)、肿瘤坏死因子-α(TNF-α)及外周血T淋巴细胞亚群CD3^(+)、CD4^(+)、CD8^(+)、CD4^(+)/CD8^(+)T细胞水平。结果:两组患者治疗后,AST、ALT、肝脏硬度值、中医证候积分、肝纤四项、血清IL-6、TNF-α和CD8^(+)T细胞水平均较治疗前降低,且治疗后治疗组低于对照组,差异均有统计学意义(P<0.05);ALB、CD3^(+)、CD4^(+)和CD4^(+)/CD8^(+)T细胞水平均较治疗前升高,且治疗后治疗组高于对照组,差异均有统计学意义(P<0.05);两组患者治疗后HBV-DNA水平均较治疗前降低,但差异无统计学意义(P>0.05);治疗组总有效率为88.9%(40/45),对照组总有效率为66.7%(30/45),治疗组优于对照组(P<0.05)。结论:在常规恩替卡韦治疗基础上,联合柔肝化纤颗粒治疗乙肝后肝纤维化的临床疗效显著,其可能作用机制是减轻患者炎症反应,调节免疫功能。

Objective:To observe the clinical efficacy of Rougan Huaxian Granules in treating liver fibrosis after hepatitis B with liver and kidney Yin deficiency,and to explore its mechanism of action.Methods:Totally90 patients with post-hepatitis B liver fibrosis were randomly divided into control and treatment groups.Patients were treated with Entecavir Dispersible Tablets in control group,and patients in treatment group were treated by Rougan Huaxian Granules on the basis of the control group.The treatment course of both groups was 12 weeks.After treatment,the TCM symptom scores,liver function,liver fiber levels,hepatitis B virus(HBV)conversion rate,liver hardness value,serum interleukin-6(IL-6),tumor necrosis factor-α(TNF-α)and peripheral blood T lymphocyte subsets,CD3^(+),CD4^(+),CD8^(+)and CD4^(+)/CD8^(+)T cell levels,were compared between the two groups.Results:After treatment,AST,ALT,liver hardness value,TCM syndrome score,four items of liver fibrosis,serum IL-6,TNF-αand CD8^(+)T cell levels decreased in the two groups and the treatment group showed lower levels than control group,with statistically significant differences(P<0.05).The ALB and CD3^(+),CD4^(+),CD8^(+)and CD4^(+)/CD8^(+)T cell levels increased in the two groups after treatment and the treatment group showed higher levels than control group,with statistically significant differences(P<0.05).The HBV-DNA levels decreased in the two groups after treatment,but there was no significant difference(P>0.05).The total effective rate was 88.9%(40/45)in treatment group and 66.7%(30/45)in control group,and the treatment group showed better effect than control group(P<0.05).Conclusion:On the basis of conventional Entecavir,the Rougan Huaxian Granules shows significant clinical effect on liver fibrosis after hepatitis B.The possible mechanism is to reduce the patient’s inflammatory response and regulate immune function.