补肾温阳中药辅助抗病毒药物治疗肾阳亏虚型高ALT水平慢性乙肝疗效及对免疫功能的影响

Effect of adjuvant Bushen Wenyang Traditional Chinese Medicine with antiviral drug on high ALT level chronic hepatitis B of type of kidney-yang deficiency and its effect on immune function

目的探讨补肾温阳中药辅助抗病毒药物治疗肾阳亏虚型高谷丙转氨酶(ALT)水平慢性乙肝疗效及对白细胞介素-6(IL-6)、Toll样受体4(TLR4)及辅助性T细胞17(Th17)/调节性T细胞(Treg)水平的影响。方法将136例肾阳亏虚型高ALT水平慢性乙肝患者随机分为2组,对照组68例给予替比夫定治疗,试验组68例在此基础上辅以补肾温阳中药治疗,2组疗程均为24周。统计2组血清转换率、乙肝病毒(HBV)DNA转阴率、乙型肝炎E抗原(HBeAg)转阴率、近期疗效、药物毒副作用发生情况,检测2组治疗前后ALT、谷草转氨酶(AST)、总胆红素(TBil)、IL-6、TLR4、Th17/Treg水平。结果试验组治疗12周和24周后HBV DNA转阴率和治疗24周后血清转换率、HBeAg转阴率均显著高于对照组(P均<0.05)。与治疗前比较,2组治疗后AST、ALT、TBil水平明显降低,IL-6、TLR4及Th17/Treg水平均明显升高(P均<0.05);与对照组比较,试验组上述各指标改善程度更明显(P均<0.05)。治疗24周后,试验组临床总有效率明显高于对照组(P<0.05);2组不良反应发生率比较差异无统计学意义(P>0.05)。结论补肾温阳中药辅助抗病毒药物治疗肾阳亏虚型高ALT水平慢性乙肝能够有效提高血清转换率,促进HBV DNA和HBeAg转阴,保护肝功能,调节IL-6、TLR4及Th17/Treg水平,且未加重药物不良反应。

Objective It is to investigate the efficacy of Bushen Wenyang traditional Chinese medicine as an adjuvant therapy with antiviral drug in the treatment of chronic hepatitis B with high-level of alanine aminotransferase(ALT) and kidney-yang deficiency syndrome and its effect on the levels of interleukin-6(IL-6), Toll-like receptor 4(TLR4) and helper T cell 17(Th17)/regulatory T cell(Treg). Methods 136 patients with high ALT level chronic hepatitis B of type of kidney-yang deficiency were randomly divided into 2 groups. 68 patients in the control group were treated with telbivudine. 68 patients in the experimental group were supplemented with Bushen Wenyang Chinese medicine on the basis of the control group. Both groups were treated for 24 weeks. The seroconversion rate, hepatitis B virus(HBV)-DNA negative rate, HBeAg negative rate, short-term efficacy, drug side effects were calculated or assessed, the levels of ALT and aspartate aminotransferase(AST), total bilirubin(TBil), IL-6, TLR4, Thl7/Treg were detected before and after treatment. Results The HBV DNA negative rate after treatment for 12 weeks and 24 weeks and the seroconversion rate and HBeAg negative rate after treatment for 24 weeks in the experimental group were significantly higher than those in the control group(P<0.05). Compared with that before treatment, the levels of AST, ALT and TBil were significantly decreased in the two groups, and the levels of IL-6, TLR4 and Th17/Treg were significantly increased(P<0.05). Compared with the control group, the improvements of the above indicators in the experimental group were more significant(P<0.05). After 24 weeks of treatment, the total clinical effective rate of the experimental group was significantly higher than that of the control group(P<0.05). There was no significant difference in the incidence of adverse reactions between the two groups(P>0.05). Conclusion Bushen Wenyang Chinese medicine as adjuvant therapy with antiviral drugs can effectively improve seroconversion rate, promote HBV DNA and HBeAg being negative, protect liver function, regulate the levels of IL-6, TLR4 and Th17/Treg, and did not aggravate adverse drug reactions in the treatment of high ALT level chronic hepatitis B of kidney yang deficiency type.