目的 探讨六味五灵片联合恩替卡韦治疗慢性乙型肝炎的临床疗效和作用机制。方法 选取2012年1月至2013年12月青海省第四人民医院收治的慢性乙型肝炎78例，随机分为治疗组（39例）和对照组（39例），对照组采用口服恩替卡韦片，1片/次，1次/d，餐前或餐后2 h服用；治疗组在对照组基础上口服六味五灵片，1片/次，3次/d，3个月后逐渐减量至1片/次，1次/d。两组均连续治疗48周。比较两组患者的临床疗效，并测定Th1/Th2细胞因子水平、外周血T淋巴细胞亚群及红细胞免疫功能。结果 治疗组和对照组总有效率分别为89.74%、82.05%，两组比较差异有统计学意义（P<0.01）。从治疗12周开始，两组谷丙转氨酶（ALT）、谷草转氨酶（AST）均较治疗前明显下降；治疗12周后，治疗组ALT显著低于同期对照组水平；治疗24周后，治疗组AST低于对照组，HBeAg转阴率高于对照组，两组比较差异有统计学意义（P<0.01）。治疗后，两组IL-12、IL-2、和Th1/Th2细胞因子均较治疗前明显升高，IL-10、IL-4较治疗前明显降低，同组与治疗前相比差异有统计学意义（P<0.01）；且治疗后，治疗组这些细胞因子水平改善程度优于对照组，两组比较差异有统计学意义（P<0.01）。治疗后，两组患者CD3⁺、CD4⁺/CD8⁺均高于同组治疗前水平，CD8⁺显著降低，同组治疗前后差异有统计学意义（P<0.01）。治疗组各亚群的改善程度优于对照组，两组比较差异有统计学意义（P<0.01）。治疗后，两组患者红细胞黏附活性RCR明显上升，红细胞免疫复合物RICR明显下降，与治疗前相比差异有统计学意义（P<0.01）；治疗组的改善程度优于对照组，两组比较差异有统计学意义（P<0.01）。结论 六味五灵片联合恩替卡韦治疗慢性乙型肝炎具有较好的临床疗效，提高患者肝功能和HBeAg转阴率，改善患者细胞免疫和RBC免疫功能，值得临床推广应用。

Objective To investigate the clinical effect and mechanism of Liuwei Wuling Tablets combined with entecavir in the treatment of chronic hepatitis B. Methods Collected 78 cases from January, 2012 to December, 2013 in the Fourth People’s Hospital of Qinghai province, with chronic hepatitis B, and randomly divided into treatment group (39 cases) and control group (39 cases). Patients in the control group were po administered with Entecavir Tablets 2 h before or after meal, 1 tablets each time, 1 time daily. Patients in the treatment group were po administered with Liuwei Wuling Tablets, 1 tablets each time, 3 times daily, than gradually reduced to 1 tablets each time, 1 time daily after 3 months. Two groups were treated for 48 weeks. The clinical efficacy of two groups were compared, and the Th1/Th2 cytokine levels, T lymphocytes and subsets, and erythrocytes immune function in peripheral blood were compared, too.Results The efficiency rate of the treatment and control groups were 89.74% and 82.05%, with significant difference between two groups (P < 0.01). After 12 weeks of treatment, ALT and AST of two groups were significantly decreased than before treatment; after 12 weeks of treatment, the ALT in the treatment group was significantly lower than that in the control group. After 24 weeks, the AST in the treatment group was lower than that in the control group, and the HBeAg positive rate was higher than that in the control group, wth significant difference between two groups (P < 0.01). After treatment, IL-12, IL-2, and Th1/Th2 cytokines in the two groups were significantly enhanced, IL-10 and IL-4 significantly decreased compared with those before treatment, and there was statistically significant difference compared with those before treatment (P < 0.01). After treatment, the cytokines level improvement degree in treatment group were higher than the control group, and the difference was statistically significant (P < 0.01). After treatment, CD3⁺ and CD4⁺/CD8⁺ in two groups were higher than those before treatment, CD8⁺ decreased significantly, and the difference was statistically significant before and after treatment (P < 0.01). The improvement degree of subsets was much better than that in the control group, and there was significant difference between two groups (P < 0.01). After treatment, RCR increased in two groups and RICR decreased, and the difference was statistically significant compared with before treatment (P < 0.01). The improvement degree was much better than the control group, and there was significant difference between two groups (P < 0.01). Conclusion Liuwei Wuling Tablets combined with entecavir has better clinical effect in the treatment of chronic hepatitis B, can improve the liver function and the HBeAg negative rate, and can improve immune function of blood cell and RBC immune function, which is worthy of clinical application.