目的 探討六味五靈片聯(lián)合恩替卡韋治療慢性乙型肝炎的臨床療效和作用機(jī)制。方法 選取2012年1月至2013年12月青海省第四人民醫(yī)院收治的慢性乙型肝炎78例，隨機(jī)分為治療組（39例）和對(duì)照組（39例），對(duì)照組采用口服恩替卡韋片，1片/次，1次/d，餐前或餐后2 h服用；治療組在對(duì)照組基礎(chǔ)上口服六味五靈片，1片/次，3次/d，3個(gè)月后逐漸減量至1片/次，1次/d。兩組均連續(xù)治療48周。比較兩組患者的臨床療效，并測(cè)定Th1/Th2細(xì)胞因子水平、外周血T淋巴細(xì)胞亞群及紅細(xì)胞免疫功能。結(jié)果 治療組和對(duì)照組總有效率分別為89.74%、82.05%，兩組比較差異有統(tǒng)計(jì)學(xué)意義（P<0.01）。從治療12周開始，兩組谷丙轉(zhuǎn)氨酶（ALT）、谷草轉(zhuǎn)氨酶（AST）均較治療前明顯下降；治療12周后，治療組ALT顯著低于同期對(duì)照組水平；治療24周后，治療組AST低于對(duì)照組，HBeAg轉(zhuǎn)陰率高于對(duì)照組，兩組比較差異有統(tǒng)計(jì)學(xué)意義（P<0.01）。治療后，兩組IL-12、IL-2、和Th1/Th2細(xì)胞因子均較治療前明顯升高，IL-10、IL-4較治療前明顯降低，同組與治療前相比差異有統(tǒng)計(jì)學(xué)意義（P<0.01）；且治療后，治療組這些細(xì)胞因子水平改善程度優(yōu)于對(duì)照組，兩組比較差異有統(tǒng)計(jì)學(xué)意義（P<0.01）。治療后，兩組患者CD3⁺、CD4⁺/CD8⁺均高于同組治療前水平，CD8⁺顯著降低，同組治療前后差異有統(tǒng)計(jì)學(xué)意義（P<0.01）。治療組各亞群的改善程度優(yōu)于對(duì)照組，兩組比較差異有統(tǒng)計(jì)學(xué)意義（P<0.01）。治療后，兩組患者紅細(xì)胞黏附活性RCR明顯上升，紅細(xì)胞免疫復(fù)合物RICR明顯下降，與治療前相比差異有統(tǒng)計(jì)學(xué)意義（P<0.01）；治療組的改善程度優(yōu)于對(duì)照組，兩組比較差異有統(tǒng)計(jì)學(xué)意義（P<0.01）。結(jié)論 六味五靈片聯(lián)合恩替卡韋治療慢性乙型肝炎具有較好的臨床療效，提高患者肝功能和HBeAg轉(zhuǎn)陰率，改善患者細(xì)胞免疫和RBC免疫功能，值得臨床推廣應(yīng)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.