目的 探讨和络舒肝胶囊联合双环醇治疗慢性乙型肝炎的临床疗效。方法 选取2015年5月—2016年5月于上海中医药大学附属曙光医院治疗的88例慢性乙型肝炎患者，根据用药的差别分为对照组（44例）和治疗组（44例）。对照组口服双环醇片，1片/次，3次/d。治疗组在对照组治疗基础上口服和络舒肝胶囊，5粒/次，3次/d。两组均连续治疗48周。观察两组的临床疗效，比较两组治疗前后肝纤维化指标、肝功能指标、血清细胞因子水平的变化情况。比较治疗24、48周两组HBV-DNA和HBeAg转阴率。结果 治疗后，对照组和治疗组的总有效率分别为79.55%、93.18%，两组比较差异具有统计学意义（P < 0.05）。治疗24、48周，两组患者血清透明质酸（HA）、层粘连蛋白（LN）、Ⅳ型胶原（Ⅳ-C）、Ⅲ型前胶原（PC-Ⅲ）、丙氨酸氨基转移酶（ALT）、天门冬氨酸氨基转移酶（AST）、总胆红素（TBIL）、肿瘤坏死因子-α（TNF-α）、白细胞介素-18（IL-18）均较治疗前显著降低，γ干扰素（IFN-γ）、白细胞介素-21（IL-21）显著增高，同组治疗前后比较差异有统计学意义（P < 0.05）；治疗组治疗24、48周HA、LN、PC-Ⅲ、IV-C、ALT、AST、TBIL、TNF-α、IL-18水平显著低于对照组，IFN-γ、IL-21高于对照组，两组比较差异具有统计学意义（P < 0.05）。对照组在治疗24、48周时HBeAg阴转率分别为61.36%、77.27%，HBV-DNA阴转率分别为63.64%、79.55%；治疗组在治疗24、48周时HBeAg阴转率分别为81.82%、93.18%，HBV-DNA阴转率分别为86.36%、90.91%；治疗组HBV-DNA和HBeAg转阴率均显著高于对照组，两组比较差异具有统计学意义（P < 0.05）。结论 和络舒肝胶囊联合双环醇片治疗慢性乙型肝炎具有较好的临床疗效，可显著改善患者肝功能，抑制肝纤维化，增强机体免疫能力，促进机体病毒清除率，具有一定的临床推广应用价值。

Objective To investigate the clinical curative effect of Heluo Shugan Capsules combined with bicyclol in treatment of chronic hepatitis B. Methods Patients (88 cases) with chronic hepatitis b in Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from May 2015 to May 2016 were divided into control (44 cases) and treatment (44 cases) groups according to the medication regimen. Patients in the control group were po administered with Bicyclol Tablets, 1 tablet/time, three times daily. Patients in the treatment group were po administered with Heluo Shugan Capsules, 5 grains/time, three times daily. Patients in two groups were treated for 48 weeks. After treatment, the clinical efficacy were evaluated, and the changes of liver fibrosis indexes, liver function indexes, serum cytokine level in two groups before and after treatment were compared. Results After treatment, the clinical efficacy in the control and treatment groups were 79.55% and 93.18%, respectively, and there was difference between two groups (P < 0.05). Treatment for 24, 48 weeks, the levels of HA, LN, PC-Ⅲ, IV-C, ALT, AST, TBIL, TNF-α, and IL-18 in two groups significantly reduced, but IFN-γ and IL-21 were significantly increased, and the difference was statistically significant in the same group (P < 0.05). After treatment, HA, LN, PC-Ⅲ, IV-C, ALT, AST, TBIL, TNF-α, and IL-18 were lower than those in the control group, but IFN-γ and IL-21 were higher than those in the control group, and there was difference between two groups (P < 0.05). In the treatment of 24 and 48 weeks, HBeAg overcast rate in the control group was 61.36% and 77.27%, respectively, HBV-DNA overcast rate was 63.64% and 79.55%, respectively. HBeAg overcast rate in the treatment group was 81.82% and 93.18%, respectively, and HBV-DNA overcast rate was 86.36% and 90.91%, respectively. The overcast rates of HBeAg and HBeAg in the treatment group were significantly higher than those in the control group, and there was difference between two groups (P < 0.05). Conclusion Heluo Shugan Capsules combined with bicyclol has clinical curative effect in treatment of chronic hepatitis b, and can significantly improve the liver function, inhibit liver fibrosis, and can enhance the immune capacity, promote the clearance rate of the body virus, which has a certain clinical application value.

国家自然科学基金面上项目（81774256）