目的 观察和和络舒肝胶囊联合恩替卡韦胶囊治疗乙型肝炎肝硬化的临床疗效。方法 选取2015年9月-2018年5月在重庆市大足区人民医院治疗的乙型肝炎肝硬化患者124例作为研究对象，将患者随机分为对照组（62例）和治疗组（62例）。对照组患者口服恩替卡韦胶囊，1粒/次，1次/d；治疗组在对照组治疗的基础上口服和络舒肝胶囊，5粒/次，3次/d。两组患者疗程均为12个月。观察两组患者的临床疗效，比较两组治疗前后的肝功能指标、肝纤维化指标、T淋巴细胞亚群水平和炎症因子水平。结果 治疗后，对照组和治疗组的总有效率分别为82.26%、93.55%，两组比较差异具有统计学意义（P<0.05）。治疗6、12个月后，两组血清的丙氨酸氨基转移酶（ALT）、天门冬氨酸氨基转移酶（AST）、总胆红素（TBIL）和谷氨酰转肽酶（GGT）水平均显著降低，同组治疗前后比较差异具有统计学意义（P<0.05）；且治疗组肝功能指标水平显著低于同期对照组，两组比较差异具有统计学意义（P<0.05）。治疗6、12个月后，两组的血清Ⅲ型前胶原（PC-Ⅲ）、IV型胶原（IV-C）、层黏连蛋白（LN）和透明质酸酶（HA）水平均显著降低，同组治疗前后比较差异具有统计学意义（P<0.05）；且治疗组肝纤维化指标显著低于同期对照组，两组比较差异具有统计学意义（P<0.05）。治疗6、12个月后，两组患者的CD3⁺、CD4⁺和CD4⁺/CD8⁺水平显著升高，同组治疗前后比较差异具有统计学意义（P<0.05）；治疗6、12个月后，治疗组T淋巴细胞亚群水平显著高于同期对照组，两组比较差异具有统计学意义（P<0.05）。治疗6、12个月后，两组的白细胞介素-2（IL-2）、肿瘤坏死因子-α（TNF-α）水平均显著降低，而白细胞介素-10（IL-10）水平显著升高，同组治疗前后比较差异具有统计学意义（P<0.05）；治疗6、12个月后，治疗组炎症因子水平明显优于同期对照组，两组比较差异具有统计学意义（P<0.05）。结论 和络舒肝胶囊联合恩替卡韦胶囊治疗乙型肝炎肝硬化具有较好的临床疗效，可明显改善肝功能，抑制早期肝硬化的进程，改善机体的免疫功能，减轻炎症反应，且不良反应少，安全性高，具有一定临床推广应用价值。

Objective To observe the clinical efficacy of Heluo Shugan Capsules combined with Entecavir Capsules in treatment of hepatitis B cirrhosis. Methods Patients (124 cases) with hepatitis B cirrhosis in Chongqing Dazu District People's Hospital from September 2015 to May 2018 were divided into control (62 cases) and treatment (62 cases) groups. Patients in the control group were po administered with Entecavir Capsules, 1 grain/time, once daily. Patients in the treatment group were po administered with Heluo Shugan Capsules on the basis of the control group, 5 grains/time, three times daily. Patients in the two groups were treated for 12 months. After treatment, the clinical efficacy was evaluated, and liver function indexes, liver fibrosis indexes, T lymphocyte subsets, and inflammatory factor levels in two groups before and after treatment were compared. Results After treatment, the clinical efficacy in the control and treatment groups was 82.26% and 93.55%, respectively, and there were differences between two groups (P < 0.05). After treatment for 6 and 12 months, the serum ALT, AST, TBIL, and GGT levels in the two groups were significantly decreased, and the difference was statistically significant in the same group (P < 0.05). And the liver function indexes in the treatment group were significantly lower than those in the control group during the same period, with significant difference between two groups (P < 0.05). After treatment for 6 and 12 months, the serum PC-Ⅲ, IV-C, LN, and HA levels in the two groups were significantly decreased, and the difference was statistically significant in the same group (P < 0.05). And the liver fibrosis indexes in the treatment group were significantly lower than those in the control group during the same period, with significant difference between two groups (P < 0.05). After treatment for 6 and 12 months, the levels of CD3⁺, CD4⁺, and CD4⁺/CD8⁺ in two groups were significantly increased, and the difference was statistically significant in the same group (P < 0.05). And the levels of T lymphocyte subsets in the treatment group were significantly higher than those in the control group during the same period, with significant difference between two groups (P < 0.05). After treatment, IL-2 and TNF-α level in two groups were significantly decreased, but IL-10 in two groups were significantly increased, and the difference was statistically significant in the same group (P < 0.05). And the inflammatory factor levels in the treatment group were significantly better than those in the control group during the same period, with significant difference between two groups (P < 0.05). Conclusion Heluo Shugan Capsules combined with Entecavir Capsules has good clinical effect in treatment of hepatitis B cirrhosis, can significantly improve the liver function, inhibit the process of early cirrhosis, improve the immune function, and reduce inflammation, with less adverse reactions and high safety, which has a certain clinical application value.