目的 探讨肝达康胶囊联合恩替卡韦治疗慢性乙型肝炎的临床疗效。方法 选取2018年1月-2019年6月于新乡医学院第一附属医院感染科就诊的124例慢性乙型肝炎患者，随机分为对照组和治疗组，每组各62例。对照组口服马来酸恩替卡韦片，1片/次，1次/d。治疗组在对照组治疗的基础上口服肝达康胶囊，8粒/次，3次/d。两组均连续治疗3个月。观察两组的临床疗效，比较两组治疗前后肝功能指标、肝纤维化指标、Th1和Th2细胞百分比和细胞因子水平的变化情况。结果 治疗后，治疗组和对照组的总有效率分别是95.16%、82.26%（P<0.05）。治疗后，两组患者血清丙氨酸氨基转氨酶（ALT）和天门冬氨酸氨基转移酶（AST）同各组治疗前相比均显著降低（P<0.05）；与对照组相比，治疗后治疗组患者血清ALT和AST水平降低更加明显（P<0.05）。治疗后两组患者血清层黏连蛋白（LN）、透明质酸（HA）、Ⅲ型前胶原N端肽（PCIII）、Ⅳ型胶原（IV-C）水平均明显下降（P<0.05）；且治疗后治疗组上述指标同对照组相比降低更加明显（P<0.05）。治疗后，两组Th1、Th1/Th2显著降低，而Th2显著升高（P<0.05）；与对照组相比，治疗后治疗组Th1、Th1/Th2显著更低，而Th2显著更高（P<0.05）。治疗后，两组患者γ干扰素（IFN-γ）、肿瘤坏死因子α（TNF-α）水平均显著下降，而白细胞介素4（IL-4）、白细胞介素6（IL-6）水平均显著升高（P<0.05）；治疗后，治疗组患者IFN-γ、TNF-α水平低于对照组，而IL-4、IL-6水平高于对照组（P<0.05）。结论 肝达康胶囊联合恩替卡韦治疗慢性乙型肝炎具有较好的临床疗效，能显著改善患者肝脏损伤情况，可能与改善Th1/Th2细胞失衡有关，具有一定的临床推广应用价值。

Objective To explore the efficacy of Gandakang Capsules combined with entecavir in treatment of chronic hepatitis B. Methods A total of 124 patients with chronic hepatitis B who were treated in the Department of Infectious Diseases of the First Affiliated Hospital of Xinxiang Medical University from January 2018 to June 2019 were randomly divided into control group and treatment group, with 62 patients in each group. Patients in the control group were po administered with Entecavir Maleate Tablets, 1 tablet/time, once daily. Patients in the treatment group were po administered with Gandakang Capsules on the basis of the control group, 8 grains/time, three times daily. Patients in two groups were treated for 3 months. After treatment, the clinical efficacy was evaluated, and the changes of liver function indexes, liver fibrosis indexes, Th1 and Th2 cell percentage and cytokine levels before and after treatment were compared between two groups. Results After treatment, the total effective rate of treatment group and control group was 95.16% and 82.26%, respectively (P<0.05). After treatment, the levels of ALT and AST in both groups were significantly reduced compared with those before treatment (P<0.05). Compared with the control group, the serum ALT and AST levels in the treatment group were significantly reduced after treatment (P<0.05). After treatment, LN, HA, PCIII, and IV-C in two groups were significantly decreased (P<0.05). After treatment, the above indexes in the treatment group were significantly lower than those in the control group (P<0.05). After treatment, Th1 and Th1/Th2 in both groups were significantly decreased, but Th2 was significantly increased (P<0.05). Compared with the control group, Th1 and Th1/Th2 in the treatment group were significantly lower after treatment, while Th2 was significantly higher (P<0.05). After treatment, the levels of IFN-γ and TNF-α were significantly decreased, but the levels of IL-4 and IL-6 were significantly increased in both groups (P<0.05). After treatment, the levels of IFN-γ, and TNF-α were lower than those in the control group, but IL-4, and IL-6 levels were higher than the control group (P<0.05). Conclusion Gandakang Capsules combined with entecavir has good clinical effect in treatment of chronic hepatitis B, and can significantly improve the patient's liver injury, may be related to the improvement of Th1/Th2 cell imbalance, which has a certain clinical application value.

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河南省卫生科技攻关工程资助项目（182102311234）