肝泰舒胶囊联合恩替卡韦治疗慢性乙型肝炎的临床研究

Clinical study on Gantaishu Capsules combined with entecavir in treatment of chronic hepatitis B

目的探讨肝泰舒胶囊联合恩替卡韦分散片治疗慢性乙型肝炎的临床疗效。方法回顾性分析2018年6月—2019年6月在郑州大学第一附属医院治疗的104例慢性乙型肝炎患者的临床资料,采用双色球随机分组法分成对照组和治疗组,每组各52例。对照组口服恩替卡韦分散片,0.5 mg/次,1次/d;治疗组在对照组基础上口服肝泰舒胶囊,1.6 g/次,3次/d;两组患者均治疗5个月。观察两组患者临床疗效,比较治疗前后两组患者HBV-DNA和HBeAg转阴率,天冬氨酸氨基转移酶(AST)、血小板(PLT)、总胆红素(TBIL)和丙氨酸氨基转移酶(ALT)水平,血清组织蛋白酶S(CatS)、甲壳质酶蛋白40(YKL-40)、巨噬细胞移动抑制因子(MIF)、基质金属蛋白酶抑制因子2(TIMP2)和转化生长因子β1(TGFβ1)水平及肝组织硬度(LSM)、纤维化-4(FIB-4)、血小板比率指数(APRI)变化情况。结果治疗后,对照组总有效率为82.69%,显著低于治疗组98.08%(P<0.05)。治疗后,治疗组HBV-DNA转阴率和HBeAg血清转换率上均高于对照组(P<0.05)。治疗后,两组AST、ALT、PLT、TBIL均显著降低(P<0.05),且治疗组降低最明显(P<0.05)。治疗后,两组血清CatS、YKL-40、MIF、TIMP2、TGF-β1水平均显著下降(P<0.05),且治疗组更明显(P<0.05)。治疗后,两组LSM、FIB-4、APRI均明显下降(P<0.05),且治疗组更显著(P<0.05)。结论肝泰舒胶囊联合恩替卡韦分散片治疗慢性乙型肝炎可有效改善患者肝功能,抑制肝纤维化进程,促进HBV-DNA、HBeAg转阴,具有一定的临床推广应用价值。

Objective To investigate the clinical efficacy of Gantaishu Capsules combined with entecavir in treatment of chronic hepatitis B. Methods The clinical data of 104 patients with chronic hepatitis B in the First Affiliated Hospital of Zhengzhou University from From June 2018 to June 2019 were analyzed retrospectively, and randomly divided into control and treatment groups by the double chromosphere, and each group had 52 cases. Patients in the control group were po administered with Entecavir Dispersible Tablets, 0.5 mg/time, once daily. Patients in the treatment group were po administered with Gantaishu Capsules on the basis of the control group, 1.6 g/time, three times daily. Patients in two groups were treated for 5 months. After treatment, the clinical efficacy was evaluated, and the negative rate of HBV-DNA and HBeAg, the levels of AST, ALT, PLT, and TBIL, the levels of serum CatS, YKL-40, MIF, TIMP2, and TGF-β1, and the change of LSM, FIB-4 and APRI in two groups before and after treatment were compared. Results After treatment, total effective rate of the control group was 82.69%, which was significantly lower than 98.08% of the treatment group(P < 0.05). After treatment, the negative conversion rate of HBV-DNA and the seroconversion rate of HBeAg in the treatment group were higher than those in the control group(P < 0.05). After treatment, AST, ALT, PLT and TBIL in two groups were significantly decreased(P < 0.05), especially in the treatment group(P < 0.05). After treatment, the serum levels of CatS, YKL-40, MIF, TIMP2, and TGF-β 1 were significantly decreased in two groups(P < 0.05), especially in the treatment group(P < 0.05). After treatment, LSM, FIB-4, and APRI were significantly decreased in two groups(P < 0.05), especially in the treatment group(P < 0.05). Conclusion Gantaishu Capsules combined with Entecavir Dispersible Tablets in treatment of chronic hepatitis B can effectively improve liver function, inhibit the process of liver fibrosis and promote the negative conversion of HBV-DNA and HBeAg, which has a certain clinical application value.