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目的:探讨大黄蛰虫丸联合替诺福韦酯治疗慢性乙型肝炎肝纤维化的疗效以及对肠道菌群的影响。方法:选取2018年3月至2019年11月南通大学附属如皋医院收治的慢性乙型肝炎肝纤维化患者120例,按随机数字表法分为观察组和对照组,各60例。对照组给予替诺福韦酯治疗,每次口服1片,每天1次。观察组在对照组治疗的基础上给予大黄蛰虫丸内服,3 g/次,2次/d。两组患者均观察48周。比较两组患者治疗前后肝功能指标、肝纤维化指标、乙肝病毒e抗原(HBeAg)转阴率、乙型肝炎病毒(HBV)-DNA载量、临床疗效以及肠道菌群变化,并比较两组不良反应。结果:治疗后观察组肝功能指标天冬氨酸氨基转移酶、丙氨酸氨基转移酶、γ-谷氨酰基转移酶、总胆红素水平均低于对照组[(41.62 ± 5.93)U/L比(50.41 ± 7.12)U/L、(41.99 ± 5.76)U/L比(52.17 ± 7.09)U/L、(34.46 ± 5.31)U/L比(49.41 ± 6.23)U/L、(20.35 ± 3.04)μmol/L比(25.60 ± 3.95)μmol/L],差异有统计学意义(n P<0.01)。治疗后观察组肝纤维化指标透明质酸、Ⅲ型前胶原、Ⅳ型胶原、层黏蛋白水平均低于对照组[(167.45 ± 18.75)μg/L比(209.44 ± 22.96)μg/L、(103.44 ± 12.75)μg/L比(140.08 ± 16.33)μg/L、(81.41 ± 10.06)μg/L比(126.36 ± 14.94)μg/L、(108.41 ± 12.72)μg/L比(169.41 ± 19.22)μg/L],差异有统计学意义(n P<0.01)。治疗后观察组临床总有效率高于对照组[91.67%(55/60)比76.27%(45/59)],差异有统计学意义(n χ2=4.170,n P=0.041)。观察组治疗后HBeAg、HBV-DNA转阴率均高于对照组[28.33%(17/60)比11.86%(7/59)、83.33%(50/60)比66.10%(39/59)],差异有统计学意义(n χ2=4.041,n P=0.044;n χ2=4.685,n P=0.030)。观察组治疗后肠道菌群指标双歧杆菌、乳酸杆菌明显增加,大肠杆菌、肠球菌显著降低,且观察组肠道菌群改善均显著优于对照组(n P0.05)。n 结论:大黄蛰虫丸联合替诺福韦酯治疗慢性乙型肝炎肝纤维化,可改善患者的肝功能、肝纤维化,提高HBeAg血清学转阴率,抑制HBV-DNA复制,增加治疗效果,且安全性好。大黄蛰虫丸的调节肠道菌群作用可能与其疗效有关。“,”Objective:To investigate the efficacy of Dahuang Zhechong pill combined with tenofovir disoproxil fumarate in treating liver fibrosis of chronic hepatitis B and its effect of intestinal flora.Methods:One hundred and twenty chronic hepatitis B cases with liver fibrosis treating in Rugao Hospital Affiliated to Nantong University from March 2018 to November 2019 were randomly divided into the control group and the observation group with 60 cases in each group according to the random number table. The control group was orally given with tenofovir disoproxil fumarate (1 tablet/time and quaque die).The observation group was treated with Dahuang Zhechong pill(3 g/time and bis in die) at basis of control group. The course was for 48 weeks for two groups. Liver function, liver fibrosis, hepatitis B virus e antigen(HBeAg) negative conversion rate, hepatitis b virus (HBV)-DNA negative conversion rate, the efficacy and intestinal flora changes were compared between the two groups before and after treatment. The adverse reactions were recorded in two groups.Results:After treatment, the levels of aspartic transaminase(AST), alanine aminotransferase (ALT), gamma-glutamyltransferase(GGT), total bilirubin (TBIL) in observation group were lower than those in control group [(41.62 ± 5.93) U/L vs. (50.41 ± 7.12) U/L, (41.99 ± 5.76) U/L vs. (52.17 ± 7.09) U/L, (34.46 ± 5.31) U/L vs. (49.41 ± 6.23) U/L, (20.35 ± 3.04) μmol/L vs. (25.60 ± 3.95) μmol/L], and the differences were statistically significant ( n P<0.05). After treatment, the levels of hyaluronic acid (HA), procollagen Ⅲ (PCⅢ), type Ⅳ collagen (Ⅳ-C), Laminin(LN) in observation group were lower than those in control group [(167.45 ± 18.75) μg/L vs. (209.44 ± 22.96) μg/L, (103.44 ± 12.75) μg/L vs. (140.08 ± 16.33) μg/L, (81.41 ± 10.06) μg/L vs. (126.36 ± 14.94) μg/L, (108.41 ± 12.72) μg/L vs. (169.41 ± 19.22) μg/L], and the differences were statistically significant (n P<0.05). The total effective rate in the observation group was higher than that in the control group [91.67%(55/60) vs. 76.27%(45/59)], and the difference was statistically significant (n P<0.05). The negative conversion ratio of HBeAg, HBV-DNA in the observation group were higher than those in the control group [28.33%(17/60) vs. 11.86%(7/59), 83.33%(50/60) vs. 66.10%(39/59)], and the differences were statistically significant (n P<0.05). Compared with the control group, the levels of bifidobacteria and lactobacillus in the observation group were higher and the levels of escherichia coli and enterococcus in observation group were lower, and the improvement of intestinal flora in the observation group were better than those in the control group (n P<0.01).n Conclusions:Dahuang Zhechong pill combined with tenofovir disoproxil fumarate in treating liver fibrosis of chronic hepatitis B can improve the liver function and liver fibrosis, and can improve the serological conversion rate of HBeAg, inhibit HBV DNA replication, increase the therapeutic effect, and is safety. The effect of Dahuang Zhechong pill on intestinal flora may be related to the curative effect.