目的 探讨扶正化瘀片联合富马酸替诺福韦二吡呋酯片治疗慢性乙型肝炎肝硬化患者的临床疗效。方法 收集2022年6月—2024年6月在南通市第三人民医院就诊的慢性乙型肝炎肝硬化代偿期患者104例，根据随机数字表法将104例患者分成对照组和治疗组，每组各52例。对照组口服富马酸替诺福韦二吡呋酯片，1片/次，１次/d。治疗组患者在对照组基础上口服扶正化瘀片，2片/次，3次/d。两组治疗24周。观察两组患者临床疗效，比较治疗前后两组患者肝功能，乙肝e抗原（HBeAg）和乙肝病毒DNA转阴率，肝纤维化和肠道菌群指标。结果 治疗后，治疗组总有效率（90.38%）比对照组（75.00%）明显升高（P＜0.05）。治疗后，治疗组HBeAg和乙肝病毒DNA转阴率分别是32.69%和65.38%，比对照组的15.38%和48.08%分别明显上调（P＜0.05）。治疗后，两组天氨酸氨基转移酶（AST）、丙氨酸氨基转移酶（ALT）、γ-谷氨酸酰基转移酶（GGT）、透明质酸（HA）、Ⅲ型前胶原（PCⅢ）、Ⅳ型胶原（Ⅳ-C）和层黏蛋白（LN）水平比治疗前显著下降（P＜0.05），且治疗组肝功能指标和肝纤维化指标明显好于对照组（P＜0.05）。治疗后，两组肠杆菌、肠球菌明显减少，而双歧杆菌、乳杆菌明显提高（P＜0.05），同时治疗组患者肠道菌群指标比对照组改善更明显（P＜0.05）。结论 扶正化瘀片联合富马酸替诺福韦二吡呋酯片治疗慢性乙型肝炎肝硬化的疗效明显，能改善肝功能，提高抗病毒作用，抑制肝纤维化，以及调节肠道菌群。

Objective To investigate the efficacy of Fuzheng Huayu Tablets combined with Tenofovir Disoproxil Fumarate Tablets in treatment of hepatitis B cirrhosis. Methods Patients (104 cases) with hepatitis B cirrhosis in the Third People’s Hospital of Nantong from June 2022 to June 2024 were divided into control group and treatment group according to random number table method, with 52 cases in each group. Patient in control group werepo administered with Tenofovir Disoproxil Fumarate Tablets, 1 tablets/time, once daily. Patient in treatment group were po administered with Fuzheng Huayu Tablets on the basis of the control group, 2 tablets/time, three times daily. Patient in two groups were treated for 24 weeks. After treatment, the clinical efficacy were evaluated, and the liver function, the negative conversion rates of HBeAg and HBV-DNA, liver fibrosis and Intestinal flora indicators in two groups were compared before and after treatment. Results After treatment, the total effective rate in the treatment group (90.38%) was significantly higher than that in the control group (75.00%, P< 0.05). After treatment, the negative rates of HBeAg and hepatitis B virus DNA in the treatment group were 32.69% and 65.38%, respectively, which were significantly increased compared with 15.38% and 48.08% in the control group (P < 0.05). After treatment, the levels of AST, ALT, GGT, HA, PCⅢ, Ⅳ-C and LN in two groups were significantly decreased compared with those before treatment, and the liver function indicators and liver fibrosis indicators in the treatment group were significantly better than those in the control group (P < 0.05). After treatment, the number of enterobacteria and enterococci in two groups were significantly decreased, while the number of bifidobacterium and lactobacilli were significantly increased (P < 0.05). At the same time, the intestinal flora indicators of patients in the treatment group were improved more significantly than that in the control group (P < 0.05).Conclusion The efficacy of Fuzheng Huayu Tablets combined with Tenofovir Disoproxil Fumarate Tablets has an definite efficacy in treatment of chronic hepatitis B cirrhosis, can improve liver function and antiviral effect, inhibit liver fibrosis, regulate intestinal flora.

R975

南通市卫生健康委员会科研课题（MSZ2323046）；南通市科技局社会民生科技计划项目（MSZ2022026）