目的 探讨复方鳖甲软肝片联合苯扎贝特片治疗胆汁性肝硬化的临床疗效。方法 选取2019年7月—2021年1月郑州人民医院收治的92例胆汁性肝硬化患者作为研究对象，按照随机数字表法将所有患者分为对照组和治疗组，各46例。对照组口服苯扎贝特片，200 mg/次，2次/d。治疗组在对照组治疗的基础上口服复方鳖甲软肝片，2.0 g/次，3次/d。两组患者连续治疗6个月。观察两组患者临床疗效，比较两组肝脏弹力硬度值、肝功能指标、肝纤维化指标。结果 治疗后，治疗组的总有效率为93.48%，对照组的总有效率为78.26%，组间有明显差异（P<0.05）。治疗后，两组患者肝脏弹力硬度值明显降低（P<0.05），治疗组肝脏弹力硬度值比对照组降低更明显（P<0.05）。治疗后，两组的谷氨酰转肽酶（GGT）、碱性磷酸酶（ALP）、总胆红素（TBIL）水平显著降低，差异有统计学意义（P<0.05）；治疗组GGT、ALP、TBIL水平降低更明显，差异有统计学意义（P<0.05）。治疗后，两组的转化生长因子-β₁（TGF-β₁）、层黏连蛋白（LN）、Ⅲ型前胶原（PCⅢ）水平明显降低（P<0.05）；治疗组的TGF-β₁、LN、PCⅢ水平低于对照组，差异有统计学意义（P<0.05）。结论 复方鳖甲软肝片联合苯扎贝特片治疗胆汁性肝硬化的疗效确切，能延缓肝纤维化进程，改善肝功能，减轻肝硬化程度，安全性较好。

Objective To investigate the clinical efficacy of Compound Biejia Ruangan Tablets combined with Bezafibrate Tablets in treatment of biliary cirrhosis. Methods Patients (92 cases) with biliary cirrhosis in People's Hospital of Zhengzhou from July 2019 to January 2021 were divided into control and treatment groups according to the random number table method, and each group had 46 cases. Patients in the control group were po administered with Bezafibrate Tablets, 200 mg/time, twice daily. Patients in the treatment group were po administered with Compound Biejia Ruangan Tablets on the basis of the control group, 2.0 g/time, three times daily. Patients in two groups were treated for 6 months. After treatment, the clinical efficacies were evaluated, and liver elastic hardness value, liver function index, and liver fibrosis index in two groups were compared. Results After treatment, the total effective rate was 93.48% in the treatment group, and 78.26% in the control group (P < 0.05). After treatment, the liver elastic hardness value in two groups were significantly decreased (P < 0.05), and the liver elastic hardness value in the treatment group were significantly lower than that in the control group (P < 0.05). After treatment, the levels of GGT, ALP, and TBIL in two groups were significantly decreased (P < 0.05), and the levels of GGT, ALP, and TBIL in the treatment group were significantly lower than those in the control group (P < 0.05). After treatment, the levels of TGF-β₁, LN, and PCⅢ in two groups were significantly decreased (P < 0.05), and the levels of TGF-β₁, LN, and PCⅢ in the treatment group were lower than those in the control group (P < 0.05). Conclusion Compound Biejia Ruangan Tablets combined with Bezafibrate Tablets has clinical curative effect in treatment of biliary cirrhosis, can delay the process of liver fibrosis, improve liver function, reduce the degree of liver cirrhosis, with good safety.

R975

国家科技重大专项（民口）课题（2018ZX10303-502）