目的 探討復方鱉甲軟肝片聯(lián)合苯扎貝特片治療膽汁性肝硬化的臨床療效。方法 選取2019年7月—2021年1月鄭州人民醫(yī)院收治的92例膽汁性肝硬化患者作為研究對象，按照隨機數(shù)字表法將所有患者分為對照組和治療組，各46例。對照組口服苯扎貝特片，200 mg/次，2次/d。治療組在對照組治療的基礎(chǔ)上口服復方鱉甲軟肝片，2.0 g/次，3次/d。兩組患者連續(xù)治療6個月。觀察兩組患者臨床療效，比較兩組肝臟彈力硬度值、肝功能指標、肝纖維化指標。結(jié)果 治療后，治療組的總有效率為93.48%，對照組的總有效率為78.26%，組間有明顯差異（P<0.05）。治療后，兩組患者肝臟彈力硬度值明顯降低（P<0.05），治療組肝臟彈力硬度值比對照組降低更明顯（P<0.05）。治療后，兩組的谷氨酰轉(zhuǎn)肽酶（GGT）、堿性磷酸酶（ALP）、總膽紅素（TBIL）水平顯著降低，差異有統(tǒng)計學意義（P<0.05）；治療組GGT、ALP、TBIL水平降低更明顯，差異有統(tǒng)計學意義（P<0.05）。治療后，兩組的轉(zhuǎn)化生長因子-β₁（TGF-β₁）、層黏連蛋白（LN）、Ⅲ型前膠原（PCⅢ）水平明顯降低（P<0.05）；治療組的TGF-β₁、LN、PCⅢ水平低于對照組，差異有統(tǒng)計學意義（P<0.05）。結(jié)論 復方鱉甲軟肝片聯(lián)合苯扎貝特片治療膽汁性肝硬化的療效確切，能延緩肝纖維化進程，改善肝功能，減輕肝硬化程度，安全性較好。

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

國家科技重大專項（民口）課題（2018ZX10303-502）