目的 探讨护肝片联合丁二磺酸腺苷蛋氨酸治疗原发性胆汁性肝硬化患者的安全性与有效性。方法 选取2016年1月-2018年1月在本溪钢铁集团总医院治疗的原发性胆汁性肝硬化患者141例，随机分成对照组（70例）和治疗组（71例）。对照组患者口服丁二磺酸腺苷蛋氨酸肠溶片，2片/次，1次/d；治疗组患者在对照组的基础上口服护肝片，4片/次，3次/d。两组患者连续治疗3个月。观察两组患者临床疗效，同时比较治疗前后两组患者生活质量评分和肝纤维化指标水平及肝硬化血清学指标。结果 治疗后，对照组和治疗组临床有效率分别为81.43%和94.37%，两组比较差异具有统计学意义（P<0.05）。治疗后，两组患者WHOQOL-BREF评分均显著升高（P<0.05），血清透明质酸（HA）和Ⅳ型胶原检测试剂盒（Ⅳ-C）水平均显著降低（P<0.05），且治疗组这些指标明显好于对照组（P<0.05）。治疗后，两组患者A/G水平显著升高（P<0.05），血清同型半胱氨酸（Hcy）和胰岛素（Ins）水平均显著降低（P<0.05），且治疗组患者肝硬化血清学指标明显优于对照组（P<0.05）。结论 护肝片联合丁二磺酸腺苷蛋氨酸治疗原发性胆汁性肝硬化疗效显著，不但能够改善患者的肝纤维化水平，而且还能提升患者生活质量，具有一定的临床推广应用价值。

Objective To investigate the safety and efficacy of Hugan Tablets combined with ademetionine 1,4-butanedisulfonate in treatment of primary biliary cirrhosis.Methods Patients (141 cases) with primary biliary cirrhosis in General Hospital of Benxi Steel Group from January 2016 to January 2018 were randomly divided into control (70 cases) and treatment (71 cases) groups. Patients in the control group were po administered with Ademetionine 1,4-Butanedisulfonate Enteric Coated Tablets, 2 tablets/time, once daily. Patients in the treatment group were po administered with Hugan Tablets on the basis of the control group, 4 tablets/time, three times daily. Patients in two groups were treated for 3 months. After treatment, the clinical efficacy was evaluated, and the quality of life scores, liver fibrosis markers and serological indicators of liver cirrhosis in two groups before and after treatment were compared.Results After treatment, the clinical efficacy in the control and treatment groups was 81.43% and 94.37% respectively, and there were differences between two groups (P<0.05). After treatment, the WHOQOL-BREF scores in two groups were significantly increased (P<0.05), but serum HA and Ⅳ-C levels were significantly decreased (P<0.05), and these indexes in the treatment group were significantly better than those in the control group (P<0.05). After treatment, the A/G levels in two groups were significantly increased (P<0.05), but serum Hcy and Ins levels were significantly decreased (P<0.05), and these serological indicators of liver cirrhosis levels in the treatment group were significantly better than those in the control group (P<0.05).Conclusion Hugan Tablets combined with ademetionine 1,4-butanedisulfonate has significant curative effect on treatment of primary biliary cirrhosis, can not only improve liver fibrosis, but also improve the quality of life, which has a certain clinical application value.