疏肝利胆汤加减联合熊去氧胆酸治疗早、中期原发性胆汁性肝硬化的临床观察

Efficacy of Shugan Lidan Tang Combined Ursodeoxycholic Acid in Treating Early and Mid-term Primary Biliary Cirrhosis

目的：观察疏肝利胆汤加减联合熊去氧胆酸治疗湿滞血瘀证早、中期原发性胆汁性肝硬化的疗效及安全性。方法：将171例符合条件的患者随机分为中药组、西药组和中西药组,各57例。分别给予疏肝利胆汤加减、熊去氧胆酸、疏肝利胆汤加减联合熊去氧胆酸,疗程均为48周。观察各组用药前及用药24,48周临床症状、肝功能、肝纤维化、免疫学指标的变化;比较各组完全反应率和安全性指标。结果：治疗第24,48周中西药组完全反应率均高于同期中药组和西药组（P〈0.05）;治疗第48周中西药组临床症状,肝纤维化,肝功能,免疫球蛋白G（IgG）,免疫球蛋白M（IgM）,免疫球蛋白A（IgA）,抗线粒体抗体（AMA）改善明显优于中药组和西药组（P〈0.05）;不良反应和血、尿常规异常发生率中药组〈中西药组〈西药组（P〈0.05）。结论：中药疏肝利胆汤加减治疗早、中期原发性胆汁性肝硬化的完全反应率与西药熊去氧胆酸无明显差异,说明其具有有效性,且安全性评价优于熊去氧胆酸;疏肝利胆汤加减联合熊去氧胆酸治疗早、中期原发性胆汁性肝硬化湿滞血瘀证具有协同增效的作用,在一定程度上可以逆转肝脏的病理改变,疗效优于单用疏肝利胆汤加减和熊去氧胆酸。

Objective： To explore the efficacy and safety of Shugan Lidan Tang combined ursodeoxycholic acid in treatment of early and mid-term primary biliary cirrhosis hygroscopic blood stasis syndrome. Method： A total of 171 cases primary biliary cirrhosis patients were randomly divided into the traditional Chinese medicine（ TCM） group,the chemical medicine group and the combined group,with 57 cases in each group. The TCM group was treated with Shugan Lidan Tang,ursodesoxycholic acid was applied in the chemical medicine group,Shugan Lidan Tang and ursodesoxycholic acid was provided to the combined group. A course of treatment was 48 weeks. The changes of clinical symptom,serum fibrosis,liver function and immunological indicators were observed before and after treatment. To compare the complete response and safety index in three groups. Result： The total response rate in combined group in the 24^th,48^th weeks was higher than that of the TCM group and the combined group（ P〈0. 05）. There was no significant difference between the TCM group and the western medicine group.The clinical symptoms,serum fibrosis,liver function,immunoglobulin G（ IgG）,immunoglobulin M（ IgM）,immunoglobulin A（ IgA）,anti-mitochondrial antibody（ AMA） were superior to those in TCM group and the chemical medicine groups in the 48^th week（ P〈0. 05）. The order of the groups in terms of adverse reactions and blood and urine routine was the TCM group the combined group 〈the chemical medicine group（ P〈0. 05）.Conclusion： Shugan Lidan Tang has the effect in the treatment of early and mid-term primary biliary cirrhosis.Compared with ursodesoxycholic acid,there is no obvious difference,with a better safety index. Shugan Lidan Tang combined with ursodeoxy-cholic acid has a remarkable efficacy in treating early and mid-term primary biliary cirrhosis hygroscopic blood stasis syndrome.