熊去氧胆酸联合不同药物治疗原发性胆汁性肝硬化疗效及安全性分析

Efficacy and safety of ursodeoxycholic acid combined with different drug in the treatment of primary biliary cirrhosis

目的探讨熊去氧胆酸联合不同药物治疗原发性胆汁性肝硬化的疗效及安全性。方法选择2013年1月至2014年12月我院收治的原发性胆汁性肝硬化患者120例为研究对象,随机分为三组:单用熊去氧胆酸治疗(A组);熊去氧胆酸+多烯磷胆碱胶囊治疗(B组);熊去氧胆酸+水飞蓟宾胶囊治疗(C组)。每组40例,疗程12个月,观察3种不同治疗方案的临床疗效,观察用药前、用药后1、3、6、12个月肝功、主要症状等指标变化,记录治疗过程中不良反应发生情况。结果三组患者治疗后各项症状均有改善,治疗前后比较均有统计学差异(P<0.05),治疗后6、12个月症状积分比较,B、C组优于A组(P<0.05),治疗后各时间点B、C组之间比较无统计学差异(P>0.05);治疗后12个月B、C组完全反应率优于A组(P<0.05),B、C组之间比较无统计学差异(P>0.05);治疗前三组血清ALT、AST、ALP、GGT、TBI组间比较无统计学差异(P>0.05),各指标治疗后与治疗前比较均显著降低(P<0.05),第一个月降低幅度最大,降低幅度B、C组优于A组(P<0.05),B、C组组间比较无统计学差异(P>0.05);不良反应发生率组间比较无统计学差异(P=0.89)。结论熊去氧胆酸联合多烯磷胆碱胶囊或水飞蓟宾胶囊治疗原发性胆汁性肝硬化安全有效,有助于改善患者肝功能及临床症状。

Objective The aim of this study isto explore the efficacy and safetyof ursodeoxycholic acid combined with different drug in the treatment of primary biliary cirrhosis. Methods A total of 120 patients with primary biliary cirrhosis from January 2013 to December 2014 in our hospital were selected. They were randomly divided into group A who were treated with ursodeoxycholic acid, group B treated with UDCA ＋ polyene choline capsule, and group C treated with UDCA ＋ silibinin capsule, each with 40 patients. The treatment course was 12 months. The clinical effect of three different regimens was observed. Liverfunction, the main symptoms and otherindicatorsbefore treatment and 1, 3, 6, 12 months after treatment were observed. Adverse events during treatment were record. Results The symptoms in three groups were significantlyim- provedafter treatment （P 〈 0.05）, the symptom scores in group B, C were lowerthat than in group A after 6, 12 months of treatment （P 〈 0.05）. There was no significant difference betweengroups B, C after treatment at each time point （ P 〉 0.05）. The complete response rate after 12 months in group B, C was higher than that in group A （P 〈0.05）. There was no statistical difference between groups B, C （P 〉 0.05）. The serum ALT, AST, ALP, GGT, TBI of three groups before treatment had no significant difference （P 〉 0.05）, the index after treatment were significantly lower compared with before treatment （ P 〈 0.05）. The maximum reduction was in the firstmonth, the reduction in group B, C washigherthan in group A （P 〈 0.05）, comparison between groups B, C had no statistically difference （P 〉 0.05）. The incidence of adversereaction in three groups had no significant difference （P = 0.89）. Conclusion Ursodeoxycholic acid combined with polyene choline capsule or silibinin capsule in treatment of primary biliary cirrhosis is safe and effective, helpful to improve liver function and clinical symptoms.