熊去氧胆酸治疗原发性胆汁性肝硬化临床疗效的Meta分析

Clinical efficacy of ursodesoxycholic acid for the treatment of primary biliary cirrhosis: a Meta-analysis

目的探讨熊去氧胆酸(UCDA)治疗原发性胆汁性肝硬化(PBC)的临床疗效及安全性。方法计算机检索2016年10月之前Pub Med、万方学术期刊全文数据库、中国知网(CNKI)收录的关于UDCA治疗PBC的随机对照试验文献。英文检索词:ursodeoxycholic acid、ursodiol、primary biliary cirrhosis、random clinical trials。中文检索词:熊去氧胆酸、原发性胆汁性肝硬化、随机对照试验。提取肝功能指标、临床症状、不良反应发生率、病死率等临床数据进行Meta分析。异质性研究采用随机效应模型分析,同质性研究采用固定效应模型分析。结果共纳入8篇文献,总计863例患者。Meta分析显示UCDA能明显改善患者ALT、AST、ALP、GGT、TB水平(SMD=-0.73,-0.87,-1.22,-1.58,-0.32;P<0.05)。UCDA不能明显改善患者瘙痒和疲劳症状,未明显增加患者不良反应发生率(OR=1.03,P>0.05),且不能明显降低患者肝移植率、病死率及肝病相关病死率(OR=0.50,0.79,0.75;P>0.05)。结论 UCDA能明显改善PBC患者肝功能,但不能阻止PBC向终末期肝病发展、延长患者生存期或改善临床症状。

Objective To investigate the clinical efficacy and safety of ursodesoxycholic acid （UCDA） for the treatment of primary biliary cirrhosis （PBC）. Methods Randomized control trials literatures related to the treatment of PBC with UDCA up to October 2016 were searched by computer from PubMed, Wanfang database and CNKI. The keywords were respectively ursodeoxycholic acid, ursodiol, primary biliary cirrhosis and random clinical trials both in Chinese and English. Clinical data including liver function indexes, clinical symptoms, incidence of adverse reactions and morality were extracted and subjected to Meta-analysis. Heterogenous studies were analyzed using random effect model, and homogenous studies were analyzed using fixed effect model. Results A total of 863 patients in 8 literatures were included in this study. Meta-analysis indicated that UCDA could significantly improve the levels ofALT, AST, ALP, GGT and TB （SMD=-0.73, -0.87, -1.22, -1.58, -0.32; P〈0.05）. UCDA could not significantly improve the symptoms of pruritus and fatigue, and did not significantly increase the incidence of adverse reactions （OR=1.03,P〉0.05） and decrease the liver transplantation rate, mortality and liver disease related-mortality （OR=0.50, 0.79, 0.75; P〉0.05）. Conclusions UCDA can significantly improve the liver function of the PBC patients. But it fails to prevent the progression of PBC to end-stage liver disease, prolong the survival of the patients or improve the clinical symptoms.