奥贝胆酸治疗原发性胆汁性胆管炎的Meta分析

Obeticholic Acid for Primary Biliary Cholangitis:A Meta-Analysis

目的评价奥贝胆酸治疗原发性胆汁性胆管炎的疗效及安全性。方法截至2018年6月计算机检索Pubmed、Embase及Cochrane数据库,纳入奥贝胆酸治疗原发性胆汁性胆管炎的所有随机对照试验,并进行Meta分析。结果共纳入3个随机对照试验,包括440例患者。结果显示,奥贝胆酸能显著改善原发性胆汁性胆管炎患者的肝功能。奥贝胆酸治疗组碱性磷酸酶下降水平明显高于安慰剂组(OR=0.51,95%CI:0.42~0.59,P<0.00001)。奥贝胆酸治疗组不良反应发生率与安慰剂组比较,差异无统计学意义(OR=2.73,95%CI:0.98~7.55,P=0.054)。奥贝胆酸治疗组的瘙痒发生率显著高于安慰剂组(OR=3.05,95%CI:1.99~4.66,P<0.00001)。结论奥贝胆酸能显著改善原发性胆汁性胆管炎患者的肝功能,在瘙痒发生率方面,奥贝胆酸组高于安慰剂组。但鉴于纳入研究的患者数目少,平均观察期短,因此所得结论需扩大样本进一步验证。

Objective To evaluate the efficacy and safety of obeticholic acid for treatment of primary biliary cholangitis. Methods Database search of Pubmed,Embase and Cochrane Library(up to June 2018) was conducted.The quality of included randomized controlled trials about obeticholic acid for primary biliary cholangitis was assessed,then Meta analysis was performed.Results Three trials with 440 participants were included.The results of Meta-analysis showed that compared with the placebo group,obeticholic acid significantly improved the liver function of patients with primary biliary cholangitis.Obeticholic acid was superior to placebo for the decreased levels of alkaline phosphatase[odds ratio(OR)=0.51,5%confidence interval(95%CI:0.42-0.59),P <0.00001).As for the incidence of adverse effects,obeticholic acid was not uperior to placebo(OR=2.73,95%CI:0.98-7.55,P =0.054).In terms of the pruritus incidence,the rate for obeticholic acid was superior to placebo(OR=3.05,95%CI:1.99-4.66,P <0.00001).Conclusion Based on the evidence in this Meta-analysis,obeticholic acid can ameliorate primary biliary cholangitis,which was superior to placebo in the pruritus incidence.Due to limitation of the quality of included studies and the short average observation period,larger sample and more clinical trials are needed to further support this conclusion.