Combination Therapy Of Bezafibrate And Ursodeoxycholic Acid For Primary Biliary Cirrhosis Showing Refractory Response To Ursodeoxycholic Acid:A Meta-Analysis

Background and aim: To evaluate the efficacy,safety and remission rate of pruritus between bezafibrate(BF)and ursodeoxycholic acid(UDCA)combination therapy for Primary biliary cholangitis(PBC)patients who are refractory to UDCA.Methods: Data based of PubMed、Embase、The Cochrane Library databases、Science direct、Web of Science、CBM、WangFang Data、CNKI、VIP databases were used to search Chinese/English articles about the application of bezafibrate in the treatment of PBC up to June 2018,which were analyzed by randomized controlled clinical trials(RCTs)、crossover trials and Self-control clinical trials.RevMan 5.3 software was used for meta-analysis.Two evaluators independently screened the literature,extracted the data and assessed the risk of bias of relevant studies.Results: Eleven trials,with a total of 465 patients,were included.Compared with UDCA alone,combination therapy with bezafibrate improved liver biochemistry(P<0.00001),the Mayo risk score(MD=-0.55;95%CI(-0.82,-0.28);P<0.0001)and pruritus score(MD=-2.97;95%CI(-4.34,-1.60);P<0.0001).However,there was no statistically significant differences in the incidence of liver-stiffness measurement(MD=0.21;95%CI(-0.40,0.82);P=0.50),all cause mortality(RR=2.58;95%CI(0.57,11.73);P=0.22),adverse events(RR=1.28;95%CI(0.96,1.70);P=0.09)and liver related complications(RR=1.40;95%CI(0.80,2.44);P=0.24)between the two groups.Conclusion: Combination therapy can availably improve liver biochemistry,the Mayo risk score and pruritus score of refractory PBC,but has no significant effect on liver-stiffness measurement,adverse events,the incidence of death and liver related complications.