Objective: To evaluate the efficacy, safety and remission rates of pruritus of bezafibrate and UDCA combination therapy in the treatment of refractory PBC. Methods: PubMed, Embase, The Cochrane Library databases, Science direct, Web of Science, CBM, WangFang Data, CNKI, VIP databases were searched to collect randomized controlled trials, crossover trials and self-control clinical trials of combination therapy of UDCA and bezafibrate with UDCA monotherapy for PBC up to June, 2018. RevMan 5.3 software was used for meta-analysis. Two evaluators independently screened the literature, extracted the data, and evaluated the risk of bias of relevant study. Results: Eleven studies, including 465 patients were included. Ursodeoxycholic acid combined with bezafibrate had greatly improved liver biochemical indicators (P < 0.01) and pruritus scores in patients with refractory primary biliary cholangitis (MD = -2.97, 95% CI: -4.34~ -1.60, P < 0.01). However, there was no statistically significant differences in adverse events (RR = 1.28, 95% CI: 0.96 to 1.70, P = 0.09), and mortality rate (RR = 2.58, 95% CI: 0.57 to 11.73, P = 0.22) between the two groups. Conclusion Ursodeoxycholic acid combined with bezafibrate may improve the biochemical response and pruritus score of refractory PBC, but has no significant effect on adverse events and mortality rate.

Objective To evaluate the efficacy,safety and remission rates of pruritus of bezafibrate and UDCA combination therapy in the treatment of refractory PBC.Methods PubMed,Embase,The Cochrane Library databases,Science direct,Web of Science,CBM,WangFang Data,CNKI,VIP databases were searched to collect randomized controlled trials,crossover trials and self-control clinical trials of combination therapy of UDCA and bezafibrate with UDCA monotherapy for PBC up to June,2018.RevMan 5.3 software was used for meta-analysis.Two evaluators independently screened the literature,extracted the data,and evaluated the risk of bias of relevant study.Results Eleven studies,including 465 patients were included.Ursodeoxycholic acid combined with bezafibrate had greatly improved liver biochemical indicators(P<0.01)and pruritus scores in patients with refractory primary biliary cholangitis(MD=-2.97,95% CI:-4.34～-1.60,P<0.01).However,there was no statistically significant differences in adverse events(RR=1.28,95% CI:0.96 to 1.70,P=0.09),and mortality rate(RR=2.58,95% CI:0.57 to 11.73,P=0.22)between the two groups.Conclusion Ursodeoxycholic acid combined with bezafibrate may improve the biochemical response and pruritus score of refractory PBC,but has no significant effect on adverse events and mortality rate.