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.
目的： 评价熊去氧胆酸联合苯扎贝特治疗难治性原发性胆汁性胆管炎的有效性、安全性及瘙痒缓解程度。 方法： 检索Pubmed、Embase、The Cochrane library、Science direct、Web of Science、CBM，万方，CNKI，VIP数据库,搜集熊去氧胆酸联合苯扎贝特及熊去氧胆酸单一治疗原发性胆汁性胆管炎的临床随机试验、交叉试验及自身对照试验。检索时限均为建库至2018年6月。由2名评价员独立筛选文献、提取资料并评价纳入研究的偏倚风险后，采用RevMan 5.3软件进行Meta分析。 结果： 共纳入11项研究，包括465例患者。熊去氧胆酸联合苯扎贝特能极大地改善难治性原发性胆汁性胆管炎患者肝脏生物化学指标（P<0.01）和瘙痒评分（MD = -2.97，95% CI：-4.34～-1.60，P<0.01）;但两组在不良事件（RR = 1.28，95% CI：0.96～1.70，P = 0.09）、病死率（RR = 2.58，95% CI：0.57～11.73，P = 0.22）方面的差异均无统计学意义。 结论： 熊去氧胆酸联合苯扎贝特治疗可以提高难治性原发性胆汁性胆管炎患者生物化学应答，改善瘙痒评分；联合治疗对不良事件及病死率无明显影响。.
Keywords: Bezafibrate; Deoxycholic acid; Liver cirrhosis, biliary; Meta-analysis.