牛磺熊去氧胆酸与熊去氧胆酸治疗非酒精性脂肪性肝病患者疗效和安全性的Meta分析

Efficacy and safety of tauroursodeoxycholic acid and ursodeoxycholic acid combination in the treatment of patients with nonalcoholic fatty liver disease:a Meta-analysis

目的系统评价应用牛磺熊去氧胆酸联合多烯磷脂酰胆碱治疗非酒精性脂肪性肝病(NAFLD)患者的疗效与安全性。方法全面检索CNKI、VIP、WanFang Data、CBM、PubMed、The Cochrane Library、EMbase数据库公开发表的比较牛磺熊去氧胆酸与熊去氧胆酸治疗NAFLD患者的随机对照试验(RCT)研究,采用RevMan 5.3处理软件行Meta分析。结果在纳入的6项RCT研究中,共计682例NAFLD患者,其中342例试验组接受牛磺熊去氧胆酸联合多烯磷脂酰胆碱治疗,340例对照组接受熊去氧胆酸联合多烯磷脂酰胆碱治疗。Meta分析结果显示,试验组总体有效率显著高于对照组[RR=1.10,95%CI(1.03,1.18),P=0.004];试验组在降低ALT[MD=13.34,95%CI(12.20,14.48),P<0.00001]、降低AST[MD=11.29,95%CI(5.85,16.72),P<0.0001]、降低GGT[MD=22.54,95%CI(20.75,24.33),P<0.00001]、降低TG[MD=0.48,95%CI(0.25,0.70),P<0.0001]、降低LDL-C[MD=0.67,95%CI(0.51,0.83),P<0.00001]和降低BMI水平[MD=1.57,95%CI(1.29,1.84),P<0.00001]和提升HDL-C水平[MD=0.23,95%CI(0.18,0.27),P<0.00001]方面,优于对照组;试验组在降低TC水平[MD=0.30,95%CI(-0.03,0.64),P=0.08]和不良反应发生率[RR=1.00,95%CI(0.41,2.47),P=1.00]方面与对照组比较,无显著差异;试验组也未明显改善肝脏脂肪变程度[RR=2.2,95%CI(0.97,4.98),P=0.06]。结论应用牛磺熊去氧胆酸联合多烯磷脂酰胆碱治疗NAFLD患者疗效较好,可以更显著地改善肝功能,降低血脂水平,但这些研究的总体水平不高。

Objective To systematically evaluate the efficacy and safety of tauroursodeoxycholic acid and ursodeoxycholic acid combination in the treatment of patients with nonalcoholic fatty liver disease(NAFLD).Methods We searched CNKI,VIP,WanFang Data,CBM,PubMed,The Cochrane Library,EMbase database and retrieved randomized controlled trials(RCT)on the observation of tauro ursodesoxycholic acid and ursodeoxycholic acid combination in the treatment of patients with NAFLD since inception of database.Meta analysis was performed by using RevMan 5.3 software.Results A total of 682 NAFLD patients were included in 6 RCT studies,and 342 in the observation group were treated by tauro ursodesoxy cholic acid and polyene phosphatidyl choline,and 340 in the control group were treated by ursodeoxycholic acid and polyene phosphatidyl choline combination.The results showed that the overall effective rate[RR=1.10,95%CI(1.03,1.18),P=0.004],serum ALT reduction[MD=13.34,95%CI(12.20,14.48),P<0.00001],AST reduction[MD=11.29,95%CI(5.85,16.72),P<0.0001],GGT reduction[MD=22.54,95%CI(20.75,24.33),P<0.00001],TG reduction[MD=0.48,95%CI(0.25,0.70),P<0.0001],LDL-C reduction[MD=0.67,95%CI(0.51,0.83),P<0.00001]and BMI reduction[MD=1.57,95%CI(1.29,1.84),P<0.00001]as well s HDL-C elevation[MD=0.23,95%CI(0.18,0.27),P<0.00001]in the observation group in the treatment of patients with NAFLD were significantly superior to those in the control group;however,there was no significant difference between the two groups as respect to serum TC reduction[MD=0.30,95%CI(-0.03,0.64),P=0.08]and the incidence of adverse reactions[RR=1.00,95%CI(0.41,2.47),P=1.00];the improvement of hepatic steatosis was also not significantly different between the two groups[RR=2.2,95%CI(0.97,4.98),P=0.06].Conclusion The efficacy of tauro ursodesoxy cholic acid combined with polyene phosphatidyl choline in the treatment of patients with NAFLD is good based on the domestic studies,which might be at a low level observations.