熊去氧胆酸对原发性硬化性胆管炎疗效的meta分析

Evaluation of ursodeoxycholic acid for primary sclerosing cholangitis:a meta-analysis

目的基于循证药学方法系统评价熊去氧胆酸(ursodesoxycholic acid,UDCA)对原发性硬化性胆管炎(primary sclerosing cholangitis,PSC)的疗效。方法纳入国内外有关UDCA治疗PSC的试验,根据标准进行筛选,提取满足条件的高质量文献,采用Q检验及I2检验对纳入研究进行质量评价,用Stata 13.0进行分析。检索文献截止时间限定至2019年5月30日。结果纳入5篇文献,共364例患者。与安慰剂组相比,UDCA组肝功能指标[碱性磷酸酶(ALP)、天冬氨酸转氨酶(AST)、丙氨酸转氨酶(ALT)、白蛋白(ALB)和总胆红素(TBIL)]得到明显改善(SMD=-0.43,95%CI-0.65~-0.22,P<0.001;SMD=-0.90,95%CI-1.24~-0.56,P<0.001;SMD=-0.01,95%CI-0.28~0.27,P<0.001;SMD=0.00,95%CI-0.20~0.21,P<0.001;SMD=-0.31,95%CI-0.52~-0.10,P=0.001)。在免疫球蛋白(Ig)方面,UDCA能显著改善IgA(SMD=-0.02,95%CI-0.28~0.25,P=0.013),但对IgG(SMD=-0.17,95%CI-0.44~0.09,P=0.399)和IgM(SMD=0.16,95%CI-0.11~0.42,P=0.715)无明显影响。结论UDCA可显著改善PSC患者肝功能指标,但对免疫学相关指标无明显影响。

Objective To evaluate the efficacy of ursodeoxycholic acid(UDCA)for primary sclerosing cholangitis(PSC)by the evidence-based pharmaceutical method.Methods The trials of UDCA in the treatment of PSC published at home and abroad were collected,and high-quality literatures meeting the standards were screened and used for meta-analysis.The quality of the included studies was evaluated by Q test and I2 test and analyzed by Stata 13.0.The deadline for literature publishing was May 30,2019.Results Five studies with a total of 364 patientswere included.Liver functionindexes[alkalinephosphatase(ALP),aspartate aminotransferase(AST),alanine aminotransferase(ALT),albumin(ALB),and total bilirubin(TBIL)]were significantly improved in the UDCA group compared with those in the placebo group(SMD=-0.43,95%CI[-0.65,-0.22],P<0.001;SMD=-0.90,95%CI[-1.24,-0.56],P<0.001;SMD=-0.01,95%CI[-0.28,0.27],P<0.001;SMD=0.00,95%CI[-0.20,0.21],P<0.001;SMD=-0.31,95%CI[-0.52,-0.10],P=0.001).In terms of immunoglobulin(Ig),UDCA significantly improved IgA(SMD=-0.02,95%CI[-0.28,0.25],P=0.013),but had no significant effects on IgG(SMD=-0.17,95%CI[-0.44,0.09],P=0.399)and IgM(SMD=0.16,95%CI[-0.11,0.42],P=0.715).Conclusion UDCA can significantly improve the liver function indexes in PSC patients,but has no significant effects on the immunological indexes.