罗沙司他治疗透析患者肾性贫血的效果和安全性的meta分析  

Meta-analysis of efficacy and safety of Roxadustat in the treatment of renal anemia in dialysis patients

作　　者：薛泽湖 刘其锋[1] 顾晓霞[1] 刘曦 郁丽霞[1] XUE Zehu;LIU Qifeng;GU Xiaoxia;LIU Xi;YU Lixia(Department of Nephrology,Kunshan Hospital Affiliated to Jiangsu University,Jiangsu Province,Suzhou215300,China)

机构地区：[1]江苏大学附属昆山医院肾脏内科,江苏苏州215300

出　　处：《中国医药导报》2024年第28期109-118,共10页China Medical Herald

基　　金：江苏省2023年昆山市级科技专项(社会发展)指导项目(KSZ2306);江苏大学2023年度医教协同创新基金重点项目(JDY2023016)。

摘　　要：目的系统评价罗沙司他治疗透析患者肾性贫血的效果与安全性。方法检索Pub Med、Embase、中国知网和万方数据知识服务平台数据库,收集建库至2024年6月发表的所有罗沙司他治疗透析患者肾性贫血的随机对照试验,运用Rev Man 5.4软件对纳入文献的研究结果进行meta分析。结果纳入20项研究,共6529例受试者(3384例试验组,3145例对照组)。试验组口服罗沙司他,对照组皮下注射红细胞生成刺激剂。与对照组比较,试验组血红蛋白水平明显增加(MD=3.47,95%CI:2.12~4.81,P<0.05),同时,转铁蛋白饱和度(MD=1.43,95%CI:0.12~2.74,P<0.05)和总铁结合力水平升高(MD=6.32,95%CI:5.53~7.10,P<0.05),铁调素(MD=-21.23,95%CI:-28.04~-14.42,P<0.05)、甘油三酯(MD=-0.14,95%CI:-0.24~-0.04,P<0.05)、总胆固醇(MD=-0.48,95%CI:-0.56~-0.40,P<0.05)和低密度脂蛋白水平(MD=-0.37,95%CI:-0.43~-0.31,P<0.05)降低,两组在血清铁蛋白、安全性上的比较,差异无统计学意义(P>0.05)。结论与常规红细胞生成刺激剂比较,罗沙司他显著提高血红蛋白水平,同时改善铁代谢及调节血脂,且并未增加不良事件的发生率。Objective To systematically evaluate the efficacy and safety of Roxadustat in the treatment of renal anemia in dialysis patients.Methods PubMed,Embase,CNKI,and Wanfang data were searched to collect all the randomized controlled trials of Roxadustat for the treatment of renal anemia in dialysis patients from inception to June 2024,and meta-analysis was performed on the findings of the included literature by using RevMan 5.4 software.Results Twenty studies with a total of 6529 subjects(3384 experimental group,3145 control group)were included.Roxallistat was taken orally in experimental group and erythropoiesis-stimulating agent was injected subcutaneously in control group.Compared with the control group,the hemoglobin level of experimental groups was significantly increased(MD=3.47,95%CI:2.12 to 4.81,P<0.05),meanwhile,transferrin saturation(MD=1.43,95%CI:0.12 to 2.74,P<0.05)and the total iron binding capacity level were increased(MD=6.32,95%CI:5.53 to 7.10,P<0.05),ferritin(MD=-21.23,95%CI:-28.04 to-14.42,P<0.05),triglyceride(MD=-0.14,95%CI:-0.24 to-0.04,P<0.05),total cholesterol(MD=-0.48,95%CI:-0.56 to-0.40,P<0.05)and low density lipoprotein(MD=-0.37,95%CI:-0.43 to-0.31,P<0.05)were decreased,and there was no significant difference in serum ferritin and safety between the two groups(P>0.05).Conclusion Compared with erythropoiesis-stimulating agent,Roxadustat significantly increased hemoglobin levels while improving iron metabolism and regulating lipids without increasing the incidence of adverse events.

关 键 词：罗沙司他 透析 肾性贫血 META分析 

分 类 号：R459.5[医药卫生—治疗学]