新型口服抗凝药在心房颤动合并慢性肾功能不全患者中应用的有效性与安全性的系统评价与Meta分析

Systematic review and meta-analysis of the efficacy and safety of novel oral anticoagulants in patients with atrial fibrillation and chronic renal insufficiency

目的 系统评价新型口服抗凝药在心房颤动(房颤)合并慢性肾功能不全患者中应用的有效性和安全性.方法 检索有关数据库,纳入加用新型口服抗凝药治疗急性冠脉综合征的随机对照试验.检索时间截至2019年4月30日.按纳入与排除标准筛选文献、提取资料并评价纳入研究的方法学质量后,采用Rev Man 5.3软件进行Meta分析.结果 5项RCT纳入分析,包括72762例患者.试验组使用的新型口服抗凝药包括阿哌沙班、利伐沙班、依度沙班和达比加群.肾功能评价公式为Cockcroft-Gault.Meta分析结果如下:有效性终点指标包括卒中和系统性栓塞或非中枢性系统性栓塞.结果显示,肾功能不全组新型口服抗凝药与华法林存在显著性差异(OR=0.82,95%CI:0.74~0.92,P=0.0004).安全性终点指标为大出血,另有两项研究对全因死亡进行了分析.大出血事件分析结果显示,肾功能不全组新型口服抗凝药和华法林存在显著性差异(OR=0.74,95%CI:0.61~0.90,P=0.002).结论 根据现有相关研究,在减少合并慢性肾功能不全的房颤患者的卒中、(非中枢性)系统性栓塞及大出血事件上,新型口服抗凝药总体优于华法林;在全因死亡上,新型口服抗凝药总体不劣于华法林.

Objective To systematically assess the efficacy and safety of novel oral anticoagulation(NOAC)with atrial fibrillation and chronic renal insufficiency patients.Methods Databases including multiple databases were searched electronically for randomized controlled trials(RCTs)of NOAC in acute coronary syndrome patients up to 30th April,2019.Two reviewers independently screened literatures according to the inclusion and exclusion criteria,extracted data,and assessed the methodological quality of the included studies.Then Meta-analysis was performed using Rev Man 5.3 software.Results A total of 5 RCTs involving 72762 patients were included.The apixaban,rivaroxaban,edoxaban and dabigatran were included in experimental group.Meta-analysis was performed for different degrees of renal insufficiency patients,the formula for evaluating kidney function is Cockcroft-Gault.The results of the meta-analysis were as follows:The efficacy endpoints included stroke and systemic embolism or non-central systemic embolism.The results showed that there was a significant difference between the new oral anticoagulants and warfarin in the renal insufficiency group(OR=0.82,95%CI:0.74~0.92,P=0.0004).The safety endpoint was major bleeding,and two other studies analyzed all-cause deaths.The analysis of major bleeding events showed that there was a significant difference between the new oral anticoagulants and warfarin in the renal insufficiency group(OR=0.74,95%CI:0.61~0.90,P=0.002).Conclusion According to existing relevant studies,NOACs was generally superior to warfarin in reducing stroke,(non-CNS)embolism and major bleeding in atrial fibrillation patients with chronic renal insufficiency;NOAC is not inferior to warfarin in reducing all-cause mortality.