利伐沙班在非瓣膜性房颤合并缺血性卒中患者中的疗效与安全性影响因素分析  

Risk factor analysis on efficacy and safety of rivaroxaban in patients with nonvalvular atrial fibrillation and ischemic stroke

作　　者：章袁[1] 黄维惠[2] 卢轶[2] 高丽娜[2] 马景鑑[3] 汪志云[2] ZHANG Yuan;HUANG Wei-hui;LU Yi;GAO Li-na;MA Jing-jian;WANG Zhi-yun(Department of Pharmacy,Tianjin First Central Hospital,TIANJIN 300192,China;Department of Neurology,Tianjin First Central Hospital,TIANJIN 300192,China;Department of Neurosurgery,Tianjin First Central Hospital,TIANJIN 300192,China)

机构地区：[1]天津市第一中心医院药学部,天津300192 [2]天津市第一中心医院神经内科,天津300192 [3]天津市第一中心医院神经外科,天津300192

出　　处：《中国新药与临床杂志》2022年第5期291-297,共7页Chinese Journal of New Drugs and Clinical Remedies

基　　金：天津市卫生健康科技项目(KJ20143)。

摘　　要：目的探讨不同剂量利伐沙班在非瓣膜性房颤(NVAF)合并缺血性卒中(IS)患者中疗效与安全性的影响因素。方法将171例NVAF合并IS患者根据利伐沙班剂量分为10 mg·d^(-1)组(n=47)、15 mg·d^(-1)组(n=50)和20 mg·d^(-1)组(n=74),收集并比较3组患者临床基线资料。随访记录3组患者用药一年间发生的血栓栓塞和出血事件。采用单因素和多因素logistic回归分析栓塞和出血的危险因素。结果20 mg·d^(-1)组患者年龄、中重度肾功能不全(15 mL·min^(-1)≤肌酐清除率<50 mL·min^(-1))比例和HAS-BLED评分均显著低于10 mg·d^(-1)组、15 mg·d^(-1)组,20 mg·d^(-1)组CHA_(2)DS_(2)-VASc评分显著低于15 mg·d^(-1)组(P<0.05)。10、15、20 mg·d^(-1)组分别发生血栓栓塞事件11例(23%)、7例(14%)和6例(8%),发生出血事件3例(6%)、7例(14%)和18例(24%),20 mg·d^(-1)组血栓栓塞事件发生率低于10 mg·d^(-1)组,出血事件发生率高于10 mg·d^(-1)组(P<0.05)。多因素分析显示利伐沙班20 mg·d^(-1)(OR=0.27,95%CI:0.086~0.854,P=0.026)、饮酒量≥62.5 g·d^(-1)(OR=3.488,95%CI:0.993~12.253,P=0.031)是影响血栓栓塞事件的独立危险因素;利伐沙班20 mg·d^(-1)(OR=13.431,95%CI:2.399~75.185,P=0.003),中重度肾功能不全(OR=5.125,95%CI:1.234~21.261,P=0.025),CHA_(2)DS_(2)-VASc评分(OR=1.529,95%CI:1.047~2.232,P=0.028),合用硝酸酯类(OR=3.668,95%CI:1.266~10.630,P=0.017)是影响出血事件的独立危险因素。结论利伐沙班20 mg·d^(-1)在降低NVAF合并IS患者血栓栓塞风险的同时显著增加出血风险,饮酒量≥62.5 g·d^(-1)是增加栓塞风险的独立危险因素,CHA_(2)DS_(2)-VASc评分升高、中重度肾功能不全和合用硝酸酯类是增加出血风险的独立危险因素。AIM To explore the risk factors on anticoagulant efficacy and safety of different dose of rivaroxaban in patients with nonvalvular atrial fibrillation(NVAF)and ischemic stroke(IS).METHODS One hundred and seventyone patients with NVAF and IS were divided into 10 mg·d^(-1)group(n=47),15 mg·d^(-1)group(n=50)and 20 mg·d^(-1)group(n=74).The clinical baseline data of the three groups was collected and compared.The thromboembolism and bleeding events occurred in the three groups during one year of medication were followed up.Univariate and multivariate logistic regression was used to analyze the risk factors for thromboembolism and bleeding.RESULTS The age,proportion of moderate to severe renal dysfunction(15 mL·min^(-1)≤creatinine clearance<50 mL·min^(-1))and HAS-BLED score of patients in 20 mg·d^(-1)group were significantly lower than those in the 10 mg·d^(-1)group and 15 mg·d^(-1)group(P<0.05).CHA_(2)DS_(2)-VASc score in 20 mg·d^(-1)group was significantly lower than that in 15 mg·d^(-1)group(P<0.05).In the 10,15,20 mg·d^(-1)group,thromboembolism events occurred in 11(23%),7(14%)and 6(8%)patients,bleeding events occurred in 3(6%),7(14%)and 18(24%)patients,respectively.The incidences of thromboembolism events was lower in the 20 mg·d^(-1)group than that in the 10 mg·d^(-1)group and the incidence of bleeding events was higher than that in 10 mg·d^(-1)group(P<0.05).Multivariate analysis showed that rivaroxaban 20 mg·d^(-1)(OR=0.27,95%CI:0.086 to 0.854,P=0.026),alcohol consumption≥62.5 g·d^(-1)(OR=3.488,95%CI:0.993 to 12.253,P=0.031)was an independent risk factor for thromboembolism events.Rivaroxaban 20 mg·d^(-1)(OR=13.431,95%CI:2.399 to 75.185,P=0.003),CHA_(2)DS_(2)-VASc score(OR=1.529,95%CI:1.047 to 2.232,P=0.028),moderate to severe renal dysfunction(OR=5.125,95%CI:1.234 to 21.261,P=0.025)and combined with nitrates(OR=3.668,95%CI:1.266 to 10.630,P=0.017)were independent risk factors for bleeding events.CONCLUSION Rivaroxaban 20 mg·d^(-1)significantly increases the risk of bleeding while reducing

关 键 词：缺血性卒中 心房颤动 利伐沙班 安全 危险因素 

分 类 号：R973.2[医药卫生—药品]