不同剂量利伐沙班在房颤患者治疗中有效性和安全性的研究  

A Study of the Efficacy and Safety of Different Dosages of Rivaroxaban in Patients with Atrial Fibrillation

作　　者：颜新生 张李涛 刘晓辉[2] 张真路[2] 闫宝 夏凌云 王晓苏 YAN Xinsheng;ZHANG Litao;LIU Xiaohui;ZHANG Zhenlu;YAN Bao;XIA Lingyun;WANG Xiaosu(Department of Clinical Laboratory,Wuhan Asia General Hospital,Wuhan 430056,China;Department of Clinical Laboratory,Wuhan Asia Heart Hospital,Wuhan 430022,China;Department of Cardiology,Wuhan Asia General Hospital,Wuhan 430056,China)

机构地区：[1]武汉亚心总医院检验科,武汉430056 [2]武汉亚洲心脏病医院检验科,武汉430022 [3]武汉亚心总医院心内科,武汉430056

出　　处：《标记免疫分析与临床》2024年第2期270-275,共6页Labeled Immunoassays and Clinical Medicine

基　　金：武汉市卫生健康委青年项目(编号:WX21Q29);武汉市卫生健康委面上项目(编号:WX21D49);湖北省自然科学基金(编号:2019CFB393)。

摘　　要：目的探讨不同剂量利伐沙班对心房颤动患者栓塞预防效果及安全性。方法选择2018年3月至2021年12月武汉亚洲心脏病医院和武汉亚心总医院口服利伐沙班的房颤患者,按每日处方剂量分为利伐沙班10mg剂量组和15mg剂量组,记录并比较随访期间两组的血栓、出血和全因死亡不良事件发生率,分析相关的影响因素。结果两组患者血栓、出血和全因死亡发生率比较,10mg剂量组均高于15mg剂量组,差异没有统计学意义(χ^(2)=0.418、3.757、2.084,均P>0.05);两组患者总不良事件发生率比较,10mg剂量组高于15mg剂量组,差异有统计学意义(χ^(2)=5.071,P=0.024);多因素Logistic回归结果显示D二聚体水平[OR(95%CI)=1.07(1.00~1.14)]是房颤患者发生血栓事件的独立危险因素(P=0.035);糖尿病[OR(95%CI)=3.44(1.24~9.51)]是房颤患者全因死亡事件的独立危险因素(P=0.017)。结论临床实践中10mg利伐沙班剂量没有显著的获益,患者的有效性和安全性不优于甚至劣于15mg剂量。D二聚体水平升高、糖尿病史为发生不良事件的危险因素。Objective To investigate the effect and safety of different dosages of rivaroxaban on embolization prevention in patients with atrial fibrillation.Methods Atrial fibrillation patients with oral rivaroxaban in Wuhan Asia Heart Hospital and Wuhan Asia Heart General Hospital from March,2018 to December,2021 were enrolled and divided into 10mg-dose group and 15mg-dose group according to the daily prescription dosage information.The incidence of thrombosis,bleeding and all-cause death in these two groups during follow-up duration was recorded and compared,and the related influencing factors were analyzed.Results The incidence of thrombus,hemorrhage and all-cause death in 2 groups was higher in 10mg-dose group than in 15mg-dose group,with no statistical significance(χ^(2)=0.418,3.757,2.084,all P>0.05).The incidence of total adverse events was higher in 10mg-dose group than in 15mg low-dose group,and the difference was statistically significant(χ^(2)=5.071,P=0.024).Multivariate logistic regression showed that D-dimer level[OR(95%CI)=1.07(1.00-1.14)]was an independent risk factor for thrombotic events in patients with atrial fibrillation(P=0.035).Diabetes mellitus[OR(95%CI)=3.44(1.24-9.51)]was an independent risk factor for all-cause mortality in patients with atrial fibrillation(P=0.017).Conclusion In clinical practice,10mg rivaroxaban dosage has no significant benefit,and the efficacy and safety of patients are not better or worse than 15mg dosage.Advanced age,elevated D-dimer level,and history of diabetes are risk factors for adverse events.

关 键 词：房颤 利伐沙班 剂量 有效性 

分 类 号：R541.75[医药卫生—心血管疾病]