具有不同肌酐清除率水平的中国高龄非瓣膜性心房颤动患者应用利伐沙班的剂量选择研究  

Dose Selection of Rivaroxaban for Elderly Patients of Non-valvular Atrial Fibrillation with Different Levels of Creatinine Clearance in China

作　　者：林莹[1,2] 徐勇 郭新红[1] 刘昱圻[1] LIN Ying;XU Yong;GUO Xinhong;LIU Yuqi(Department of Cardiology,Chinese PLA General Hospital,Beijing 100853,China;Department of Cardiology,Hainan Hospital of Chinese PLA General Hospital,Sanya 572013,Hainan,China)

机构地区：[1]中国人民解放军总医院心血管内科,北京100853 [2]中国人民解放军总医院海南医院心血管内科,海南三亚572013

出　　处：《心血管病学进展》2019年第8期1176-1181,共6页Advances in Cardiovascular Diseases

摘　　要：目的探讨具有不同肌酐清除率水平的中国高龄非瓣膜性心房颤动(房颤)患者应用利伐沙班如何选择剂量。方法纳入共195例高龄非瓣膜性房颤患者。根据肌酐清除率水平将患者分为肌酐清除率≥50 mL/min组和肌酐清除率15~49 mL/min组,给予利伐沙班片10 mg每日1次或15 mg每日1次,测定利伐沙班药物的谷浓度和峰浓度,随访1年内的栓塞和出血事件。结果全体患者年龄(83.7±5.0)岁(75~96岁),男性152例(77.9%)。在肌酐清除率15~49 mL/min组,应用利伐沙班15 mg的患者出血事件显著多于应用利伐沙班10 mg的患者(P<0.05),但栓塞事件不具有统计学差异(P>0.05)。在肌酐清除率15~49 mL/min和肌酐清除率≥50 mL/min两组中,监测利伐沙班10 mg的谷浓度(95%CI)分别为:30~36 ng/mL和26~36 ng/mL,峰浓度(95%CI)分别为:126~169 ng/mL和107~201 ng/mL;利伐沙班15 mg谷浓度(95%CI)分别为:31~55 ng/mL和32~41 ng/mL,峰浓度(95%CI)分别为:153~205 ng/mL和146~187 ng/mL。在肌酐清除率15~49 mL/min组,利伐沙班的谷浓度有统计学差异(P<0.05)外,其他均不具有显著的统计学差异(均P>0.05)。应用利伐沙班15 mg患者,谷浓度与峰浓度均高于利伐沙班10 mg的患者,且栓塞风险降低(肌酐清除率15~49 mL/min组:2.4%vs 4.5%;肌酐清除率≥50 mL/min组:2.8%vs 6.7%),出血事件增加(肌酐清除率15~49 mL/min组:16.7%vs 3.0%;肌酐清除率≥50 mL/min组:15.3%vs 13.3%)。结论利伐沙班10 mg更适合肌酐清除率15~49 mL/min的中国高龄非瓣膜性房颤患者。利伐沙班10 mg和15 mg均适合肌酐清除率≥50 mL/min的中国高龄非瓣膜性房颤患者。根据抗Xa因子活性显色底物法测定利伐沙班血浆浓度水平,对中国高龄房颤患者的抗凝强度和出血风险有一定的指导意义。Objective To investigate how to choose the dose of rivaroxaban for elderly patients of non-valvular atrial fibrillation(NVAF)with different levels of creatinine clearance(CrCl)in China.Methods One hundred and ninety-five elderly patients with NVAF were divided into two groups according to the level of CrCl.One group was CrCl≥50 mL/min,and the other group was CrCl 15~49 mL/min.Of all patients,and they were given 10 mg or 15 mg of rivaroxaban once a day.Their trough and peak plasma concentrations of rivaroxaban(Criv)based on an anti-factor Xa chromogenic assay at the steady state level were measured,and embolism and bleeding events were followed up for 1 year.Results Of 195 patients,their mean ages were(83.7±5.0)years old,and 77.9%patients were males.In the group of CrCl 15~49 mL/min,patients took 15 mg of rivaroxaban had more bleeding events than those took 10 mg(P<0.05),but there was no significant difference in embolic events(P>0.05).In groups of CrCl 15~49 mL/min and CrCl>50 mL/min,the trough concentration for the Criv(95%CI)of patients taking 10 mg were 30~36 ng/mL and 26~36 ng/mL respectively,and the peak were 126~169 ng/mL and 107~201 ng/mL respectively;the trough concentration for the Criv(95%CI)of patients taking 15 mg were 31~55 ng/mL and 32~41 ng/mL respectively,and the peak were 153~205 ng/mL and 146~187 ng/mL respectively.Compared with patients taking 15 mg,the trough and peak Criv were higher than those taking 10 mg.However,there was no significant difference(P>0.05)except for the trough Criv in the group of CrCl 15~49 mL/min(P<0.05).The trough and peak Criv were higher in patients with taking 15 mg than 10 mg.Furthermore,the embolism events reduced(in the group of CrCl 15~49 mL/min:2.4%vs 4.5%;the group of CrCl≥50 mL/min:2.8%vs 6.7%),and bleeding events increased(in the group of CrCl 15~49 mL/min:16.7%vs 3.0%;in the group of CrCl≥50 mL/min:15.3%vs 13.3%).Conclusion Taking 10 mg of rivaroxaban once a day is more suitable for CrCl 15~49 mL/min in elderly patients with NVAF in China.Taking 10 mg

关 键 词：非瓣膜性心房颤动 高龄 肌酐清除率 利伐沙班 

分 类 号：R54[医药卫生—心血管疾病]