[1]林莹 徐勇郭新红 刘昱圻.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[J].心血管病学进展,2019,(8):1176-1181.[doi:10.16806/j.cnki.issn.1004-3934.2019.08.027]
　LIN Ying,XU Yong,GUO Xinhong,et al.Dose Selection of Rivaroxaban for Elderly Patients of Non-valvular Atrial Fibrillation with Different Levels of Creatinine Clearance in China[J].Advances in Cardiovascular Diseases,2019,(8):1176-1181.[doi:10.16806/j.cnki.issn.1004-3934.2019.08.027]
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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()
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《心血管病学进展》[ISSN:51-1187/R/CN:1004-3934]

卷:
期数:
2019年8期
页码:
1176-1181
栏目:
论著
出版日期:
2019-11-25

文章信息/Info

Title:
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1郭新红1 刘昱圻1
（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)
Author(s):
LIN Ying1; 2; XU Yong1; GUO Xinhong1; LIU Yuqi1
(1.Department of Cardiovascular,Chinese PLA General Hospital,Beijing 100853, China;2.Department of Cardiology,Hainan Hospital of Chinese PLA General Hospital,Sanya 572013,Hainan,China)
关键词:
非瓣膜性房颤; 高龄; 肌酐清除率; 利伐沙班
Keywords:
font-family: tahoma;  arial;  helvetica;  sans-serif; ">?Non-valvular atrial fibrillation;  Elderly patients;  Creatinine clearance;  Rivaroxaban
DOI:
10.16806/j.cnki.issn.1004-3934.2019.08.027
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房颤患者应用利伐沙班如何选择剂量。方法：纳入共195例非瓣膜房颤高龄患者。根据肌酐清除率将患者分为肌酐清除率≥50ml/min组和肌酐清除率15-49ml/min组，给予两组患者利伐沙班片10mg或15mg，测定利伐沙班药物的谷浓度与峰浓度，并随访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15-49ml/min组，应用利伐沙班15mg的患者出血事件显著多于应用利伐沙班10mg的患者(P<0.05)，但栓塞事件不具有显著的统计学差异(P>0.05)。在肌酐清除率≥50ml/min组，应用利伐沙班15mg和10mg的患者栓塞和出血事件均不具有显著的统计学差异(均P>0.05)。在肌酐清除率15-49ml/min和肌酐清除率≥50ml/min两组中，监测利伐沙班 10mg的谷浓度95%CI分别为：（30～36）ng/ml，（26～36）ng/ml，峰浓度95%CI分别为：（126～169）ng/ml，（107～201）ng/ml，利伐沙班 15mg谷浓度95%CI分别为：（31～55）ng/ml， ( 32～41）ng/ml，峰浓度95%CI分别为：（153～205）ng/ml，(146～187）ng/ml。除了肌酐清除率15-49ml/min组的利伐沙班谷浓度有显著差异(P<0.05)外，其它均不具有显著的统计学差异(均P>0.05)。应用利伐沙班15mg患者，谷浓度与峰浓度均高于利伐沙班10mg的患者，且栓塞风险降低（肌酐清除率 15-49ml/min组：2.4% vs 4.5%；肌酐清除率≥50ml/min组：2.8% vs 6.7%），出血事件增加（肌酐清除率 15-49ml/min组：16.7% vs 3.0%；肌酐清除率≥50ml/min组：15.3% vs 13.3%）。结论： 利伐沙班10mg是更为适合肌酐清除率15-49ml/min中国高龄非瓣膜房颤患者的剂量选择。利伐沙班10mg和15mg均是适合肌酐清除率≥50ml/min中国高龄非瓣膜房颤患者的剂量选择。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，对我国高龄房颤患者的抗凝强度及出血风险有一定的指导意义。
Abstract:
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 ninety-five elderly patients with NVAF were divided into two groups according to 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 or 15 mg are both suitable?dosages for elderly Chinese patients with NVAF whose CrCl is more than 50 mL/min. The levels of Criv have a certain guide for the anticoagulation intensity and bleeding risk for the elderly patients with?NVAF.

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更新日期/Last Update: 2020-03-02