利伐沙班的药物浓度与非瓣膜性心房颤动患者出血事件的相关性  

Correlation between the Rivaroxaban concentration and bleeding events in patients with non-valvular atrial fibrillation

作　　者：王艳[1] 孟旭阳 杨晨光[1] 裕丽[1] 任静[2] 汪芳[1] Wang Yan;Meng Xuyang;Yang Chenguang;Yu Li;Ren Jing;Wang Fang(Department of Cardiovascular Medicine,Beijing Hospital,National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Sciences,Beijing 100730,China;Precision Medicine Center,General Hospital of Tianjin Medical University,Tianjin,300052,China)

机构地区：[1]北京医院心血管内科国家老年医学中心中国医学科学院老年医学研究院,100730 [2]天津医科大学总医院精准医学中心,300052

出　　处：《中华老年医学杂志》2020年第5期501-504,共4页Chinese Journal of Geriatrics

基　　金：十三五国家科技重大新药创制专项课题(2017ZX09304026);首都卫生发展科研专项(重点)(2016-1-4051);中国医学科学院临床与转化基金项目(2019XK320078)。

摘　　要：目的研究利伐沙班在非瓣膜性心房颤动(房颤)患者中的药物浓度与出血事件的相关性。方法该研究是回顾性研究,根据入排标准纳入北京医院和天津医科大学总医院2018年1月至2019年6月间共369例诊断为非瓣膜性房颤的患者,口服利伐沙班抗凝治疗。记录患者性别、身高、体重、肝肾功能、药物谷及峰浓度,服用药物用量,CHADS2评分等临床资料,记录用药6个月后的出血事件。结果受试患者平均药物谷浓度(44.92±38.39)mg/L,平均药物峰浓度(226.96±139.34)mg/L,CHADS2评分(2.8±1.2)分,发生出血22例,未发生出血事件347例;无论是药物峰浓度和谷浓度,两组差异均无统计学意义(P=0.324和0.960);随着年龄的增长,药物峰和谷浓度逐渐递增(均P<0.001);出血事件组的药物平均谷浓度比未发生出血事件组高(P=0.009),药物平均峰浓度比未发生出血事件组略高,但比较差异无统计学意义(P=0.360);出血事件组的谷值/峰值的剂量比均较未发生出血事件组高(P=0.001,P=0.028)。结论年龄影响药物峰、谷浓度,尤其高龄老年人应考虑适当减量服用,监测药物峰、谷浓度对高危出血患者有重要意义。Objective To study the correlation between the Rivaroxaban concentration and bleeding events in patients with nonvalvular atrial fibrillation(NVAF).Methods This was a retrospective study.According to the inclusion and exclusion criteria,369 patients with NVAF taking Rivaroxaban admitted to Beijing Hospital or Tianjin Medical University General Hospital from January 2018 to June 2019 were enrolled.Clinical data including sex,height,weight,liver and kidney function,drug valley concentrations and peak concentrations,doses,CHADS2 scores and bleeding events after 6 months of medication were recorded.Results The average drug valley concentration was(44.92±38.39)mg/L,the average drug peak concentration was(226.96±139.34)mg/L,and the average CHADS2 score was(2.8±1.2).Among the 369 patients,22 had bleeding events.The peak drug concentration and valley drug concentration were similar between those with or without bleeding events(P=0.324 and 0.960,respectively).With the increase of age,the peak drug concentration and valley drug concentration were significantly elevated(all P<0.001).In addition,compared with those without bleeding events,patients with bleeding events had a significantly higher average valley concentration(P=0.009),valley/dose ratio(P=0.001),peak/dose ratio(P=0.028)and similar peak drug concentration(P=0.360).Conclusions Age affects the peak and valley drug concentration of Rivaroxaban,especially for the elderly,who should be given appropriately reduced doses.Monitoring the peak and valley drug concentration is of great significance for patients at high-risk for bleeding.

关 键 词：心房颤动 血药浓度 出血 

分 类 号：R541.75[医药卫生—心血管疾病]