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直接口服抗凝药物的临床患者管理中的药物水平监测。

Direct-acting oral anticoagulant drug level monitoring in clinical patient management.

机构信息

Hematology Department, Hadassah-Hebrew University Medical Center, POB 12000, 91120, Jerusalem, Israel.

Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.

出版信息

J Thromb Thrombolysis. 2018 May;45(4):543-549. doi: 10.1007/s11239-018-1643-0.

Abstract

The role of drug-level monitoring among patients using direct-acting oral anticoagulant (DOAC) is unclear. We aimed to investigate its 'real-life' utilization and effect on clinical management. A review of records of patients who underwent DOAC level testing during 2013-2017. Overall, 212 patients (median age 77 years) underwent 292 DOAC measurements [apixaban (n = 147), rivaroxaban (n = 102), dabigatran (n = 43)]. Monitoring volume increased by 460% during study period. DOAC level testing was performed during routine follow-up in 51 (17.5%) cases, whereas the remaining 241 (82.5%) measurements were performed due to selected clinical circumstances, most commonly: bleeding (n = 60), perioperative status (n = 45), breakthrough thrombosis (n = 37) and renal failure (n = 35). Drug levels were within the expected range in 210 (71.9%), above the expected range in 62 (21.2%) and lower than expected range in 20 (6.8%). In multivariate analysis, older age (P = 0.005), lower glomerular filtration rate (P = 0.001) and lower body mass index (P = 0.006) were associated with DOAC levels above the expected range. Clinical decisions were affected by DOAC monitoring following most (140/241, 58.1%) measurements for which we identified an indication for testing; yet only rarely when monitoring was performed during routine follow-up (7.8%, 4/51) (P < 0.0001). While no benefit of routine DOAC monitoring was observed, drug level measurement has an important role in the management of patients in selected circumstances. Age, body weight and creatinine clearance were found to be significant predictors of drug levels. Future studies are warranted to establish associations between drug levels and outcomes, and better delineate the role of DOAC monitoring.

摘要

在使用直接作用的口服抗凝剂 (DOAC) 的患者中,药物水平监测的作用尚不清楚。我们旨在研究其在现实生活中的应用及其对临床管理的影响。对 2013-2017 年期间接受 DOAC 水平检测的患者记录进行了回顾。共有 212 名患者(中位年龄 77 岁)进行了 292 次 DOAC 测量[阿哌沙班(n=147)、利伐沙班(n=102)、达比加群(n=43)]。研究期间,监测量增加了 460%。51 例(17.5%)在常规随访期间进行 DOAC 水平检测,而其余 241 例(82.5%)因特定临床情况进行检测,最常见的是:出血(n=60)、围手术期状态(n=45)、突破性血栓形成(n=37)和肾功能衰竭(n=35)。药物水平在预期范围内的有 210 例(71.9%),高于预期范围的有 62 例(21.2%),低于预期范围的有 20 例(6.8%)。多变量分析显示,年龄较大(P=0.005)、肾小球滤过率较低(P=0.001)和体重指数较低(P=0.006)与 DOAC 水平高于预期范围相关。在我们确定检测适应证的 241 次检测中,大多数(140/241,58.1%)检测结果影响了临床决策;而在常规随访中进行监测时(7.8%,4/51)则很少影响(P<0.0001)。虽然未观察到常规 DOAC 监测的益处,但药物水平测量在某些情况下对患者的管理具有重要作用。年龄、体重和肌酐清除率被发现是药物水平的重要预测因素。需要进一步的研究来确定药物水平与结局之间的关系,并更好地阐明 DOAC 监测的作用。

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