即时检测（POCT）用于评估接受非维生素 K 拮抗剂口服抗凝剂（NOACs）治疗的患者的药物浓度。

Point of Care Testing (POCT) to assess drug concentration in patients treated with non-vitamin K antagonist oral anticoagulants (NOACs).

机构信息

Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Italy.

Department of Laboratory Medicine, St. Antony Hospital, Padua, Italy.

出版信息

Thromb Res. 2018 Mar;163:100-104. doi: 10.1016/j.thromres.2018.01.044. Epub 2018 Feb 6.

DOI:10.1016/j.thromres.2018.01.044

PMID:29407620

Abstract

BACKGROUND

Non-vitamin K antagonist oral anticoagulants (NOACs) do not need routine laboratory monitoring but measurement of drug concentration is important in emergency conditions. Specific laboratory tests are not readily available or not implemented in every hospital. Point-of-Care Tests (POCT) may bridge this gap and be used as a bedside solution.

OBJECTIVES

Feasibility of POCT to assess plasma levels of dabigatran, rivaroxaban and apixaban.

PATIENTS/METHODS: Activated Coagulation Time-Low Range (ACT - LR) using a portable Hemochron Signature Elite for dabigatran and prothrombin time (expressed as INR) by Coaguchek XS Pro for rivaroxaban and apixaban were obtained at trough and peak in 136 consecutive patients taking NOACs (70 on dabigatran, 45 on rivaroxaban and 20 on apixaban). Using a paired study design, drug concentrations were concurrently determined by functional specific tests.

RESULTS AND CONCLUSIONS

The correlation between NOACs concentration and the values obtained using the POCTs was high for dabigatran and rivaroxaban (r = 0.80 and r = 0.82, respectively) and low for apixaban (r = 0.21). ACT-LR ≤ 188 s better detected dabigatran levels ≤ 50 ng/ml, with a sensitivity of 87.5% and a specificity of 84.1%. ACT-LR values > 217 s better discriminated value of dabigatran > 200 ng/ml, with a sensitivity of 86.7% and a specificity of 81.4%. INR Coaguchek values ≤ 1.2 better identified patients with rivaroxaban values < 100 ng/ml, with sensitivity of 90%, specificity of 88.5%. This analysis was not possible for apixaban.

CONCLUSION

In emergency situations POCT use may provide useful immediate information on dabigatran and rivaroxaban concentration.

摘要

背景

非维生素 K 拮抗剂口服抗凝剂（NOACs）不需要常规的实验室监测，但在紧急情况下测量药物浓度很重要。特定的实验室检测并非在每个医院都能轻易获得或实施。即时检测（POCT）可能会弥补这一差距，并作为床边解决方案使用。

目的

评估即时检测用于评估达比加群、利伐沙班和阿哌沙班的血浆水平的可行性。

患者/方法：在 136 例连续服用 NOACs 的患者（达比加群 70 例，利伐沙班 45 例，阿哌沙班 20 例）中，使用便携式 Hemochron Signature Elite 进行活化凝血时间-低值范围（ACT-LR）检测，并使用 Coaguchek XS Pro 进行凝血酶原时间（以 INR 表示）检测，分别在药物谷值和峰值时进行。采用配对研究设计，同时使用功能特异性检测方法确定药物浓度。

结果与结论

达比加群和利伐沙班的 POCT 值与药物浓度之间的相关性较高（r=0.80 和 r=0.82），而阿哌沙班的相关性较低（r=0.21）。ACT-LR≤188 s 更好地检测达比加群浓度≤50 ng/ml，其敏感性为 87.5%，特异性为 84.1%。ACT-LR 值>217 s 更好地区分达比加群浓度>200 ng/ml，其敏感性为 86.7%，特异性为 81.4%。INR Coaguchek 值≤1.2 更好地识别利伐沙班值<100 ng/ml 的患者，其敏感性为 90%，特异性为 88.5%。对于阿哌沙班，无法进行此分析。