Irvine Department of Pathology and Laboratory Medicine, University of California, Orange, CA, USA.
Clin Appl Thromb Hemost. 2024 Jan-Dec;30:10760296241241524. doi: 10.1177/10760296241241524.
Direct oral anticoagulants (DOACs) exert anticoagulation effect by directly inhibiting Factor Xa (rivaroxaban, apixaban, and edoxaban) or thrombin (dabigatran). Though DOACs are characterized by fixed-dose prescribing and generally do not require routine laboratory drug-level monitoring (DLM), circumstances may arise where the DLM may aid in clinical decision-making, including DOAC dose adjustment, anticoagulant class change, or decisions to withhold or administer reversal agents. We review the current literature that describes high-risk patient groups in which DLM may be beneficial for improved patient anticoagulation management and stewardship. The review also summarizes the limitations of conventional coagulation testing and discuss the emerging utility of quantitative methods for routine and rapid emergent evaluation of DOAC drug levels-in particular, the Anti-Xa activity to detect Factor Xa Inhibitors (rivaroxaban, apixaban, and edoxaban). Both technical and regulatory barriers to widespread DLM implementation are limiting factors to further clinical research that must be overcome, in order to propose universal DOAC DLM strategies and provide clinical-laboratory correlation to formally classify high-risk patient groups.
直接口服抗凝剂（DOACs）通过直接抑制因子 Xa（利伐沙班、阿哌沙班和依度沙班）或凝血酶（达比加群）发挥抗凝作用。尽管 DOACs 的特点是固定剂量给药，通常不需要常规实验室药物浓度监测（DLM），但在某些情况下，DLM 可能有助于临床决策，包括 DOAC 剂量调整、抗凝剂类别改变，或决定是否停用或给予逆转剂。我们回顾了目前描述高危患者群体的文献，在这些患者群体中，DLM 可能有助于改善患者的抗凝管理和监护。该综述还总结了传统凝血检测的局限性，并讨论了定量方法在常规和快速紧急评估 DOAC 药物浓度方面的新应用，特别是抗 Xa 活性检测用于检测因子 Xa 抑制剂（利伐沙班、阿哌沙班和依度沙班）。广泛实施 DLM 的技术和监管障碍是限制进一步临床研究的因素，必须克服这些障碍，才能提出通用的 DOAC DLM 策略，并提供临床-实验室相关性，正式分类高危患者群体。
