Laboratory measurement of the anticoagulant activity of edoxaban: a systematic review.

Laboratory measurement of the anticoagulant activity of edoxaban: a systematic review.
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DOI:
10.1007/s11239-015-1185-7
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发表时间:
2015-04
影响因子:
4
通讯作者:
Husseinzadeh H
Husseinzadeh H
中科院分区:
医学4区
文献类型:
--
作者:
Cuker A;Husseinzadeh H

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Edoxaban是一种Xa因子的口服直接抑制剂,最近在美国和日本获批用于预防非瓣膜性房颤患者的卒中和全身性栓塞以及治疗静脉血栓栓塞(VTE)。它也在日本获得许可,用于预防大型骨科手术后的VTE。虽然不需要对依度沙班进行常规实验室监测,但在特殊情况下可能需要进行实验室测量。我们的目的是提供一个系统的审查,目前的证据,实验室测量艾多沙班的抗凝活性。在PubMed和科克伦图书馆中检索报告凝血试验与血浆依度沙班水平之间关系的研究。使用诊断准确性研究2的质量评估(QUADAS-2)评估研究质量。我们确定了9项合格研究。抗Xa活性在宽的药物水平范围内呈线性(R2>0.95),可用于依度沙班定量。在高于治疗中药物浓度时,该测定显示出更大的变异性。PT对依度沙班不太敏感。正常的凝血酶原时间不能排除临床相关的治疗中药物水平。活化部分凝血活酶时间对依度沙班的敏感性不足,无法测定其抗凝活性。依度沙班对凝血试验具有不同的影响。了解这些影响有助于解释依度沙班治疗患者的检测结果。需要更多关于药物水平、凝血试验结果和患者临床结局之间关系的数据。
Edoxaban, an oral direct inhibitor of factor Xa, was recently approved in the United States and Japan for prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and for treatment of venous thromboembolism (VTE). It is also licensed in Japan for prevention of VTE after major orthopedic surgery. Although routine laboratory monitoring of edoxaban is not required, laboratory measurement may be desirable in special circumstances. Our objective was to provide a systematic review of current evidence on laboratory measurement of the anticoagulant activity of edoxaban. PubMed and the Cochrane Library were searched for studies that reported a relationship between coagulation tests and plasma edoxaban levels. Study quality was assessed using Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2). We identified 9 eligible studies. Anti-Xa activity is linear across a broad range of drug levels (R2>0.95) and may be used for edoxaban quantification. The assay shows greater variability at above on-therapy drug concentrations. The PT is less sensitive to edoxaban. A normal prothrombin time may not exclude clinically relevant on-therapy drug levels. The activated partial thromboplastin time has insufficient sensitivity to edoxaban for measurement of its anticoagulant activity. Edoxaban exhibits variable effects on coagulation assays. Understanding these effects facilitates interpretation of test results in edoxaban-treated patients. More data on the relationship between drug levels, coagulation test results, and clinical outcomes in patients are needed.