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凝血指标对直接口服抗凝剂浓度的诊断性能。

Diagnostic performance of coagulation indices for direct oral anticoagulant concentration.

机构信息

Department of Pharmacy, Peking University First Hospital, Beijing, China; School of Pharmaceutical Sciences, Peking University Health Science Center, Beijing, China.

Department of Pharmacy, Peking University First Hospital, Beijing, China.

出版信息

Thromb Res. 2020 Nov;195:171-179. doi: 10.1016/j.thromres.2020.07.031. Epub 2020 Jul 16.

Abstract

INTRODUCTION

Different coagulation indices for direct oral anticoagulants (DOACs) exist in clinical practice, but limited data are available for the diagnostic power of these indices. This review and meta-analysis aims to explore the diagnostic value of coagulation indices for DOACs.

MATERIALS AND METHODS

PubMed, Web of Science, EMBASE, Clinical Trials.gov, and the Cochrane Library were searched from inception of each database to 15 February 2020. Studies reporting a relationship between coagulation indices and the gold standard (liquid chromatography/tandem mass spectrometry) were included in the analysis.

RESULTS

Sixteen articles from 9169 citations evaluating the performance of coagulation indices were included in this review. A total of 236, 273, 273 rivaroxaban samples were included to assess the diagnostic power of anti-Xa activity (AXA), prothrombin time (PT), combined PT and activated partial thromboplastin time, respectively. A total of 268 dabigatran samples were included to assess the diagnostic performance of diluted thromboplastin time (dTT). AXA calibrated by rivaroxaban showed a sensitivity of 0.98 (95% confidence interval (CI): 0.91-0.99) and a specificity of 0.98 (95% CI: 0.94-0.99) at the threshold of 30 ng/mL. For dabigatran, the combined sensitivity of dTT was 0.76 (95% CI: 0.66-0.84) and combined specificity was 0.97 (95% CI: 0.92-0.99).

CONCLUSIONS

DOAC-specific calibrated AXA was a good index to indicate concentration for rivaroxaban and apixaban. More studies on edoxaban and betrixaban are in need. Diluted TT, thrombin inhibitor assay, and ecarin-based assays were potential to measure dabigatran concentration. Due to the limited data, results should be validated in the future.

摘要

简介

临床上存在用于直接口服抗凝剂(DOACs)的不同凝血指数,但这些指数的诊断能力数据有限。本综述和荟萃分析旨在探讨凝血指数用于 DOACs 的诊断价值。

材料和方法

从每个数据库的创建到 2020 年 2 月 15 日,检索了 PubMed、Web of Science、EMBASE、ClinicalTrials.gov 和 Cochrane Library。分析纳入了报告凝血指数与金标准(液相色谱/串联质谱法)之间关系的研究。

结果

从 9169 篇引文中共纳入了 16 篇评估凝血指数性能的文章。共纳入了 236、273 和 273 例利伐沙班样本,分别评估抗-Xa 活性(AXA)、凝血酶原时间(PT)和联合 PT 及活化部分凝血活酶时间的诊断能力。共纳入了 268 例达比加群样本,评估稀释凝血酶时间(dTT)的诊断性能。利伐沙班校准的 AXA 在 30ng/mL 阈值下的敏感性为 0.98(95%置信区间(CI):0.91-0.99),特异性为 0.98(95% CI:0.94-0.99)。对于达比加群,dTT 的联合敏感性为 0.76(95% CI:0.66-0.84),联合特异性为 0.97(95% CI:0.92-0.99)。

结论

DOAC 特异性校准的 AXA 是指示利伐沙班和阿哌沙班浓度的良好指标。需要更多关于依度沙班和贝曲沙班的研究。稀释 TT、凝血酶抑制剂测定和基于蝰蛇毒素的测定可能用于测量达比加群的浓度。由于数据有限,结果需要在未来进行验证。

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