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在达峰浓度时接受直接口服 FXa 抑制剂的患者中狼疮抗凝物的诊断:一项真实世界研究。

Lupus anticoagulant diagnosis in patients receiving direct oral FXa inhibitors at trough levels: A real-life study.

机构信息

Service d'Hématologie Biologique, AP-HP, Cochin Hospital, Paris, France.

Inserm U1016, CNRS UMR 8104, Cochin Institute, Université de Paris, Paris, France.

出版信息

Int J Lab Hematol. 2019 Dec;41(6):738-744. doi: 10.1111/ijlh.13101. Epub 2019 Sep 5.

Abstract

INTRODUCTION

Direct oral factor Xa inhibitors (xabans) induce false positive results for lupus anticoagulant (LA) diagnosis. Consequently, it is suggested not to perform LA testing in xabans patients although it may be useful in selected patients. In this monocentric study, we evaluated xabans impact at trough levels (ie, just before the next intake) on LA diagnosis in treated patients using dilute Russell viper venom time (dRVVT) and two LA sensitive activated partial thromboplastin time (aPTT).

METHODS

Sixty patients receiving rivaroxaban (30) or apixaban (30) were included. Plasma concentrations were measured using specific anti-Xa assays. LA testing was performed using one dRVVT (LAC-Screening /Confirm ; Siemens) and two LA sensitive aPTT-based assays (Hemosil Silica Clotting Time (SCT) Screen/Confirm; Werfen and Dade Actin Factor Sensitivity FSL/FS (Actin F); Siemens).

RESULTS

Median [min-max] concentrations were 23 [<18-68] for rivaroxaban and 42 ng/mL [19-99] for apixaban. dRVVT was positive in 93% of rivaroxaban and 40% of apixaban samples. SCT was positive in 40 and 30% and Actin F in 17 and 20% of samples respectively. Xabans affected more significantly dRVVT than aPTT-based assays (P < .001) with less false positive results with apixaban than with rivaroxaban samples irrespective of the assay used.

CONCLUSION

lupus anticoagulant diagnosis in rivaroxaban and apixaban samples drawn at trough levels remains questionable whenever positive results are obtained. If LA testing in apixaban samples might be useful to rule-out LA using dRVVT and/or aPTT-based assays, the wide majority of rivaroxaban samples would give false positive results.

摘要

简介

直接口服因子 Xa 抑制剂(沙班类药物)会导致狼疮抗凝物(LA)检测出现假阳性结果。因此,建议在沙班类药物治疗的患者中不进行 LA 检测,尽管在某些特定患者中可能有用。在这项单中心研究中,我们评估了在治疗患者中,沙班类药物在谷浓度(即在下一次服药前)对 LA 诊断的影响,使用稀释蝰蛇毒时间(dRVVT)和两种 LA 敏感的活化部分凝血活酶时间(aPTT)进行检测。

方法

共纳入 60 例接受利伐沙班(30 例)或阿哌沙班(30 例)治疗的患者。使用特定的抗-Xa 检测方法测量血浆浓度。使用一种 dRVVT(LAC-Screening/Confirm;西门子)和两种 LA 敏感的 aPTT 检测方法(Hemosil 硅化凝血时间(SCT)Screen/Confirm;Werfen 和 Dade Actin Factor Sensitivity FSL/FS(Actin F);西门子)进行 LA 检测。

结果

利伐沙班的中位浓度 [最小值-最大值]为 23 [18-68]ng/mL,阿哌沙班的浓度为 42 ng/mL [19-99]ng/mL。dRVVT 在 93%的利伐沙班和 40%的阿哌沙班样本中呈阳性。SCT 在 40%和 30%的样本中呈阳性,Actin F 在 17%和 20%的样本中呈阳性。沙班类药物对 dRVVT 的影响明显大于基于 aPTT 的检测方法(P<0.001),与利伐沙班样本相比,阿哌沙班样本的假阳性结果更少,无论使用哪种检测方法。

结论

在利伐沙班和阿哌沙班样本中,无论获得的结果如何,在谷浓度时进行 LA 检测仍存在疑问。如果在阿哌沙班样本中进行 LA 检测可能有助于使用 dRVVT 和/或基于 aPTT 的检测方法排除 LA,那么绝大多数利伐沙班样本都会产生假阳性结果。

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