Detecting direct oral anticoagulants in trauma patients using liquid chromatography-mass spectrometry: A novel approach to medication reconciliation.
Detecting direct oral anticoagulants in trauma patients using liquid chromatography-mass spectrometry: A novel approach to medication reconciliation.
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DOI：
10.1097/ta.0000000000002527
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发表时间：
2020-04
期刊：
影响因子：
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通讯作者：
Wijesinghe DS
中科院分区：
文献类型：
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作者：
Jayaraman S;DeAntonio JH;Leichtle SW;Han J;Liebrecht L;Contaifer D;Young C;Chou C;Staschen J;Doan D;Kumar NG;Wolfe L;Nguyen T;Chenault G;Anand RJ;Bennett JD;Ferrada P;Goldberg S;Procter LD;Rodas EB;Rossi AP;Whelan JF;Feeser VR;Vitto MJ;Broering B;Hobgood S;Mangino M;Aboutanos M;Bachmann L;Wijesinghe DS
准确的药物和解创伤患者是必不可少的，但困难。目前还没有建立检测创伤患者直接口服抗凝剂（DOAC）的临床方法。我们假设，基于液相色谱-质谱（LCMS）的测定可用于在创伤患者到达医院后准确检测DOAC。从提供知情同意书的356名患者中收集血浆样本，包括10名健康对照、19名已知阳性或阴性对照和327名65岁以上的创伤患者，这些患者在我们的大型城市1级创伤中心接受评估。在健康和已知对照中开发了测定方法，以使用LCMS检测阿哌沙班、利伐沙班和达比加群，然后应用于创伤患者的327份样本。将记录DOAC使用的电子病历中的标准药物核对过程与LCMS结果进行比较，以确定该测定的总体准确性、灵敏度、特异性以及阳性和阴性预测值（PPV、NPV）。在356例患者中，39例接受DOAC（10.96%）：21例接受阿哌沙班，14例接受利伐沙班，4例接受达比加群。该方法检测任何DOAC的总体准确性为98.60%，灵敏度为94.87%，特异性为99.06%，（PPV为92.50%，NPV为99.37%）。该方法检测阿哌沙班的灵敏度为90.48%，特异性为99.11%（PPV为86.36%，NPV为99.40%）。阿哌沙班有3个假阳性结果和2个假阴性LCMS结果。检测达比加群和利伐沙班的灵敏度和特异性均为100%。这种基于LCMS的测定在检测创伤患者中的DOAC方面高度准确。进一步的研究需要证实这种LCMS测定的临床疗效及其在创伤患者中的药物协调价值。因此，诊断测试不需要证据水平。
Accurate medication reconciliation in trauma patients is essential but difficult. Currently there is no established clinical method of detecting direct oral anticoagulants (DOACs) in trauma patients. We hypothesized that a liquid chromatography-mass spectrometry (LCMS) based assay can be used to accurately detect DOACs in trauma patients upon hospital arrival. Plasma samples were collected from 356 patients who provided informed consent including- 10 healthy controls, 19 known positive or negative controls and 327 trauma patients over 65 years of age who were evaluated at our large, urban Level 1 Trauma Center. The assay methodology was developed in healthy and known controls to detect apixaban, rivaroxaban and dabigatran using LCMS and then applied to 327 samples from trauma patients. Standard medication reconciliation processes in the electronic medical record documenting DOAC usage was compared with LCMS results to determine overall accuracy, sensitivity, specificity and positive and negative predictive values (PPV, NPV) of the assay. Of 356 patients, 39 were on DOACs (10.96%): 21 were on Apixaban, 14 on rivaroxaban and 4 on dabigatran. The overall accuracy of the assay for detecting any DOAC was 98.60%, with a sensitivity of 94.87% and specificity of 99.06%, (PPV 92.50% and NPV 99.37%). The assay detected apixaban with a sensitivity of 90.48% and specificity of 99.11% (PPV 86.36% and NPV 99.40%). There were three false positive results and two false negative LCMS results for apixaban. Dabigatran and rivaroxaban were detected with 100% sensitivity and specificity. This LCMS-based assay was highly accurate in detecting DOACs in trauma patients. Further studies need to confirm the clinical efficacy of this LCMS assay and its value for medication reconciliation in trauma patients. diagnostic test therefore does not require a level of evidence.