未经评估:应用单一的抗Xa检测,校准到普通肝素来测量利伐沙班,阿哌沙班,edoxaban将简化实验室程序并节省医疗费用。
UASSIGNED:我们假设肝素校准的抗Xa测定法可以准确测量利伐沙班,阿哌沙班,和依度沙班药物浓度,并正确预测临床相关药物水平。
UNASSIGNED:此分析是Simple-Xa研究的一部分,一项在临床实践中进行的前瞻性多中心横断面研究.利伐沙班治疗的患者,阿哌沙班,或者edoxaban也包括在内.使用SiemensINNOVANCE®肝素测定法测量抗Xa活性。使用超高效液相色谱-串联质谱法(LC-MS/MS)测定药物浓度。在推导数据集(50%的患者)中确定截止水平,并且在验证数据集(50%的患者)中计算敏感性和特异性。
未经评估:总的来说,845名患者可用于分析。对于利伐沙班,肝素校准的抗Xa测定与药物浓度之间的相关系数(rs)为0.97(95%CI0.97,0.98),阿哌沙班为0.96(0.96,0.97),依度沙班为0.96(0.94,0.99)。对于所有临床相关药物浓度,受试者工作特征曲线下面积(ROC)为0.99。在验证数据集中,30μgL-1的敏感性为94.2%(95%CI90.8-96.6),50μgL-1的敏感性为95.8%(92.4-98.0),100μgL-1的敏感性为98.7%(95.5-99.9).特殊性为86.3%(79.2-91.7),89.8%(84.5-93.7),和88.7%(84.2-92.2),分别。
未经评估:在临床实践中的一项大型前瞻性研究中,观察到肝素校准的抗Xa测量结果与LC-MS/MS结果的强相关性,并且正确预测了临床相关药物浓度.
UNASSIGNED: Applying a single anti-Xa assay, calibrated to unfractionated heparin to measure rivaroxaban, apixaban, and edoxaban would simplify laboratory procedures and save healthcare costs.
UNASSIGNED: We hypothesized that a heparin-calibrated anti-Xa assay would accurately measure rivaroxaban, apixaban, and edoxaban drug concentrations and correctly predict clinically relevant drug levels.
UNASSIGNED: This analysis is part of the Simple-Xa study, a prospective multicenter cross-sectional study conducted in clinical practice. Patients treated with rivaroxaban, apixaban, or edoxaban were included. Anti-Xa activity was measured using the Siemens INNOVANCE® Heparin assay. Drug concentrations were determined using ultra-high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS). Cut-off levels were determined in a derivation dataset (50% of patients) and sensitivities and specificities were calculated in a verification dataset (50% of patients).
UNASSIGNED: Overall, 845 patients were available for analysis. Correlation coefficients (r s ) between the heparin-calibrated anti-Xa assay and drug concentrations were 0.97 (95% CI 0.97, 0.98) for rivaroxaban, 0.96 (0.96, 0.97) for apixaban, and 0.96 (0.94, 0.99) for edoxaban. The area under the receiver operating characteristics curve (ROC) was 0.99 for all clinically relevant drug concentrations. In the verification dataset, the sensitivity was 94.2% (95% CI 90.8-96.6) for 30 μg L-1, 95.8% (92.4-98.0) for 50 μg L-1, and 98.7% (95.5-99.9) for 100 μg L-1. Specificities were 86.3% (79.2-91.7), 89.8% (84.5-93.7), and 88.7% (84.2-92.2), respectively.
UNASSIGNED: In a large prospective study in clinical practice, a strong correlation of heparin-calibrated anti-Xa measurements with LC-MS/MS results was observed and clinically relevant drug concentrations were predicted correctly.