Department of Pharmacy, Namur Thrombosis and Hemostasis Center (NTHC), Namur Research Institute for Life Sciences (NARILIS), University of Namur, Namur, Belgium.
Qualiblood s.a, Namur, Belgium.
Int J Lab Hematol. 2021 Aug;43(4):802-812. doi: 10.1111/ijlh.13427. Epub 2020 Dec 12.
Activated protein C (APC) resistance is a major risk factor of venous thrombosis which may be acquired by hormonal therapy or other causes. The FibWave, a sensitive global clot-based assay design to analyze the coagulation kinetics in plasma, may be a good candidate to assess this prothrombotic state. This study aims to assess the suitability of the FibWave to differentiate the coagulation kinetics of women on oral contraceptives.
Fifty-four healthy volunteers were divided into 5 groups: men [n = 13], women not using hormonal contraception [n = 12], women using second [n = 12] or third generation [n = 12] combined oral contraceptives, and women using progestin only contraceptive [n = 5]. Patients with coagulation abnormalities were also assessed [n = 8]. The APC resistance was assessed on the FibWave using exogenous APC or Protac, and on the Calibrated Automated Thrombogram using the ETP-based APC resistance assay.
Either in presence or in absence of APC or Protac, the FibWave was able to detect a hypercoagulable state in plasma samples. All combined oral contraceptives showed a lower FW-Max , FW-Max and FW-Min percentage of inhibition and a lower FW-Ttpeak ratio than the other groups. The sensitivity of the FibWave was similar to the one of the ETP-based APC resistance assay.
The FibWave is able to differentiate APC resistance levels observed in women on combined oral contraceptive. The FW-Max , FW-Max and to a lesser degree FW-Min were identified as the most sensitive parameters with a similar performance to the ETP-based APC resistance assay.
活化蛋白 C（APC）抵抗是静脉血栓形成的一个主要危险因素，这种抵抗可能是由激素治疗或其他原因引起的。FibWave 是一种基于敏感的全球凝血的检测方法，用于分析血浆中的凝血动力学，可能是评估这种血栓前状态的良好候选方法。本研究旨在评估 FibWave 区分口服避孕药女性凝血动力学的适用性。
54 名健康志愿者分为 5 组：男性 [n=13]、未使用激素避孕药的女性 [n=12]、使用第二代 [n=12] 或第三代 [n=12] 联合口服避孕药的女性和使用孕激素避孕药的女性 [n=5]。还评估了有凝血异常的患者 [n=8]。使用外源性 APC 或 Protac 在 FibWave 上评估 APC 抵抗，使用基于 ETP 的 APC 抵抗测定法在 Calibrated Automated Thrombogram 上评估 APC 抵抗。
无论是否存在 APC 或 Protac，FibWave 都能够检测到血浆样本中的高凝状态。所有联合口服避孕药的 FW-Max、FW-Max 和 FW-Min 的抑制百分比以及 FW-Ttpeak 比值均低于其他组。FibWave 的灵敏度与基于 ETP 的 APC 抵抗测定法相似。
FibWave 能够区分服用联合口服避孕药的女性中观察到的 APC 抵抗水平。FW-Max、FW-Max 和在较小程度上 FW-Min 被确定为最敏感的参数，其性能与基于 ETP 的 APC 抵抗测定法相似。
