Iqbal O, Tobu M, Aziz S, Gerdisch M, Da Valle M, Demir M, Hoppensteadt D A, Ahmad S, Walenga J M, Fareed J
Department of Pathology, Loyola University Medical Center, 2160 S. First Ave., Building 102, Room 2646, Maywood, IL 60153, USA.
J Card Surg. 2005 Jan-Feb;20(1):42-51. doi: 10.1111/j.0886-0440.2005.200316.x.
Refludan (lepirudin-rDNA for injection) is the first direct thrombin inhibitor approved by the United States FDA for anticoagulation to patients with heparin-induced thrombocytopenia (HIT). It was monitored by ecarin clotting time (ECT) assay in patients with HIT. Case histories and clotting parameters for three patients undergoing off-pump coronary artery revascularization procedure are discussed. The first patient received r-hirudin at a dose of 0.2 mg/kg intravenous (IV) bolus followed by 0.15 mg/kg/hour infusion. The second patient received 0.4 mg/kg IV bolus followed by infusion of 0.15 mg/kg/hour infusion. The third patient with renal failure received 0.2 mg/kg IV bolus followed by an infusion of 0.02 mg/kg/hour. Blood samples were drawn at baseline, 5 minutes post bolus and every 15 minutes during the coronary artery revascularization procedure. ECT was performed immediately on the citrated whole blood samples using the ECT cards in conjunction with the point-of-care, the thrombolytic assessment system (TAS) Analyzer (Pharmanetics, Raleigh, NC). The plasma samples were then analyzed for APTT and liquid ECT assay performed on a kinetic centrifugal analyzer (ACL 300 Plus). The ECT by cards was ideally maintained above 600 seconds during the surgical procedure. Additional boluses of Refludan were given as and when necessary (ECT < 600 sec) in order to maintain adequate anticoagulation. The calculated circulating concentrations of Refludan, following a bolus administration, based on the ECT cards, liquid ECT and APTT were 3.20 +/- 1.3, 3.51 +/- 1.35 and 2.02 +/- 1.19 microg/mL, respectively.
Refludan(注射用重组水蛭素)是美国食品药品监督管理局(FDA)批准的首个用于肝素诱导的血小板减少症(HIT)患者抗凝治疗的直接凝血酶抑制剂。在HIT患者中通过蛇静脉酶凝血时间(ECT)测定进行监测。讨论了3例接受非体外循环冠状动脉血运重建术患者的病例史和凝血参数。首例患者静脉推注剂量为0.2mg/kg的重组水蛭素,随后以0.15mg/kg/小时的速度输注。第二例患者静脉推注0.4mg/kg,随后以0.15mg/kg/小时的速度输注。第三例肾衰竭患者静脉推注0.2mg/kg,随后以0.02mg/kg/小时的速度输注。在基线、推注后5分钟以及冠状动脉血运重建术期间每15分钟采集血样。使用ECT卡结合即时检验的溶栓评估系统(TAS)分析仪(Pharmanetics,北卡罗来纳州罗利市)对枸橼酸化全血样本立即进行ECT检测。然后对血浆样本进行活化部分凝血活酶时间(APTT)分析,并在动力学离心分析仪(ACL 300 Plus)上进行液体ECT检测。在手术过程中,通过卡片检测的ECT理想情况下应维持在600秒以上。必要时(ECT<600秒)给予额外剂量的Refludan,以维持充分的抗凝作用。根据ECT卡、液体ECT和APTT计算,推注给药后Refludan的循环浓度分别为3.20±1.3、3.51±1.35和2.02±1.19μg/mL。