Riess F-C, Poetzsch B, Madlener K, Cramer E, Doll K-N, Doll S, Lorke D E, Kormann J, Mueller-Berghaus G
Department of Cardiac Surgery, Albertinen Heart Center, Hamburg, Germany.
Thorac Cardiovasc Surg. 2007 Jun;55(4):233-8. doi: 10.1055/s-2006-955956.
Lepirudin, a recombinant hirudin, is a direct acting thrombin inhibitor that has been used as a heparin alternative in patients with heparin-induced thrombocytopenia requiring on-pump cardiac surgery. To evaluate the efficacy, safety, and clinical utility of lepirudin as a cardiopulmonary bypass (CPB) anticoagulant, we compared lepirudin with heparin in a routine CPB setting.
Twenty patients were randomly assigned to receive lepirudin (0.25 mg/kg b. w. bolus and 0.2 mg/kg b. w. added to the CPB priming) or heparin (400 U/kg b. w. bolus) with protamine reversal. Lepirudin and heparin anticoagulation during CPB was monitored using the ecarin clotting time or ACT, respectively and additional lepirudin (5 mg) or heparin (5000 U) boluses were administered.
The CPB circuit was performed in both groups without thromboembolic complications. Median blood loss during the first 36 hours was statistically higher ( P = 0.007) in the lepirudin group (1.226 +/- 316 ml) compared to the heparin group (869 +/- 189 ml). One patient of the lepirudin group developed pulmonary embolism 24 hours after surgery. This patient was tested homozygous for the FV-Leiden mutation.
Lepirudin provides effective CPB anticoagulation but induces a higher postoperative blood loss than heparin. Lepirudin should be restricted to patients undergoing CPB who cannot be exposed to heparin.
重组水蛭素（lepirudin）是一种直接作用的凝血酶抑制剂，已被用作肝素诱导的血小板减少症且需要体外循环心脏手术患者的肝素替代药物。为了评估重组水蛭素作为体外循环（CPB）抗凝剂的疗效、安全性和临床实用性，我们在常规CPB环境中将重组水蛭素与肝素进行了比较。
20例患者被随机分配接受重组水蛭素（0.25mg/kg体重静脉推注，0.2mg/kg体重加入CPB预充液中）或肝素（400U/kg体重静脉推注）并使用鱼精蛋白进行中和。分别使用蛇毒凝血时间或活化凝血时间（ACT）监测CPB期间重组水蛭素和肝素的抗凝效果，并额外给予重组水蛭素（5mg）或肝素（5000U）静脉推注。
两组均顺利完成CPB回路，无血栓栓塞并发症。重组水蛭素组术后36小时内的中位失血量（1.226±316ml）在统计学上显著高于肝素组（869±189ml）（P = 0.007）。重组水蛭素组有1例患者术后24小时发生肺栓塞。该患者检测出FV-Leiden突变纯合子。
重组水蛭素可有效用于CPB抗凝，但与肝素相比，术后失血量更高。重组水蛭素应仅限于不能使用肝素进行CPB的患者。
