Harder M P, Eijsman L, Roozendaal K J, van Oeveren W, Wildevuur C R
Department of Cardiopulmonary Surgery, University Hospital, Groningen, The Netherlands.
Ann Thorac Surg. 1991 Jun;51(6):936-41. doi: 10.1016/0003-4975(91)91009-k.
To determine whether aprotinin can provide a significant improvement of hemostasis in cardiopulmonary bypass using a membrane oxygenator, we tested this drug in a prospective, randomized, double-blind, placebo-controlled clinical trial. The subjects were 80 male patients undergoing cardiopulmonary bypass for coronary artery bypass grafting. Forty patients received aprotinin and 40 patients served as placebo controls. Aprotinin (4 x 10(6) KIU) was given as a continuous infusion, starting before operation and continuing until after cardiopulmonary bypass; additionally, 2 x 10(6) KIU aprotinin was added to the pump prime. Intraoperative and postoperative bleeding, respectively two thirds and one third of the total perioperative blood loss, were both significantly reduced in the aprotinin-treated group (p less than 0.01). The total average perioperative blood loss, corrected to a hemoglobin concentration of 7 mmol/L, was 550 mL in the aprotinin-treated patients versus 900 mL in the control patients. This reduction in blood loss, furthermore, significantly decreased the amount of postoperative blood transfusions (p less than 0.05) and increased the percentage of patients who did not receive postoperative donor blood from 42% to 68%. Aprotinin increased the activated clotting time significantly during cardiopulmonary bypass, which led to a reduction in heparin usage. The improved hemostasis during operation, despite the prolonged activated clotting time, might even abolish the need for heparin conversion with protamine at the end of cardiopulmonary bypass, thus allowing retransfusion through cardiotomy suction to be continued, which saves the blood that is currently lost with vacuum suction.
为了确定抑肽酶能否显著改善使用膜式氧合器的体外循环中的止血情况,我们在一项前瞻性、随机、双盲、安慰剂对照的临床试验中对这种药物进行了测试。研究对象为80例接受冠状动脉旁路移植术体外循环的男性患者。40例患者接受抑肽酶治疗,40例患者作为安慰剂对照。抑肽酶(4×10⁶KIU)在手术前开始持续输注,并持续至体外循环结束;此外,在预充液中加入2×10⁶KIU抑肽酶。抑肽酶治疗组术中及术后出血(分别占围手术期总失血量的三分之二和三分之一)均显著减少(p<0.01)。以血红蛋白浓度校正至7mmol/L后,抑肽酶治疗患者围手术期总平均失血量为550mL,而对照组患者为900mL。此外,失血量的减少显著降低了术后输血的量(p<0.05),并使未接受术后异体输血的患者比例从42%增加到68%。抑肽酶在体外循环期间显著延长激活凝血时间,从而减少了肝素的用量。尽管激活凝血时间延长,但术中止血的改善甚至可能消除体外循环结束时用鱼精蛋白进行肝素中和的必要性,从而允许通过心内吸引继续进行再输血,这节省了目前因真空吸引而流失的血液。