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超低剂量抑肽酶方案用于再次手术和/或复杂心脏手术的随机、安慰剂对照、双盲研究。

Randomized, placebo-controlled, double-blind study of an ultra-low-dose aprotinin regimen in reoperative and/or complex cardiac operations.

作者信息

Hardy J F, Bélisle S, Couturier A, Robitaille D

机构信息

Department of Anesthesia, Université de Montréal, Québec.

出版信息

J Card Surg. 1997 Jan-Feb;12(1):15-22. doi: 10.1111/j.1540-8191.1997.tb00083.x.

DOI:10.1111/j.1540-8191.1997.tb00083.x
PMID:9169364
Abstract

BACKGROUND AND AIM OF THE STUDY

High-dose aprotinin is an effective but costly method to reduce transfusions after cardiopulmonary bypass (CPB). Very low doses of aprotinin have been shown to be effective in primary cardiac surgery, but not in patients undergoing procedures associated with the greatest usage of allogeneic blood products after CPB. We evaluated the efficacy of ultra-low-dose aprotinin in this patient population.

METHODS

Aprotinin 1 million KIU or placebo was added to the priming solution of the CPB circuit of 52 patients undergoing a reoperation and/or a complex surgical procedure. Dryness of operative field, hemoglobin concentrations, coagulation parameters, chest drainage, and transfusion requirements were compared.

RESULTS

Total chest drainage was not different between groups, but fewer patients in the aprotinin group required additional protamine postoperatively (35% vs 69% for controls, p = 0.03) and fewer received fresh frozen plasma (FFP; 19% vs 46% for controls, p = 0.04). Red cell transfusion was smaller in the aprotinin group compared to placebo (median 4 and 2 units, respectively, p = 0.04). Transfusion of FFP, platelets, cryoprecipitates was not different between groups. Total number of units transfused tended to be reduced in the aprotinin group compared to control (median 2 and 7 units, respectively, p = 0.06).

CONCLUSIONS

Prophylactic administration of ultra-low-dose aprotinin reduced transfusions in patients undergoing repeat operations or complex procedures. Aprotinin could be used in a more economical manner, even in this patient population at high-risk of receiving allogeneic blood products.

摘要

研究背景与目的

高剂量抑肽酶是一种减少体外循环(CPB)后输血的有效但昂贵的方法。极低剂量的抑肽酶已被证明在原发性心脏手术中有效,但在CPB后同种异体血制品使用量最大的相关手术患者中无效。我们评估了超低剂量抑肽酶在该患者群体中的疗效。

方法

将100万KIU抑肽酶或安慰剂添加到52例接受再次手术和/或复杂手术的患者的CPB回路预充液中。比较手术视野干燥程度、血红蛋白浓度、凝血参数、胸腔引流量和输血需求。

结果

两组的总胸腔引流量无差异,但抑肽酶组术后需要额外使用鱼精蛋白的患者较少(35%对对照组的69%,p = 0.03),接受新鲜冰冻血浆(FFP)的患者也较少(19%对对照组的46%,p = 0.04)。与安慰剂组相比,抑肽酶组的红细胞输注量较小(中位数分别为4单位和2单位,p = 0.04)。两组之间FFP、血小板、冷沉淀的输注无差异。与对照组相比,抑肽酶组的总输注单位数有减少趋势(中位数分别为2单位和7单位,p = 0.06)。

结论

预防性给予超低剂量抑肽酶可减少接受再次手术或复杂手术患者的输血。即使在该有接受同种异体血制品高风险的患者群体中,抑肽酶也可以更经济地使用。

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