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三种抑肽酶方案用于心脏直视手术的随机安慰剂对照双盲研究

Randomized placebo-controlled double-blind study of three aprotinin regimens in primary cardiac surgery.

作者信息

Bailey C R, Kelleher A A, Wielogorski A K

机构信息

Cardiothoracic Unit, Brook General Hospital, London, UK.

出版信息

Br J Surg. 1994 Jul;81(7):969-73. doi: 10.1002/bjs.1800810713.

DOI:10.1002/bjs.1800810713
PMID:7522906
Abstract

The serine proteinase inhibitor aprotinin significantly reduces postoperative blood loss in patients requiring cardiac surgery using cardiopulmonary bypass. This study compared two low-dose regimens with administration of high-dose aprotinin and a control protocol to determine whether the dose of aprotinin could be greatly decreased but still maintain efficacy after primary cardiac surgery. Some 100 patients were randomly assigned to one of four groups: control group (0.9 per cent saline placebo, n = 25); high-dose group (aprotinin 2 x 10(6) kallikrein inactivator (KI) units intravenous patient bolus and 0.5 x 10(6) KI units h-1 plus 2 x 10(6) KI units into pump prime, n = 25); prime group (aprotinin 2 x 10(6) KI units added to the pump prime, n = 24); and patient group (aprotinin 10(6) KI units intravenous patient bolus plus 10(6) KI units added to the pump prime, n = 26). Only patients from the high-dose and patient groups had reduced intraoperative blood loss, but patients from all three aprotinin-treated groups demonstrated a significant decrease in median postoperative blood loss compared with the control group (high-dose 350 ml, prime 420 ml, patient 340 ml versus control 780 ml; P < 0.001). There was an even greater reduction in measured median postoperative haemoglobin loss within the chest drains in the treated compared with the control patients (high-dose 15 g, prime 24 g, patient 14 g versus control 47 g; P < 0.001). These decreases were statistically the same for all the treated groups; it is possible to lower the dose of aprotinin to approximately one-third of the currently recommended dosage and still obtain significantly reduced postoperative blood loss in primary cardiac surgery.

摘要

丝氨酸蛋白酶抑制剂抑肽酶可显著减少需要进行体外循环心脏手术的患者的术后失血量。本研究比较了两种低剂量方案与高剂量抑肽酶给药方案及一个对照方案,以确定抑肽酶的剂量是否可以大幅降低,但在初次心脏手术后仍能保持疗效。约100例患者被随机分为四组之一:对照组(0.9%生理盐水安慰剂,n = 25);高剂量组(抑肽酶2×10⁶激肽释放酶灭活剂(KI)单位静脉推注,然后0.5×10⁶ KI单位/小时持续输注,再加上2×10⁶ KI单位加入预充液,n = 25);预充液组(抑肽酶2×10⁶ KI单位加入预充液,n = 24);患者组(抑肽酶10⁶ KI单位静脉推注,再加上10⁶ KI单位加入预充液,n = 26)。只有高剂量组和患者组的患者术中失血量减少,但与对照组相比,所有三个接受抑肽酶治疗组的患者术后失血量中位数均显著降低(高剂量组350 ml,预充液组420 ml,患者组340 ml,对照组780 ml;P < 0.001)。与对照患者相比,治疗组患者胸腔引流管内测得的术后血红蛋白损失中位数减少得更多(高剂量组15 g,预充液组24 g,患者组14 g,对照组47 g;P < 0.001)。所有治疗组的这些减少在统计学上是相同的;可以将抑肽酶的剂量降低至目前推荐剂量的约三分之一,并且在初次心脏手术中仍能显著减少术后失血量。

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Randomized placebo-controlled double-blind study of three aprotinin regimens in primary cardiac surgery.三种抑肽酶方案用于心脏直视手术的随机安慰剂对照双盲研究
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Anaesth Intensive Care. 1994 Oct;22(5):529-33. doi: 10.1177/0310057X9402200505.

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