Department of Thoracic and Cardiovascular Surgery, Carolinas Heart and Vascular Institute, Carolinas Medical Center, Charlotte, NC 28203, USA.
Eur J Cardiothorac Surg. 2009 Nov;36(5):869-75. doi: 10.1016/j.ejcts.2009.04.053. Epub 2009 Sep 25.
Aprotinin is the only Food and Drug Administration-approved agent to reduce haemorrhage related to cardiac surgery and its safety and efficacy has been extensively studied. Our study sought to compare the efficacy, early and late mortality and major morbidity associated with aprotinin compared with e-aminocaproic acid (EACA) in cardiac surgery operations.
Between January 2002 and December 2006, 2101 patients underwent coronary artery bypass grafting (CABG), valve surgery or CABG and valve surgery in our institution with the use of aprotinin (1898 patients) or EACA (203 patients). Logistic regression and propensity score analysis were used to adjust for imbalances in the patients' preoperative characteristics. The propensity score-adjusted sample included 570 patients who received aprotinin and 114 who received EACA (1-5 matching).
Operative mortality was higher in the aprotinin group in univariate (aprotinin 4.3% vs EACA 1%, p=0.023) but not propensity score-adjusted multivariate analysis (4% vs 0.9%, p=0.16). In propensity score-adjusted analysis, aprotinin was also associated with a lower rate of blood transfusion (38.8% vs 50%, p=0.04), a lower rate of haemorrhage-related re-exploration (3.7% vs 7.9%, p=0.04) and a higher risk of in-hospital cardiac arrest (3.7% vs 0%, p=0.03) and a marginally but not statistically significantly higher risk of acute renal failure (6.8% vs 2.6%, p=0.09). In Cox proportional hazards regression analysis, the risk of late death was higher in the aprotinin compared to EACA group (hazard ratio=4.33, 95% confidence interval (CI)=1.60-11.67, p=0.004).
Aprotinin decreases the rate of postoperative blood transfusion and haemorrhage-related re-exploration, but increases the risk of in-hospital cardiac arrest and late mortality after cardiac surgery when compared to EACA. Cumulative evidence suggests that the risk associated with aprotinin may not be worth the haemostatic benefit.
抑肽酶是唯一获得美国食品和药物管理局批准用于减少心脏手术相关出血的药物，其安全性和有效性已得到广泛研究。我们的研究旨在比较抑肽酶与氨基己酸（EACA）在心脏手术中的疗效、早期和晚期死亡率以及主要发病率。
在 2002 年 1 月至 2006 年 12 月期间，本机构的 2101 例患者接受了冠状动脉旁路移植术（CABG）、瓣膜手术或 CABG 和瓣膜手术，其中使用抑肽酶（1898 例）或 EACA（203 例）。使用逻辑回归和倾向评分分析来调整患者术前特征的不平衡。倾向评分调整后的样本包括接受抑肽酶的 570 例患者和接受 EACA 的 114 例患者（1-5 匹配）。
在单变量分析中，抑肽酶组的手术死亡率较高（抑肽酶 4.3% vs EACA 1%，p=0.023），但在倾向评分调整后的多变量分析中则不然（4% vs 0.9%，p=0.16）。在倾向评分调整分析中，抑肽酶也与较低的输血率（38.8% vs 50%，p=0.04）、较低的出血相关再次探查率（3.7% vs 7.9%，p=0.04）和较高的院内心脏骤停风险（3.7% vs 0%，p=0.03）相关，并且急性肾功能衰竭的风险略高，但无统计学意义（6.8% vs 2.6%，p=0.09）。在 Cox 比例风险回归分析中，与 EACA 相比，抑肽酶组的晚期死亡风险更高（风险比=4.33，95%置信区间（CI）=1.60-11.67，p=0.004）。
与 EACA 相比，抑肽酶可降低心脏手术后的输血率和出血相关再次探查率，但增加院内心脏骤停和心脏手术后晚期死亡率的风险。累积证据表明，与抑肽酶相关的风险可能不值得获得止血益处。
