背景:抑肽酶,一种丝氨酸蛋白酶抑制剂,在之前的几项研究之后,在关于其安全性的持续辩论中,已经在心脏手术中得到了不同的应用。这项研究评估了抑肽酶在高危孤立冠状动脉旁路移植术(iCABG)患者中的预后。
方法:该研究回顾性分析了1026例iCABG患者的队列,包括接受抑肽酶治疗的51例患者。采用Logistic回归加力评分匹配法对抑肽酶患者与对照组进行比较,在96名患者的倾向匹配队列中。测量的主要结果是住院死亡,次要结局包括肾功能不全,中风,心肌梗塞,再次探查出血或填塞,和术后停留时间。
结果:抑肽酶队列中有高风险的术前患者,其EUROSCOREII值明显更高,7.5(±4.2),对照组为3.9(±2.5)。然而,抑肽酶组住院死亡率无统计学显著增加(p值:0.44),OR为2.5[95%CI0.51,12.3].与对照组相比,肾脏替代治疗和术后卒中的主要次要结局率在两组之间也无统计学意义。
结论:这项研究表明,抑肽酶可以安全地用于选择的高危iCABG患者组。在特定条件下重新引入抑肽酶反映了其在高风险手术中管理出血的潜在益处。但也强调了其在这种重症监护环境中的风险收益特征的复杂性。尽管如此,它强调了仔细选择患者和进行额外研究的重要性,包括更大规模和更受控的研究,以充分理解抑肽酶的潜在风险和益处。
BACKGROUND: Aprotinin, a serine protease inhibitor, has been used variably in cardiac surgery amidst ongoing debates about its safety following several previous studies. This study assesses the outcomes of aprotinin in high-risk isolated Coronary Artery Bypass Graft (iCABG) patients.
METHODS: The study retrospectively analysed a cohort of 1026 iCABG patients, including 51 patients who underwent aprotinin treatment. Logistic regression powered score matching was employed to compare aprotinin patients with a control group, in a propensity-matched cohort of 96 patients. The primary outcome measured was in-hospital death, with secondary outcomes including renal dysfunction, stroke, myocardial infarction, re-exploration for bleeding or tamponade, and postoperative stay durations.
RESULTS: The aprotinin cohort had high-risk preoperative patients with significantly higher EUROSCORE II values, 7.5 (± 4.2), compared to 3.9 (± 2.5) in control group. However, aprotinin group showed no statistically significant increase (p-value: 0.44) in hospital mortality with OR 2.5 [95% CI 0.51, 12.3]. Major secondary outcome rates of renal replacement therapy and postoperative stroke compared to the control group were also statistically insignificant between the two groups.
CONCLUSIONS: This study suggests that aprotinin may be safely used in a select group of high-risk iCABG patients. The reintroduction of aprotinin under specific conditions reflects its potential benefits in managing bleeding in high-risk surgeries, but also underscores the complexity of its risk-benefit profile in such critical care settings. Nonetheless, it highlights the importance of carefully selecting patients and conducting additional research, including larger and more controlled studies to fully comprehend the potential risks and benefits of aprotinin.