Use of aprotinin in cardiac surgery: effectiveness and safety in a population-based study
Use of aprotinin in cardiac surgery: effectiveness and safety in a population-based study
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DOI：
10.1016/j.ejcts.2009.05.040
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发表时间：
2009-11-01
影响因子：
3.4
通讯作者：
Johnsen, Soren P.
中科院分区：
文献类型：
--
作者：
Jakobsen, Carl-Johan;Sondergaard, Flemming;Johnsen, Soren P.
目的：抑肽酶在心脏手术中应用的有效性和安全性受到质疑。需要更多的数据反映大规模、大规模人群的日常临床实践。我们在一项随访研究中，使用基于人群的丹麦卫生保健数据库，比较了抑肽酶与氨甲环酸在心脏手术中的有效性和安全性。研究方法：我们确定了2003年1月1日至2006年12月31日在奥胡斯大学医院Skejby接受心脏手术的3535例患者，其中635例患者接受抑肽酶治疗，2900例患者接受氨甲环酸治疗。我们使用倾向评分匹配，以1：1的比例匹配抑肽酶治疗的患者与氨甲环酸治疗的患者，然后使用泊松回归分析计算相对风险（RR）。结果：与氨甲环酸治疗的患者相比，抑肽酶治疗的患者具有更严重的术前风险特征。两组的术后引流和红细胞输注率相似，而抑肽酶组接受血浆（校正RR = 1.39; 95%置信区间（CI）：1.15-1.68）和血小板（校正RR = 1.47; 95% CI：1.19-1.81）的频率高于氨甲环酸组。由于出血而再次手术的风险没有统计学显著差异（校正RR = 1.22; 95% CI：0.84-1.78），30天死亡率（校正RR = 1.03; 95% CI：0.69-1.54），急性心肌梗死两组之间的主要事件（校正RR = 1.06; 95% CI：0.69-1.64）、卒中（校正RR = 1.36; 95% CI：0.75-2.44）或复合主要事件（校正RR = 1.14; 95% CI：0.87-1.50）。然而，接受抑肽酶治疗的患者术后透析的风险增加（校正的RR = 1.76; 95% CI：1.15-2.70）。结论：抑肽酶治疗与血浆和血小板输注使用增加以及术后透析风险增加相关，但与其他不良结局（包括短期死亡率）无关。(C)2009年欧洲胸外科协会。Elsevier B. V.出版，保留所有权利。
Objective: The effectiveness and safety of aprotinin use in cardiac surgery have been questioned. More data reflecting everyday clinical practice from large-scale, unselected populations are needed. We compared the effectiveness and safety of aprotinin in cardiac surgery with those of tranexamic acid in a follow-up study using the population-based Danish health-care databases. Methods: We identified a total of 3535 patients who underwent cardiac surgery at the Aarhus University Hospital, Skejby, between 1 January 2003 and 31 December 2006; of these, 635 patients were treated with aprotinin and 2900 with tranexamic acid. We used propensity score matching to match aprotinin-treated patients with tranexamic-acid-treated patients in a 1: 1 ratio, followed by Poisson regression analysis to compute relative risks (RRs). Results: Patients treated with aprotinin had more severe preoperative risk profiles than the tranexamic-acid-treated patients. The rates of postoperative drainage and transfusion of red blood cells were similar in the two groups, whereas the aprotinin group received plasma (adjusted RR = 1.39; 95% confidence interval (CI): 1.15-1.68) and platelets (adjusted RR = 1.47; 95% CI: 1.19-1.81) more frequently than the tranexamic acid group. There were no statistically significant differences in risks of re-operation due to bleeding (adjusted RR = 1.22; 95% CI: 0.84-1.78), 30-day mortality (adjusted RR = 1.03; 95% CI: 0.69-1.54), acute myocardial infarction (adjusted RR = 1.06; 95% CI: 0.69-1.64), stroke (adjusted RR = 1.36; 95% CI: 0.75-2.44) or composite major event (adjusted RR = 1.14; 95% CI: 0.87-1.50) between the two groups. However, patients who received aprotinin had an increased risk of postoperative dialysis (adjusted RR = 1.76; 95% CI: 1.15-2.70). Conclusions: Aprotinin treatment was associated with an increased use of plasma and platelet transfusion and an increased risk for postoperative dialysis, but not with other adverse outcomes, including short-term mortality. (C) 2009 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.