Department of Anaesthesia & Intensive Care, Aarhus University Hospital, Skejby, Aarhus, Denmark.
Eur J Cardiothorac Surg. 2009 Nov;36(5):863-8. doi: 10.1016/j.ejcts.2009.05.040. Epub 2009 Sep 25.
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.
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).
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).
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.
关于抑肽酶在心脏手术中的有效性和安全性一直存在争议。我们需要更多反映大规模、未选择人群日常临床实践的数据。在使用基于人群的丹麦医疗保健数据库的后续研究中，我们比较了抑肽酶和氨甲环酸在心脏手术中的有效性和安全性。
我们共确定了 3535 名于 2003 年 1 月 1 日至 2006 年 12 月 31 日期间在奥胡斯大学医院 Skejby 接受心脏手术的患者；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 的比例将抑肽酶治疗的患者与氨甲环酸治疗的患者相匹配，然后使用泊松回归分析计算相对风险（RR）。
接受抑肽酶治疗的患者术前风险状况比接受氨甲环酸治疗的患者更为严重。两组患者术后引流和红细胞输注率相似，而抑肽酶组输注血浆（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）更为频繁。两组因出血（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（校正 RR=1.06；95% CI：0.69-1.64）、卒中和复合主要事件（校正 RR=1.14；95% CI：0.87-1.50）的再次手术风险无统计学差异。然而，接受抑肽酶治疗的患者术后透析风险增加（校正 RR=1.76；95% CI：1.15-2.70）。
抑肽酶治疗与血浆和血小板输注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。
