Shaw Andrew D, Stafford-Smith Mark, White William D, Phillips-Bute Barbara, Swaminathan Madhav, Milano Carmelo, Welsby Ian J, Aronson Solomon, Mathew Joseph P, Peterson Eric D, Newman Mark F
Department of Anesthesiology, Duke University Medical Center, Durham, NC 27516, USA.
N Engl J Med. 2008 Feb 21;358(8):784-93. doi: 10.1056/NEJMoa0707768.
Aprotinin has recently been associated with adverse outcomes in patients undergoing cardiac surgery. We reviewed our experience with this agent in patients undergoing cardiac surgery at Duke University Medical Center.
We retrieved data on 10,275 consecutive patients undergoing surgical coronary revascularization at Duke between January 1, 1996, and December 31, 2005. We fit data to a logistic-regression model predicting each patient's likelihood of receiving aprotinin on the basis of preoperative characteristics and to models predicting long-term survival (up to 10 years) and decline in renal function, as measured by increases in serum creatinine levels.
A total of 1343 patients (13.2%) received aprotinin, 6776 patients (66.8%) received aminocaproic acid, and 2029 patients (20.0%) received no antifibrinolytic therapy. All patients underwent coronary-artery bypass grafting, and 1181 patients (11.5%) underwent combined coronary-artery bypass grafting and valve surgery. In the risk-adjusted model, survival was worse among patients treated with aprotinin, with a main-effects hazard ratio for death of 1.32 (95% confidence interval [CI], 1.12 to 1.55) for the comparison with patients receiving no antifibrinolytic therapy (P=0.003) and 1.27 (95% CI, 1.10 to 1.46) for the comparison with patients receiving aminocaproic acid (P=0.004). As compared with the use of aminocaproic acid or no antifibrinolytic agent, aprotinin use was also associated with a larger risk-adjusted increase in the serum creatinine level (P<0.001) but not with a greater risk-adjusted incidence of dialysis (P=0.56).
Patients who received aprotinin had a higher mortality rate and larger increases in serum creatinine levels than those who received aminocaproic acid or no antifibrinolytic agent.
近来，抑肽酶与心脏手术患者的不良预后相关。我们回顾了在杜克大学医学中心接受心脏手术患者使用该药物的经验。
我们检索了1996年1月1日至2005年12月31日期间在杜克大学接受外科冠状动脉血运重建术的10275例连续患者的数据。我们将数据拟合到一个逻辑回归模型，该模型根据术前特征预测每位患者接受抑肽酶的可能性，并拟合到预测长期生存（长达10年）和肾功能下降（以血清肌酐水平升高衡量）的模型。
共有1343例患者（13.2%）接受了抑肽酶治疗，6776例患者（66.8%）接受了氨基己酸治疗，2029例患者（20.0%）未接受抗纤溶治疗。所有患者均接受了冠状动脉旁路移植术，1181例患者（11.5%）接受了冠状动脉旁路移植术和瓣膜手术联合治疗。在风险调整模型中，接受抑肽酶治疗的患者生存率较差，与未接受抗纤溶治疗的患者相比，死亡的主效应风险比为1.32（95%置信区间[CI]，1.12至1.55）（P=0.003），与接受氨基己酸治疗的患者相比为1.27（95%CI，1.10至1.46）（P=0.004）。与使用氨基己酸或不使用抗纤溶药物相比，使用抑肽酶还与血清肌酐水平更大的风险调整增加相关（P<0.001），但与风险调整后的透析发生率更高无关（P=0.56）。
与接受氨基己酸或未接受抗纤溶药物的患者相比，接受抑肽酶治疗的患者死亡率更高，血清肌酐水平升高幅度更大。
