Pagano Domenico, Howell Neil J, Freemantle Nick, Cunningham David, Bonser Robert S, Graham Timothy R, Mascaro Jorge, Rooney Stephen J, Wilson Ian C, Cramb Rob, Keogh Bruce E
Department of Cardiothoracic Surgery, University Hospital Birmingham, Birmingham, United Kingdom.
J Thorac Cardiovasc Surg. 2008 Mar;135(3):495-502. doi: 10.1016/j.jtcvs.2007.11.045.
The antifibrinolytic drug aprotinin has been the most widely used agent to reduce bleeding and its complications in cardiac surgery. Several randomized trials and meta-analyses have demonstrated it to be effective and safe. However, 2 recent reports from a single database have implicated the use of aprotinin as a risk for postoperative complications and reduced long-term survival.
In this single-institution observational study involving 7836 consecutive patients (1998-2006), we assessed the safety of using aprotinin in risk reduction strategy for postoperative bleeding.
Aprotinin was used in 44% of patients. Multivariate analysis identified aprotinin use in risk reduction for reoperation for bleeding (odds ratio, 0.51; 95% confidence interval, 0.36-0.72; P = .001) and need for blood transfusion postoperatively (odds ratio, 0.67; 95% confidence interval, 0.57-0.79; P = .0002). The use of aprotinin did not affect in-hospital mortality (odds ratio, 1.03; 95% confidence interval, 0.71-1.49; P = 0.73), intermediate-term survival (median follow-up, 3.4 years; range, 0-8.9 years; hazard ratio, 1.09; 95% confidence interval, 0.93-1.28; P = .30), incidence of postoperative hemodialysis (odds ratio, 1.16; 95% confidence interval, 0.73-1.85; P = .49), and incidence of postoperative renal dysfunction (odds ratio, 0.78; 95% confidence interval, 0.59-1.03; P = .07).
This study demonstrates that aprotinin is effective in reducing bleeding after cardiac surgery, is safe, and does not affect short- or medium-term survival.
抗纤溶药物抑肽酶是心脏手术中用于减少出血及其并发症的最广泛使用的药物。多项随机试验和荟萃分析已证明其有效且安全。然而，来自单一数据库的两份近期报告表明，使用抑肽酶会增加术后并发症风险并降低长期生存率。
在这项涉及7836例连续患者（1998 - 2006年）的单机构观察性研究中，我们评估了在降低术后出血风险策略中使用抑肽酶的安全性。
44%的患者使用了抑肽酶。多变量分析确定，使用抑肽酶可降低因出血而再次手术的风险（比值比，0.51；95%置信区间，0.36 - 0.72；P = 0.001）以及术后输血需求（比值比，0.67；95%置信区间，0.57 - 0.79；P = 0.0002）。使用抑肽酶不影响住院死亡率（比值比，1.03；95%置信区间，0.71 - 1.49；P = 0.73）、中期生存率（中位随访时间，3.4年；范围，0 - 8.9年；风险比，1.09；95%置信区间，0.93 - 1.28；P = 0.30）、术后血液透析发生率（比值比，1.16；95%置信区间，0.73 - 1.85；P = 0.49）以及术后肾功能不全发生率（比值比，0.78；95%置信区间，0.59 - 1.03；P = 0.07）。
本研究表明，抑肽酶在减少心脏手术后出血方面有效、安全，且不影响短期或中期生存率。
