抑肽酶与心脏手术围手术期并发症

Kertai M D, Varga K S, Royston D, London M J, Szabolcs Z, Grebenik C R, Acsady G, Gal J

Department of Cardiovascular Surgery, Semmelweis University, Budapest, Hungary.

J Cardiovasc Surg (Torino). 2007 Dec;48(6):761-72.

AIM

Recently, the clinical significance of aprotinin-induced renal dysfunction and other end-organ complications in patients undergoing cardiac surgery has engendered substantial controversy. Therefore, we assessed the effect of aprotinin on end-organ complications in patients undergoing cardiac surgery.

METHODS

Data of 674 patients (mean age 65.4 +/- 11.0 years, 457 males) undergoing cardiac surgery between January 1 and December 31, 2005 at Semmelweis University were used for the analyses. Preoperative, intraoperative and postoperative clinical and surgical variables were recorded. Patients administered aprotinin received the drug either as a low-dose regimen, a loading dose of 1 million kallikrein-inhibitor units (KIU), 1 million KIU in pump, and 1 million KIU post pump (or continuous infusion of 0.25 million KIU per hour); or a high-dose regimen, a loading dose of 2 million KIU, 2 million KIU in pump, and 2 million KIU post pump (or continuous infusion of 0.5 million KIU per hour). The outcomes were renal complications defined as a 25% reduction in postoperative calculated creatinine clearance compared to the preoperative baseline or renal failure requiring dialysis; and the composite of renal, cardiovascular and cerebrovascular complications and all-cause mortality.

RESULTS

Patients underwent coronary artery bypass surgery (63%), valvular (27%) or a combination (5%) and surgery on the ascending aorta (5%). There were 550 patients (81.6%) who received aprotinin treatment. In multivariate regression analyses when the relation between high or low dose aprotinin compared to no aprotinin was evaluated, the likelihood of renal complications [high dose: odds ratio (OR)=1.4, 95% confidence interval (CI), 0.6-3.0, P=0.4; low dose: OR=1.2, 95%CI, 0.7-2.3, p=0.5], and the composite outcome variable (high dose: OR=1.6, 95%CI, 0.8-3.4, P=0.2; low dose: OR=1.3, 95%CI, 0.7-2.3, P=0.4) were not significantly increased.

CONCLUSION

Our analysis suggests that aprotinin use in either a high or low dose regimen was not associated with an increase in adverse end-organ complications.

目的

近期，抑肽酶诱发的肾功能障碍及其他终末器官并发症在心脏手术患者中的临床意义引发了大量争议。因此，我们评估了抑肽酶对心脏手术患者终末器官并发症的影响。

方法

分析2005年1月1日至12月31日在塞梅尔维斯大学接受心脏手术的674例患者（平均年龄65.4±11.0岁，男性457例）的数据。记录术前、术中和术后的临床及手术变量。接受抑肽酶治疗的患者，药物给药方式为低剂量方案，负荷剂量为100万激肽释放酶抑制单位（KIU），泵入100万KIU，泵后100万KIU（或每小时持续输注25万KIU）；或高剂量方案，负荷剂量为200万KIU，泵入200万KIU，泵后200万KIU（或每小时持续输注50万KIU）。观察指标为：肾功能并发症定义为术后计算的肌酐清除率较术前基线降低25%或需要透析的肾衰竭；以及肾脏、心血管和脑血管并发症的综合指标和全因死亡率。

结果

患者接受冠状动脉搭桥手术（63%）、瓣膜手术（27%）或联合手术（5%）以及升主动脉手术（5%）。550例患者（81.6%）接受了抑肽酶治疗。在多因素回归分析中，评估高剂量或低剂量抑肽酶与未使用抑肽酶相比的关系时，肾功能并发症的发生可能性[高剂量：比值比（OR）=1.4，95%置信区间（CI），0.6 - 3.0，P = 0.4；低剂量：OR = 1.2，95%CI，0.7 - 2.3，P = 0.5]，以及综合结局变量（高剂量：OR = 1.6，95%CI，0.8 - 3.4，P = 0.2；低剂量：OR = 1.3，95%CI，0.7 - 2.3，P = 0.4）均未显著增加。