术中低剂量重组活化因子 VII 在胸主动脉手术中的应用。
Intraoperative use of low-dose recombinant activated factor VII during thoracic aortic operations.
机构信息
Department of Surgery, Division of Cardiovascular and Thoracic Surgery, Duke University Medical Center, Durham, North Carolina 27710, USA.
出版信息
Ann Thorac Surg. 2012 Jun;93(6):1921-8; discussion 1928-9. doi: 10.1016/j.athoracsur.2012.02.037. Epub 2012 May 1.
BACKGROUND
Numerous studies have supported the effectiveness of recombinant activated factor VII (rFVIIa) for the control of bleeding after cardiac procedures; however safety concerns persist. Here we report the novel use of intraoperative low-dose rFVIIa in thoracic aortic operations, a strategy intended to improve safety by minimizing rFVIIa exposure.
METHODS
Between July 2005 and December 2010, 425 consecutive patients at a single referral center underwent thoracic aortic operations with cardiopulmonary bypass (CPB); 77 of these patients received intraoperative low-dose rFVIIa (≤60 μg/kg) for severe coagulopathy after CPB. Propensity matching produced a cohort of 88 patients (44 received intraoperative low-dose rFVIIa and 44 controls) for comparison.
RESULTS
Matched patients receiving intraoperative low-dose rFVIIa got an initial median dose of 32 μg/kg (interquartile range [IQR], 16-43 μg/kg) rFVIIa given 51 minutes (42-67 minutes) after separation from CPB. Patients receiving intraoperative low-dose rFVIIa demonstrated improved postoperative coagulation measurements (partial thromboplastin time 28.6 versus 31.5 seconds; p=0.05; international normalized ratio, 0.8 versus 1.2; p<0.0001) and received 50% fewer postoperative blood product transfusions (2.5 versus 5.0 units; p=0.05) compared with control patients. No patient receiving intraoperative low-dose rFVIIa required postoperative rFVIIa administration or reexploration for bleeding. Rates of stroke, thromboembolism, myocardial infarction, and other adverse events were equivalent between groups.
CONCLUSIONS
Intraoperative low-dose rFVIIa led to improved postoperative hemostasis with no apparent increase in adverse events. Intraoperative rFVIIa administration in appropriately selected patients may correct coagulopathy early in the course of refractory blood loss and lead to improved safety through the use of smaller rFVIIa doses. Appropriately powered randomized studies are necessary to confirm the safety and efficacy of this approach.
背景
许多研究支持重组活化因子 VII(rFVIIa)在心脏手术后控制出血的有效性；然而，安全性问题仍然存在。在这里，我们报告了术中低剂量 rFVIIa 在胸主动脉手术中的新应用，这一策略旨在通过最小化 rFVIIa 的暴露来提高安全性。
方法
在 2005 年 7 月至 2010 年 12 月期间，单一转诊中心的 425 例连续患者接受了心肺转流术（CPB）下的胸主动脉手术；其中 77 例患者在 CPB 后出现严重凝血障碍时接受了术中低剂量 rFVIIa（≤60μg/kg）治疗。通过倾向匹配产生了一组 88 例患者（44 例接受术中低剂量 rFVIIa，44 例对照）进行比较。
结果
接受术中低剂量 rFVIIa 的匹配患者在与 CPB 分离后 51 分钟（42-67 分钟）时给予初始中位数剂量为 32μg/kg（四分位距 [IQR]，16-43μg/kg）rFVIIa。接受术中低剂量 rFVIIa 的患者术后凝血测量值得到改善（部分凝血活酶时间 28.6 秒对 31.5 秒；p=0.05；国际标准化比值 0.8 对 1.2；p<0.0001），与对照组相比，术后血液制品输注量减少 50%（2.5 单位对 5.0 单位；p=0.05）。没有接受术中低剂量 rFVIIa 的患者需要术后 rFVIIa 治疗或再次探查出血。两组之间的中风、血栓栓塞、心肌梗死和其他不良事件发生率相当。
结论
术中低剂量 rFVIIa 可改善术后止血效果，且不良事件发生率无明显增加。在适当选择的患者中，术中 rFVIIa 的给药可能会在难治性失血过程中早期纠正凝血障碍，并通过使用较小剂量的 rFVIIa 来提高安全性。需要进行适当的、有影响力的随机研究来证实这种方法的安全性和有效性。
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