von Heymann Christian, Redlich Uwe, Jain Uday, Kastrup Marc, Schroeder Torsten, Sander Michael, Grosse Joachim, Ziemer Sabine, Koscielny Juergen, Konertz Wolfgang F, Wernecke Klaus-Dieter, Spies Claudia
Department of Anesthesiology and Intensive Care Medicine, St. Mary's Medical Center, San Francisco, CA, USA.
Crit Care Med. 2005 Oct;33(10):2241-6. doi: 10.1097/01.ccm.0000181527.47749.57.
Analysis of safety and efficacy of recombinant activated factor VII (rFVIIa) used as the last resort for refractory bleeding after cardiac surgery.
Retrospective cohort analysis and matched pairs analysis with historic controls were performed. In the rFVIIa group, which also received conventional hemostatic therapy, data were collected for a median of 14 hrs from admission to the intensive care unit (ICU) to the administration of rFVIIa and for the following 24 hrs. In the control group, which received only conventional hemostatic therapy, data were collected for 14 and then for 24 hrs after admission to the ICU.
University hospital.
Twenty-four patients matched with historic controls.
None.
No thromboembolic complications were observed in the rFVIIa group. Blood loss and transfusion requirements were significantly reduced in the period after the administration of rFVIIa. However, in the 24-hr period after rFVIIa administration, blood loss (p = .140) and transfusion of packed red blood cells (p = .442) and fresh frozen plasma (p = .063) were not different between the rFVIIa and control groups. Platelet concentrates (p = .004) were transfused less in the control group. Mortality and 6-month survival rates were not different between the groups.
When used as a last resort, rFVIIa was safe but not incrementally efficacious over conventional hemostatic therapy.
分析重组活化凝血因子 VII（rFVIIa）作为心脏手术后难治性出血的最后治疗手段的安全性和有效性。
进行回顾性队列分析以及与历史对照的配对分析。在 rFVIIa 组（该组也接受了传统止血治疗），收集从入住重症监护病房（ICU）至给予 rFVIIa 期间中位数为 14 小时的数据以及随后 24 小时的数据。在仅接受传统止血治疗的对照组，收集入住 ICU 后 14 小时以及随后 24 小时的数据。
大学医院。
24 例与历史对照匹配的患者。
无。
rFVIIa 组未观察到血栓栓塞并发症。给予 rFVIIa 后期间的失血量和输血需求显著减少。然而，在给予 rFVIIa 后的 24 小时期间，rFVIIa 组与对照组之间的失血量（p = 0.140）、浓缩红细胞输注量（p = 0.442）和新鲜冰冻血浆输注量（p = 0.063）并无差异。对照组输注的血小板浓缩物较少（p = 0.004）。两组之间的死亡率和 6 个月生存率无差异。
当作为最后治疗手段使用时，rFVIIa 是安全的，但相对于传统止血治疗并无额外疗效。
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