Duchesne Juan C, Mathew Kavitha A, Marr Alan B, Pinsky Michael R, Barbeau James M, McSwain Norman E
Department of Surgery, Tulane School of Medicine, New Orleans, Louisiana 70112-2699, USA.
Am Surg. 2008 Dec;74(12):1159-65.
Recombinant factor VII (rFVIIa) has arisen as an option for the control of life-threatening traumatic bleeding unresponsive to other means. The timing of administration, dosage, mortality, units of blood transfusion saved, risk of thrombotic events, and risk/benefits ratio are presently poorly defined. A Medline search from 1995 through March 2008 was conducted. All English language articles containing the terms "trauma" and "factor VII" or its variants were retrieved. Letters to the editor, animal studies, and general reviews were excluded. A total of 19 articles met inclusion criteria. These articles were then reviewed and stratified into three classes of evidence according to the quality assessment instrument developed by the Brain and Trauma Foundation. Levels of recommendation were developed. A total of 118 articles were identified. Only one Class I study was identified. This study demonstrated that three doses of rFVIIa given in blunt traumatic hemorrhage yielded a significant reduction of 2.6 of red blood cells used. These findings were not statistically significant for penetrating trauma patients. There was no reduction in mortality and no increase in thromboembolic events. Four Class II studies were identified; three showed a significant decrease of blood product usage and one demonstrated significant reductions in 24-hour and 30 day death from hemorrhage in patients receiving rFVIIa. The remaining 14 studies were Class III reviews of databases, registries, case series, and case reports. No identified study specifically addressed the cost/benefit analysis of rFVIIa usage in trauma hemorrhage. Utility of rFVIIa in trauma-associated hemorrhage remains controversial. There is Level I supporting the use of rFVIIa for blunt trauma patients only. There is no Class I evidence supporting decreased mortality or differences in thromboembolic events. Minimal effective dosing regimens and cost/benefit analyses have not yet been examined.
重组因子VII（rFVIIa）已成为控制其他方法无法应对的危及生命的创伤性出血的一种选择。目前，给药时间、剂量、死亡率、节省的输血单位数、血栓形成事件的风险以及风险/效益比尚不清楚。我们进行了一项从1995年至2008年3月的医学在线数据库检索。检索了所有包含“创伤”和“因子VII”或其变体的英文文章。排除了给编辑的信、动物研究和综述。共有19篇文章符合纳入标准。然后根据脑与创伤基金会制定的质量评估工具对这些文章进行审查，并分为三类证据。制定了推荐级别。共识别出118篇文章。仅识别出一项I类研究。该研究表明，在钝性创伤性出血中给予三剂rFVIIa可使红细胞使用量显著减少2.6个单位。这些结果在穿透性创伤患者中无统计学意义。死亡率没有降低，血栓栓塞事件也没有增加。识别出四项II类研究；三项显示血液制品使用量显著减少，一项显示接受rFVIIa的患者24小时和30天内出血死亡显著减少。其余14项研究为III类对数据库、登记处、病例系列和病例报告的综述。没有识别出的研究专门探讨rFVIIa在创伤性出血中使用的成本/效益分析。rFVIIa在创伤相关性出血中的效用仍存在争议。有I级证据仅支持对钝性创伤患者使用rFVIIa。没有I类证据支持死亡率降低或血栓栓塞事件存在差异。尚未研究最小有效给药方案和成本/效益分析。
