Nishijima Daniel K, Zehtabchi Shahriar
Department of Emergency Medicine, University of California-Davis Medical Center, Sacramento, CA 95817, USA.
Ann Emerg Med. 2009 Nov;54(5):737-744.e1. doi: 10.1016/j.annemergmed.2009.01.027. Epub 2009 Mar 14.
The use of recombinant activated factor VII (rFVIIa) in severe trauma is controversial. This evidence-based emergency medicine review evaluates the existing evidence about the efficacy and safety of rFVIIa for the management of severe trauma.
We searched MEDLINE, EMBASE, the Cochrane Library, and other databases. We limited our review to prospective, controlled trials that involved the therapeutic use of rFVIIa in the emergency department phase of care. We included studies with blunt and penetrating severe trauma. The primary outcome measure of interest was mortality. Secondary patient-important outcome measures included neurologic outcome, delayed surgical intervention, and adverse effects. Standard criteria were used to evaluate the quality of published trials.
One randomized, blinded trial met the inclusion criteria. There was no significant difference in mortality or adverse effects between rFVIIa and placebo. Our other selected secondary outcome measures of interest were not reported.
Existing evidence suggests that there is no significant difference in mortality between rFVIIa and placebo. Further research is needed to better understand the efficacy and safety of rFVIIa in patients with severe trauma.
重组活化凝血因子VII（rFVIIa）在严重创伤中的应用存在争议。本循证急诊医学综述评估了关于rFVIIa治疗严重创伤的疗效和安全性的现有证据。
我们检索了MEDLINE、EMBASE、Cochrane图书馆及其他数据库。我们将综述局限于前瞻性对照试验，这些试验涉及在急诊科护理阶段对rFVIIa的治疗性使用。我们纳入了钝性和穿透性严重创伤的研究。感兴趣的主要结局指标是死亡率。次要的对患者重要的结局指标包括神经学结局、延迟手术干预和不良反应。采用标准标准评估已发表试验的质量。
一项随机、双盲试验符合纳入标准。rFVIIa与安慰剂在死亡率或不良反应方面无显著差异。我们感兴趣的其他选定次要结局指标未报告。
现有证据表明，rFVIIa与安慰剂在死亡率方面无显著差异。需要进一步研究以更好地了解rFVIIa在严重创伤患者中的疗效和安全性。
