Use of recombinant Factor VIIa (rFVIIa) has extended to nonhemophiliac patients anticipated to be at risk of major bleeding (prophylactic) or who have uncontrolled bleeding (therapeutic). The aim of this review was to systematically appraise randomized controlled trial (RCT) evidence for effectiveness of rFVIIa, by updating and extending the earlier Cochrane Systematic Review. Up to January 2007, 17 RCTs were identified in which rFVIIa was used to try to reduce bleeding in patients undergoing planned high blood loss surgery or in acute situations such as trauma, gastrointestinal bleeding, and intracerebral hemorrhage (ICH). Overall, there was little evidence of rFVIIa benefit during planned surgical procedures. Although use in ICH was impressive as both bleed progression and mortality were reduced, preliminary results from a subsequent phase III trial have found no outcome benefit. Selected subgroup analysis or secondary outcome results for other therapeutic trials appeared promising but were usually associated with methodological limitations. The thromboembolic adverse event incidence in subjects who received rFVIIa is of concern and occurred despite a common trial exclusion criterion of patients with a history of previous thromboembolic or vasoocclusive disease. The reasons for increasing use of this drug off license remain unclear, and the results of further trials are required to establish effectiveness.

中文翻译：

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在无血友病患者中使用重组因子VIIa预防和治疗出血的证据。

重组凝血因子VIIa（rFVIIa）的使用已扩展到非血友病患者，这些患者预计有大出血的风险（预防性）或出血失控（治疗性）。这篇综述的目的是通过更新和扩展早期的Cochrane系统评价，系统地评估rFVIIa有效性的随机对照试验（RCT）证据。截至2007年1月，已鉴定出17项RCT，其中rFVIIa用于尝试减少计划内的高失血手术或在诸如创伤，胃肠道出血和脑出血（ICH）等急性情况下的出血。总体而言，几乎没有证据表明在计划的手术过程中rFVIIa获益。尽管ICH的使用令人印象深刻，因为出血进展和死亡率均降低，随后的III期临床试验的初步结果未发现任何获益。其他治疗试验的选定亚组分析或次要结局结果似乎很有希望，但通常与方法学局限性有关。尽管有既往血栓栓塞性疾病或血管闭塞性疾病病史的患者有共同的试验排除标准，但接受rFVIIa的受试者中的血栓栓塞性不良事件发生率值得关注。尚不清楚增加使用这种药物的许可的原因，还需要进一步试验的结果以证实其有效性。尽管有既往血栓栓塞性疾病或血管闭塞性疾病病史的患者有共同的试验排除标准，但接受rFVIIa的受试者中的血栓栓塞性不良事件发生率值得关注。尚不清楚增加使用这种药物的许可的原因，还需要进一步试验的结果以证实其有效性。尽管有既往血栓栓塞性疾病或血管闭塞性疾病病史的患者有共同的试验排除标准，但接受rFVIIa的受试者中的血栓栓塞性不良事件发生率值得关注。尚不清楚增加使用这种药物的许可的原因，还需要进一步试验的结果以证实其有效性。