Franchini Massimo, Franchi Massimo, Bergamini Valentino, Salvagno Gian Luca, Montagnana Martina, Lippi Giuseppe
Servizio di Immunoematologia e Trasfusione - Centro Emofilia, Azienda Ospedaliera di Verona, Verona; Italy.
Semin Thromb Hemost. 2008 Feb;34(1):104-12. doi: 10.1055/s-2008-1066022.
The objective of this review was to evaluate and summarize the current literature on the unlicensed use of the novel agent recombinant activated factor VII (rFVIIa) in the management of major postpartum hemorrhage. After a systematic electronic search without temporal limits on MEDLINE, EMBASE, OVID and SCOPUS, the bibliographic references of all retrieved studies and reviews were additionally assessed for further reports of clinical trials. Unpublished works were also identified by searching abstracts from the most eminent conferences on this topic. In total, there were 31 studies that fulfilled our inclusion criteria. These studies incorporated 118 cases of massive postpartum hemorrhage treated with rFVIIa. The median age of the patients was 31.4 years, and cesarean section appeared to increase the risk of postpartum hemorrhage. At a median dose of 71.6 mug/kg, rFVIIa was reported to be effective in stopping or reducing bleeding in nearly 90% of the reported cases. Based on the evidence from the literature, we give some recommendations on the use of rFVIIa in massive postpartum hemorrhage. Nevertheless, although these reports suggest the potential role of rFVIIa in treating massive postpartum hemorrhage refractory to standard therapy, we advise particular caution in interpreting these results, as they are derived from few and uncontrolled studies. Further evidence is needed using well-designed clinical trials to better assess the optimal dose, the effectiveness, and the safety of rFVIIa in such critical bleeding conditions.
本综述的目的是评估和总结有关新型药物重组活化因子VII（rFVIIa）在治疗严重产后出血中未获许可使用的当前文献。在对MEDLINE、EMBASE、OVID和SCOPUS进行无时间限制的系统电子检索后，还对所有检索到的研究和综述的参考文献进行了评估，以查找进一步的临床试验报告。通过搜索关于该主题的最著名会议的摘要，也确定了未发表的作品。总共有31项研究符合我们的纳入标准。这些研究纳入了118例接受rFVIIa治疗的大量产后出血病例。患者的中位年龄为31.4岁，剖宫产似乎会增加产后出血的风险。据报道，rFVIIa的中位剂量为71.6微克/千克，在近90%的报告病例中可有效止血或减少出血。基于文献证据，我们对rFVIIa在大量产后出血中的使用提出了一些建议。然而，尽管这些报告表明rFVIIa在治疗对标准疗法难治的大量产后出血中可能发挥作用，但我们建议在解释这些结果时要格外谨慎，因为它们来自少数且无对照的研究。需要使用设计良好的临床试验获得进一步证据，以更好地评估rFVIIa在这种严重出血情况下的最佳剂量、有效性和安全性。
