PDF(Pubmed)
Abstract：
The administration of 4-factor prothrombin complex concentrate (4F-PCC) has expanded beyond its Food and Drug Administration (FDA)-approved indication for the emergent reversal of vitamin K antagonists (VKAs). Therefore, this study aimed to evaluate the risks and benefits associated with the expanded use of 4F-PCC. We conducted a single-center retrospective review of 4F-PCC administrations at our university hospital. Of the 159 patients who received 4F-PCC, 76% (n = 121) and 24% (n = 38) received it for the FDA-approved indication in the vitamin K-related coagulopathy (VKA) group and for expanded use in the nonvitamin K-related coagulopathy (nVKA) group, respectively. The expanded use of 4F-PCC was associated with a less robust reduction in the international normalized ratio (INR) (INR of -0.7 ± 1.3 vs INR of -1.6 ± 1.8, P = .002), and fewer patients in the nVKA group achieved a postadministration INR of less than1.5 (11% vs 79%, P = .001) than those in the VKA group. Furthermore, the 30-day mortality rate was significantly higher in the nVKA cohort than in the VKA cohort (42% vs 20%, P = .04). Notably, based on our data, underlying differences in the patient\'s comorbidities, particularly advanced liver disease, may have contributed to the observed outcome variations, including mortality rate. Therefore, factors, including comorbidities and the underlying etiology of coagulopathy, should be considered when deciding on the expanded use of 4F-PCC. Further research is needed to better understand the potential risks and benefits of 4F-PCC in expanded use scenarios, and the clinical decision to use 4F-PCC outside its FDA-approved indication should be made carefully, considering this information.
摘要：
4因子凝血酶原复合物浓缩物（4F-PCC）的给药范围已超出其食品和药物管理局（FDA）批准的维生素K拮抗剂（VKAs）紧急逆转适应症。因此,本研究旨在评估与4F-PCC扩大使用相关的风险和收益.我们对我们大学医院的4F-PCC管理部门进行了单中心回顾性审查。在接受4F-PCC的159名患者中，76％（n=121）和24％（n=38）在维生素K相关凝血病（VKA）组中获得FDA批准的适应症以及在非维生素K相关凝血病（nVKA）组中扩大使用，分别。4F-PCC的扩大使用与国际标准化比率（INR）（INR为-0.7±1.3，INR为-1.6±1.8，P=0.002）的较不稳健的降低有关，nVKA组患者的给药后INR小于1.5(11%vs79%，P=.001）比VKA组。此外，nVKA队列的30天死亡率明显高于VKA队列(42%vs20%,P=.04）。值得注意的是,根据我们的数据，患者合并症的潜在差异，尤其是晚期肝病，可能导致了观察到的结果变化，包括死亡率。因此,因素，包括合并症和凝血病的潜在病因，在决定扩大使用4F-PCC时应予以考虑。需要进一步研究，以更好地了解4F-PCC在扩展使用场景中的潜在风险和益处，在FDA批准的适应症之外使用4F-PCC的临床决定应该谨慎做出，考虑到这些信息。
