Refaai Majed A, Kothari Truptesh H, Straub Shana, Falcon Jacob, Sarode Ravi, Goldstein Joshua N, Brainsky Andres, Omert Laurel, Lee Martin L, Milling Truman J
University of Rochester Medical Center, Rochester, NY, USA.
Seton Dell Medical School Stroke Institute, Dell Children's Medical Center, University Medical Center at Brackenridge, Austin, TX, USA.
Emerg Med Int. 2017;2017:8024356. doi: 10.1155/2017/8024356. Epub 2017 Sep 19.
To investigate the impact of a 4-factor prothrombin complex concentrate (4F-PCC [Beriplex®/Kcentra®]) versus plasma on "time to procedure" in patients with acute/severe gastrointestinal bleeding requiring rapid vitamin K antagonist (VKA) reversal prior to invasive procedure.
A post hoc analysis of two phase III trials of 4F-PCC versus plasma in patients with acute/severe gastrointestinal bleeding. The treatment arms were compared for study treatment volume, infusion times, and time from start of study treatment to procedure.
Analysis included 42 patients (plasma, = 20; 4F-PCC, = 22). Median (interquartile range) infusion time was significantly shorter for the 4F-PCC group than for the plasma group (16 [13, 26] min versus 210 [149, 393] min; < 0.0001). Median infusion volumes were significantly smaller (103 [80, 130] mL versus 870 [748, 1001] mL; < 0.0001) and median time from study treatment initiation to first procedure was significantly shorter in the 4F-PCC group than in the plasma group (17.5 [12.8, 22.8] versus 23.9 [18.5, 62.0] h; = 0.037).
In this analysis of patients with acute/severe gastrointestinal bleeding requiring urgent VKA reversal prior to an invasive procedure, 4F-PCC (compared with plasma) was associated with smaller infusion volumes, shorter infusion times, and reduced time to procedure.
探讨四因子凝血酶原复合物浓缩剂（4F-PCC [百瑞凝®/科恩凝血因子®]）与血浆相比，对需要在侵入性操作前快速逆转维生素K拮抗剂（VKA）的急性/严重胃肠道出血患者的“至操作时间”的影响。
对两项4F-PCC与血浆用于急性/严重胃肠道出血患者的III期试验进行事后分析。比较治疗组的研究治疗量、输注时间以及从开始研究治疗到进行操作的时间。
分析纳入42例患者（血浆组，n = 20；4F-PCC组，n = 22）。4F-PCC组的中位（四分位间距）输注时间显著短于血浆组（16 [13, 26]分钟对210 [149, 393]分钟；P < 0.0001）。4F-PCC组的中位输注量显著更小（103 [80, 130]毫升对870 [748, 1001]毫升；P < 0.0001），且4F-PCC组从开始研究治疗到首次操作的中位时间显著短于血浆组（17.5 [12.8, 22.8]对23.9 [18.5, 62.0]小时；P = 0.037）。
在这项对需要在侵入性操作前紧急逆转VKA的急性/严重胃肠道出血患者的分析中，4F-PCC（与血浆相比）与输注量更小、输注时间更短以及至操作时间缩短相关。
