Brekelmans Marjolein P A, Ginkel Kim van, Daams Joost G, Hutten Barbara A, Middeldorp Saskia, Coppens Michiel
Department of Vascular Medicine, Academic Medical Center, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.
University of Amsterdam, Amsterdam, the Netherlands.
J Thromb Thrombolysis. 2017 Jul;44(1):118-129. doi: 10.1007/s11239-017-1506-0.
Prothrombin complex concentrate (PCC) is used for reversal of vitamin K antagonists (VKA) in patients with bleeding complications. This study aims to assess benefits and harms of 4-factor PCC compared to fresh frozen plasma (FFP) or no treatment in VKA associated bleeding. PubMed, EMBASE and CENTRAL were searched from 1945 to August 2015. Studies reporting 4-factor PCC use for VKA associated bleeding and providing data on INR normalization, mortality or thromboembolic (TE) complications were eligible. Two authors screened titles and full articles for inclusion, extracted data, and assessed risk of bias. Mortality data were pooled using Mantel-Haenszel random effects meta-analysis. Nineteen studies were included (N = 2878); 18 cohort studies and one RCT. Six studies had good methodological quality, 9 moderate and 4 poor. Baseline INR values ranged from 2.2 to >20. The INR within 1 h after PCC administration ranged from 1.4 to 1.9, and after FFP administration from 2.2 to 12. PCC reduced the time to reach INR correction in comparison with FFP or no treatment. The observed mortality rate ranged from 0 to 43% (mean 17%) in the PCC, 4.8-54% (mean 16%) in the FFP and 23-69% (mean 51%) in the no treatment group. Meta-analysis of mortality data resulted in an OR of 0.64 (95% confidence interval [CI] 0.27-1.5) for PCC versus FFP and an OR 0.41 (95% CI 0.13-1.3) for PCC versus no treatment. TE complications were observed in 0-18% (mean 2.5%) of PCC and in 6.4% of FFP recipients. Four-factor PCC is an effective and safe option in reversal of VKA bleeding events.
凝血酶原复合物浓缩剂（PCC）用于有出血并发症的维生素K拮抗剂（VKA）逆转治疗。本研究旨在评估与新鲜冰冻血浆（FFP）或不治疗相比，四因子PCC在VKA相关出血中的益处和危害。检索了1945年至2015年8月的PubMed、EMBASE和CENTRAL数据库。纳入报告使用四因子PCC治疗VKA相关出血并提供国际标准化比值（INR）正常化、死亡率或血栓栓塞（TE）并发症数据的研究。两位作者筛选标题和全文以确定纳入研究，提取数据并评估偏倚风险。使用Mantel-Haenszel随机效应荟萃分析汇总死亡率数据。共纳入19项研究（N = 2878）；18项队列研究和1项随机对照试验。6项研究方法学质量良好，9项中等，4项较差。基线INR值范围为2.2至>20。PCC给药后1小时内INR范围为1.4至1.9，FFP给药后为2.2至12。与FFP或不治疗相比，PCC缩短了达到INR纠正的时间。PCC组观察到的死亡率范围为0至43%（平均17%），FFP组为4.8%至54%（平均16%），不治疗组为23%至69%（平均51%）。死亡率数据的荟萃分析显示，PCC与FFP相比的比值比（OR）为0.64（95%置信区间[CI] 0.27 - 1.5），PCC与不治疗相比的OR为0.41（95% CI 0.13 - 1.3）。PCC组TE并发症发生率为0至18%（平均2.5%），FFP接受者中为6.4%。四因子PCC是逆转VKA出血事件的有效且安全的选择。
