Huttner Hagen B, Schellinger Peter D, Hartmann Marius, Köhrmann Martin, Juettler Eric, Wikner Johannes, Mueller Stephan, Meyding-Lamade Uta, Strobl Ralf, Mansmann Ulrich, Schwab Stefan, Steiner Thorsten
Department of Neurology, University of Heidelberg, Germany.
Stroke. 2006 Jun;37(6):1465-70. doi: 10.1161/01.STR.0000221786.81354.d6. Epub 2006 May 4.
Intracerebral hemorrhage (ICH) is the most serious and potentially fatal complication of oral anticoagulant therapy (OAT). Still, there are no universally accepted treatment regimens for patients with OAT-ICH, and randomized controlled trials do not exist. The aim of the present study was to compare the acute treatment strategies of OAT-associated ICH using vitamin K (VAK), fresh frozen plasma (FFP), and prothrombin complex concentrates (PCCs) with regard to hematoma growth and outcome.
In this retrospective study, a total of 55 treated patients were analyzed. Three groups were compared by reviewing the clinical, laboratory, and neuroradiological parameters: (1) patients who received PCCs alone or in combination with FFP or VAK (n=31), (2) patients treated with FFP alone or in combination with VAK (n=18), and (3) patients who received VAK as a monotherapy (n=6). The end points of early hematoma growth and outcome after 12 months were analyzed including multivariate analysis.
Hematoma growth within 24 hours occurred in 27% of patients. Incidence and extent of hematoma growth were significantly lower in patients receiving PCCs (19%/44%) compared with FFP (33%/54%) and VAK (50%/59%). However, this effect was no longer seen between PCC- and FFP-treated patients if international normalized ratio (INR) was completely reversed within 2 hours after admission. The overall outcome was poor (modified Rankin scale 4 to 6 in 77%). Predictors for hematoma growth were an increased INR after 2 hours, whereas administration of PCCs was significantly protective in multivariate analyses. Predictors for a poor outcome were age, baseline hematoma volume, and occurrence of hematoma growth.
Overall, PCC was associated with a reduced incidence and extent of hematoma growth compared with FFP and VAK. This effect seems to be related to a more rapid INR reversal. Randomized controlled trials are needed to identify the most effective acute treatment regimen for lasting INR reversal because increased levels of INR were predisposing for hematoma enlargement.
脑出血（ICH）是口服抗凝治疗（OAT）最严重且可能致命的并发症。然而，对于OAT-ICH患者，尚无普遍接受的治疗方案，也不存在随机对照试验。本研究的目的是比较使用维生素K（VAK）、新鲜冰冻血浆（FFP）和凝血酶原复合物浓缩剂（PCCs）治疗OAT相关性ICH的急性治疗策略在血肿扩大和预后方面的差异。
在这项回顾性研究中，共分析了55例接受治疗的患者。通过回顾临床、实验室和神经放射学参数对三组进行比较：（1）单独接受PCCs或与FFP或VAK联合使用的患者（n = 31），（2）单独接受FFP或与VAK联合使用的患者（n = 18），以及（3）接受VAK单一疗法的患者（n = 6）。分析了早期血肿扩大和12个月后的预后终点，包括多因素分析。
24小时内血肿扩大发生在27%的患者中。与FFP（33%/54%）和VAK（50%/59%）相比，接受PCCs的患者血肿扩大的发生率和程度显著更低（19%/44%）。然而，如果入院后2小时内国际标准化比值（INR）完全逆转，PCC治疗组和FFP治疗组患者之间则不再有此差异。总体预后较差（改良Rankin量表评分为4至6分的患者占77%）。血肿扩大的预测因素是2小时后INR升高，而在多因素分析中，使用PCCs具有显著的保护作用。预后不良的预测因素是年龄、基线血肿体积和血肿扩大的发生情况。
总体而言，与FFP和VAK相比，PCC与血肿扩大的发生率和程度降低相关。这种效应似乎与INR更快逆转有关。需要进行随机对照试验以确定最有效的急性治疗方案，实现持续的INR逆转，因为INR升高易导致血肿扩大。
