本文由小咖机器人翻译整理

期刊来源：N Engl J Med

原文链接：https://doi.org/10.1056/NEJMoa2313040

摘要内容如下：

背景

接受Xa因子抑制剂治疗的急性脑出血患者有血肿扩大的风险。Andexanet Alfa（一种可逆转Xa因子抑制剂作用的药物）对血肿体积扩张的影响尚未得到充分研究。

方法

我们以1:1的比例将急性脑出血前15小时内服用Xa因子抑制剂的患者随机分配接受Andexanet或常规护理。主要终点是止血疗效，定义为基线后12小时血肿体积扩大35%或更少，12小时美国国立卫生研究院卒中量表评分增加小于7分（评分范围为0至42，评分越高表明神经功能缺损越严重），并且在3小时至12小时内未接受补救治疗。安全性终点为血栓事件和死亡。

结果

共有263名患者接受Andexanet治疗，267名患者接受常规治疗。在一项包括452名患者的中期分析中评估了疗效，并在所有530名入选患者中分析了安全性。心房颤动是Xa因子抑制剂最常见的适应症。在接受常规护理的患者中，85.5%接受了凝血酶原复合物浓缩物。接受Andexanet治疗的224例患者中有150例（67.0%）达到止血效果，接受常规治疗的228例患者中有121例（53.1%）达到止血效果（调整后差异为13.4个百分点；95%置信区间[CI]，4.6至22.2；P=0.00 3）。从基线到1-2小时最低点，Andexanet的抗Xa因子活性降低的中位数为94.5%，常规护理为26.9%（P<0.001）。263例接受Andexanet治疗的患者中有27例（10.3%）发生血栓事件，267例接受常规治疗的患者中有15例（5.6%）发生血栓事件（差异4.6个百分点；95%可信区间为0.1~9.2；P=0.048）；缺血性卒中分别为17例（6.5%）和4例（1.5%）。两组在改良Rankin量表评分或30天内死亡方面没有明显差异。

结论

在接受Xa因子抑制剂治疗的脑出血患者中，与常规治疗相比，Andexanet能更好地控制血肿扩大，但与血栓事件（包括缺血性卒中）相关。（由Alexion AstraZeneca Rare Disease和其他公司资助；Annexa-I ClinicalTrials.gov编号，NCT03661528。）

英文原文如下：

Abstracts

BACKGROUND  Patients with acute intracerebral hemorrhage who are receiving factor Xa inhibitors have a risk of hematoma expansion. The effect of andexanet alfa, an agent that reverses the effects of factor Xa inhibitors, on hematoma volume expansion has not been well studied.

METHODS  We randomly assigned, in a 1:1 ratio, patients who had taken factor Xa inhibitors within 15 hours before having an acute intracerebral hemorrhage to receive andexanet or usual care. The primary end point was hemostatic efficacy, defined by expansion of the hematoma volume by 35% or less at 12 hours after baseline, an increase in the score on the National Institutes of Health Stroke Scale of less than 7 points (scores range from 0 to 42, with higher scores indicating worse neurologic deficit) at 12 hours, and no receipt of rescue therapy between 3 hours and 12 hours. Safety end points were thrombotic events and death.

RESULTS  A total of 263 patients were assigned to receive andexanet, and 267 to receive usual care. Efficacy was assessed in an interim analysis that included 452 patients, and safety was analyzed in all 530 enrolled patients. Atrial fibrillation was the most common indication for factor Xa inhibitors. Of the patients receiving usual care, 85.5% received prothrombin complex concentrate. Hemostatic efficacy was achieved in 150 of 224 patients (67.0%) receiving andexanet and in 121 of 228 (53.1%) receiving usual care (adjusted difference, 13.4 percentage points; 95% confidence interval [CI], 4.6 to 22.2; P = 0.003). The median reduction from baseline to the 1-to-2-hour nadir in anti-factor Xa activity was 94.5% with andexanet and 26.9% with usual care (P<0.001). Thrombotic events occurred in 27 of 263 patients (10.3%) receiving andexanet and in 15 of 267 (5.6%) receiving usual care (difference, 4.6 percentage points; 95% CI, 0.1 to 9.2; P = 0.048); ischemic stroke occurred in 17 patients (6.5%) and 4 patients (1.5%), respectively. There were no appreciable differences between the groups in the score on the modified Rankin scale or in death within 30 days.

CONCLUSIONS  Among patients with intracerebral hemorrhage who were receiving factor Xa inhibitors, andexanet resulted in better control of hematoma expansion than usual care but was associated with thrombotic events, including ischemic stroke. (Funded by Alexion AstraZeneca Rare Disease and others; ANNEXA-I ClinicalTrials.gov number, NCT03661528.).

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