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使用包括andexanet alfa和四因子凝血酶原复合物浓缩物在内的逆转或替代药物对口服Xa因子抑制剂相关出血进行的真实世界管理:一项多中心研究。

Real-world management of oral factor Xa inhibitor-related bleeds with reversal or replacement agents including andexanet alfa and four-factor prothrombin complex concentrate: a multicenter study.

作者信息

Coleman Craig I, Dobesh Paul P, Danese Sherry, Ulloa Julie, Lovelace Belinda

机构信息

Department of Pharmacy Practice, University of Connecticut School of Pharmacy, 69 North Eagleville Road, Unit 3092, Storrs, CT 06269-3092, USA.

Department of Pharmacy Practice & Science, College of Pharmacy, University of Nebraska Medical Center, 986145 Nebraska Medical Center, Omaha, NE 68198-6145, USA.

出版信息

Future Cardiol. 2021 Jan;17(1):127-135. doi: 10.2217/fca-2020-0073. Epub 2020 Jul 3.

DOI:10.2217/fca-2020-0073
PMID:32618210
Abstract

We describe the real-world utilization and outcomes associated with managing oral factor Xa inhibitor (FXai)-related major bleeds. Electronic records from 45 US hospitals were queried (ICD-10-CM billing codes D68.32, T45.515x or T45.525x) to identify major bleed hospitalizations related to FXai use. Patient demographics, bleed type (intracranial hemorrhage, gastrointestinal, critical compartment, traumatic, other), FXai taken, reversal or replacement agents administered (including andexanet alfa, four-factor prothrombin complex concentrate, fresh frozen plasma, others), in-hospital mortality and length of stay were recorded. Of 3030 FXai-related hospitalizations for major bleeds, patients averaged 68 years old and 47% were women. In-hospital mortality was highest for intracranial hemorrhage (23%, n = 507) and lowest for gastrointestinal bleeds (4%, n = 1453). In-hospital mortality was lowest (4%) for bleeds managed with andexanet alfa (n = 342), compared with 10% for four-factor prothrombin complex concentrate (n = 733), 11% for fresh frozen plasma (n = 925) and 8% for both other agents (n = 794) and no agents (n = 438). Median length of stay was 5 days across all agents, while ICU length of stay was shorter andexanet alfa (2 days) compared with other agents (3 days). In-hospital mortality differed by bleed type and agents administered. Andexanet alfa was associated with the lowest rate of in-hospital mortality across all bleed types.

摘要

我们描述了与管理口服Xa因子抑制剂(FXai)相关的严重出血相关的实际应用情况及结果。查询了美国45家医院的电子记录(国际疾病分类第十版临床修正版(ICD-10-CM)计费代码D68.32、T45.515x或T45.525x),以确定与使用FXai相关的严重出血住院病例。记录了患者的人口统计学特征、出血类型(颅内出血、胃肠道出血、关键腔隙出血、创伤性出血、其他)、服用的FXai、给予的逆转或替代药物(包括andexanet alfa、四因子凝血酶原复合物浓缩物、新鲜冰冻血浆、其他)、住院死亡率和住院时间。在3030例与FXai相关的严重出血住院病例中,患者平均年龄为68岁,47%为女性。颅内出血的住院死亡率最高(23%,n = 507),胃肠道出血的住院死亡率最低(4%,n = 1453)。使用andexanet alfa治疗的出血患者住院死亡率最低(4%,n = 342),而使用四因子凝血酶原复合物浓缩物治疗的患者住院死亡率为10%(n = 733),使用新鲜冰冻血浆治疗的患者住院死亡率为11%(n = 925),使用其他药物治疗的患者住院死亡率为8%(n = 794),未使用任何药物治疗的患者住院死亡率为8%(n = 438)。所有药物治疗的患者住院时间中位数为5天,而使用andexanet alfa治疗的患者重症监护病房住院时间较短(2天),其他药物治疗的患者为3天。住院死亡率因出血类型和使用的药物而异。在所有出血类型中,andexanet alfa的住院死亡率最低。

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