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在一家学术医疗中心为严重出血患者实施一项非标签使用重组凝血因子VIIa的方案。

Implementation of an off-label recombinant factor VIIa protocol for patients with critical bleeding at an academic medical center.

作者信息

Bain Jonathan, Lewis Daniel, Bernard Andrew, Hatton Kevin, Reda Hassan, Flynn Jeremy

机构信息

Pharmacy Services, Cedars-Sinai Medical Center, West Hollywood, CA, USA,

出版信息

J Thromb Thrombolysis. 2014 Nov;38(4):447-52. doi: 10.1007/s11239-014-1107-0.

DOI:10.1007/s11239-014-1107-0
PMID:24980752
Abstract

To describe the development of a pharmacy driven off-label recombinant factor seven (rFVIIa) protocol by a multi-disciplinary team for critical bleeding. A multi-disciplinary team made up of members from several critical care and surgical departments within the hospital were formed and charged with developing a standardized approach to how rFVIIa would be used for critical bleeding in an academic medical center. Groups represented on the multi-disciplinary team included clinical pharmacy, emergency medicine, pulmonary, hematology, cardiothoracic surgery, trauma, neurosurgery, and vascular surgery physicians. A pharmacist driven off-label rFVIIa protocol was developed and implemented for the use in those patients with critical bleeding. The protocol was based on the available literature and local expert opinion. Through the use of this protocol a significantly smaller average dose of rFVIIa is now being used when compared to those patients treated prior to the new protocol (47.5 vs. 62.2 mcg/kg, p = 0.036) while all-cause mortality was not significantly altered (35 vs. 48.8%, p = 0.057). An effective and safe pharmacy driven protocol was implemented by a multi-disciplinary team for rFVIIa as seen by providing a significantly lower average dose of rFVIIa while not sacrificing for overall patient mortality.

摘要

描述一个多学科团队制定的由药房主导的非标签使用重组凝血因子 VII(rFVIIa)治疗严重出血的方案。医院组建了一个由多个重症监护和外科部门成员组成的多学科团队,负责制定在学术医疗中心将 rFVIIa 用于严重出血的标准化方法。多学科团队的代表群体包括临床药学、急诊医学、肺病学、血液学、心胸外科、创伤外科、神经外科和血管外科的医生。制定并实施了一个由药剂师主导的非标签使用 rFVIIa 的方案,用于那些严重出血的患者。该方案基于现有文献和当地专家意见。通过使用该方案,与新方案实施前接受治疗的患者相比,现在使用的 rFVIIa 平均剂量显著更小(47.5 微克/千克对 62.2 微克/千克,p = 0.036),而全因死亡率没有显著变化(35%对 48.8%,p = 0.057)。如通过显著降低 rFVIIa 的平均剂量同时不影响患者总体死亡率所示,一个由多学科团队实施的有效且安全的药房主导方案用于 rFVIIa。

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Implementation of an off-label recombinant factor VIIa protocol for patients with critical bleeding at an academic medical center.在一家学术医疗中心为严重出血患者实施一项非标签使用重组凝血因子VIIa的方案。
J Thromb Thrombolysis. 2014 Nov;38(4):447-52. doi: 10.1007/s11239-014-1107-0.
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引用本文的文献

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Antithrombotic and hemostatic stewardship: evaluation of clinical outcomes and adverse events of recombinant factor VIIa (Novoseven) utilization at a large academic medical center.抗栓与止血管理:大型学术医疗中心使用重组凝血因子VIIa(诺其)的临床结局及不良事件评估
Ther Adv Cardiovasc Dis. 2020 Jan-Dec;14:1753944720924255. doi: 10.1177/1753944720924255.
2
Evaluation of Aryoseven Safety (Recombinant Activated Factor VII) in Patients with Bleeding Disorders (An Observational Post-Marketing Surveillance Study).Aryoseven(重组活化凝血因子VII)在出血性疾病患者中的安全性评估(一项上市后观察性监测研究)
Iran J Pathol. 2016 Summer;11(3):204-209.
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