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磺达肝癸钠作为心脏手术后患者肝素诱导的血小板减少症管理的安全替代药物。

Fondaparinux as a safe alternative for managing heparin-induced thrombocytopenia in postoperative cardiac surgery patients.

作者信息

Cegarra-Sanmartín Virginia, González-Rodríguez Raúl, Paniagua-Iglesias Pilar, Santamaría-Ortiz Amparo, Cueva Luisa F, Galán-Serrano Josefa, Moral-García M Victoria

机构信息

Service of Anesthesiology, Post Operative Care Unit of Cardiac Surgery.

Service of Anesthesiology, Post Operative Care Unit of Cardiac Surgery.

出版信息

J Cardiothorac Vasc Anesth. 2014 Aug;28(4):1008-12. doi: 10.1053/j.jvca.2013.09.008. Epub 2014 Jan 16.

Abstract

OBJECTIVE

Heparin-induced thrombocytopenia (HIT) is a rare but severe prothrombotic disorder of heparin treatment that leads to a decline in platelet count and thrombotic complications. If HIT is suspected, then heparin should be stopped and an alternative anticoagulant started. Fondaparinux is a factor Xa-inhibitor that is not FDA-approved for this condition, but preliminary experience in HIT patients has been reported in the literature. The present study describes an experience of anticoagulation management with fondaparinux in postoperative cardiac surgery patients.

DESIGN

Retrospective study.

SETTING

Tertiary hospital.

PARTICIPANTS

Patients who had undergone cardiac surgery from October 2009 to June 2012.

INTERVENTIONS

After HIT was suspected clinically, PaGIA and ELISA test were performed in all patients to diagnose HIT. In the patients included, anticoagulation was managed with a low dose of fondaparinux and daily monitoring of platelet count and anti-Xa level.

MEASUREMENTS AND MAIN RESULTS

Of a total of 1,338 postoperative cardiac surgery patients, 15 patients were included (1.1%). Twelve of the 15 patients with HIT presented with renal failure and were under continuous renal replacement therapy. Two major bleeding events occurred during fondaparinux treatment, although platelet count and anti-Xa activity remained within the normal range. No thrombotic episodes were diagnosed.

CONCLUSION

With daily monitoring of anti-Xa activity, fondaparinux appeared to be a good alternative to heparin in the study group; however, randomized clinical trials are needed to establish the safety and efficacy of this drug in critically ill, previously HIT patients.

摘要

目的

肝素诱导的血小板减少症(HIT)是肝素治疗中一种罕见但严重的促血栓形成疾病,会导致血小板计数下降和血栓形成并发症。如果怀疑发生HIT,则应停用肝素并开始使用替代抗凝剂。磺达肝癸钠是一种Xa因子抑制剂,虽未获美国食品药品监督管理局(FDA)批准用于此病症,但文献中已报道了其在HIT患者中的初步应用经验。本研究描述了磺达肝癸钠在心脏手术后患者抗凝管理中的应用经验。

设计

回顾性研究。

地点

三级医院。

参与者

2009年10月至2012年6月期间接受心脏手术的患者。

干预措施

临床怀疑发生HIT后,对所有患者进行血小板功能免疫分析(PaGIA)和酶联免疫吸附测定(ELISA)以诊断HIT。纳入的患者采用低剂量磺达肝癸钠进行抗凝管理,并每日监测血小板计数和抗Xa水平。

测量指标和主要结果

在总共1338例心脏手术后患者中,有15例被纳入研究(1.1%)。15例HIT患者中有12例出现肾衰竭并接受持续肾脏替代治疗。在磺达肝癸钠治疗期间发生了2例严重出血事件,尽管血小板计数和抗Xa活性仍在正常范围内。未诊断出血栓形成事件。

结论

通过每日监测抗Xa活性,磺达肝癸钠在研究组中似乎是肝素的良好替代品;然而,需要进行随机临床试验以确定该药物在重症、既往有HIT的患者中的安全性和有效性。

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