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阿加曲班和比伐卢定在疑似肝素诱导的血小板减少症患者中的疗效和安全性。

Efficacy and safety of argatroban and bivalirudine in patients with suspected heparin-induced thrombocytopenia.

作者信息

Vo Quynh-Anh T, Lin Joyce K, Tong Lisa M

机构信息

Quynh-Anh T. Vo, PharmD, BCPS, at time of writing, Pharmacy Practice Resident, Veterans Affairs Medical Center, San Francisco, CA.

Joyce K. Lin, PharmD, CACP, BCACP, Anticoagulation Clinical Pharmacist, Veterans Affairs Medical Center, San Francisco, CA; Assistant Clinical Professor of Pharmacy, University of California at San Francisco.

出版信息

Ann Pharmacother. 2015 Feb;49(2):178-84. doi: 10.1177/1060028014562949. Epub 2014 Dec 16.

Abstract

BACKGROUND

Argatroban is the only commercially available Food and Drug Administration (FDA)-approved anticoagulant for managing heparin-induced thrombocytopenia (HIT). However, bivalirudin may be an attractive alternative.

OBJECTIVE

To assess the efficacy and safety of argatroban and bivalirudin in patients with suspected HIT.

METHODS

This single-center, retrospective analysis included patients who received argatroban or bivalirudin for at least 24 hours between January 1, 2000, and June 30, 2012. The primary end point assessed anticoagulation goals, specifically time to therapeutic activated partial thromboplastin time (aPTT) goal and percentage of aPTT values within therapeutic range. Secondary end points included new thromboembolic events, bleeding, and mortality.

RESULTS

Of the 68 patients who met the inclusion criteria, 48 received argatroban and 20 received bivalirudin. Baseline characteristics were similar between the 2 groups except for age, percentage of patients with liver dysfunction, aPTT immediately prior to drug initiation, and the serotonin release assay results. The mean ± SD times to reach therapeutic aPTT goal for argatroban and bivalirudin were 14 ± 15 and 7 ± 8 hours, respectively (P = 0.024). The mean ± SD percentage of aPTT values within therapeutic aPTT goal was 69% ± 23% for argatroban and 84% ± 18% for bivalirudin (P = 0.005). Rates of thromboembolic events were similar between the 2 groups, as were the rates of bleeding and all-cause mortality.

CONCLUSIONS

Bivalirudin appears to reach therapeutic aPTT goal faster with more aPTT values within therapeutic aPTT goal while achieving similar clinical outcomes. Although not approved by the FDA for managing HIT, bivalirudin may be an attractive alternative anticoagulant.

摘要

背景

阿加曲班是唯一一种获得美国食品药品监督管理局(FDA)批准的用于治疗肝素诱导的血小板减少症(HIT)的商业抗凝剂。然而,比伐卢定可能是一种有吸引力的替代药物。

目的

评估阿加曲班和比伐卢定对疑似HIT患者的疗效和安全性。

方法

这项单中心回顾性分析纳入了2000年1月1日至2012年6月30日期间接受阿加曲班或比伐卢定治疗至少24小时的患者。主要终点评估抗凝目标,特别是达到治疗性活化部分凝血活酶时间(aPTT)目标的时间以及aPTT值在治疗范围内的百分比。次要终点包括新的血栓栓塞事件、出血和死亡率。

结果

在符合纳入标准的68例患者中,48例接受了阿加曲班治疗,20例接受了比伐卢定治疗。除年龄、肝功能不全患者百分比、开始用药前的aPTT以及血清素释放试验结果外,两组的基线特征相似。阿加曲班和比伐卢定达到治疗性aPTT目标的平均±标准差时间分别为14±15小时和7±8小时(P = 0.024)。阿加曲班治疗性aPTT目标范围内aPTT值的平均±标准差百分比为69%±23%,比伐卢定为84%±18%(P = 0.005)。两组的血栓栓塞事件发生率、出血率和全因死亡率相似。

结论

比伐卢定似乎能更快达到治疗性aPTT目标,且更多aPTT值处于治疗性aPTT目标范围内,同时临床结果相似。尽管比伐卢定未获FDA批准用于治疗HIT,但它可能是一种有吸引力的替代抗凝剂。

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