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评估比伐卢定对国际标准化比值的影响,以确定过渡到华法林的合适策略。

Evaluation of Bivalirudin's Effect on International Normalized Ratio to Determine an Appropriate Strategy for Transitioning to Warfarin.

作者信息

Fetea Andrea, Gulbis Brian E, Hall Andrea C

机构信息

Houston Methodist San Jacinto Hospital, Baytown, TX, USA.

Memorial Hermann-Texas Medical Center, Houston, TX, USA.

出版信息

J Pharm Technol. 2018 Jun;34(3):117-122. doi: 10.1177/8755122518757973. Epub 2018 Feb 20.

Abstract

Direct thrombin inhibitors are recommended in confirmed or suspected heparin-induced thrombocytopenia. False elevation of the international normalized ratio (INR) occurs with these agents making bridging to warfarin challenging. There is limited data regarding bivalirudin's effect on INR. To evaluate bivalirudin's effect on the INR and determine a strategy for transitioning to warfarin. This was a retrospective observational study. Included patients were >18 years old receiving primary bridging therapy with overlapping bivalirudin and warfarin for at least 72 hours. Patients with administration of alternate anticoagulants during the transition interval or active major bleeding within 48 hours prior to bivalirudin initiation were excluded. The primary endpoint was to determine the effect on INR at first therapeutic activated partial thromboplastin time after bivalirudin initiation and prior to warfarin initiation. Secondary endpoints included change in INR 12 and 24 hours after bivalirudin initiation, change in INR 4 hours after bivalirudin cessation, and incidence of major bleeding or new thrombotic events. Thirty-four patients met study criteria. For the primary endpoint, the change in INR at first therapeutic activated partial thromboplastin time was 0.37 (range = 0.28-0.48), which occurred at 8.4 hours (range = 4.6-14.2; n = 14). INR increased at 12 and 24 hours by a median of 0.55 and 0.5 from baseline, respectively. Median change in INR 4 to 8 hours post-bivalirudin cessation was -0.48. Targeting an INR > 2.5 when bridging to warfarin will account for this false elevation and maintain an INR above 2.0 on bivalirudin discontinuation.

摘要

确诊或疑似肝素诱导的血小板减少症时,推荐使用直接凝血酶抑制剂。使用这些药物会出现国际标准化比值(INR)假性升高的情况,使得过渡到华法林治疗具有挑战性。关于比伐卢定对INR影响的数据有限。为了评估比伐卢定对INR的影响并确定过渡到华法林的策略。这是一项回顾性观察研究。纳入的患者年龄大于18岁,接受比伐卢定和华法林重叠的初始桥接治疗至少72小时。排除在过渡期间使用其他抗凝剂或在比伐卢定开始使用前48小时内有活动性大出血的患者。主要终点是确定在比伐卢定开始使用后且华法林开始使用前首次达到治疗性活化部分凝血活酶时间时对INR的影响。次要终点包括比伐卢定开始使用后12小时和24小时INR的变化、比伐卢定停用后4小时INR的变化以及大出血或新血栓形成事件的发生率。34例患者符合研究标准。对于主要终点,首次达到治疗性活化部分凝血活酶时间时INR的变化为0.37(范围=0.28-0.48),发生在8.4小时(范围=4.6-14.2;n=14)。INR在12小时和24小时分别较基线中位数增加0.55和0.5。比伐卢定停用后4至8小时INR的中位数变化为-0.48。在过渡到华法林时,将INR目标设定>2.5可应对这种假性升高,并在比伐卢定停用后维持INR>2.0。

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