是时候重新审视治疗范围内的时间了。
Time to Revisit the Time in the Therapeutic Range.
作者信息
A Reiffel James
机构信息
Professor Emeritus of Medicine, Columbia University.
出版信息
J Atr Fibrillation. 2017 Feb 28;9(5):1569. doi: 10.4022/jafib.1569. eCollection 2017 Feb-Mar.
Abstract
In recent clinical trials, the "quality" of warfarin management has been characterized by the time in therapeutic range (TTR) -- with the therapeutic range being an INR between 2.0 and 3.0. In many reviews of recent clinical trials, differences in the TTR have been used comparatively to critique and contrast the trials. However, TTR is a more complex measurement than is commonly appreciated, and many factors that underlie the TTR calculation, which can differ from trial to trial, have not been adequately addressed. This manuscript attempts to explain these issues so as to help the reader understand the factors that contribute to TTR and to understand the limitations of TTR so as to better understand anticoagulation trial results. It also addresses the issue of INRs below or above the therapeutic range, that can differ among trials, that are not provided simply by presenting a TTR value, but that can in a substantial way affect the bleeding risk and embolism-prevention likelihood of anticoagulation in a trial.
摘要
在最近的临床试验中，华法林管理的“质量”以处于治疗范围内的时间（TTR）为特征，治疗范围是国际标准化比值（INR）在2.0至3.0之间。在最近许多对临床试验的综述中，TTR的差异已被用于比较，以批评和对比各试验。然而，TTR是一个比通常所认为的更为复杂的测量指标，而且TTR计算所依据的许多因素在不同试验中可能有所不同，这些因素尚未得到充分探讨。本手稿试图解释这些问题，以帮助读者理解促成TTR的因素，并理解TTR的局限性，从而更好地理解抗凝试验结果。它还讨论了INR低于或高于治疗范围的问题，这些问题在不同试验中可能不同，仅给出一个TTR值并不能体现这些问题，但它们会在很大程度上影响试验中抗凝治疗的出血风险和预防栓塞的可能性。
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本文引用的文献
1
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J Am Heart Assoc. 2013 Feb 19;2(1):e000067. doi: 10.1161/JAHA.112.000067.
2
Apixaban versus warfarin in patients with atrial fibrillation.阿哌沙班与华法林用于房颤患者。
N Engl J Med. 2011 Sep 15;365(11):981-92. doi: 10.1056/NEJMoa1107039. Epub 2011 Aug 27.
3
Rivaroxaban versus warfarin in nonvalvular atrial fibrillation.利伐沙班与华法林用于非瓣膜性心房颤动。
N Engl J Med. 2011 Sep 8;365(10):883-91. doi: 10.1056/NEJMoa1009638. Epub 2011 Aug 10.
4
An important indirect drug interaction between dronedarone and warfarin that may be extrapolated to other drugs that can alter gastrointestinal function.
Am Heart J. 2011 Feb;161(2):e5; author reply e7. doi: 10.1016/j.ahj.2010.11.013.
5
Dabigatran versus warfarin in patients with atrial fibrillation.达比加群与华法林用于房颤患者的比较。
N Engl J Med. 2009 Sep 17;361(12):1139-51. doi: 10.1056/NEJMoa0905561. Epub 2009 Aug 30.
6
Determinants and measures of quality in oral anticoagulation therapy.口服抗凝治疗的质量决定因素及衡量标准。
J Thromb Thrombolysis. 2008 Feb;25(1):61-6. doi: 10.1007/s11239-007-0106-9. Epub 2007 Sep 29.
7
Optimal INR for prevention of stroke and death in atrial fibrillation: a critical appraisal.心房颤动患者预防卒中及死亡的最佳国际标准化比值：一项批判性评估
Thromb Res. 2006;117(5):493-9. doi: 10.1016/j.thromres.2004.11.025. Epub 2004 Dec 25.
8
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J Thromb Thrombolysis. 2003 Jun;15(3):213-6. doi: 10.1023/B:THRO.0000011377.78585.63.
9
Atrial fibrillation and thromboembolism: a decade of progress in stroke prevention.心房颤动与血栓栓塞：卒中预防十年进展
Ann Intern Med. 1999 Nov 2;131(9):688-95. doi: 10.7326/0003-4819-131-9-199911020-00010.
10
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