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首次无诱因静脉血栓栓塞症停止抗凝治疗后重复检测 D-二聚体的意义:PROLONG II 前瞻性研究。

Usefulness of repeated D-dimer testing after stopping anticoagulation for a first episode of unprovoked venous thromboembolism: the PROLONG II prospective study.

机构信息

Department of Angiology and Blood Coagulation, Marino Golinelli University Hospital St Orsola-Malpighi, Bologna, Italy.

出版信息

Blood. 2010 Jan 21;115(3):481-8. doi: 10.1182/blood-2009-08-237354. Epub 2009 Nov 16.

Abstract

The PROLONG randomized trial showed that a normal D-dimer (D-d) 1 month after anticoagulation suspension for unprovoked venous thromboembolism (VTE) was associated with a low risk of late recurrences (4.4% patient years). However, it is unknown whether D-d changes subsequently. The aim of this prospective multicenter study was to assess D-d time course and its relation with late recurrences in patients with normal D-d 1 month after anticoagulation suspension for a first episode of unprovoked VTE. D-d was measured with a qualitative method (Clearview Simplify D-dimer; Inverness Medical Professional Diagnostics). Patients with a normal D-d 1 month after stopping anticoagulation repeated D-d testing every 2 months for 1 year. D-d was normal in 68% (243/355) of patients 1 month after anticoagulation suspension. Patients in whom D-d became abnormal at the third month and remained abnormal afterward had a higher risk of recurrence (7/31; 27% patient years; 95% confidence interval [CI]: 12-48) than patients in whom D-d remained normal at the third month and afterward (4/149; 2.9% patient years; 95% CI: 1-7; adjusted hazard ratio: 7.9; 95% CI: 2.1-30; P = .002). Repeated D-d testing after anticoagulation suspension for a first episode of unprovoked VTE could help tailor the duration of treatment. This trial is registered at http://clinicaltrials.gov as NCT00266045.

摘要

PROLONG 随机试验表明,在未诱发的静脉血栓栓塞症(VTE)抗凝治疗停止 1 个月后 D-二聚体(D-d)正常与晚期复发风险低(4.4%患者年)相关。然而,尚不清楚随后 D-d 是否会发生变化。本前瞻性多中心研究的目的是评估在首次未诱发 VTE 抗凝治疗停止 1 个月后 D-d 正常的患者中 D-d 的时间过程及其与晚期复发的关系。D-d 使用定性方法(Clearview Simplify D-dimer;Inverness Medical Professional Diagnostics)进行测量。D-d 正常的患者在停止抗凝治疗 1 个月后每 2 个月重复 D-d 检测,持续 1 年。在停止抗凝治疗 1 个月后,68%(243/355)的患者 D-d 正常。在第 3 个月 D-d 异常且此后持续异常的患者比第 3 个月和此后 D-d 正常的患者复发风险更高(7/31;27%患者年;95%置信区间 [CI]:12-48)(4/149;2.9%患者年;95% CI:1-7;调整后的危险比:7.9;95% CI:2.1-30;P =.002)。在首次未诱发的 VTE 抗凝治疗停止后重复进行 D-d 检测,可能有助于调整治疗持续时间。该试验在 http://clinicaltrials.gov 上注册,编号为 NCT00266045。

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