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【文摘发布】缺血性卒中后预防致死性血凝块

Title:The efficacy and safety of enoxaparin versus unfractionated heparin for the prevention of venous thromboembolism after acute ischaemic stroke (PREVAIL Study): an open-label randomised comparison
Author: Prof David G Sherman MD, Prof Gregory W Albers MD, Prof Christopher Bladin MD, et al
Resource:The Lancet 2007; Volume 369:1347-1355
ABSTRACT
Summary
Background
Venous thromboembolism prophylaxis with low molecular weight heparin or unfractionated heparin is recommended in acute ischaemic stroke, but which regimen provides
optimum treatment is uncertain. We aimed to compare the efficacy and safety of enoxaparin with that of unfractionated heparin for patients with stroke.

Methods
1762 patients with acute ischaemic stroke who were unable to walk unassisted were randomly assigned within 48 h of symptoms to receive either enoxaparin 40 mg subcutaneously once daily or unfractionated heparin 5000 U subcutaneously every 12 h for 10 days (range 6–14). Patients were stratified by National Institutes of Health Stroke Scale (NIHSS) score (severe stroke ≥14, less severe stroke <14). The primary efficacy endpoint was the composite of symptomatic or asymptomatic deep vein thrombosis, symptomatic pulmonary embolism, or fatal pulmonary embolism. Primary safety endpoints were symptomatic intracranial haemorrhage, major extracranial haemorrhage, and all-cause mortality. This study is registered with ClinicalTrials.gov, number NCT00077805.

Findings
In the efficacy population (ie, one or more dose received, presence of deep vein thrombosis or pulmonary embolism, or assessment for venous thromboembolism), enoxaparin (n=666) and unfractionated heparin (669) were given for 10·5 days (SD 3·2). Enoxaparin reduced the risk of venous thromboembolism by 43% compared with unfractionated heparin (68 [10%] vs 121 [18%]; relative risk 0·57, 95% CI 0·44–0·76, p=0·0001; difference −7·9%, −11·6 to −4·2); this reduction was consistent for patients with an NIHSS score of 14 or more (26 [16%] vs 52 [30%]; p=0·0036) or less than 14 (42 [8%] vs 69 [14%]; p=0·0044). The occurrence of any bleeding was similar with enoxaparin (69 [8%]) or unfractionated heparin (71 [8%]; p=0·83). The frequency of the composite of symptomatic intracranial and major extracranial haemorrhage was small and closely similar between groups (enoxaparin 11 [1%] vs unfractionated heparin 6 [1%]; p=0·23). We noted no difference for symptomatic intracranial haemorrhage between groups (4 [1%] vs 6 [1%], respectively; p=0·55); the rate of major extracranial bleeding was higher with enoxaparin than with unfractionated heparin (7 [1%] vs 0; p=0·015).
Interpretation
Our results suggest that for patients with acute ischaemic stroke, enoxaparin is preferable to unfractionated heparin for venous thromboembolism prophylaxis in view of its better clinical benefits to risk ratio and convenience of once daily administration. 本人已经认领该文翻译,如48小时内未提交译文,请其他战友自由认领。 Title:The efficacy and safety of enoxaparin versus unfractionated heparin for the prevention of venous thromboembolism after acute ischaemic stroke (PREVAIL Study): an open-label randomised comparison
Author: Prof David G Sherman MD, Prof Gregory W Albers MD, Prof Christopher Bladin MD, et al
Resource:The Lancet 2007; Volume 369:1347-1355

题目:依诺肝素和普通肝素预防急性缺血性卒中后静脉血栓形成的效能和安全性(prevail研究):一项开放标记的随机对照研究
作者:Prof David G Sherman MD, Prof Gregory W Albers MD, Prof Christopher Bladin MD, et al
来源:Lancet, 2007; Volume 369:1347-1355

ABSTRACT
Summary
Background
Venous thromboembolism prophylaxis with low molecular weight heparin or unfractionated heparin is recommended in acute ischaemic stroke, but which regimen provides optimum treatment is uncertain. We aimed to compare the efficacy and safety of enoxaparin with that of unfractionated heparin for patients with stroke.
摘要
摘要
背景:急性缺血性卒中后肾静脉血栓形成的预防一般推荐使用低分子量肝素或普通肝素,但哪一种方法的疗效最佳尚无定论。本研究的目的是观察依诺肝素与普通肝素相比,其疗效和安全性如何。

Methods
1762 patients with acute ischaemic stroke who were unable to walk unassisted were randomly assigned within 48 h of symptoms to receive either enoxaparin 40 mg subcutaneously once daily or unfractionated heparin 5000 U subcutaneously every 12 h for 10 days (range 6–14). Patients were stratified by National Institutes of Health Stroke Scale (NIHSS) score (severe stroke ≥14, less severe stroke <14). The primary efficacy endpoint was the composite of symptomatic or asymptomatic deep vein thrombosis, symptomatic pulmonary embolism, or fatal pulmonary embolism. Primary safety endpoints were symptomatic intracranial haemorrhage, major extracranial haemorrhage, and all-cause mortality. This study is registered with ClinicalTrials.gov, number NCT00077805.

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作者:admin@医学,生命科学    2010-10-29 17:11
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