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有症状的终点指标在静脉血栓预防研究中是否可接受?

Are symptomatic endpoints acceptable in venous thromboprophylactic studies?

作者信息

Prentice C R

机构信息

Department of Clinical Medicine, General Infirmary and University of Leeds, UK.

出版信息

Haemostasis. 1998;28 Suppl 3:109-12. doi: 10.1159/000022387.

DOI:10.1159/000022387
PMID:10069771
Abstract

Chemoprophylaxis with subcutaneous low-molecular-weight heparin has been shown to reduce deep vein thrombosis detected by surrogate endpoints such as fibrinogen scanning and venography. However, there have been few trials which have assessed clinical endpoints attributed to fatal and non-fatal pulmonary embolism following surgery. As these clinical endpoints are rare, large-scale trials using vascular mortality, vascular morbidity and the incidence of haemorrhage as clinical endpoints need to be performed to assess the efficacy of chemical thromboprophylaxis. The benefit of using clinical endpoints against the risk of haemorrhage should also be evaluated.

摘要

皮下注射低分子量肝素进行化学预防已被证明可减少通过纤维蛋白原扫描和静脉造影等替代终点检测到的深静脉血栓形成。然而,很少有试验评估手术后归因于致命和非致命性肺栓塞的临床终点。由于这些临床终点很少见,因此需要进行以血管死亡率、血管发病率和出血发生率作为临床终点的大规模试验,以评估化学血栓预防的疗效。还应评估使用临床终点相对于出血风险的益处。

相似文献

1
Are symptomatic endpoints acceptable in venous thromboprophylactic studies?有症状的终点指标在静脉血栓预防研究中是否可接受?
Haemostasis. 1998;28 Suppl 3:109-12. doi: 10.1159/000022387.
2
What are the most reliable detection methods for deep vein thrombosis and pulmonary embolism to be used as endpoints in trials of venous thromboprophylaxis?在静脉血栓预防试验中,用作终点的深静脉血栓形成和肺栓塞最可靠的检测方法有哪些?
Haemostasis. 1998;28 Suppl 3:113-9. doi: 10.1159/000022388.
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A fixed-dose combination of low molecular weight heparin with dihydroergotamine versus adjusted-dose unfractionated heparin in the prevention of deep-vein thrombosis after total hip replacement.低分子量肝素与双氢麦角胺固定剂量组合对比调整剂量普通肝素预防全髋关节置换术后深静脉血栓形成的研究
Thromb Haemost. 1996 Feb;75(2):246-50.
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[Efficient ambulatory and post-discharge thromboprophylaxis with fully automated pens].[使用全自动笔进行有效的门诊和出院后血栓预防]
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A comparison of subcutaneous low-molecular-weight heparin with warfarin sodium for prophylaxis against deep-vein thrombosis after hip or knee implantation.皮下注射低分子量肝素与华法林钠预防髋或膝关节置换术后深静脉血栓形成的比较。
N Engl J Med. 1993 Nov 4;329(19):1370-6. doi: 10.1056/NEJM199311043291902.
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Preventing venous thromboembolism in general medical inpatients and after an ischaemic stroke.
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Surrogate endpoints for the assessment of efficacy in venous thromboembolism treatment trials.
Haemostasis. 1998;28 Suppl 3:127-30. doi: 10.1159/000022390.
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Prevention of fatal postoperative pulmonary embolism by low doses of heparin. An international multicentre trial.小剂量肝素预防术后致命性肺栓塞。一项国际多中心试验。
Lancet. 1975 Jul 12;2(7924):45-51.
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Low-molecular-weight heparin in the treatment of pulmonary embolism.低分子量肝素治疗肺栓塞
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引用本文的文献

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J Am Coll Surg. 2011 Nov;213(5):596-603, 603.e1. doi: 10.1016/j.jamcollsurg.2011.07.015. Epub 2011 Aug 25.
2
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达肝素:其在预防和治疗血栓栓塞性疾病方面的药理特性及临床疗效的最新进展
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