当前位置： SCI文献检索 > ANNALS OF INTERNAL MEDICINE期刊下所有文献 > Fondaparinux or enoxaparin for the initial treatment of symptomatic deep venous thrombosis: a randomized trial.

Fondaparinux or enoxaparin for the initial treatment of symptomatic deep venous thrombosis: a randomized trial.

Abstract：

BACKGROUND:The current standard initial therapies for deep venous thrombosis are low-molecular-weight heparin and unfractionated heparin. In a dose-ranging study of patients with symptomatic deep venous thrombosis, fondaparinux had efficacy and a safety profile similar to those of low-molecular-weight heparin (dalteparin). OBJECTIVE:To evaluate whether fondaparinux has efficacy and safety similar to those of enoxaparin in patients with deep venous thrombosis. DESIGN:Randomized, double-blind study. SETTING:154 centers worldwide. PATIENTS:2205 patients with acute symptomatic deep venous thrombosis. INTERVENTION:Fondaparinux, 7.5 mg (5.0 mg in patients weighing <50 kg and 10.0 mg in patients weighing >100 kg) subcutaneously once daily, or enoxaparin, 1 mg/kg of body weight, subcutaneously twice daily for at least 5 days and until vitamin K antagonists induced an international normalized ratio greater than 2.0. MEASUREMENTS:The primary efficacy outcome was the 3-month incidence of symptomatic recurrent venous thromboembolic complications. The main safety outcomes were major bleeding during initial treatment and death. An independent, blinded committee adjudicated all outcomes. RESULTS:43 (3.9%) of 1098 patients randomly assigned to fondaparinux had recurrent thromboembolic events compared with 45 (4.1%) of 1107 patients randomly assigned to enoxaparin (absolute difference, -0.15 percentage point [95% CI, -1.8 to 1.5 percentage points]). Major bleeding occurred in 1.1% of patients receiving fondaparinux and 1.2% of patients receiving enoxaparin. Mortality rates were 3.8% and 3.0%, respectively. LIMITATIONS:Follow-up was incomplete in 0.4% of fondaparinux-treated patients and 1.0% of enoxaparin-treated patients. CONCLUSIONS:Once-daily subcutaneous fondaparinux was at least as effective (not inferior) and safe as twice-daily, body weight-adjusted enoxaparin in the initial treatment of patients with symptomatic deep venous thrombosis.

journal_name

Ann Intern Med

journal_title

Annals of internal medicine

authors

Büller HR,Davidson BL,Decousus H,Gallus A,Gent M,Piovella F,Prins MH,Raskob G,Segers AE,Cariou R,Leeuwenkamp O,Lensing AW,Matisse Investigators.

doi

10.7326/0003-4819-140-11-200406010-00007

subject

Has Abstract

pub_date

2004-06-01 00:00:00

pages

867-73

issue

eissn

0003-4819

issn

1539-3704

pii

140/11/867

journal_volume

140

pub_type

临床试验,杂志文章,多中心研究,随机对照试验

在线工具

Fondaparinux or enoxaparin for the initial treatment of symptomatic deep venous thrombosis: a randomized trial.