Acute ischemic heart disease - Randomized comparison of enoxaparin with unfractionated heparin for the prevention of venous thromboembolism in medical patients with heart failure or severe respiratory disease
Acute ischemic heart disease - Randomized comparison of enoxaparin with unfractionated heparin for the prevention of venous thromboembolism in medical patients with heart failure or severe respiratory disease
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DOI：
10.1067/mhj.2003.189
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发表时间：
2003-04-01
影响因子：
4.8
通讯作者：
Flosbach, CW
中科院分区：
文献类型：
--
作者：
Kleber, FX;Witt, C;Flosbach, CW
背景我们比较了低分子肝素依诺肝素和普通肝素（UFH）预防心力衰竭或严重呼吸系统疾病患者静脉血栓栓塞性疾病的有效性和安全性。一项开放性研究，患者在德国的64个医疗部门接受依诺肝素（40 mg，每日一次）或UFH（5000 IU，每日3次）治疗10 +/- 2天。根据患者的基础疾病（重度呼吸系统疾病或心力衰竭）对患者进行分层和入组。主要疗效参数是治疗期后1天内的血栓栓塞事件，结果在665例入组患者中，451例患者能够在主要疗效分析中进行评价。血栓栓塞事件的发生率在依诺肝素组为8.4%，在普通肝素组为10.4%。依诺肝素至少与UFH一样有效，单侧等效区域为4%（90% CI-2.5 - 6.5，P = 0.015）。依诺肝素与更少的死亡，更少的出血，并显着减少不良事件（45.8%比53.8%，P = 0.044）。结论依诺肝素是至少一样有效的UFH在预防血栓栓塞事件的心力衰竭或严重呼吸系统疾病患者。其有益的安全性特征和每日一次给药有利于住院和门诊使用。
Background We compared the efficacy and safety of the low-molecular weight heparin enoxaparin with unfractionated heparin (UFH) for the prevention of venous thromboembolic disease in patients with heart failure or severe respiratory disease.Methods This was a multicenter, controlled, randomized, open study in which patients received either enoxaparin (40 mg once daily) or UFH (5000 IU 3 times daily) for 10 +/- 2 days in 64 medical departments in Germany. Patients were stratified and enrolled according to their underlying disease: severe respiratory disease or heart failure. The primary efficacy parameter was a thromboembolic event up to 1 day after the treatment period.Results of the 665 patients enrolled, 451 patients were able to be evaluated in the primary efficacy analysis. The incidence of thromboembolic events was 8.4% with enoxaparin and 10.4% with UFH. Enoxaparin was at least as effective as UFH, with a I-sided equivalence region of 4% (90% Cl -2.5-6.5, P = .015). Enoxaparin was associated with fewer deaths, less bleeding, and significantly fewer adverse events (45.8% vs 53.8%, P = .044).Conclusions Enoxaparin is at least as effective as UFH in the prevention of thromboembolic events in patients with heart failure or severe respiratory disease. Its beneficial safety profile and once-daily administration is advantageous for inpatient and outpatient use.