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依诺肝素术后预防深静脉血栓形成方案的疗效

Efficacy of a postoperative regimen of enoxaparin in deep vein thrombosis prophylaxis.

作者信息

Turpie A G

机构信息

McMaster University Department of Medicine, Hamilton, Ontario, Canada.

出版信息

Am J Surg. 1991 Apr;161(4):532-6. doi: 10.1016/0002-9610(91)91126-4.

Abstract

Venous thromboembolism is a common complication in patients undergoing elective hip replacement, in whom the incidence of calf vein thrombosis is 40% to 60%; proximal vein thrombosis, 20%; and fatal pulmonary embolism, 1% to 2% when prophylaxis is not used. A double-blind, randomized trial comparing low-molecular-weight heparin (enoxaparin) with placebo for the prevention of venous thrombosis in patients undergoing elective hip surgery was carried out. Prophylactic treatment with a fixed dose was begun postoperatively and continued for 14 days. Fifty patients in each treatment group underwent surveillance with 125I-fibrinogen leg scanning and impedance plethysmography. In the first 24 patients, venography was performed only if their surveillance test was positive. Venography was requested in the remaining 76 patients even if the screening tests were negative; in this latter group, venous thrombosis occurred in 4 patients (10.8%) given enoxaparin and 20 patients (51.3%) given placebo (p = 0.0002). The corresponding rates for proximal vein thrombosis were 5.4% and 23.1%, respectively (p = 0.029). In the entire group of 100 patients, venous thrombosis occurred in 12% of those given enoxaparin and 42% of those given placebo (p = 0.0007). The corresponding rates for proximal vein thrombi were 4% and 20%, respectively (p = 0.014). The observed hemorrhagic rate was 5% in each treatment group. The results of this study show that prophylaxis with fixed-dose enoxaparin is effective and safe for patients undergoing elective hip replacement.

摘要

静脉血栓栓塞是择期髋关节置换患者常见的并发症,在未采取预防措施的情况下,小腿静脉血栓形成的发生率为40%至60%;近端静脉血栓形成的发生率为20%;致命性肺栓塞的发生率为1%至2%。开展了一项双盲随机试验,比较低分子量肝素(依诺肝素)与安慰剂对择期髋关节手术患者预防静脉血栓形成的效果。术后开始使用固定剂量进行预防性治疗,并持续14天。每个治疗组的50名患者接受了¹²⁵I-纤维蛋白原腿部扫描和阻抗体积描记法监测。在前24名患者中,仅在监测试验呈阳性时才进行静脉造影。即使筛查试验为阴性,其余76名患者也被要求进行静脉造影;在这后一组中,接受依诺肝素治疗的患者中有4名(10.8%)发生静脉血栓,接受安慰剂治疗的患者中有20名(51.3%)发生静脉血栓(p = 0.0002)。近端静脉血栓形成的相应发生率分别为5.4%和23.1%(p = 0.029)。在100名患者的整个组中,接受依诺肝素治疗的患者中有12%发生静脉血栓,接受安慰剂治疗的患者中有42%发生静脉血栓(p = 0.0007)。近端静脉血栓的相应发生率分别为4%和20%(p = 0.014)。每个治疗组观察到的出血率均为5%。本研究结果表明,固定剂量依诺肝素预防对择期髋关节置换患者有效且安全。

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