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首页> 外文期刊>The New England journal of medicine >A comparison of enoxaparin with placebo for the prevention of venous thromboembolism in acutely ill medical patients. Prophylaxis in Medical Patients with Enoxaparin Study Group.
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A comparison of enoxaparin with placebo for the prevention of venous thromboembolism in acutely ill medical patients. Prophylaxis in Medical Patients with Enoxaparin Study Group.

机译：依诺肝素与安慰剂在急性病医疗患者中预防静脉血栓栓塞的比较。依诺肝素研究组的内科患者的预防。

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BACKGROUND: The efficacy and safety of thromboprophylaxis in patients with acute medical illnesses who may be at risk for venous thromboembolism have not been determined in adequately designed trials. METHODS: In a double-blind study, we randomly assigned 1102 hospitalized patients older than 40 years to receive 40 mg of enoxaparin, 20 mg of enoxaparin, or placebo subcutaneously once daily for 6 to 14 days. Most patients were not in an intensive care unit. The primary outcome was venous thromboembolism between days 1 and 14, defined as deep-vein thrombosis detected by bilateral venography (or duplex ultrasonography) between days 6 and 14 (or earlier if clinically indicated) or documented pulmonary embolism. The duration of follow-up was three months. RESULTS: The primary outcome could be assessed in 866 patients. The incidence of venous thromboembolism was significantly lower in the group that received 40 mg of enoxaparin (5.5 percent [16 of 291 patients]) than in the group that received placebo (14.9 percent [43 of 288 patients]) (relative risk, 0.37; 97.6 percent confidence interval, 0.22 to 0.63; P< 0.001). The benefit observed with 40 mg of enoxaparin was maintained at three months. There was no significant difference in the incidence of venous thromboembolism between the group that received 20 mg of enoxaparin (43 of 287 patients [15.0 percent]) and the placebo group. The incidence of adverse effects did not differ significantly between the placebo group and either enoxaparin group. By day 110, 50 patients had died in the placebo group (13.9 percent), 51 had died in the 20-mg group (14.7 percent), and 41 had died in the 40-mg group (11.4 percent); the differences were not significant. CONCLUSIONS: Prophylactic treatment with 40 mg of enoxaparin subcutaneously per day safely and effectively reduces the risk of venous thromboembolism in patients with acute medical illnesses.
机译：背景：在经过适当设计的试验中，尚未确定在可能存在静脉血栓栓塞风险的急性内科疾病患者中预防血栓形成的有效性和安全性。方法：在一项双盲研究中，我们随机分配1102名40岁以上的住院患者，每天皮下注射40毫克依诺肝素，20毫克依诺肝素或安慰剂，持续6至14天。大多数患者不在重症监护室。主要结局是第1天至第14天之间的静脉血栓栓塞，定义为在第6天至第14天之间（或临床上较早时）通过双侧静脉造影（或双工超声检查）检测到的深静脉血栓形成或已记录的肺栓塞。随访时间为三个月。结果：866例患者可以评估主要结局。接受依诺肝素40 mg组的静脉血栓栓塞发生率（5.5％[291名患者中的16名]）显着低于接受安慰剂的组（14.9％[288名患者中的43名]）（相对危险度，0.37;对照组）。置信区间为97.6％，0.22至0.63; P <0.001）。用40 mg依诺肝素观察到的益处维持三个月。接受依诺肝素20 mg组（287例患者中的43例[15.0％]）与安慰剂组之间的静脉血栓栓塞发生率无显着差异。安慰剂组和依诺肝素组之间的不良反应发生率无明显差异。到第110天，安慰剂组死亡50例（占13.9％），20毫克组死亡51例（占14.7％），40毫克组死亡41例（占11.4％）。差异不明显。结论：每天皮下注射40毫克依诺肝素预防性治疗可安全有效地减少急性内科疾病患者静脉血栓栓塞的风险。

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