Thrombosis Research Institute and University College London, London, United Kingdom.
N Engl J Med. 2011 Dec 29;365(26):2463-72. doi: 10.1056/NEJMoa1111288.
Although thromboprophylaxis reduces the incidence of venous thromboembolism in acutely ill medical patients, an associated reduction in the rate of death from any cause has not been shown.
We conducted a double-blind, placebo-controlled, randomized trial to assess the effect of subcutaneous enoxaparin (40 mg daily) as compared with placebo--both administered for 10±4 days in patients who were wearing elastic stockings with graduated compression--on the rate of death from any cause among hospitalized, acutely ill medical patients at participating sites in China, India, Korea, Malaysia, Mexico, the Philippines, and Tunisia. Inclusion criteria were an age of at least 40 years and hospitalization for acute decompensated heart failure, severe systemic infection with at least one risk factor for venous thromboembolism, or active cancer. The primary efficacy outcome was the rate of death from any cause at 30 days after randomization. The primary safety outcome was the rate of major bleeding during and up to 48 hours after the treatment period.
A total of 8307 patients were randomly assigned to receive enoxaparin plus elastic stockings with graduated compression (4171 patients) or placebo plus elastic stockings with graduated compression (4136 patients) and were included in the intention-to-treat population. The rate of death from any cause at day 30 was 4.9% in the enoxaparin group as compared with 4.8% in the placebo group (risk ratio, 1.0; 95% confidence interval [CI], 0.8 to 1.2; P=0.83). The rate of major bleeding was 0.4% in the enoxaparin group and 0.3% in the placebo group (risk ratio, 1.4; 95% CI, 0.7 to 3.1; P=0.35).
The use of enoxaparin plus elastic stockings with graduated compression, as compared with elastic stockings with graduated compression alone, was not associated with a reduction in the rate of death from any cause among hospitalized, acutely ill medical patients. (Funded by Sanofi; LIFENOX ClinicalTrials.gov number, NCT00622648.).
尽管血栓预防可降低急性病医学患者静脉血栓栓塞的发生率，但并未显示其可降低任何原因导致的死亡率。
我们进行了一项双盲、安慰剂对照、随机试验，评估皮下依诺肝素（每日 40mg）与安慰剂（在穿着有梯度压缩弹力袜的患者中使用 10±4 天）相比，在参加中国、印度、韩国、马来西亚、墨西哥、菲律宾和突尼斯的参与站点住院的急性病医学患者中的任何原因导致的死亡率的影响。纳入标准为年龄至少 40 岁且因急性失代偿性心力衰竭、至少有一个静脉血栓栓塞风险因素的严重全身感染或活动性癌症而住院。主要疗效终点为随机分组后 30 天的任何原因死亡率。主要安全性终点为治疗期间和治疗结束后 48 小时内的大出血发生率。
共 8307 例患者随机分配接受依诺肝素加有梯度压缩弹力袜（4171 例）或安慰剂加有梯度压缩弹力袜（4136 例）治疗，并纳入意向治疗人群。依诺肝素组第 30 天的任何原因死亡率为 4.9%，安慰剂组为 4.8%（风险比，1.0；95%置信区间[CI]，0.8 至 1.2；P=0.83）。依诺肝素组的大出血发生率为 0.4%，安慰剂组为 0.3%（风险比，1.4；95%CI，0.7 至 3.1；P=0.35）。
与单独使用有梯度压缩弹力袜相比，依诺肝素加有梯度压缩弹力袜的使用并未降低住院急性病医学患者的任何原因死亡率。（由赛诺菲资助；LIFENOX ClinicalTrials.gov 编号，NCT00622648）。
