University of Birmingham Centre for Cardiovascular Sciences, City Hospital, Birmingham, UK.
Drugs. 2012 Sep 10;72(13):1755-64. doi: 10.2165/11635630-000000000-00000.
Venous thromboembolism (VTE) is a common and potentially avoidable cause of morbidity and mortality in patients hospitalized for acute medical illness.
Our objective was to conduct a systematic review of studies that assessed the efficacy and safety of new oral anticoagulant (OAC) drugs versus standard pharmacological drugs and/or placebo in prevention of VTE in acute medically ill patients.
PubMed.org and ClinicalTrials.gov databases were searched to identify studies that evaluated the efficacy and safety of a new OAC versus the standard pharmacological treatment and/or placebo in the prevention of VTE in medically ill patients. Relative risks (RR), weighted means and 95% CIs were calculated. Statistical heterogeneity was evaluated using Chi2 and I2 statistics. Two studies were included in the meta-analysis. The primary outcome in both studies was the composite of VTE-related death, symptomatic non-fatal pulmonary embolism (PE), symptomatic deep venous thrombosis (DVT) and asymptomatic proximal DVT. Both studies compared a factor (F)Xa inhibitor with enoxaparin in standard short-term thromboprophylaxis followed by a period where the FXa inhibitor was compared with placebo as prolonged thromboprophylaxis in medically ill patients. The primary major safety outcome in both studies was a composite of treatment-related major bleeding and clinically relevant non-major bleeding. A total of 14 629 patients were randomized.
Compared with subjects treated with enoxaparin followed by placebo, the RR of the primary outcome during the prolonged treatment period was 0.79 (95% CI 0.66, 0.94), the RR for the primary outcome during the first short-term treatment period was 1.03 (95% CI 0.81, 1.31). For major bleeding during the prolonged treatment period, the RR was 2.69 (95% CI 1.65, 4.39) for patients treated with an FXa inhibitor compared with enoxaparin/placebo. For major bleeding during the shorter treatment period, the RR was 2.01 (95% CI 1.10, 3.65) in favour of enoxaparin.
In acute medically ill patients, prolonged thromboprophylaxis with an oral FXa inhibitor is more protective than regular short-term treatment with enoxaparin. However, treatment with FXa inhibitors is significantly associated with major bleeding, both in long- and short-term treatment compared with enoxaparin.
静脉血栓栓塞症（VTE）是急性内科疾病住院患者发病率和死亡率的常见且潜在可预防的原因。
我们的目的是系统地回顾评估新型口服抗凝药物（OAC）与标准药物治疗和/或安慰剂在预防急性内科疾病患者 VTE 方面的疗效和安全性的研究。
检索 PubMed.org 和 ClinicalTrials.gov 数据库，以确定评估新型 OAC 与标准药物治疗和/或安慰剂在预防内科疾病患者 VTE 方面的疗效和安全性的研究。计算相对风险（RR）、加权平均值和 95%置信区间。使用 Chi2 和 I2 统计评估统计异质性。两项研究被纳入荟萃分析。两项研究的主要结局均为 VTE 相关死亡、有症状非致命性肺栓塞（PE）、有症状深部静脉血栓形成（DVT）和无症状近端 DVT 的复合结局。这两项研究均比较了因子（F）Xa 抑制剂与依诺肝素在标准短期血栓预防后的效果，然后比较了 FXa 抑制剂与安慰剂在延长的内科疾病患者血栓预防中的效果。这两项研究的主要安全性结局均为治疗相关大出血和临床相关非大出血的复合结局。共有 14629 名患者被随机分组。
与接受依诺肝素联合安慰剂治疗的患者相比，延长治疗期间主要结局的 RR 为 0.79（95%CI 0.66，0.94），短期治疗期间主要结局的 RR 为 1.03（95%CI 0.81，1.31）。在延长治疗期间，与依诺肝素/安慰剂相比，接受 FXa 抑制剂治疗的患者大出血的 RR 为 2.69（95%CI 1.65，4.39）。在较短的治疗期间，与依诺肝素相比，接受 FXa 抑制剂治疗的患者大出血的 RR 为 2.01（95%CI 1.10，3.65）。
在急性内科疾病患者中，口服 FXa 抑制剂的延长血栓预防比依诺肝素的常规短期治疗更具保护作用。然而，与依诺肝素相比，FXa 抑制剂的治疗与大出血显著相关，无论是在长期还是短期治疗中。
