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抗凝在恶性肿瘤患者静脉血栓栓塞症一级预防中的作用:随机对照试验的系统评价和荟萃分析。

The role of anticoagulation in venous thromboembolism primary prophylaxis in patients with malignancy: A systematic review and meta-analysis of randomized controlled trials.

机构信息

Department of Internal Medicine, Hurley Medical Center, Michigan State University, Flint, MI, USA.

Department of Internal Medicine, Hurley Medical Center, Michigan State University, Flint, MI, USA.

出版信息

Thromb Res. 2019 Sep;181:36-45. doi: 10.1016/j.thromres.2019.07.007. Epub 2019 Jul 16.

Abstract

BACKGROUND

Venous thromboembolism (VTE) is a common cause of morbidity and mortality among patients with cancer. As such, we conducted a meta-analysis of randomized controlled trials (RCTs) that evaluated anticoagulants as primary prophylaxis against VTE in cancer patients.

METHODS

Pubmed/MEDLINE, Embase, and the Cochrane Library were screened for all RCTs that used anticoagulation therapy in cancer patients for primary prevention of VTE. The primary outcomes were VTE events. Secondary outcomes included all-cause mortality, VTE-related mortality and major bleeding. A random effects model was used to report the risk ratios (RR) with 95% confidence intervals (CIs), and odds ratios (ORs) with Bayesian 95% credible intervals for both direct and network meta-analyses, respectively.

RESULTS

Twenty-four RCTs were included totaling 13,338 patients (7197 received anticoagulation and 6141 received placebo). The mean age ranged between 54.6 and 68.1 years, with 50.5% male. Compared with placebo, low-molecular-weight heparin (LMWH) or direct Xa inhibitors were associated with lower VTE events (RR 0.58; 95%CI 0.48-0.69, P < 0.001) and (RR 0.39; 95%CI 0.24-0.63, p < 0.001), respectively. LMWH was associated with decreased VTE and all-cause mortality when compared with placebo (P < 0.05). Regarding safety outcomes, LMWH and direct Xa inhibitors were not associated with increased risks of major bleeding (P > 0.05) when compared with placebo. Results regarding VTE events and major bleeding were consistent in both lung and pancreatic cancers.

CONCLUSIONS

Both LMWH and direct Xa inhibitors were associated with a lower VTE events compared with placebo. However, this potentially protective effect must be balanced against the possible increased risk of bleeding for some patients.

摘要

背景

静脉血栓栓塞症(VTE)是癌症患者发病率和死亡率的常见原因。因此,我们对评估抗凝剂作为癌症患者 VTE 一级预防的随机对照试验(RCT)进行了荟萃分析。

方法

通过 Pubmed/MEDLINE、Embase 和 Cochrane 图书馆对所有使用抗凝治疗的癌症患者进行 VTE 一级预防的 RCT 进行了筛选。主要结局是 VTE 事件。次要结局包括全因死亡率、VTE 相关死亡率和大出血。使用随机效应模型报告风险比(RR)和 95%置信区间(CI),以及直接和网络荟萃分析的贝叶斯 95%可信区间的优势比(OR)。

结果

共纳入 24 项 RCT,共计 13338 例患者(7197 例接受抗凝治疗,6141 例接受安慰剂)。平均年龄在 54.6 至 68.1 岁之间,男性占 50.5%。与安慰剂相比,低分子肝素(LMWH)或直接 Xa 抑制剂与较低的 VTE 事件相关(RR 0.58;95%CI 0.48-0.69,P<0.001)和(RR 0.39;95%CI 0.24-0.63,P<0.001)。与安慰剂相比,LMWH 可降低 VTE 和全因死亡率(P<0.05)。关于安全性结局,与安慰剂相比,LMWH 和直接 Xa 抑制剂并未增加大出血的风险(P>0.05)。在肺癌和胰腺癌中,VTE 事件和大出血的结果一致。

结论

与安慰剂相比,LMWH 和直接 Xa 抑制剂均可降低 VTE 事件的发生率。然而,对于某些患者,这种潜在的保护作用必须与出血风险增加相平衡。

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