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Xa 因子抑制治疗与癌症相关的静脉血栓栓塞症:随机对照试验的荟萃分析。

Factor Xa Inhibition for the Treatment of Venous Thromboembolism Associated With Cancer: A Meta-Analysis of the Randomised Controlled Trials.

机构信息

Department of Cardiology, Austin Health, Melbourne, Vic, Australia; Department of Medicine, The University of Melbourne, Vic, Australia; Department of Oncology, The Olivia Newton John Cancer and Wellness Centre, Melbourne, Vic, Australia.

Department of Cardiology, Austin Health, Melbourne, Vic, Australia; Department of Medicine, The University of Melbourne, Vic, Australia.

出版信息

Heart Lung Circ. 2022 May;31(5):716-725. doi: 10.1016/j.hlc.2021.10.024. Epub 2021 Dec 9.

Abstract

BACKGROUND

Venous thromboembolism (VTE) is a common cause of morbidity and mortality in cancer patients. Until recently, guidelines recommended the use of low-molecular weight heparin (LMWH) as standard of care for VTE in patients with cancer. Despite the proven efficacy of direct oral anticoagulants (DOACs) for treatment of VTE, there is equipoise supporting their use in cancer patients.

METHODS

A systematic review of PubMed, Medline and EMBASE identified four randomised controlled trials (RCTs) in patients with cancer and VTE comparing a factor Xa inhibitor (FXaI) to LMWH. A meta-analysis was performed with a primary outcome of VTE recurrence and key secondary outcomes of major bleeding, clinically relevant non-major bleeding (CRNMB) and gastrointestinal (GI) bleeding.

RESULTS

Four RCTs with 2,907 patients were included. 1,451 patients were randomised to FXaI and 1,456 to LMWH. VTE recurrence was lower in the FXaI group (RR 0.62, 95%CI 0.44-0.87; p=0.01; I=24.90), with an absolute risk difference of -4% equating to a number needed to treat of 25 for prevention of recurrent VTE with FXaI. No significant difference in major bleeding was noted between groups (RR 1.33, 95%CI 0.84-2.11; p=0.23). Rates of GI bleeding (RR 1.87, 95%CI 1.06-3.29; p=0.03) and CRNMB (RR 1.57, 95%CI 1.11-2.23; p=0.01) were greater with FXaIs.

CONCLUSION

In patients with cancer and VTE, the rate of VTE recurrence was significantly lower with FXaI than with LMWH without an increased risk of major bleeding. Our data supports the use of FXaIs as the standard of care for the treatment of VTE in this population.

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。直到最近,指南建议使用低分子量肝素(LMWH)作为癌症患者 VTE 的标准治疗方法。尽管直接口服抗凝剂(DOACs)在治疗 VTE 方面已被证明具有疗效,但在癌症患者中使用它们仍存在争议。

方法

对 PubMed、Medline 和 EMBASE 进行系统评价,确定了四项比较 Xa 因子抑制剂(FXaI)与 LMWH 的癌症合并 VTE 患者的随机对照试验(RCT)。主要结局为 VTE 复发,次要结局为大出血、临床相关非大出血(CRNMB)和胃肠道(GI)出血,进行荟萃分析。

结果

纳入四项 RCT,共 2907 例患者。1451 例患者被随机分配至 FXaI 组,1456 例患者被分配至 LMWH 组。FXaI 组 VTE 复发率较低(RR0.62,95%CI0.44-0.87;p=0.01;I²=24.90),绝对风险差异为-4%,意味着使用 FXaI 预防 VTE 复发的治疗人数为 25。两组大出血无显著差异(RR1.33,95%CI0.84-2.11;p=0.23)。GI 出血(RR1.87,95%CI1.06-3.29;p=0.03)和 CRNMB(RR1.57,95%CI1.11-2.23;p=0.01)的发生率更高。

结论

在癌症合并 VTE 的患者中,与 LMWH 相比,使用 FXaI 治疗 VTE 的复发率显著降低,而大出血的风险没有增加。我们的数据支持将 FXaIs 作为该人群 VTE 治疗的标准治疗方法。

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