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直接口服抗凝剂用于癌症门诊患者的血栓预防

Direct oral anticoagulants for thromboprophylaxis in ambulatory patients with cancer.

作者信息

Wang Yiwei, Wang Maoyun, Ni Yuenan, Liang Zongan

机构信息

Department of Respiratory and Critical Care Medicine, West China School of Medicine and West China Hospital, Sichuan University, Chengdu, People's Republic of China.

出版信息

Hematology. 2020 Dec;25(1):63-70. doi: 10.1080/16078454.2020.1719726.

Abstract

Venous thromboembolism (VTE) is a common complication in cancer patients. We aim to evaluate the effect and safety of direct oral anticoagulants (DOACs) as primary prophylaxis in ambulatory cancer patients. We conducted a literature search in PubMed, EMBASE and ClinicalTrials for studies that evaluated DOACs for thromboprophylaxis in cancer patients. RevMan 5.3 software was used for this meta-analysis. Three randomized controlled trials (RCTs) with a total of 1465 patients were pooled in the meta-analysis. DOACs significantly reduced the symptomatic VTE incidence during intervention period (RR 0.23, CI 0.11-0.47, <0.0001, =9%). Significantly lower total VTE incidence (RR 0.53, CI 0.36-0.78,  = 0.001, =30%) and PE incidence (RR 0.50, CI 0.28-0.89,  = 0.02, =5%) were found during the observation period, and a trend for less symptomatic DVT events was found in the DOACs group (RR 0.62, CI 0.37-1.04,  = 0.07, =5%). No differences for all-cause mortality were found between groups (RR 0.92, CI 0.74-1.15,  = 0.47, =14%). DOACs did not significantly increase major bleeding risks (RR 1.66, CI 0.72-3.83,  = 0.24, =0%) during the intervention period or clinically relevant non-major bleeding events (RR 1.50, CI 0.90-2.49,  = 0.12, =0%) and total bleeding events during the observation period (RR 1.50, CI 0.98-2.29,  = 0.06, =0%). DOACs are effective for thromboprophylaxis in ambulatory cancer patients, but there is a potential risk of bleeding. DOACs may be recommended in selected patients at high risk of VTE. More high-quality studies are needed to further validate our results. CAT: cancer-associated thrombosis; CI: confidence interval; DOAC: direct oral anticoagulant; DVT: deep vein thrombosis; LMWH: low molecular weight heparin; NNH: number needed to harm; NNT: number needed to treat; PE: pulmonary embolism; RCT: randomized controlled trials; RR: risk ratio; RD: rate difference; VTE: venous thromboembolism.

摘要

静脉血栓栓塞症(VTE)是癌症患者常见的并发症。我们旨在评估直接口服抗凝剂(DOACs)作为门诊癌症患者一级预防措施的效果和安全性。我们在PubMed、EMBASE和ClinicalTrials中进行文献检索,以查找评估DOACs用于癌症患者血栓预防的研究。本荟萃分析使用RevMan 5.3软件。三项随机对照试验(RCTs)共纳入1465例患者,被纳入荟萃分析。DOACs在干预期显著降低了有症状VTE的发生率(风险比[RR] 0.23,置信区间[CI] 0.11 - 0.47,<0.0001,异质性检验I² = 9%)。在观察期发现总VTE发生率显著降低(RR 0.53,CI 0.36 - 0.78,P = 0.001,I² = 30%)以及肺栓塞(PE)发生率显著降低(RR 0.50,CI 0.28 - 0.89,P = 0.02,I² = 5%),并且在DOACs组发现有症状深静脉血栓形成(DVT)事件有减少趋势(RR 0.62,CI 0.37 - 1.04,P = 0.07,I² = 5%)。两组间全因死亡率无差异(RR 0.92,CI 0.74 - 1.15,P = 0.47,I² = 14%)。DOACs在干预期未显著增加大出血风险(RR 1.66,CI 0.72 - 3.83,P = 0.24,I² = 0%)或临床相关非大出血事件(RR 1.50,CI 0.90 - 2.49,P = 0.12,I² = 0%),在观察期也未显著增加总出血事件(RR 1.50,CI 0.98 - 2.29,P = 0.06,I² = 0%)。DOACs对门诊癌症患者血栓预防有效,但存在出血潜在风险。对于VTE高风险的特定患者,可能推荐使用DOACs。需要更多高质量研究来进一步验证我们的结果。CAT:癌症相关血栓形成;CI:置信区间;DOAC:直接口服抗凝剂;DVT:深静脉血栓形成;LMWH:低分子量肝素;NNH:伤害所需人数;NNT:治疗所需人数;PE:肺栓塞;RCT:随机对照试验;RR:风险比;RD:率差;VTE:静脉血栓栓塞症

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