1 Center for Clinical Epidemiology and Methodology (CCEM), Guangdong Second Provincial General Hospital, Guangzhou, China.
2 School of Public Health, Southern Medical University, Guangzhou, China.
Clin Appl Thromb Hemost. 2019 Jan-Dec;25:1076029619853629. doi: 10.1177/1076029619853629.
Efficacy and safety of direct oral anticoagulants (DOACs) for preventing primary and recurrent venous thromboembolism (VTE) in patients with cancer remain unclear. In this study, we conducted a systematic review to summarize the most up-to-date evidence from randomized controlled trials (RCTs). Our primary outcomes included the benefit outcome (VTE) and safety outcome (major bleeding). A random-effects model was used to pool the relative risks (RRs) for data syntheses. The Grading of Recommendations Assessment, Development and Evaluation tool was used to evaluate the quality of the entire body of evidence across studies. We included 11 RCTs with a total of 3741 patients with cancer for analyses. The DOACs were significantly related with a reduced risk of VTE when compared with non-DOACs: RR = 0.77, 95% confidence interval [CI]: 0.61-0.99, P = .04. Nonsignificant trend towards a higher risk of major bleeding was found in DOACs: RR = 1.28 95% CI: 0.81-2.02, P = .29. The quality of the entire body of evidence was graded as moderate for risk of VTE, and low for risk of major bleeding. To summarize, DOACs were found to have a favorable effect on risk of VTE but a nonsignificant higher risk of major bleeding compared with non-DOACs in patients with cancer. The safety effect of DOACs in patients with cancer requires further evaluation in adequately powered and designed studies.
直接口服抗凝剂(DOACs)在预防癌症患者首发和复发性静脉血栓栓塞症(VTE)方面的疗效和安全性尚不清楚。本研究对随机对照试验(RCT)进行了系统评价,以汇总最新的证据。主要结局包括疗效结局(VTE)和安全性结局(大出血)。采用随机效应模型对相对风险(RR)进行数据合成。采用推荐评估、制定与评估分级工具对研究间整个证据体的质量进行评估。我们纳入了 11 项 RCT,共纳入 3741 例癌症患者进行分析。与非 DOACs 相比,DOACs 显著降低 VTE 风险:RR=0.77,95%置信区间[CI]:0.61-0.99,P=0.04。DOACs 有较高大出血风险的趋势,但无统计学意义:RR=1.28,95%CI:0.81-2.02,P=0.29。VTE 风险的整个证据体质量被评为中度,大出血风险的质量为低度。总之,与非 DOACs 相比,DOACs 可降低癌症患者的 VTE 风险,但大出血风险增加无统计学意义。癌症患者中 DOACs 的安全性效应需要在充分的、设计良好的研究中进一步评估。