Department of Medicine, University of Alberta, Canada.
Thromb Res. 2013 Aug;132(2):185-9. doi: 10.1016/j.thromres.2013.07.017. Epub 2013 Jul 26.
Bleeding complications occur more frequently in women than men in clinical trials of warfarin and thrombolytics. It is unknown whether these sex-related differences exist for new oral anticoagulants, including dabigatran, rivaroxaban, and apixaban. To determine whether women suffer more bleeding complications with these agents, we conducted a systematic review and meta-analysis of randomized controlled trials on new oral anticoagulants for venous thromboembolism (VTE).
Medline, Embase, and the Cochrane-controlled trial register on the Cochrane library were searched to identify studies that evaluated novel oral anticoagulants versus any comparator, and reported outcomes, including major bleeding and recurrent VTE, stratified by sex. No language restrictions were applied. Studies were evaluated according to a priori inclusion criteria and critically appraised using established internal validity criteria. Pooled relative risk was estimated using a random effects model.
Eight studies were eligible, comprising 9417 patients. There was no difference in the primary efficacy outcome of recurrent VTE between men and women [Relative Risk (RR) 1.02, 95% confidence interval (CI) 0.74-1.39]. However, men had less major bleeding with novel oral anticoagulants compared to women [RR 0.79, 95% CI 0.66-0.97, p=0.03]. All-cause mortality was not reported by sex in any of the studies.
Women suffer more bleeding complications than men when receiving novel oral anticoagulants for VTE. Future clinical trials should report outcomes stratified by sex, and further studies are needed to investigate the clinical impact of this sex-related safety difference.
在华法令和溶栓剂的临床试验中，女性出血并发症的发生率高于男性。目前尚不清楚这些与性别相关的差异是否存在于新型口服抗凝剂中，包括达比加群、利伐沙班和阿哌沙班。为了确定女性在使用这些药物时是否会出现更多的出血并发症，我们对新的口服抗凝剂治疗静脉血栓栓塞症（VTE）的随机对照试验进行了系统评价和荟萃分析。
我们检索了 Medline、Embase 和 Cochrane 图书馆的 Cochrane 对照试验注册中心，以确定评估新型口服抗凝剂与任何对照药物，并报告结局的研究，包括大出血和复发性 VTE，并按性别分层。未应用语言限制。根据预先确定的纳入标准评估研究，并使用既定的内部有效性标准进行批判性评价。使用随机效应模型估计合并相对风险。
共有 8 项研究符合条件，包括 9417 名患者。男性和女性之间的主要疗效结局（复发性 VTE）没有差异[相对风险（RR）1.02，95%置信区间（CI）0.74-1.39]。然而，与女性相比，男性使用新型口服抗凝剂时大出血的风险较低[RR 0.79，95% CI 0.66-0.97，p=0.03]。在任何研究中，都没有按性别报告全因死亡率。
在接受新型口服抗凝剂治疗 VTE 时，女性出血并发症的发生率高于男性。未来的临床试验应按性别报告结局，并需要进一步研究以调查这种与性别相关的安全性差异的临床影响。
