心房颤动患者口服抗凝剂的性别特异性比较结果：一项系统评价和荟萃分析。
Sex-specific comparative outcomes between oral anticoagulants in patients with atrial fibrillation: a systematic review and meta-analysis.
作者信息
Chobanov Jan D, Wang Zixuan, Man Kenneth K C, Dayib Edil, Lip Gregory Y H, Hingorani Aroon D, Leung Wai K, Wong Ian C K, Mongkhon Pajaree, Lau Wallis C Y
机构信息
Research Department of Practice and Policy, UCL School of Pharmacy, London, UK.
Centre for Medicines Optimisation Research and Education, University College London Hospitals NHS Foundation Trust, London, UK.
出版信息
Open Heart. 2024 Jul 16;11(2):e002792. doi: 10.1136/openhrt-2024-002792.
AIMS
Women with atrial fibrillation (AF) are under-represented in randomised controlled trials (RCTs) of direct oral anticoagulants (DOACs). This systematic review and meta-analysis of RCTs and observational studies examined sex-specific outcomes of DOACs in AF.
METHODS
PubMed, Embase, Web of Science and Cochrane Library were searched from January 2008 to November 2022. Sex-specific comparative outcomes of stroke/systemic embolism (SE), major bleeding, intracranial haemorrhage (ICH) and gastrointestinal bleeding (GIB) between oral anticoagulants were pooled using random effects models. P values for interaction were calculated to examine differences in results between sexes. RCTs and observational studies were meta-analysed separately.
RESULTS
5 RCTs and 33 observational studies were included, totalling 1 085 931 women and 1 387 123 men. Meta-analyses showed that for both sexes, DOAC versus warfarin was generally associated with lower risk of stroke/SE, major bleeding and ICH; in DOAC-DOAC comparisons, rivaroxaban versus dabigatran had higher GIB risk. The only sex-specific difference observed was that when compared with warfarin, women had higher GIB risk with rivaroxaban (women: pooled risk ratio (pRR)=1.34, 95% CI=1.18 to 1.51; men: pRR=0.97, 95% CI=0.85 to 1.10; p value for interaction (p for interaction)<0.001) and possibly dabigatran (women: pRR=1.25, 95% CI=0.92 to 1.70; men: pRR=0.83, 95% CI=0.72 to 0.97; p-for-interaction=0.02). The sex difference in GIB remained for rivaroxaban when a Bonferroni-corrected significance level was used (α=0.003). No sex-specific GIB data for apixaban and edoxaban was available for the meta-analysis.
CONCLUSIONS
For both sexes, DOACs generally demonstrated favourable effectiveness and safety over warfarin. However, observational data suggested that women may have higher GIB risk with rivaroxaban and possibly dabigatran than warfarin. Further studies are warranted to verify our findings and elucidate sex-specific GIB risk with apixaban and edoxaban, of which the data is currently lacking.
PROSPERO REGISTRATION NUMBER
CRD42022325027.
目的
在直接口服抗凝剂（DOACs）的随机对照试验（RCTs）中，患有心房颤动（AF）的女性代表性不足。本系统评价和RCTs及观察性研究的荟萃分析，探讨了DOACs在AF中的性别特异性结局。
方法
检索2008年1月至2022年11月的PubMed、Embase、Web of Science和Cochrane图书馆。使用随机效应模型汇总口服抗凝剂之间中风/全身性栓塞（SE）、大出血、颅内出血（ICH）和胃肠道出血（GIB）的性别特异性比较结局。计算交互作用的P值，以检验性别之间结果的差异。RCTs和观察性研究分别进行荟萃分析。
结果
纳入了5项RCTs和33项观察性研究，共1085931名女性和1387123名男性。荟萃分析表明，对于男女两性，DOAC与华法林相比，通常与较低的中风/SE、大出血和ICH风险相关；在DOAC-DOAC比较中，利伐沙班与达比加群相比，GIB风险更高。观察到的唯一性别特异性差异是，与华法林相比，女性使用利伐沙班时GIB风险更高（女性：合并风险比（pRR）=1.34，95%CI=1.18至1.51；男性：pRR=0.97，95%CI=0.85至1.10；交互作用P值（交互作用p）<0.001），使用达比加群时可能也更高（女性：pRR=1.25，95%CI=0.92至1.70；男性：pRR=0.83，95%CI=0.72至0.97；交互作用p=0.02）。当使用Bonferroni校正的显著性水平（α=0.003）时，利伐沙班的GIB性别差异仍然存在。荟萃分析没有阿哌沙班和依度沙班的性别特异性GIB数据。
结论
对于男女两性，DOACs总体上显示出比华法林更有利的确有效性和安全性。然而，观察性数据表明，与华法林相比，女性使用利伐沙班和可能使用达比加群时GIB风险可能更高。有必要进行进一步研究以验证我们的发现，并阐明阿哌沙班和依度沙班的性别特异性GIB风险，目前缺乏相关数据。
PROSPERO注册号：CRD42022325027。
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