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新型口服抗凝药与华法林相比在合并癌症的房颤患者中的安全性和有效性:一项随机临床试验和观察性研究的荟萃分析

Safety and efficacy of new oral anticoagulants compared to those of warfarin in AF patients with cancer: a meta-analysis of randomized clinical trials and observational studies.

作者信息

Chen Yueming, Mao Min, Chang Jing, Yan Jing, Yang Tiantian, Liu Yang, Luo Meng, Hu Yuhao, Yang Qi, Zhou Lin, Ma Kanghua

机构信息

Department of Cardiology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.

Department of Cardiology, The General Hospital of Chongqing Iron and Steel Group, Chongqing, China.

出版信息

Eur J Clin Pharmacol. 2021 Jun;77(6):849-857. doi: 10.1007/s00228-021-03132-x. Epub 2021 Apr 1.

Abstract

BACKGROUND

Data on the efficacy and safety of nonvitamin K antagonist oral anticoagulants (NOACs) in atrial fibrillation (AF) patients with cancer are limited. Therefore, we conducted a meta-analysis to compare the efficacy and safety between NOACs and warfarin in this population.

METHODS

A comprehensive search of the PubMed, Embase, and Cochrane databases for articles published through July 2020 was performed. An evaluation of each study was conducted, and data were extracted. Pooled odds ratio (OR) estimates and 95% CIs were calculated.

RESULTS

Eight studies (3 randomized controlled trials (RCTs) and 5 retrospective cohort studies) involving a total of 24,665 patients were included. Among the RCTs, there were no significant differences in the rates of stroke or systemic embolism (OR=0.69; 95% CI, 0.45-1.06; P=0.09), venous thromboembolism (OR=0.91; 95% CI, 0.33-2.52; P=0.86), myocardial infarction (OR=0.74; 95% CI, 0.44-1.23; P=0.24), major bleeding (OR=0.81; 95% CI, 0.61-1.06; P=0.12), or major or nonmajor clinically relevant bleeding (OR= 0.98; 95% CI, 0.82-1.19; P=0.86) between the NOAC and warfarin groups. Among the observational studies, patients who used NOACs had a significantly lower risk than those who used warfarin. The prevalence rates of ischemic stroke (OR=0.51; 95% CI, 0.28-0.92; P=0.02), VTE (OR=0.50; 95% CI, 0.41-0.60; P<0.00001), major bleeding (OR=0.28; 95% CI, 0.14-0.55; P=0.0002), and intracranial or gastrointestinal bleeding (OR=0.59; 95% CI, 0.37-0.92; P=0.02) were significantly reduced in the NOAC group.

CONCLUSION

Our meta-analysis confirms that NOACs are as safe and effective as warfarin and can be applied in the real world; this data can serve as a reference for clinical doctors for formulating treatment strategies.

摘要

背景

关于非维生素K拮抗剂口服抗凝药(NOACs)在癌症合并心房颤动(AF)患者中的疗效和安全性数据有限。因此,我们进行了一项荟萃分析,以比较该人群中NOACs与华法林的疗效和安全性。

方法

全面检索了截至2020年7月发表在PubMed、Embase和Cochrane数据库上的文章。对每项研究进行评估,并提取数据。计算合并比值比(OR)估计值和95%置信区间(CIs)。

结果

纳入了八项研究(三项随机对照试验(RCTs)和五项回顾性队列研究),共涉及24665例患者。在随机对照试验中,NOAC组和华法林组在卒中或全身性栓塞发生率(OR = 0.69;95% CI,0.45 - 1.06;P = 0.09)、静脉血栓栓塞发生率(OR = 0.91;95% CI,0.33 - 2.52;P = 0.86)、心肌梗死发生率(OR = 0.74;95% CI,0.44 - 1.23;P = 0.24)、大出血发生率(OR = 0.81;95% CI,0.61 - 1.06;P = 0.12)或主要或非主要临床相关出血发生率(OR = 0.98;95% CI,0.82 - 1.19;P = 0.86)方面无显著差异。在观察性研究中,使用NOACs的患者风险显著低于使用华法林的患者。NOAC组缺血性卒中患病率(OR = 0.51;95% CI,0.28 - 0.92;P = 0.02)、静脉血栓栓塞患病率(OR = 0.50;95% CI,0.41 - 0.60;P < 0.00001)、大出血患病率(OR = 0.28;95% CI,0.14 - 0.55;P = 0.0002)以及颅内或胃肠道出血患病率(OR = 0.59;95% CI,0.37 - 0.92;P = 0.02)均显著降低。

结论

我们的荟萃分析证实,NOACs与华法林一样安全有效,可应用于临床实际;这些数据可为临床医生制定治疗策略提供参考。

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