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非维生素K拮抗剂口服抗凝药与华法林对日本房颤患者的疗效及安全性——荟萃分析

Efficacy and safety of non-vitamin K antagonist oral anticoagulants vs. warfarin in Japanese patients with atrial fibrillation – meta-analysis.

作者信息

Senoo Keitaro, Lau Yee Cheng, Dzeshka Mikhail, Lane Deirdre, Okumura Ken, Lip Gregory Y H

机构信息

University of Birmingham Centre for Cardiovascular Sciences, City Hospital, Birmingham.

出版信息

Circ J. 2015;79(2):339-45. doi: 10.1253/circj.CJ-14-1042. Epub 2014 Dec 11.

Abstract

BACKGROUND

Non-vitamin K antagonist oral anticoagulants (NOAC) have been developed as alternatives to warfarin. Until recently, the latter was the standard oral anticoagulant for patients with non-valvular atrial fibrillation (NVAF). The efficacy and safety of NOAC in Japanese patients with NVAF has been investigated in small trials or subgroups from global randomized control trials (RCT).

METHODS AND RESULTS

We conducted a systematic review and meta-analysis of RCT, to compare the efficacy and safety of NOAC to those of warfarin in Japanese patients with NVAF. Published research was systematically searched for RCT that compared NOAC to warfarin in Japanese patients with NVAF. Random-effects models were used to pool efficacy and safety data across RCT. Three studies, involving 1,940 patients, were identified. Patients randomized to NOAC had a decreased risk for stroke and systemic thromboembolism (relative risk [RR], 0.45; 95% CI: 0.24-0.85), with a non-significant trend for lower major bleeding (RR, 0.66; 95% CI: 0.29-1.47), intracranial bleeding (RR, 0.46; 95% CI: 0.18-1.16) and gastrointestinal bleeding (RR, 0.52; 95% CI: 0.25-1.08).

CONCLUSIONS

NOAC are more efficacious than warfarin for the prevention of stroke and systemic embolism in Japanese patients with NVAF. The present findings offer clinicians a more comprehensive picture of NOAC as a therapeutic option to reduce the risk of stroke in Japanese NVAF patients.

摘要

背景

非维生素K拮抗剂口服抗凝药(NOAC)已被开发出来作为华法林的替代药物。直到最近,华法林仍是非瓣膜性心房颤动(NVAF)患者的标准口服抗凝药。NOAC在日本NVAF患者中的疗效和安全性已在小型试验或全球随机对照试验(RCT)的亚组中进行了研究。

方法与结果

我们对RCT进行了系统评价和荟萃分析,以比较NOAC与华法林在日本NVAF患者中的疗效和安全性。系统检索已发表的研究,寻找比较NOAC与华法林在日本NVAF患者中的RCT。采用随机效应模型汇总各RCT的疗效和安全性数据。共纳入3项研究,涉及1940例患者。随机接受NOAC治疗的患者发生中风和全身性血栓栓塞的风险降低(相对风险[RR],0.45;95%可信区间:0.24 - 0.85),大出血(RR,0.66;95%可信区间:0.29 - 1.47)、颅内出血(RR,0.46;95%可信区间:0.18 - 1.16)和胃肠道出血(RR,0.52;95%可信区间:0.25 - 1.08)的趋势不显著。

结论

在日本NVAF患者中,NOAC在预防中风和全身性栓塞方面比华法林更有效。本研究结果为临床医生提供了关于NOAC作为降低日本NVAF患者中风风险治疗选择的更全面情况。

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