新型口服抗凝药和华法林对<75岁和≥75岁房颤患者的有效性和安全性的meta分析

Meta-analysis of Efficacy and Safety of New Oral Anticoagulants and Warfarin in Patients with Atrial Fibrillation Aged <75 Years and ≥75 Years

目的系统评价新型口服抗凝药(new oral anticoagulants,NOACs)和华法林对<75岁和≥75岁房颤患者的有效性和安全性。方法系统检索PubMed、Embase、the Cochrane Library、CNKI、万方数据库等数据库,检索时限均为从建库至2020年6月。由2名研究者独立筛选文献、提取资料并评价纳入研究的方法学质量,使用RevMan 5.3软件进行meta分析。结果共纳入12篇研究,其中7篇随机对照研究(randomized controlled trial,RCT)和5篇观察性研究,包括572 968例患者。<75岁房颤患者meta分析结果显示:(1)在RCT中,与华法林相比,NOACs可以降低卒中/全身性栓塞(systemic embolism,SSE)、大出血、颅内出血风险和全因死亡的发生,不降低胃肠道出血风险的发生;(2)在观察性研究中,与华法林相比,NOACs可以降低卒中/SSE、大出血和颅内出血风险的发生,不降低胃肠道出血和全因死亡风险的发生。≥75岁房颤患者meta分析结果显示,(1)在RCT中,与华法林相比,NOACs可以降低卒中/SSE和颅内出血风险的发生,不降低大出血和全因死亡风险的发生,且会增加胃肠道出血风险的发生;(2)在观察性研究中,与华法林相比,NOACs可以降低卒中/SSE、大出血、颅内出血和全因死亡风险的发生;增加胃肠道出血风险的发生。结论对于<75岁房颤患者,NOACs的有效性和安全性优于华法林。对于≥75岁房颤患者,NOACs在卒中/SSE和颅内出血方面优于华法林,但胃肠道出血方面劣于华法林。对于老年房颤患者应用NOACs,需根据具体情况慎重选择抗凝药物。

OBJECTIVE To systematically review the efficacy and safety of new oral anticoagulants(NOACs) and warfarin in patients with atrial fibrillation aged <75 years and≥75 years. METHODS Such databases as PubMed, Embase, the Cochrane Library, CNKI, Wanfang database, etc. were electronically searched for relevant studies from inception to June 2020. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies, then, meta-analysis was performed by RevMan 5.3. RESULTS A total of 12 studies were included, including 7 randomized controlled trials(RCT) and 5 observational studies, including 572 968 patients. Meta-analysis results of <75 years old patients with atrial fibrillation showed that:(1)in RCT, compared with warfarin, NOACs could reduce the risk of stroke/systemic embolism(SSE), major bleeding, intracranial hemorrhage and all-cause mortality without reducing the risk of gastrointestinal bleeding;(2) in observational studies, compared with warfarin, NOACs reduced the risk of stroke/SSE, major bleeding and intracranial hemorrhage with increasing the risk of gastrointestinal bleeding and all-cause mortality. Meta-analysis results of ≥75 years old patients with atrial fibrillation showed that:(1)in RCT, compared with warfarin, NOACs could reduce the risk of stroke/SSE and intracranial hemorrhage with increasing the risk of gastrointestinal bleeding, but without reducing the risk of major bleeding and all-cause mortality;(1)in observational studies, compared with warfarin, NOACs reduced the risk of stroke/SSE, major bleeding, intracranial hemorrhage and all-cause mortality with increasing the risk of gastrointestinal bleeding. CONCLUSION For patients <75 years of age with atrial fibrillation, NOACs are more effective and safer than warfarin. For patients with atrial fibrillation ≥75 years of age, NOACs are superior to warfarin in stroke/SSE and intracranial hemorrhage, but inferior to warfarin in gastrointestinal bleeding. For the application of NOACs in elderly patients with atrial fibrillation, anticoagulant drugs need to be carefully selected according to specific conditions.