卵圆孔未闭封堵治疗隐源性卒中合并卵圆孔未闭疗效的Meta分析

Meta-analysis for the effect of patent foramen ovale transcatheter closure in the treatment of cryptogenic stroke patients with patent foramen ovale

目的评价卵圆孔未闭(PFO)封堵治疗隐源性卒中合并PFO的有效性和安全性。方法检索PubMed、EMbase、Web of Science、Cochrane Library以及中国知网、万方等数据库,获取关于PFO封堵治疗隐源性卒中合并PFO的随机对照研究,检索时间为建库至2017-10-01。由两名研究者独立筛选文献及提取资料,采用RevMan 5.3软件进行Meta分析。结果共纳入6篇文献,共包括4420例患者。Meta分析结果显示,与药物治疗相比,PFO封堵治疗后复发性卒中发生率降低(OR=0.47,95%CI:0.35~0.65,P<0.01),而两种治疗方案出血风险(OR=0.96,95%CI:0.57~1.62,P=0.88)和死亡风险(OR=0.71,95%CI:0.38~1.36,P=0.31)均无统计学差异,而PFO封堵组新发房扑或房颤的发生率增高(OR=5.81,95%CI:3.04~11.12,P<0.01)。结论基于PFO及隐源性卒中患者的现有数据,PFO封堵治疗在疗效方面优于药物,但封堵治疗与新发房颤或房扑的发生率增加有关。

Objective To systematically review the efficacy and safety of patent foramen ovale（PFO）transcatheter closure in the treatment of cryptogenic stroke patients with patent foramen ovale.Methods The PubMed,EMbase, Web of science,Cochrane library,CNKI,and Wanfang databases were electronically searched from inception to October 1th,2017,to collect the randomized controlled trials on the effects of PFO transcatheter closure and drugs in the treatment of cryptogenic stroke patients with patent foramen ovale.Two investigators independently screened the literatures,extracted the data and assessed the quality of enrolled studies.All analyses were performed using the Revman 5.3 software.Results Six studies involving 4420 patients were finally included.Meta analysis results show that PFO transcatheter device closure（TDC）led to a significantly reduced incidence of stroke compared with medical therapy[odds ratio（OR）=0.47,95%CI：035-0.65,P〈0.01].Moreover,there was no significant difference in the risk of bleeding or death between the two treatment options（risk of bleeding：OR=0.96,95%CI：0.57-1.62,P=0.88;risk of death：OR=0.71,95%CI：0.38-1.36,P=0.31）.However,the occurrence of new-onset atrial flutter or atrial fibrillation was more frequent in the PFO closure group（OR=5.81,95%CI：3.04-11.12,P〈0.01）.Conclusions Based on the current RCT data for patients with PFO and cryptogenic stroke,the use of closure is better than medication in efficacy.However,PFO TDC is associated with an increased incidence of new-onset atrial fibrillation or atrial flutter.