卵圆孔未闭封堵与药物比较预防卵圆孔未闭相关隐源性卒中复发的有效性和安全性的Meta分析

Efficacy and safety of patent foramen ovale closure versus medicine for preventing recurrence of cryptogenic stroke associated with patent foramen ovale: a meta-ananlysis

目的通过Meta分析比较卵圆孔未闭(Patent foramen ovale,PFO)封堵治疗与药物治疗在预防PFO相关隐源性卒中复发的有效性及安全性。方法计算机检索Pubmed、EMbase、Web of Science和Cochrane图书馆等数据库,同时辅以手工和其他检索,收集关于PFO封堵治疗与药物治疗在预防PFO相关隐源性卒中复发的所有文献,检索时间截止2018年4月。由两名作者严格按照纳入与排除标准独立检索以及提取数据。使用RevMan 5. 3软件对提取资料进行统计分析。结果入选5篇文献,均为前瞻性随机对照研究,共纳入3627名患者。与药物治疗相比,PFO封堵治疗可显著降低卒中复发率(OR=0. 43,95%CI:0. 21~0. 90,P=0. 02);在降低短暂性脑缺血发作(transient ischemic attack,TIA)的复发上,两组治疗无明显统计学差异(OR=0. 79,95%CI:0. 53~1. 19,P=0. 26);在新发房颤率上,PFO封堵组显著高于药物治疗组(OR=4. 93,95%CI:1. 74~13. 94,P=0. 003);在全因死亡率(OR=0. 79,95%95%CI:0. 39~1. 61,P=0. 52)和主要出血率(OR=0. 76,95%CI:0. 32~1. 81,P=0. 54)等不良事件的发生率上,两组均无明显差异。结论在预防卵圆孔未闭相关隐源性卒中复发的治疗上,与药物治疗相比,PFO封堵治疗可显著降低卒中复发率,但同时PFO封堵治疗的患者发生房颤的风险较高。

Objective To compare the effectiveness and safety of patent foramen ovale(PFO)closure and medical therapy for preventing recurrence of cryptogenic stroke associated with PFO through a meta-analysis.Methods The databases including Pub Med,EMbase,Web of Science,and Cochrane Library were retrieved by computer,and also supplemented by manual and other retrievals.The studies on the effectiveness and safety of PFO closure and medicine for preventing recurrence of cryptogenic stroke associated with PFO were collected.The deadline of the retrieval time was April 2018.After two reviewers independently retrieve literature and extract datas according to the inclusion and exclusion criteria,Revman 5.3 software was used to make statistical analysis.Results A total of 5 paper were enrolled,they are randomized controlled trials,including 3627 patients.Compared with medical therapy,PFO closure can significantly reduce in the recurrence rate of stroke(OR=0.43,95%CI:0.21~0.90,P=0.02).There was no significant difference in reduceing recurrence of transient ischemic attack(TIA)between the two groups(OR=0.79,95%CI:0.53~1.19,P=0.26).In the newly diagnosed atrial fibrillation,PFO closure group was significantly higher than medical therapy group(OR=4.93,95%CI:1.74~13.94,P=0.003).The incidence of adverse events such as all-cause mortality(OR=0.79,95%CI:0.39~1.61,P=0.52)and major bleeding(OR=0.76,95%CI:0.32~1.81,P=0.54)was no significant difference between the two groups.Conclusion In preventing recurrence of cryptogenic stroke associated with PFO,PFO closure results in a significant reduction in the recurrence rate of stroke compared to medical therapy.But at the same time patients with PFO closure have a higher risk of atrial fibrillation.