Research advances in patent foramen oval related non-apoplectic disease

doi:10.3877/cma.j.issn.2095-6568.2025.03.004

Abstract

Zhiqiang Li, Cheng Wang. Research advances in patent foramen oval related non-apoplectic disease[J]. Chinese Journal of Heart and Heart Rhythm(Electronic Edition), 2025, 13(03): 149-155.

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References 67

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作者，发表年份	研究类型	样本量	主要研究结果	主要研究结论
季春影等^［33］，2024	回顾性单臂观察性研究	106	封堵术后1年，不同残余分流级别（0～Ⅲ级）患者的偏头痛缓解率存在显著差异［18.75%（Ⅲ级）对58%～69%（0～Ⅱ级），P=0.02］	PFO封堵术后0～Ⅱ级残余分流患者偏头痛明显缓解，Ⅲ级残余分流患者偏头痛无明显缓解
Mas等^［28］，2021	开放标签RCT（CLOSE-MIG）	145	平均5年随访显示封堵组和对照组患者偏头痛平均年发作次数及完全停止率差异均无统计学意义（P<0.05）	在PFO-AS合并偏头痛患者中，PFO封堵术联合抗血小板治疗未能减少偏头痛平均年发作次数
He等^［29］，2020	前瞻性队列研究结合单臂试验	103	封堵术后6个月时MA患者的MIDAS和HIT-6评分显著降低（P<0.05）	PFO封堵术可明显缓解MA患者的头痛症状
Tobis等^［26］，2017	双盲RCT（PREMIUM）	230	封堵组与假手术组患者在主要终点应答率（发作减少50%）上差异无统计学意义（P=0.32），但次要终点显示封堵组每月偏头痛天数显著减少和完全缓解率提高（P<0.05），且在MA亚组中封堵组的应答率和完全缓解率也显著优于假手术组（P<0.05）	PFO封堵术未达到主要终点（应答率），但显著减少每月偏头痛天数，且少数患者完全缓解。PFO封堵术可能对MA患者有效
Mattle等^［27］，2016	开放标签RCT（PRIMA）	107	封堵组在主要终点（每月偏头痛减少）上与对照组差异无统计学意义（P=0.17），但在偏头痛天数减少≥50%、MA天数和发作次数减少方面均显著优于对照组（均P<0.05）	PFO封堵术未显著减少每月偏头痛发作天数，但对MA亚组可能有效
Xing等^［32］，2016	非随机对照试验（EASTFORM）	241	封堵组术后12个月HIT-6评分显著低于对照组（P<0.001），且73.6%患者评分较术前显著降低	PFO封堵术是一种治疗中国人群偏头痛的有效方法
Dowson等^［25］，2008	双盲RCT（MIST）	147	封堵组与假手术组在主要终点（偏头痛停止）上差异无统计学意义，但探索性分析显示封堵组总偏头痛天数显著减少（P=0.027）	PFO封堵术未显示对难治性偏头痛具有显著疗效
Luermans等^［30］，2008	前瞻性观察性研究	92	封堵术后偏头痛患病率由28.6%降至10.7%（P=0.001），MA比例由11.9%降至2.4%（P=0.02）	PFO封堵术与偏头痛（尤其是MA）患病率的降低有关
Reisma等^［31］，2005	回顾性单臂观察性研究	162	封堵术后56%反常性脑栓塞患者偏头痛完全缓解，14%显著缓解，且偏头痛月均发作次数减少80%（P<0.001）	PFO封堵术显著减少反常性脑栓塞患者的偏头痛发作频率

作者，发表年份	研究类型	样本量	主要研究结果	主要研究结论
季春影等^［33］，2024	回顾性单臂观察性研究	106	封堵术后1年，不同残余分流级别（0～Ⅲ级）患者的偏头痛缓解率存在显著差异［18.75%（Ⅲ级）对58%～69%（0～Ⅱ级），P=0.02］	PFO封堵术后0～Ⅱ级残余分流患者偏头痛明显缓解，Ⅲ级残余分流患者偏头痛无明显缓解
Mas等^［28］，2021	开放标签RCT（CLOSE-MIG）	145	平均5年随访显示封堵组和对照组患者偏头痛平均年发作次数及完全停止率差异均无统计学意义（P<0.05）	在PFO-AS合并偏头痛患者中，PFO封堵术联合抗血小板治疗未能减少偏头痛平均年发作次数
He等^［29］，2020	前瞻性队列研究结合单臂试验	103	封堵术后6个月时MA患者的MIDAS和HIT-6评分显著降低（P<0.05）	PFO封堵术可明显缓解MA患者的头痛症状
Tobis等^［26］，2017	双盲RCT（PREMIUM）	230	封堵组与假手术组患者在主要终点应答率（发作减少50%）上差异无统计学意义（P=0.32），但次要终点显示封堵组每月偏头痛天数显著减少和完全缓解率提高（P<0.05），且在MA亚组中封堵组的应答率和完全缓解率也显著优于假手术组（P<0.05）	PFO封堵术未达到主要终点（应答率），但显著减少每月偏头痛天数，且少数患者完全缓解。PFO封堵术可能对MA患者有效
Mattle等^［27］，2016	开放标签RCT（PRIMA）	107	封堵组在主要终点（每月偏头痛减少）上与对照组差异无统计学意义（P=0.17），但在偏头痛天数减少≥50%、MA天数和发作次数减少方面均显著优于对照组（均P<0.05）	PFO封堵术未显著减少每月偏头痛发作天数，但对MA亚组可能有效
Xing等^［32］，2016	非随机对照试验（EASTFORM）	241	封堵组术后12个月HIT-6评分显著低于对照组（P<0.001），且73.6%患者评分较术前显著降低	PFO封堵术是一种治疗中国人群偏头痛的有效方法
Dowson等^［25］，2008	双盲RCT（MIST）	147	封堵组与假手术组在主要终点（偏头痛停止）上差异无统计学意义，但探索性分析显示封堵组总偏头痛天数显著减少（P=0.027）	PFO封堵术未显示对难治性偏头痛具有显著疗效
Luermans等^［30］，2008	前瞻性观察性研究	92	封堵术后偏头痛患病率由28.6%降至10.7%（P=0.001），MA比例由11.9%降至2.4%（P=0.02）	PFO封堵术与偏头痛（尤其是MA）患病率的降低有关
Reisma等^［31］，2005	回顾性单臂观察性研究	162	封堵术后56%反常性脑栓塞患者偏头痛完全缓解，14%显著缓解，且偏头痛月均发作次数减少80%（P<0.001）	PFO封堵术显著减少反常性脑栓塞患者的偏头痛发作频率

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