Department of Neurology and Neuroscience Center, the First Hospital of Jilin University, Changchun, China.
Department of Neurology, Peking University Shenzhen Hospital, Shenzhen, China.
Sci Rep. 2016 Dec 14;6:39081. doi: 10.1038/srep39081.
We evaluated the safety and effectiveness of transcatheter patent foramen ovale (PFO) closure for the treatment of migraine in a Chinese population. This non-randomized clinical trial enrolled 258 consecutive substantial or severe migraineurs with a right-to-left shunt (RLS) (grade II-IV) and grouped subjects according to their election or refusal of PFO closure. Migraine was diagnosed according to the International Classification of Headache Disorders III-beta and evaluated using the Headache Impact Test-6 (HIT-6). In total, 241 participants (125 in the transcatheter closure group and 116 in the control group) were included in the study. In general, the PFO closure procedure was found to be safe. At 1 month after closure, 76.1% of patients returned for c-TCD evaluation; of these, 85.7% were downgraded to negative status or a grade-I shunt. Residual shunts and placebo effects were thought to resolve by 12 months post-procedure, when migraine impact was reported to decrease by 73.6%. Transcatheter PFO closure was demonstrated to be effective for the treatment of migraine by comparing HIT-6 scores between the transcatheter closure and control groups (p < 0.001). Our results suggest that transcatheter PFO closure is a safe and effective approach for the treatment of migraine in the Chinese population, especially in females with constant RLS. Clinical trial no. NCT02127294 (registered on April 29, 2014).
我们评估了经导管卵圆孔未闭（PFO）封堵术治疗中国人群偏头痛的安全性和有效性。这项非随机临床试验纳入了 258 例连续的、存在右向左分流（RLS）（Ⅱ级-IV 级）的大量或严重偏头痛患者，并根据他们对 PFO 封堵的选择或拒绝将患者分组。偏头痛根据国际头痛疾病分类第三版β标准进行诊断，并使用头痛影响测试-6（HIT-6）进行评估。共有 241 名参与者（经导管封堵组 125 名，对照组 116 名）纳入研究。一般来说，PFO 封堵术是安全的。在封堵后 1 个月，76.1%的患者进行 c-TCD 评估；其中 85.7%的分流程度降级为阴性或 I 级分流。残余分流和安慰剂效应被认为在术后 12 个月内得到解决，此时偏头痛的影响减少了 73.6%。通过比较经导管封堵组和对照组的 HIT-6 评分，经导管 PFO 封堵术治疗偏头痛是有效的（p<0.001）。我们的结果表明，经导管 PFO 封堵术治疗中国人群偏头痛是安全有效的，尤其是对于持续存在 RLS 的女性患者。临床试验注册号 NCT02127294（于 2014 年 4 月 29 日注册）。
