SPRING 试验的原理和设计：Pfo 闭合术与药物缓解偏头痛的效果和安全性：一项多中心、随机、开放标签试验。
Rationale and design of the SPRING trail: effectivity and safety of Pfo closuRe vs medIcine in alleviatiNg migraine, a multicenter, randomized and open-label trail.
机构信息
Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Zhong Shan Er Road No. 106, Yue Xiu District, Guangzhou, Guangdong, 510080, China.
Guangdong Provincial Key Laboratory of South China Structural Heart Disease, Guangzhou, Guangdong, China.
出版信息
BMC Cardiovasc Disord. 2024 Apr 5;24(1):198. doi: 10.1186/s12872-024-03866-3.
BACKGROUND
Migraine is a leading cause of disability worldwide. Several retrospective studies have suggested that the closure of the Patent Foramen Ovale (PFO) may provide relief from migraines. However, three randomized controlled trials did not meet their primary endpoints regarding migraine cessation, reduction in monthly migraine days, and responder rates.
METHODS
The SPRING study is a multicenter, prospective, randomized, and open-label trial designed to compare the effectiveness and safety of PFO closure versus medication in the relief of migraines. The primary endpoint is the total cessation of migraines, as recorded in patient headache diaries during the follow-up period. Additional diagnostic tools include echocardiography with agitated saline contrast, transcranial Doppler, and routine laboratory measurements.
CONCLUSION
The SPRING trial aims to assess the effectiveness and safety of PFO closure versus medication in mitigating migraines in real-world settings. (Clinical Trails ID: NCT04946734).
背景
偏头痛是全球范围内导致残疾的主要原因之一。几项回顾性研究表明，卵圆孔未闭（PFO）的闭合可能有助于缓解偏头痛。然而，三项随机对照试验并未达到其主要终点，即偏头痛停止、每月偏头痛天数减少和应答率。
方法
SPRING 研究是一项多中心、前瞻性、随机和开放标签试验，旨在比较 PFO 闭合与药物治疗在缓解偏头痛方面的有效性和安全性。主要终点是在随访期间患者头痛日记中记录的偏头痛完全停止。其他诊断工具包括含搅动盐水对比的超声心动图、经颅多普勒和常规实验室测量。
结论
SPRING 试验旨在评估 PFO 闭合与药物治疗在现实环境中缓解偏头痛的有效性和安全性。（临床试验 ID：NCT04946734）。
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