脑膜中动脉栓塞治疗慢性硬膜下血肿：实用试验设计的考虑,Journal of NeuroInterventional Surgery

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脑膜中动脉栓塞治疗慢性硬膜下血肿：实用试验设计的考虑
Journal of NeuroInterventional Surgery ( IF 4.5 ) Pub Date : 2021-04-01 , DOI: 10.1136/neurintsurg-2021-017458
David Fiorella _{1,

2} , Joshua A Hirsch ₃ , Adam S Arthur _{4,

5}

Affiliation

慢性硬膜下血肿 (cSDH) 是一种常见的神经系统疾病，其患病率正在增加，预计到 2030 年每年将有 60,000 例新诊断 cSDH.1,2 用于治疗 cSDH 的脑膜中动脉 (MMA) 栓塞术已迅速发展。过去 2 年中相对常规的程序的一个有趣概念。2000 年代第一个十年的初步病例报告得到了随后几年更大病例系列的支持。 2-5 这些研究导致 Ban 等人的更大系列，他们报告了在接受栓塞的患者中该手术的显着成功率与历史对照相比，作为外科撤离的辅助手段或作为独立治疗。6 几个较大的、回顾性的、自我裁决的病例系列报告了类似的乐观结果。2 MMA 栓塞术因此似乎提供了一种微创、技术上简单、相对安全的手术，可能消除对开放手术的需要和/或降低复发率。如果证明安全有效，MMA 栓塞术可以从根本上改变 cSDH 管理的护理标准。如果要实现这一愿景，前瞻性随机对照试验 (RCT) 将是必不可少的。虽然 cSDH 作为一种病理生理学可能看起来很简单，但这种疾病及其管理已被证明非常复杂。此外，确定一种疾病的治疗策略的比较“有效性”，其中相对明确的放射学发现可能与一系列临床表现相关联。从信息丰富的先前数据的角度来看，设计试验更加复杂，这些数据主要来自自我裁定的回顾性案例系列，其中许多使用不一致的终点来评估安全性和有效性。这篇评论将解决与设计一个实用的 MMA 栓塞 RCT 所涉及的一些挑战......

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Embolization of the middle meningeal artery for the treatment of chronic subdural hematoma: considerations for pragmatic trial design

Chronic subdural hematoma (cSDH) is a common neurological disease which is increasing in prevalence with an estimated 60 000 new diagnoses of cSDH per year expected by 2030.1 ,2 Embolization of the middle meningeal artery (MMA) for the treatment of cSDH has rapidly progressed from an intriguing concept to a relatively routine procedure over the past 2 years. Initial case reports from the first decade of the 2000s were bolstered by larger case series in the years that followed.2–5 These studies led to a larger series from Ban et al , who reported remarkable success rates for this procedure in patients undergoing embolization either as an adjunct to surgical evacuation or as a stand-alone treatment when compared with historical controls.6 Several larger, retrospective, self-adjudicated case series have reported similarly optimistic outcomes.2 MMA embolization would thus appear to offer a minimally invasive, technically straightforward, relatively safe procedure that potentially obviates the need for open surgery and/or decreases the rate of recurrence. If proven safe and effective, MMA embolization could fundamentally change the standard of care for the management of cSDH. Prospective randomized controlled trials (RCTs) will be essential if this vision is to become a reality. While cSDH as a pathophysiology might seem straightforward, the disease and its management have proven to be extraordinarily complex. Moreover, defining the comparative “effectiveness” of treatment strategies for a disease in which relatively unambiguous radiological findings may be associated with an array of clinical presentations is nuanced. Designing a trial is further complicated when viewed through the lens of the informative prior data, which are largely derived from self-adjudicated retrospective case series, many of which have used inconsistent endpoints to assess safety and effectiveness. This comment will address some of the challenges involved with designing a pragmatic RCT of MMA embolization for …

更新日期：2021-03-15

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