Department of Vascular Surgery, Helsinki University Central Hospital, Helsinki, Finland.
Eur J Vasc Endovasc Surg. 2013 Oct;46(4):466-72. doi: 10.1016/j.ejvs.2013.07.003. Epub 2013 Aug 3.
Chronic cerebrospinal venous insufficiency (CCSVI) has been proposed as a major risk factor for multiple sclerosis (MS). The aim of this study was to assess inter-observer agreement between two ultrasound examiners and to compare findings in MS patients and control participants.
A prospective, blinded, controlled study of MS patients diagnosed within 2 years (MS ≤ 2, n = 39), patients diagnosed more than 10 years ago (MS > 10, n = 43) and age- and sex-matched control participants (n = 40). Ultrasound examinations were performed by two independent examiners. CCSVI criteria 1, 3, 4 and 5 as proposed by Zamboni were explored: (1) reflux in the internal jugular (IJV) and vertebral veins (VV), (3) IJV cross-sectional area (CSA) ≤0.3 cm(2), (4) absence of flow in IJV and VV, and (5) reverted postural control of venous outflow.
Criteria 1, 4 and 5 were met in less than 10% of the MS patients and control participants as studied by both examiners. The level of inter-observer agreement was poor for all parameters except assessment of the CSA of IJV at the thyroid level. Findings meeting CCSVI criterion 3 (CSA ≤ 0.3 cm(2)) were observed in 18/40 (45%) of the control participants, in 24/37 (65%) of MS ≤ 2 patients (p = 0.09 vs. control participants) and in 30/43 (70%) of the MS > 10 patients (p = 0.022 vs. control participants).
The feasibility of the CCSVI criteria for common use is questionable because of low inter-observer agreement. Small-calibre IJVs meeting the CCSVI criterion 3 appear common in both Finnish control participants and MS patients, but the clinical significance of this finding is questionable.
慢性脑脊髓静脉功能不全（CCSVI）被认为是多发性硬化症（MS）的主要危险因素。本研究旨在评估两名超声检查者之间的观察者间一致性，并比较 MS 患者和对照组的检查结果。
前瞻性、盲法、对照研究纳入在 2 年内确诊的 MS 患者（MS ≤ 2，n = 39）、10 年前确诊的 MS 患者（MS > 10，n = 43）和年龄及性别匹配的对照组参与者（n = 40）。由两名独立的检查者进行超声检查。探讨了 Zamboni 提出的 CCSVI 标准 1、3、4 和 5：（1）颈内静脉（IJV）和椎静脉（VV）反流，（3）IJV 横截面积（CSA）≤0.3 cm(2)，（4）IJV 和 VV 无血流，（5）静脉流出反向姿势控制。
两名检查者均发现，不到 10%的 MS 患者和对照组参与者符合标准 1、4 和 5。除甲状腺水平 IJV CSA 评估外，所有参数的观察者间一致性水平均较差。在 40 名对照组参与者中，有 18 名（45%）发现符合 CCSVI 标准 3（CSA ≤ 0.3 cm(2)）的结果，在 MS ≤ 2 患者中，有 24/37（65%）符合该标准（与对照组相比，p = 0.09），在 MS > 10 患者中，有 30/43（70%）符合该标准（与对照组相比，p = 0.022）。
由于观察者间一致性低，CCSVI 标准的可行性值得怀疑。符合 CCSVI 标准 3 的小口径 IJVs 在芬兰对照组参与者和 MS 患者中均较为常见，但该发现的临床意义值得怀疑。
