PT -期刊文章盟Adnan h·西迪基非盟-罗伯特Zivadinov盟拉尔夫到了本笃十六世盟-尤莫盟Jihnhee Yu盟Mary l . Hartney AU -卡伦·l·马尔盟Vesela Valnarov AU -谢丽尔·l·肯尼迪盟Murali拉马纳坦AU -迪帕p . Ramasamy盟Kresimir Dolic AU -大卫·w·Hojnacki盟-艾伦·卡尔盟-兰德。利维AU - l·纳尔逊·霍普金斯盟比安卡Weinstock-Guttman TI -前瞻性随机试验的静脉血管成形术(前提)援助- 10.1212 / WNL女士。0000000000000638 DP - 2014年7月29日TA -神经病首页学第六PG - 441 - 449 - 83 IP - 5 4099 - //www.ez-admanager.com/content/83/5/441.short 4100 - //www.ez-admanager.com/content/83/5/441.full所以Neurology2014 7月29日;83 AB -目的:我们报告调查结果静脉血管成形术的安全性和有效性多发性硬化(MS)患者颅外静脉异常的结果,认为是慢性脑脊髓静脉功能不全的特点(CCSVI),二段式研究(ClinicalTrials.gov NCT01450072)。方法:第一阶段是一个非盲安全研究(10例);第二阶段是假对照,随机,双盲(10虚假的过程,9)治疗。所有研究患者实现静脉血流动力学检测标准的CCSVI的说明。评估在1、3和6个月postprocedure MRI,临床和血流动力学的结果。Primary endpoints were safety at 24 hours and 1 month, venous outflow restoration >75% at 1 month, and effect of angioplasty on new lesion activity and relapse rate over 6 months. Secondary endpoints included changes in disability, brain volume, cognitive tests, and quality of life.Results: No perioperative complications were noted; however, one patient with history of syncope was diagnosed with episodic bradycardia requiring placement of a pacemaker before discharge. Doppler evidence-based venous hemodynamic insufficiency severity score (VHISS) was reduced >75% compared to baseline in phase 1 (at 1 month) but not phase 2. In phase 2, higher MRI activity (cumulative number of new contrast-enhancing lesions [19 vs 3, p = 0.062] and new T2 lesions [17 vs 3, p = 0.066]) and relapse activity (4 vs 1, p = 0.389) were identified as nonsignificant trends in the treated vs sham arm over 6 months. Using analysis of covariance, significant cumulative new T2 lesions were related to larger VHISS decrease (p = 0.028) and angioplasty (p = 0.01) over the follow-up. No differences in other endpoints were detected.Conclusion: Venous angioplasty is not an effective treatment for MS over the short term and may exacerbate underlying disease activity.Classification of evidence: This is a Class I study demonstrating that clinical and imaging outcomes are no better or worse in patients with MS identified with venous outflow restriction who receive venous angioplasty compared to sham controls who do not receive angioplasty. This study also includes a Class IV phase 1 study of safety in 10 patients receiving the angioplasty procedure.AE=adverse event; ANCOVA=analysis of covariance; ANOVA=analysis of variance; CCSVI=chronic cerebrospinal venous insufficiency; CE=contrast-enhancing; CV=catheter venography; EDSS=Expanded Disability Status Scale; IJV=internal jugular vein; IVUS=intravascular ultrasound; MS=multiple sclerosis; MSFC=MS Functional Composite; PREMiSe=Prospective Randomized Endovascular Therapy in MS; QoL=quality of life; VH=venous hemodynamic; VHISS=venous hemodynamic insufficiency severity score

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