球囊成形术可改善多发性硬化症患者的静脉血流

马里兰州国家海港(EGMN)—— 美国纽约Albany医学院的Manish Mehta博士在血管年会上报告的一项初步研究显示，对于慢性脑静脉功能不全(CCSVI)的多发性硬化症(MS)患者，经皮球囊成形术可改善其血流动力学。

虽然近期发现MS和以颅外静脉(包括颈内静脉和奇静脉)狭窄和反流为特征的CCSVI有关联，但关于采用经皮球囊成形术治疗这类狭窄是否合理仍存在较大争议。于是Mehta博士及其同事开展了这项研究，量化分析了经皮球囊成形术对这类病灶血流动力学的影响。

研究者采用血管造影，对50例MS 合并CCSVI 患者的颈内静脉和12名健康志愿者的颈内静脉进行了评估。量化分析从颈内静脉中段到上腔静脉的造影剂飞跃时间，以及深静脉排空时间(PVET)。在球囊扩张术前后记录CCSVI患者的飞跃时间和PVET，对健康志愿者也记录这两项指标。

结果显示，在50例颈内静脉狭窄超过70%、反流且接受球囊扩张术的CCSVI-MS患者中，44例(78%)技术成功(定义为颈内静脉残余狭窄不足20%)。研究者观察到，CCSVI患者在接受球囊扩张术后，飞跃时间和PVET均明显改善，达到与健康对照者相当的程度。

上述结果提示，MS与CCSVI相关，后者导致飞跃时间和PVET异常升高。而且，对这类病变行球囊扩张术可改善血液动力学参数，达到与健康人可比的程度。

Mehta博士强调，尚需开展随机研究以进一步澄清这一问题，并指出这一患者群易受安慰剂效应的影响。他还表示，这一治疗已在全球被用于很多患者，美国食品药品管理局(FDA)已发出警告，由于缺乏安全性和有效性数据，反对在严格控制的试验之外对这类患者使用该药。

Mehta博士报告称无利益冲突。

BY MARK LESNEY
Elsevier Global Medical News
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NATIONAL HARBOR, MARYLAND (EGMN) – Percutaneous balloon angioplasty improved flow dynamics in multiple sclerosis patients with chronic cerebrospinal venous insufficiency in a pilot study.

An association has been made recently between multiple sclerosis and chronic cerebrospinal venous insufficiency (CCSVI) that is characterized by stenosis and reflux of the principal extracranial venous drainage, including the internal jugular veins and the azygous veins. But there has been considerable debate about the validity of percutaneous balloon angioplasty in the treatment of this stenosis.

Dr. Manish Mehta of Albany (New York) Medical College and his colleagues conducted the first angiographic study to quantitatively analyze the impact of percutaneous balloon angioplasty on flow dynamics across these lesions. Dr. Mehta shared their results at the Vascular Annual Meeting.

The researchers assessed 50 internal jugular veins (IJVs) from MS patients with CCSVI, as well as 12 IJVs from healthy volunteers, all of whom underwent detailed angiographic evaluation. The technical components of all venograms were standardized.

Quantitative analysis included the contrast time of flight from the mid-IJV to the superior vena cava, and the primary venous emptying time (PVET), quantified as greater than 50% of venous emptying from the IJV. The time of flight and PVET were recorded in patients with CCSVI prior to and subsequent to balloon angioplasty. The same data were recorded in the healthy controls. All data were collected prospectively, and statistical analysis was performed using two-tailed Student’s test.

Of the 50 CCSVI-MS patients who had IJV stenosis greater than 70% and reflux and who underwent balloon angioplasty, technical success (defined as less than 20% residual IJV stenosis) was achieved in 44 (78%). CCSVI patients were observed to have a significant improvement in both the time of flight and PVET following balloon angioplasty that paralleled those of healthy subjects without MS.

“The results of this prospective pilot study suggest an association between MS and CCSVI, which results in abnormally elevated time of flight and PVET through the IJV,” Dr. Mehta said. “Furthermore, balloon angioplasty of these lesions improves the hemodynamic parameters so that they are comparable to” those of healthy non-MS patients.”

Dr. Mehta stressed the need for randomized studies to further investigate this issue and said that this patient population is at high risk for a placebo effect with regard to their reported symptoms. He also stated that this treatment is being provided to many patients around the world and that the U.S. Food and Drug Administration has cautioned against its use outside of well-regulated trials due to lack of safety and efficacy data.

Dr. Mehta reported that he had nothing to disclose.