强力胶植入物可修补静脉

亚特兰大——德国希尔施贝格的Thomas Proebstle博士在美国皮肤外科学会(ASDS)2012年会上报告，根据对氰基丙烯酸酯粘合剂产品的首个人体研究的1年随访数据，氰基丙烯酸酯粘合剂为基础的植入物是可行、安全和有效的大隐静脉功能不全治疗方法。并且，这种治疗既不需要局部麻醉，也不需要使用收缩性医疗袜。

氰基丙烯酸酯粘合剂植入物也称为VenaSeal Sapheon关闭系统，已通过欧盟的监管核准。其生产商Sapheon公司正在准备进行美国临床试验，并向美国食品药品管理局提出核准申请。

研究中共纳入29例女性和9例男性患者，中位年龄为51岁。在超声引导下放置导管，并通过重复多次静脉注射的方法实施治疗，无需局部麻醉或使用收缩性医疗袜。

结果显示，在38例接受氰基丙烯酸酯粘合剂(通常称为强力胶)专利剂型注射的大隐静脉功能不全患者中，多普勒超声和临床检查100%显示即时和48 h随访时静脉完全关闭；1年随访时，92%保持静脉完全关闭。在随访1、3和6个月时，分别发生1次完全的阻塞血管再通和2次部分阻塞血管再通。多数患者(89%)在48 h内表现出下肢水肿改善，所有患者的静脉临床严重程度评分均改善，基线时的平均评分为6.1分，6个月时平均评分为1.1分。在这项研究中，平均静脉内注射的氰基丙烯酸酯粘合剂总量为1.26 ml。不良反应为轻度、自限性。

Proebstle博士担任Sapheon公司顾问，并拥有该公司的股份。

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By: SHARON WORCESTER, Cardiology News Digital Network

ATLANTA – A cyanoacrylate adhesive–based implant is feasible, safe, and effective for the treatment of great saphenous vein incompetence, according to 1-year follow-up data from the first study of the product in humans.

The treatment requires neither local anesthesia nor use of medical compression stockings, Dr. Thomas Proebstle reported at the annual meeting of the American Society for Dermatologic Surgery.

Of 38 patients with an incompetent great saphenous vein who were treated with a proprietary formulation of cyanoacrylate adhesive (commonly known as superglue), 100% demonstrated complete closure of the vein immediately and at the 48-hour follow-up, as measured using duplex ultrasound and clinical examination; at 1-year follow-up, 92% maintained complete closure of the vein, said Dr. Proebstle of Hirschberg, Germany. One complete recanalization and two partial recanalizations occurred during follow-up – at 1, 3, and 6 months, respectively, he noted.

Most patients (89%) had improvement in leg edema within 48 hours, and all had venous clinical severity score improvement, which changed from a mean of 6.1 at baseline to a mean of 1.1 at 6 months.

The study involved 29 women and 9 men with a median age of 51 years. Treatment was administered by catheter deployment under ultrasound guidance via a repetitive bolus injection algorithm, Dr. Proebstle noted. No tumescent anesthesia or compression stockings were used.

For this study, the mean total volume of endovenous cyanoacrylate adhesive delivered was 1.26 mL. Side effects were mild and self-limited.

The cyanoacrylate adhesive implant, known as the VenaSeal Sapheon closure system, has received European Union regulatory approval. The manufacturer, Sapheon, is currently preparing for U.S. clinical trials and Food and Drug Administration approval, according to the company’s website.

Dr. Proebstle is a consultant for Sapheon. He also owns stock in the company.