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標題: FDA核准Polidocanol用於治療小型靜脈曲張 [打印本頁]

作者: Tisko012    時間: 2010-4-13 10:31     標題: FDA核准Polidocanol用於治療小型靜脈曲張

作者:Emma Hitt, PhD  
出處:WebMD醫學新聞

  March 31, 2010 — 美國食品藥物管理局(FDA)核准polidocanol注射劑(商品名Asclera,Chemische Fabrik Kreussler Co公司)用於治療小型靜脈曲張。
  
  根據FDA週一發布的新聞稿,值得注意的是,polidocanol被核准用於關閉蜘蛛絲狀靜脈(直徑<1 mm)與網狀靜脈(直徑1 - 3 mm)。
  
  FDA藥物評估與研究中心的Norman Stockbridge博士在書面資料中指出,當治療目標為改善外觀時,Asclera可用於小型靜脈曲張之治療。
  
  Polidocanol會使血管細胞內層纖維化,使它們崩解;最後由其他類型組織取代該靜脈。
  
  與polidocanol有關的副作用包括外滲、血腫、刺激、變色與注射部位疼痛。


FDA Approves Polidocanol for the Treatment of Small Varicose Veins

By Emma Hitt, PhD
Medscape Medical News

March 31, 2010 — The US Food and Drug Administration (FDA) has approved polidocanol injection (Asclera, Chemische Fabrik Kreussler Co) for the treatment of small varicose veins.

Specifically, polidocanol is approved to close spider veins (<1 mm in diameter) and reticular veins (1 - 3 mm in diameter), according to the FDA press release issued on Monday.

"Asclera is indicated for the treatment of small types of varicose veins when the aim of treatment is to improve appearance," noted Norman Stockbridge, MD, PhD, from the Center for Drug Evaluation and Research at the FDA, in the written release.

Polidocanol creates fibrosis within the cell lining of blood vessels, causing them to collapse; the vein is then eventually replaced by other types of tissue.

Adverse reactions to polidocanol include leakage, hematoma, bruising, irritation, discoloration, and pain at the injection site.




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