台灣做靜脈曲張的水準愈來愈高了
愈來愈多的醫師投入這個新興的市場
硬化治療在病人間流傳神效不需醫師多做廣告就已經門庭若市應接不暇
繼FDA 核准的第一個硬化劑sodium tetradecyl sulfate, STS 之後
在歐洲廣為醫師使用的另一種很有效更不痛更不容易造成皮膚過敏或者擔心皮膚傷害的藥物
polidocanol 在叩關美國FDA好幾年phase I, II, III的試驗
美國靜脈學會每年邀請FDA專家前來解釋這個藥無法在美國上市的原因
還專門成立了一個基金會" 努力 "遊說
終於在今年三月底得到圓滿的結果...
FDA核准Polidocanol用於治療小型靜脈曲張, 指1毫米以下的蜘蛛靜脈跟1-3毫米間的網狀靜脈
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.
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。
這下子台灣要專案引進這個更沒有併發症的藥物又將是指日可待了
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