vicky3 2009-12-4 11:04
FDA首次核准用於經血過多的非荷爾蒙類產品
作者：Yael Waknine
出處：WebMD醫學新聞
November 16, 2009 — 美國食品藥物管理局(FDA)核准tranexamic acid錠劑(商品名Lysteda，Xanodyne Pharmaceuticals藥廠)，這是第一個治療經血過多的非荷爾蒙類產品。
FDA婦女健康專員Kathleen Uhl醫師在新聞稿中表示，經血過多令某些婦女感到無能為力；它會引起疼痛、情緒不穩、對工作和家庭生活都產生困擾。
Tranexamic acid藉由完整連結到胞漿素原的離氨基酸受體位置而發揮作用，因此有助於讓經血過多時經常發生的纖維蛋白溶解活性過高正常化。
該藥物的核准是根據兩篇重要的安慰劑控制第3期試驗的部份資料，顯示以tranexamic acid治療的婦女，在3次和6次治療中，經血量比開始時顯著減少(兩種療程的P值都 < .0001)。
副作用包括頭痛、鼻竇與鼻腔症狀、背痛、腹痛、肌肉/關節疼痛、肌肉痙攣、貧血與疲勞。
FDA指出，同時使用tranexamic acid和荷爾蒙類避孕藥會增加血栓形成、中風與心肌梗塞等風險。只有在有強烈醫療需求且治療利益大過風險時才可以併用這兩類藥品。
Tranexamic acid之前是以注射劑的形式獲得核准(商品名Cyclokapron，輝瑞藥廠)，短期用於血友病患以減少或預防出血，減少拔牙時和拔牙後之替代治療的需求。
FDA Approves First Nonhormonal Product for Menorrhagia
By Yael Waknine
Medscape Medical News
November 16, 2009 — The US Food and Drug Administration (FDA) has approved tranexamic acid tablets (Lysteda, Xanodyne Pharmaceuticals) as the first nonhormonal product for the treatment of menorrhagia.
"Menorrhagia can be incapacitating for some women," said Kathleen Uhl, MD, the FDA's associate commissioner of women's health in an agency news release. "Heavy menstrual periods can cause pain, mood swings, and disruptions to work and family life."
Tranexamic acid exerts its effects by competitively binding to the lysine receptor sites of plasminogen, thereby helping to normalize the hyperfibrinolytic activity often present in menorrhagia.
The drug's approval was based in part on data from 2 pivotal placebo-controlled phase 3 trials showing that women treated with tranexamic acid experienced a significant decrease in menstrual blood loss relative to baseline during 3 and 6 cycles of treatment (P < .0001 for both).
Adverse events included headache, sinus and nasal symptoms, back pain, abdominal pain, muscle/joint pain, muscle cramps, anemia, and fatigue.
The FDA notes that concomitant use of tranexamic acid with hormonal contraceptives may increase the risk for thrombosis, stroke, and myocardial infarction. Women should only use the products together if there is a strong medical need and potential benefits outweigh therapeutic risks.
Tranexamic acid previously was approved as an injection (Cyclokapron, Pfizer, Inc) for short-term use in patients with hemophilia to reduce or prevent hemorrhage and reduce the need for replacement therapy during and after tooth extraction.