Levonorgestrel IUD核准用於治療嚴重經期出血


  October 2, 2009 — 美國食品藥物管理局(FDA)已經核准levonorgestrel釋放子宮內裝置(IUD;Mirena,拜耳健康照護有限公司)用於治療選擇子宮內避孕方法女性的嚴重經期出血。
  
  估計9~14%的女性有嚴重的經期出血,以需要兩倍量的護墊、每小時的流量需要使用超過一片以上的護墊或衛生棉條、以及需要在晚上更換護墊為其特徵。
  
  FDA的女性健康辦公室主任Kathleen Uhl醫師在一篇新聞稿中表示,飽受量多、經期過長所苦的女性,有這樣的狀況是不舒服、失能且令人害怕的;這樣的出血可以是很嚴重,致使女性無法工作、上課或進行社交活動。
  
  這項FDA核准案是根據一項隨機分派、開放標記臨床研究,比較使用IUD與medroxyprogesterone acetate於160位嚴重經期出血的女性,以經期失血超過80毫升以上定義;這項研究排除可能造成嚴重出血的病況,除了纖維瘤之外(總體積小於5毫升)。
  
  研究結果顯示,85%使用IUD的女性,經期失血量降低超過50%,接受medroxyprogesterone acetate的病患則是22%(P值<0.001)。
  
  使用IUD最常報告的不良事件,包括不規律的子宮內出血與點狀出血、頭痛、卵巢囊腫、陰道炎、痛經、骨盆疼痛與乳房脹痛。
  
  Levonorgestrel釋放IUD過去核准於已經育兒的女性避孕使用;這兩個適應症的臨床研究已排除沒有懷孕史的女性。
  

Levonorgestrel IUD Approved to Treat Heavy Menstrual Bleeding

By Yael Waknine
Medscape Medical News

October 2, 2009 — The US Food and Drug Administration (FDA) has approved a new indication for a levonorgestrel-releasing intrauterine device (IUD; Mirena, Bayer Healthcare Pharmaceuticals, Inc) for the treatment of heavy menstrual bleeding in women who choose an intrauterine contraception.

Heavy menstrual bleeding occurs in 9% to 14% of women and is characterized by the need to use double sanitary protection, menstrual flow that soaks through 1 or more sanitary pads/tampons per hour, and the need to change sanitary protection during the night.

"Women who suffer heavy, prolonged menstrual periods find the condition unpleasant, disabling, and frightening," said Kathleen Uhl, MD, director of the FDA's Office of Women's Health in an agency news release. "Bleeding can be so heavy that women must miss work, school, or social activities."

The FDA approval was based on data from a randomized, open-label clinical trial that compared use of the IUD with medroxyprogesterone acetate in 160 women with heavy menstrual bleeding, defined as menstrual blood loss of 80 mL or greater. The study excluded women having conditions that cause heavy bleeding, with the exception of fibroids (total volume ? 5 mL).

Results showed that 85% of women using the IUD achieved a 50% or greater decrease in menstrual blood loss from baseline compared with 22% of those receiving medroxyprogesterone acetate (P < .001).

Adverse events most commonly reported with use of the IUD included intrauterine bleeding/spotting at irregular intervals, headache, ovarian cysts, vaginitis, dysmenorrhea, pelvic pain, and breast tenderness.

The levonorgestrel-releasing IUD previously was approved for contraceptive use in women who have had a child; clinical studies for both indications have excluded women with no history of pregnancy.

    
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