隨著Avodart在韓國第三階段臨床實驗的發表,Dutasteride還有一段未知的路要走。
 
   

 
有人會期待Dutasteride(適尿通)會重新調整劑量成為治療MPB的新藥嗎?就像由波斯卡改變劑量成柔沛上市的相同模式。
葛蘭素史克藥廠當初在沒有具體理由下結束在美國的臨床實驗,有人認為是藥廠考量預期獲利以及銷售潛力等因素而中止實驗,有人認為是副作用的疑慮。然而,最新第三階段研究,核定為0.5mg劑量治療掉髮日前在韓國獲得認可,這研究給了我們一些有關Avodart的問題與答案。

真正的核心問題是,葛蘭素史克公司未來的市場銷售策略到底是什麼?會以何種的劑量銷售?只會在韓國或其他國家獲得認可銷售?還是會再嘗試得到美國FDA的認可?大家最關心的安全性與副作用的疑慮(這是最重要的部分)已有足夠的資訊說服大家嗎?這些問題都是我們要再深入了解與追蹤的。雖然此研究是進行到第六個月時的結果,實際上應該已有超過一年以上的時間了,如果有找到更新的資料,再提供給大家參考。

研究摘要如下:以每天dutasteride 0.5 mg治療男雄性禿,安全性和耐受性的研究。採隨機,雙盲,安慰劑對照,第三階段研究。

背景:
Avodart是一種第一型與第二型5a還原脢的雙重抑制劑,從而抑制睪固酮轉化為雙氫睪固酮,DHT是導致雄性禿的關鍵原因。

目標:
為期六個月,隨機雙盲的方式,以dutasteride 0.5 mg與安慰劑做比較,治療男性雄性禿患者的療效、安全性和耐受性。
方法:
共153人,18至49歲,隨機選擇受試者每天服用dutasteride 0.5毫克,為期六個月。藉由髮量改變、受試者評估、調查人員和攝影小組評估效果。
結果:
經由受試者自我評估、調查者評估與影像評估,男子服用Avodart 0.5mg,每一平方公分/毛髮增長12.4根;比服用安慰劑每一平方公分/毛髮增長4.7根相較,有明顯的效果。
局限性:
這項研究僅限於6個月。
結論:
這項研究顯示,以dutasteride 0.5毫克治療男雄性禿,可改善頭髮生長,有相對良好的耐受性。

後記:我們要持續關心的問題所在
1.效果優於Finasteride
2.副作用風險、是否會造成不孕的疑慮
3.停留在體內時間過久 

By iwanthair's blog
圖片來源:Regrowth.com
 
   
 
Efficacy, safety, and tolerability of dutasteride 0.5 mg once daily in male patients with male pattern hair loss: A randomized, double-blind, placebo-controlled, phase III study.

J Am Acad Dermatol. 2010 Aug;63(2):252-258. Epub 2010 Jun 3.
Eun HC, Kwon OS, Yeon JH, Shin HS, Kim BY, Ro BI, Cho HK, Sim WY, Lew BL, Lee WS, Park HY, Hong SP, Ji JH.Department of Dermatology, Seoul National University College of Medicine, Seoul, Korea

BACKGROUND: Dutasteride (Avodart) is a dual inhibitor of both type I and type II 5 alpha reductases, and thus inhibits conversion of testosterone to dihydrotestosterone, a key mediator of male pattern hair loss.
OBJECTIVES: The aim of this randomized double-blind phase III study was to compare the efficacy, safety, and tolerability of dutasteride (0.5 mg) and placebo for 6 months of treatment in male patients with male pattern hair loss.
METHODS: A total of 153 men, 18 to 49 years old, were randomized to receive 0.5 mg of dutasteride or placebo daily for 6 months. Efficacy was evaluated by the change of hair counts, subject assessment, and photographic assessment by investigators and panels.
RESULTS: Mean change of hair counts from baseline to 6 months after treatment start was an increase of 12.2/cm(2) in dutasteride group and 4.7/cm(2) in placebo group and this difference was statistically significant (P = .0319). Dutasteride showed significantly higher efficacy than placebo group by subject self-assessment and by investigator and panel photographic assessment. There was no major difference in adverse events between two groups.
LIMITATIONS: The study was limited to 6 months.
CONCLUSIONS: This study clearly showed that 0.5 mg of dutasteride improved hair growth and was relatively well tolerated for the treatment of male pattern hair loss.

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