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              FDA2009年上市新藥romidepsin介紹
              2010-07-21 19:55:05 來源:不詳 瀏覽:6775

              中文名:- 
              英文名:romidepsin
              英文化學名:(1S,4Z,7S,10S,11E,20R)-4-ethylidene-7,20-dipropan-2-yl-9-oxa-15,16-dit hia-3,6,18,21-tetrazabicyclo[8.7.6]tricos-11-ene-2,5,8,19,22-pentone
              中文化學名:-
              分子式:C24H36N4O6S2
              CAS號:128517-07-7
              分子結構式:

               

              Istodax (romidepsin)
              適應癥:皮膚T細胞淋巴瘤
              生產商:Gloucester Pharmaceutical
              批準日期:2009年11月5日

              Istodax(romidepsin)屬注射類藥物,用于治療皮膚T淋巴細胞瘤(CTCL)。

              CTCL為一種生長緩慢并且能夠影響T淋巴細胞的腫瘤。大多數病例以皮膚干燥、紅疹和瘙癢為首發癥狀,并且癥狀會逐漸加重。皮膚形成腫瘤后可發生潰瘍,進而引發感染。在某些情況下CTCL可播散至血液、淋巴結及內臟器官。美國每年約有1500例新發病例。

              皮膚局限性CTCL患者可采用局部藥物治療或光療,如果腫瘤進展則可使用化療。Istodax能夠干擾細胞增殖的關鍵進程。當CTCL患者出現病情惡化或化療后復發時,可考慮將Istodax用于治療。兩項共涉及167例患者的臨床試驗對Istodax進行了評價,研究中均有約35%的患者出現腫瘤緩解,其中一項研究的平均緩解時間為15個月,另一項為11個月,研究中有6%的患者出現完全緩解。

              Istodax常見的副作用包括惡心、疲勞、感染、嘔吐、食欲減退、紅細胞降低、血小板減少和白細胞降低。Istodax還可能導致心電圖(ECG)發生變化。使用該藥物時應定期監測電解質,具有心律不齊風險者應定期監測ECG。Istodax可能對胎兒具有不良影響,因此女性在使用期間應避免受孕。

              既往批準治療CTCL的藥物包括伏立諾他(Zolinza,vorinostat)、一種白介素融合2毒素(Ontak,denileukin&nbsp;difitox)和貝沙羅汀(Targretin,bexarotene)。


               

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