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FDA扩大了艾曲波帕片在ITP中的使用年龄

2015-09-07 MedSci 译 MedSci原创

美国食品和药物管理局(FDA)近期宣布,它已经扩大了艾曲波帕片(eltrombopag (Promacta, Novartis))在一种罕件的血液紊乱病--慢性免疫性血小板减少性紫癜(ITP)中的使用年龄,包括1岁的的患儿也能使用该药。这则消息紧接着FDA在6月份的决定,要扩大该药在6岁及以上患儿的使用指标。通常,ITP患者血小板水平会异常的低。FDA在发布这则消息时说道:“人

美国食品和药物管理局(FDA)近期宣布,它已经扩大了艾曲波帕片(eltrombopag (Promacta, Novartis))在一种罕件的血液紊乱病--慢性免疫性血小板减少性紫癜(ITP)中的使用年龄,包括1岁的的患儿也能使用该药。

这则消息紧接着FDA在6月份的决定,要扩大该药在6岁及以上患儿的使用指标。

通常,ITP患者血小板水平会异常的低。FDA在发布这则消息时说道:“人体没有足够的血小板,皮肤下、嘴唇的黏膜或人体其他部位就会出血,” 

艾曲波帕片,首次运用到ITP是在2008年,最初这个药仅仅是针对那些通过皮质醇类药物、免疫球蛋白和脾切除术治疗没有作用患者。而它作为一种促血小板生成素受体激活剂能够诱导骨髓造血干细胞的增殖和分化,促进血细胞的生成。

FDA今天对于扩大艾曲波帕在ITP中的使用年龄,让1岁的患儿也使用主要是基于两次双盲安慰剂对照临床研究,共159位患者参与研究。第一次研究持续7周,服用艾曲波帕的62%的患者拥有更多的血小板量相较于服用安慰剂的32%的患者,这些患者在1到6周间均没有进行其他治疗。第二次研究持续13周,用艾曲波帕治疗的41%患者有更多的血小板量相较于用安慰剂治疗的3%患者。

根据报道,该药最普遍的副反应包括上呼吸道感染、腹泻、腹痛、皮疹及肝酶增加。

但目前对于年龄低于1周岁的ITP患儿,FDA还无法确定艾曲波帕的使用安全和功效。

原始出处:

Robert Lowes. FDA Expands Age Indication for Eltrombopag (Promacta) in ITP. Medscape. Aug 24, 2015 

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    2015-10-05 zhouxue1990

    用于再生障碍性贫血

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=37709, encodeId=2c513e70970, content=用于再生障碍性贫血, beContent=null, objectType=article, channel=null, level=null, likeNumber=128, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a1a01625167, createdName=zhouxue1990, createdTime=Mon Oct 05 16:37:00 CST 2015, time=2015-10-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=37142, encodeId=63703e14274, content=艾曲波帕片,也许在某些TPO也无效的ITP患者中有效吧!, beContent=null, objectType=article, channel=null, level=null, likeNumber=165, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=18bb1631067, createdName=xingcy, createdTime=Tue Sep 22 17:37:00 CST 2015, time=2015-09-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1418419, encodeId=c6911418419e1, content=<a href='/topic/show?id=c8f210115bc' target=_blank style='color:#2F92EE;'>#ITP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10115, encryptionId=c8f210115bc, topicName=ITP)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=e2523357226, createdName=whmdzju, createdTime=Wed Sep 09 09:16:00 CST 2015, time=2015-09-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1420125, encodeId=54a21420125f3, content=<a href='/topic/show?id=7a7286e7153' target=_blank style='color:#2F92EE;'>#艾曲波帕#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=86771, encryptionId=7a7286e7153, topicName=艾曲波帕)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=776e3562469, createdName=huangdf, createdTime=Wed Sep 09 09:16:00 CST 2015, time=2015-09-09, status=1, ipAttribution=)]
    2015-09-22 xingcy

    艾曲波帕片,也许在某些TPO也无效的ITP患者中有效吧!

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=37709, encodeId=2c513e70970, content=用于再生障碍性贫血, beContent=null, objectType=article, channel=null, level=null, likeNumber=128, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a1a01625167, createdName=zhouxue1990, createdTime=Mon Oct 05 16:37:00 CST 2015, time=2015-10-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=37142, encodeId=63703e14274, content=艾曲波帕片,也许在某些TPO也无效的ITP患者中有效吧!, beContent=null, objectType=article, channel=null, level=null, likeNumber=165, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=18bb1631067, createdName=xingcy, createdTime=Tue Sep 22 17:37:00 CST 2015, time=2015-09-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1418419, encodeId=c6911418419e1, content=<a href='/topic/show?id=c8f210115bc' target=_blank style='color:#2F92EE;'>#ITP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10115, encryptionId=c8f210115bc, topicName=ITP)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=e2523357226, createdName=whmdzju, createdTime=Wed Sep 09 09:16:00 CST 2015, time=2015-09-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1420125, encodeId=54a21420125f3, content=<a href='/topic/show?id=7a7286e7153' target=_blank style='color:#2F92EE;'>#艾曲波帕#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=86771, encryptionId=7a7286e7153, topicName=艾曲波帕)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=776e3562469, createdName=huangdf, createdTime=Wed Sep 09 09:16:00 CST 2015, time=2015-09-09, status=1, ipAttribution=)]
    2015-09-09 whmdzju
  4. [GetPortalCommentsPageByObjectIdResponse(id=37709, encodeId=2c513e70970, content=用于再生障碍性贫血, beContent=null, objectType=article, channel=null, level=null, likeNumber=128, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a1a01625167, createdName=zhouxue1990, createdTime=Mon Oct 05 16:37:00 CST 2015, time=2015-10-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=37142, encodeId=63703e14274, content=艾曲波帕片,也许在某些TPO也无效的ITP患者中有效吧!, beContent=null, objectType=article, channel=null, level=null, likeNumber=165, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=18bb1631067, createdName=xingcy, createdTime=Tue Sep 22 17:37:00 CST 2015, time=2015-09-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1418419, encodeId=c6911418419e1, content=<a href='/topic/show?id=c8f210115bc' target=_blank style='color:#2F92EE;'>#ITP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10115, encryptionId=c8f210115bc, topicName=ITP)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=e2523357226, createdName=whmdzju, createdTime=Wed Sep 09 09:16:00 CST 2015, time=2015-09-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1420125, encodeId=54a21420125f3, content=<a href='/topic/show?id=7a7286e7153' target=_blank style='color:#2F92EE;'>#艾曲波帕#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=86771, encryptionId=7a7286e7153, topicName=艾曲波帕)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=776e3562469, createdName=huangdf, createdTime=Wed Sep 09 09:16:00 CST 2015, time=2015-09-09, status=1, ipAttribution=)]
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