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EMA限制使用前列腺癌药物Xofigo

2018-07-29 MedSci MedSci原创

EMAXofigo前列腺癌
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欧洲药品管理局（EMA）已完成对癌症药物Xofigo（镭-223二氯化物）的审查，并建议限制其用于曾经接受过两次转移性前列腺癌治疗的患者（前列腺癌已经扩散到骨骼中）。

欧洲药品管理局（EMA）已完成对癌症药物Xofigo（镭-223二氯化物）的审查，并建议限制其用于曾经接受过两次转移性前列腺癌治疗的患者（前列腺癌已经扩散到骨骼中）。Xofigo也不得与药物Zytiga（醋酸阿比特龙）和皮质类固醇泼尼松或泼尼松龙一起使用。除了用于维持男性荷尔蒙水平降低的治疗（激素治疗）外，Xofigo不应与其他全身性癌症疗法一起使用。根据目前的适应症，该药也不应用于没有症状的患者。此外，不推荐在骨转移数量较少的患者（称为成骨细胞性骨转移）中使用Xofigo。

Xofigo的审查由EMA的药物警戒风险评估委员会（PRAC）进行，因为临床研究的数据表明，与Zytiga和泼尼松/泼尼松龙联合使用的Xofigo的患者可能比安慰剂患者具有更的死亡率和骨折率。该研究包括没有或仅有轻微症状的患者，而Xofigo仅在有症状的患者中被授权使用。此外，本研究中使用的组合现在是禁忌的。在该研究中，与Xofigo联合治疗的患者平均比安慰剂组合患者早死2.6个月。此外，接受Xofigo组合治疗的患者中有29％的患者出现骨折，而接受安慰剂组合治疗的患者仅为11％。


原始出处：

http://www.firstwordpharma.com/node/1581510?tsid=4#axzz5MVjkDWbV

本文系梅斯医学（MedSci）原创编译整理，转载需授权!

评论区 (7)
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  1. [GetPortalCommentsPageByObjectIdResponse(id=1317419, encodeId=e2ae131e4190b, content=<a href='/topic/show?id=74916e0414' target=_blank style='color:#2F92EE;'>#EMA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6704, encryptionId=74916e0414, topicName=EMA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a35a460, createdName=fengyi812, createdTime=Tue Jul 31 12:30:00 CST 2018, time=2018-07-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335068, encodeId=2811335068f7, content=学习谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=92, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mStl88fu4Nd44v3xHnnictn9UpctwtH62EPQ59TMdI9lnqHMgQ16nH7GmGCfpzicsHgjibYVk6vwSpXrC86gMibRkoaIzf5HwSz7/0, createdBy=78cc1691107, createdName=龙胆草, createdTime=Mon Jul 30 08:12:09 CST 2018, time=2018-07-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335015, encodeId=01973350151e, content=厉害了我的哥, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib3IzoRn621JdKCFUI4XvNELcibocrAVU6aUzEVDSaf3rYH08PUYUiagGqxAEhj8g9WqqNvD1CupIpCrmnR2OrqHZh/0, createdBy=7f181365728, createdName=飛歌, createdTime=Mon Jul 30 01:18:34 CST 2018, time=2018-07-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=334995, encodeId=a03c334995ac, content=学习了学习了我，谢谢, beContent=null, objectType=article, channel=null, level=null, likeNumber=102, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1bb241978, createdName=phoebeyan520, createdTime=Sun Jul 29 23:20:23 CST 2018, time=2018-07-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=334986, encodeId=653933498688, content=谢谢分享学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4o2XVpJ6449yqDsjibydI5HnJ8MibGxNn4HZiaZib0bdfibbwoz3KQrIyN9AGxq36ZlZRNicYlPfOOWMtwgsajY6mGNFiaPclFdowjD0/0, createdBy=97bd1338592, createdName=清风拂面, createdTime=Sun Jul 29 23:02:52 CST 2018, time=2018-07-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=334977, encodeId=b0353349e7a4, content=学习了，谢谢分享。, beContent=null, objectType=article, channel=null, level=null, likeNumber=128, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=60791943465, createdName=1e0f8808m18(暂无匿称), createdTime=Sun Jul 29 22:31:46 CST 2018, time=2018-07-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=334970, encodeId=11b03349e012, content=不错的文章值得拥有哦, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=eff51996281, createdName=1e1b8538m79(暂无匿称), createdTime=Sun Jul 29 22:07:57 CST 2018, time=2018-07-29, status=1, ipAttribution=)]
    2018-07-31 fengyi812

    #EMA#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1317419, encodeId=e2ae131e4190b, content=<a href='/topic/show?id=74916e0414' target=_blank style='color:#2F92EE;'>#EMA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6704, encryptionId=74916e0414, topicName=EMA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a35a460, createdName=fengyi812, createdTime=Tue Jul 31 12:30:00 CST 2018, time=2018-07-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335068, encodeId=2811335068f7, content=学习谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=92, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mStl88fu4Nd44v3xHnnictn9UpctwtH62EPQ59TMdI9lnqHMgQ16nH7GmGCfpzicsHgjibYVk6vwSpXrC86gMibRkoaIzf5HwSz7/0, createdBy=78cc1691107, createdName=龙胆草, createdTime=Mon Jul 30 08:12:09 CST 2018, time=2018-07-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335015, encodeId=01973350151e, content=厉害了我的哥, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib3IzoRn621JdKCFUI4XvNELcibocrAVU6aUzEVDSaf3rYH08PUYUiagGqxAEhj8g9WqqNvD1CupIpCrmnR2OrqHZh/0, createdBy=7f181365728, createdName=飛歌, createdTime=Mon Jul 30 01:18:34 CST 2018, time=2018-07-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=334995, encodeId=a03c334995ac, content=学习了学习了我，谢谢, beContent=null, objectType=article, channel=null, level=null, likeNumber=102, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1bb241978, createdName=phoebeyan520, createdTime=Sun Jul 29 23:20:23 CST 2018, time=2018-07-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=334986, encodeId=653933498688, content=谢谢分享学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4o2XVpJ6449yqDsjibydI5HnJ8MibGxNn4HZiaZib0bdfibbwoz3KQrIyN9AGxq36ZlZRNicYlPfOOWMtwgsajY6mGNFiaPclFdowjD0/0, createdBy=97bd1338592, createdName=清风拂面, createdTime=Sun Jul 29 23:02:52 CST 2018, time=2018-07-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=334977, encodeId=b0353349e7a4, content=学习了，谢谢分享。, beContent=null, objectType=article, channel=null, level=null, likeNumber=128, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=60791943465, createdName=1e0f8808m18(暂无匿称), createdTime=Sun Jul 29 22:31:46 CST 2018, time=2018-07-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=334970, encodeId=11b03349e012, content=不错的文章值得拥有哦, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=eff51996281, createdName=1e1b8538m79(暂无匿称), createdTime=Sun Jul 29 22:07:57 CST 2018, time=2018-07-29, status=1, ipAttribution=)]
    2018-07-30 龙胆草

    学习谢谢分享

    0

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    2018-07-30 飛歌

    厉害了我的哥

    0

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    2018-07-29 phoebeyan520

    学习了学习了我，谢谢

    0

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    2018-07-29 清风拂面

    谢谢分享学习

    0

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    2018-07-29 1e0f8808m18(暂无匿称)

    学习了，谢谢分享。

    0

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    2018-07-29 1e1b8538m79(暂无匿称)

    不错的文章值得拥有哦

    0

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