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美国食品和药物管理局通过Amgen的Prolia解决糖皮质激素骨质疏松症问题

2018-05-23 MedSci MedSci原创

美国监管机构已批准Amgen Prolia的新适应症,允许其用于治疗高风险骨折男性和女性的糖皮质激素诱导的骨质疏松症(GIOP)。该决定允许医生向患有骨质疏松性骨折病史的患者,具有多种骨折风险因素的患者,或者对其他可用的骨质疏松症治疗失败或不能耐受的患者开药。该批准基于III期数据,显示接受Prolia(denosumab)的患者与接受Actonel(利塞膦酸钠)的患者相比,骨密度(BMD)增加更


美国监管机构已批准Amgen Prolia的新适应症,允许其用于治疗高风险骨折男性和女性的糖皮质激素诱导的骨质疏松症(GIOP)。

该决定允许医生向患有骨质疏松性骨折病史的患者,具有多种骨折风险因素的患者,或者对其他可用的骨质疏松症治疗失败或不能耐受的患者开药。

该批准基于III期数据,显示接受Prolia(denosumab)的患者与接受Actonel(利塞膦酸钠)的患者相比,骨密度(BMD)增加更多。

在这项研究中,每6个月皮下注射Prolia 60mg与两个患者亚群口服Actonel 5mg每日进行比较--那些接受持续糖皮质激素治疗和开始治疗的患者。

数据显示,接受持续糖皮质激素治疗的患者在腰椎(分别为4.4%和2.3%)和全髋(分别为2.1%和0.6%)时,Prolia与利塞膦酸钠相比骨密度增加更多。

在新开始接受糖皮质激素治疗的患者中,Prolia也在腰椎(分别为3.8%和0.8%)和全髋(分别为1.7%和0.2%)中诱发更大的BMD增加。

GIOP是通过服用常用于治疗炎性疾病的糖皮质激素药物引起的。在治疗的头三个月内,患者骨折风险增加高达75%,尽管随后几个月BMD将继续显着下降。

"这是一个严重的病症,导致骨矿物质密度迅速下降和骨折风险增加。这一批准为患者和医生提供了一种新的治疗选择,"Amgen研发部执行副总裁Sean E. Harper指出。


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    2018-06-29 cenghis
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    2018-05-25 zhouqu_8
  4. 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13:56:00 CST 2018, time=2018-05-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=318070, encodeId=94663180e0cb, content=学习了谢谢分享!, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib2JlGvwpAibiaovVhfA9DbO7X7JLGGjM4Cic6oMgxLdnuS9piaP9cnG2OwIbkzHvX0qzS1boibyYNqR5vHZu7HQs5EIB/0, createdBy=298d1398341, createdName=lou.minghong, createdTime=Thu May 24 07:19:32 CST 2018, time=2018-05-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=317982, encodeId=73e931e982a6, content=学习了很有用不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, 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=Thu May 24 00:22:12 CST 2018, time=2018-05-24, status=1, ipAttribution=)]
  5. 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13:56:00 CST 2018, time=2018-05-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=318070, encodeId=94663180e0cb, content=学习了谢谢分享!, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib2JlGvwpAibiaovVhfA9DbO7X7JLGGjM4Cic6oMgxLdnuS9piaP9cnG2OwIbkzHvX0qzS1boibyYNqR5vHZu7HQs5EIB/0, createdBy=298d1398341, createdName=lou.minghong, createdTime=Thu May 24 07:19:32 CST 2018, time=2018-05-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=317982, encodeId=73e931e982a6, content=学习了很有用不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, 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=Thu May 24 00:22:12 CST 2018, time=2018-05-24, status=1, ipAttribution=)]
    2018-05-25 Eleven17
  6. 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encodeId=aa811600342ec, content=<a href='/topic/show?id=3565e21649e' target=_blank style='color:#2F92EE;'>#皮质激素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=72164, encryptionId=3565e21649e, topicName=皮质激素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cb1a18781011, createdName=bbwznl, createdTime=Fri May 25 13:56:00 CST 2018, time=2018-05-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1602010, encodeId=d4d61602010f1, content=<a href='/topic/show?id=2f801469e57' target=_blank style='color:#2F92EE;'>#PRO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14697, encryptionId=2f801469e57, topicName=PRO)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a60b18898917, createdName=sunylz, createdTime=Fri May 25 13:56:00 CST 2018, time=2018-05-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=318070, encodeId=94663180e0cb, content=学习了谢谢分享!, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib2JlGvwpAibiaovVhfA9DbO7X7JLGGjM4Cic6oMgxLdnuS9piaP9cnG2OwIbkzHvX0qzS1boibyYNqR5vHZu7HQs5EIB/0, createdBy=298d1398341, createdName=lou.minghong, createdTime=Thu May 24 07:19:32 CST 2018, time=2018-05-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=317982, encodeId=73e931e982a6, content=学习了很有用不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, 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=Thu May 24 00:22:12 CST 2018, time=2018-05-24, status=1, ipAttribution=)]
  7. 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encodeId=aa811600342ec, content=<a href='/topic/show?id=3565e21649e' target=_blank style='color:#2F92EE;'>#皮质激素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=72164, encryptionId=3565e21649e, topicName=皮质激素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cb1a18781011, createdName=bbwznl, createdTime=Fri May 25 13:56:00 CST 2018, time=2018-05-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1602010, encodeId=d4d61602010f1, content=<a href='/topic/show?id=2f801469e57' target=_blank style='color:#2F92EE;'>#PRO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14697, encryptionId=2f801469e57, topicName=PRO)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a60b18898917, createdName=sunylz, createdTime=Fri May 25 13:56:00 CST 2018, time=2018-05-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=318070, encodeId=94663180e0cb, content=学习了谢谢分享!, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib2JlGvwpAibiaovVhfA9DbO7X7JLGGjM4Cic6oMgxLdnuS9piaP9cnG2OwIbkzHvX0qzS1boibyYNqR5vHZu7HQs5EIB/0, createdBy=298d1398341, createdName=lou.minghong, createdTime=Thu May 24 07:19:32 CST 2018, time=2018-05-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=317982, encodeId=73e931e982a6, content=学习了很有用不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, 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=Thu May 24 00:22:12 CST 2018, time=2018-05-24, status=1, ipAttribution=)]
    2018-05-25 sunylz
  8. [GetPortalCommentsPageByObjectIdResponse(id=1701222, encodeId=c54f1e012224f, content=<a href='/topic/show?id=b5f6e6827fb' target=_blank style='color:#2F92EE;'>#糖皮质#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=76827, encryptionId=b5f6e6827fb, topicName=糖皮质)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=0f4230340116, createdName=Tommy1959, createdTime=Sun Aug 12 12:56:00 CST 2018, time=2018-08-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1746571, encodeId=eb221e4657118, content=<a href='/topic/show?id=7344241edc' target=_blank style='color:#2F92EE;'>#Amgen#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2417, encryptionId=7344241edc, topicName=Amgen)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8e1735781236, createdName=cenghis, createdTime=Fri Jun 29 12:56:00 CST 2018, time=2018-06-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1439287, encodeId=4245143928e4e, content=<a href='/topic/show?id=d087241211' target=_blank style='color:#2F92EE;'>#AMG#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2412, encryptionId=d087241211, topicName=AMG)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Fri May 25 13:56:00 CST 2018, time=2018-05-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1540130, encodeId=a4571540130f6, content=<a href='/topic/show?id=1dbd8e83641' target=_blank style='color:#2F92EE;'>#药物管理#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87836, encryptionId=1dbd8e83641, topicName=药物管理)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f83c13182684, createdName=小刀医生, createdTime=Fri May 25 13:56:00 CST 2018, time=2018-05-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1592458, encodeId=be891592458d1, content=<a href='/topic/show?id=6dc2101853ed' target=_blank style='color:#2F92EE;'>#骨质#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=101853, encryptionId=6dc2101853ed, topicName=骨质)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=e1d018108513, createdName=Eleven17, createdTime=Fri May 25 13:56:00 CST 2018, time=2018-05-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1600342, encodeId=aa811600342ec, content=<a href='/topic/show?id=3565e21649e' target=_blank style='color:#2F92EE;'>#皮质激素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=72164, encryptionId=3565e21649e, topicName=皮质激素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cb1a18781011, createdName=bbwznl, createdTime=Fri May 25 13:56:00 CST 2018, time=2018-05-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1602010, encodeId=d4d61602010f1, content=<a href='/topic/show?id=2f801469e57' target=_blank style='color:#2F92EE;'>#PRO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14697, encryptionId=2f801469e57, topicName=PRO)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a60b18898917, createdName=sunylz, createdTime=Fri May 25 13:56:00 CST 2018, time=2018-05-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=318070, encodeId=94663180e0cb, content=学习了谢谢分享!, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib2JlGvwpAibiaovVhfA9DbO7X7JLGGjM4Cic6oMgxLdnuS9piaP9cnG2OwIbkzHvX0qzS1boibyYNqR5vHZu7HQs5EIB/0, createdBy=298d1398341, createdName=lou.minghong, createdTime=Thu May 24 07:19:32 CST 2018, time=2018-05-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=317982, encodeId=73e931e982a6, content=学习了很有用不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, 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=Thu May 24 00:22:12 CST 2018, time=2018-05-24, status=1, ipAttribution=)]
    2018-05-24 lou.minghong

    学习了谢谢分享!

    0

  9. [GetPortalCommentsPageByObjectIdResponse(id=1701222, encodeId=c54f1e012224f, content=<a href='/topic/show?id=b5f6e6827fb' target=_blank style='color:#2F92EE;'>#糖皮质#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=76827, encryptionId=b5f6e6827fb, topicName=糖皮质)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=0f4230340116, createdName=Tommy1959, createdTime=Sun Aug 12 12:56:00 CST 2018, time=2018-08-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1746571, encodeId=eb221e4657118, content=<a href='/topic/show?id=7344241edc' target=_blank style='color:#2F92EE;'>#Amgen#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2417, encryptionId=7344241edc, topicName=Amgen)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8e1735781236, createdName=cenghis, createdTime=Fri Jun 29 12:56:00 CST 2018, time=2018-06-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1439287, encodeId=4245143928e4e, content=<a href='/topic/show?id=d087241211' target=_blank style='color:#2F92EE;'>#AMG#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2412, encryptionId=d087241211, topicName=AMG)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Fri May 25 13:56:00 CST 2018, time=2018-05-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1540130, encodeId=a4571540130f6, content=<a href='/topic/show?id=1dbd8e83641' target=_blank style='color:#2F92EE;'>#药物管理#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87836, encryptionId=1dbd8e83641, topicName=药物管理)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f83c13182684, createdName=小刀医生, createdTime=Fri May 25 13:56:00 CST 2018, time=2018-05-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1592458, encodeId=be891592458d1, content=<a href='/topic/show?id=6dc2101853ed' target=_blank style='color:#2F92EE;'>#骨质#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=101853, encryptionId=6dc2101853ed, topicName=骨质)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=e1d018108513, createdName=Eleven17, createdTime=Fri May 25 13:56:00 CST 2018, time=2018-05-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1600342, encodeId=aa811600342ec, content=<a href='/topic/show?id=3565e21649e' target=_blank style='color:#2F92EE;'>#皮质激素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=72164, encryptionId=3565e21649e, topicName=皮质激素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cb1a18781011, createdName=bbwznl, createdTime=Fri May 25 13:56:00 CST 2018, time=2018-05-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1602010, encodeId=d4d61602010f1, content=<a href='/topic/show?id=2f801469e57' target=_blank style='color:#2F92EE;'>#PRO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14697, encryptionId=2f801469e57, topicName=PRO)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a60b18898917, createdName=sunylz, createdTime=Fri May 25 13:56:00 CST 2018, time=2018-05-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=318070, encodeId=94663180e0cb, content=学习了谢谢分享!, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib2JlGvwpAibiaovVhfA9DbO7X7JLGGjM4Cic6oMgxLdnuS9piaP9cnG2OwIbkzHvX0qzS1boibyYNqR5vHZu7HQs5EIB/0, createdBy=298d1398341, createdName=lou.minghong, createdTime=Thu May 24 07:19:32 CST 2018, time=2018-05-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=317982, encodeId=73e931e982a6, content=学习了很有用不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, 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=Thu May 24 00:22:12 CST 2018, time=2018-05-24, status=1, ipAttribution=)]
    2018-05-24 飛歌

    学习了很有用不错

    0

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