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FDA批准Axumin用于前列腺癌复发的检测

2016-05-29 Seven L MedSci原创

AxuminFDA前列腺癌复发
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FDA批准Axumin（可注射放射性诊断试剂）用于前列腺癌复发的检测。适应于治疗后PSA升高，PET检查可疑前列腺癌复发的患者。FDA基于两项研究结果评价了Axumin (Blue Earth Diagnostics)的疗效和安全性。一项研究对105例行Axumin扫描进行前列腺穿刺活检和影像学上可疑复发行前列腺穿刺活检的患者进行了比较。在第二项研究中，研究人员对96名PSA中位数1.44 ng/

FDA批准Axumin（可注射放射性诊断试剂）用于前列腺癌复发的检测。适应于治疗后PSA升高，PET检查可疑前列腺癌复发的患者。

FDA基于两项研究结果评价了Axumin (Blue Earth Diagnostics)的疗效和安全性。一项研究对105例行Axumin扫描进行前列腺穿刺活检和影像学上可疑复发行前列腺穿刺活检的患者进行了比较。在第二项研究中，研究人员对96名PSA中位数1.44 ng/mL的患者比较了Axumin和C11胆碱扫描。

两项研究均由放射学家现场阅读扫描情况，随后由三位独立的放射学家以双盲方式阅读相同的扫描。总的来说，独立的检查结果一致，证实了阅读的现场读数的结果，从而支持Axumin对前列腺癌成像的有效性。

Axumin最常见的不良反应包括注射部位疼痛、发红和口中金属味。

“当PSA水平很低、影像学不能能确定复发性前列腺癌的位置时，”FDA药物评价和研究中心主任Libero Marzella博士说：“Axumin就能为这些患者提供一个准确的影像学检查。”

原始出处：

FDA approves Axumin to detect recurrent prostate cancer.Healio.May 27, 2016

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  1. [GetPortalCommentsPageByObjectIdResponse(id=1780262, encodeId=5d931e80262bb, content=<a href='/topic/show?id=668130e06e' target=_blank style='color:#2F92EE;'>#Axumin#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=107, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3070, encryptionId=668130e06e, topicName=Axumin)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=37d0457, createdName=yhj-time, createdTime=Tue May 09 06:02:00 CST 2017, time=2017-05-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839433, encodeId=824c1839433f6, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Mon Apr 03 15:02:00 CST 2017, time=2017-04-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=138067, encodeId=b94913806e3b, content=拜读，好文, beContent=null, objectType=article, channel=null, level=null, likeNumber=106, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzdAIB7UwTkHt6fQkBP8ictliaXtc5gCUmYdAW1sAETC2nhO3q6YjRHkUibyOCtP8ibmXNObTyd63A076/0, createdBy=d4111948983, createdName=1e10c84am36(暂无匿称), createdTime=Fri Sep 30 14:38:02 CST 2016, time=2016-09-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=95268, encodeId=5f47952680e, content=有前景，值得学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=103, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=a37a1710612, createdName=oo902, createdTime=Sun Jul 31 11:36:00 CST 2016, time=2016-07-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=89144, encodeId=242889144fe, content=研究复发的新思路, beContent=null, objectType=article, channel=null, level=null, likeNumber=186, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f5b11304786, createdName=ljh0111, createdTime=Thu Jun 09 22:37:00 CST 2016, time=2016-06-09, status=1, ipAttribution=)]
    2017-05-09 yhj-time

    #Axumin#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1780262, encodeId=5d931e80262bb, content=<a href='/topic/show?id=668130e06e' target=_blank style='color:#2F92EE;'>#Axumin#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=107, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3070, encryptionId=668130e06e, topicName=Axumin)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=37d0457, createdName=yhj-time, createdTime=Tue May 09 06:02:00 CST 2017, time=2017-05-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839433, encodeId=824c1839433f6, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Mon Apr 03 15:02:00 CST 2017, time=2017-04-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=138067, encodeId=b94913806e3b, content=拜读，好文, beContent=null, objectType=article, channel=null, level=null, likeNumber=106, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzdAIB7UwTkHt6fQkBP8ictliaXtc5gCUmYdAW1sAETC2nhO3q6YjRHkUibyOCtP8ibmXNObTyd63A076/0, createdBy=d4111948983, createdName=1e10c84am36(暂无匿称), createdTime=Fri Sep 30 14:38:02 CST 2016, time=2016-09-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=95268, encodeId=5f47952680e, content=有前景，值得学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=103, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=a37a1710612, createdName=oo902, createdTime=Sun Jul 31 11:36:00 CST 2016, time=2016-07-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=89144, encodeId=242889144fe, content=研究复发的新思路, beContent=null, objectType=article, channel=null, level=null, likeNumber=186, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f5b11304786, createdName=ljh0111, createdTime=Thu Jun 09 22:37:00 CST 2016, time=2016-06-09, status=1, ipAttribution=)]
    2017-04-03 bugit

    #FDA批准#

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1780262, encodeId=5d931e80262bb, content=<a href='/topic/show?id=668130e06e' target=_blank style='color:#2F92EE;'>#Axumin#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=107, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3070, encryptionId=668130e06e, topicName=Axumin)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=37d0457, createdName=yhj-time, createdTime=Tue May 09 06:02:00 CST 2017, time=2017-05-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839433, encodeId=824c1839433f6, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Mon Apr 03 15:02:00 CST 2017, time=2017-04-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=138067, encodeId=b94913806e3b, content=拜读，好文, beContent=null, objectType=article, channel=null, level=null, likeNumber=106, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzdAIB7UwTkHt6fQkBP8ictliaXtc5gCUmYdAW1sAETC2nhO3q6YjRHkUibyOCtP8ibmXNObTyd63A076/0, createdBy=d4111948983, createdName=1e10c84am36(暂无匿称), createdTime=Fri Sep 30 14:38:02 CST 2016, time=2016-09-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=95268, encodeId=5f47952680e, content=有前景，值得学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=103, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=a37a1710612, createdName=oo902, createdTime=Sun Jul 31 11:36:00 CST 2016, time=2016-07-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=89144, encodeId=242889144fe, content=研究复发的新思路, beContent=null, objectType=article, channel=null, level=null, likeNumber=186, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f5b11304786, createdName=ljh0111, createdTime=Thu Jun 09 22:37:00 CST 2016, time=2016-06-09, status=1, ipAttribution=)]
    2016-09-30 1e10c84am36(暂无匿称)

    拜读，好文

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1780262, encodeId=5d931e80262bb, content=<a href='/topic/show?id=668130e06e' target=_blank style='color:#2F92EE;'>#Axumin#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=107, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3070, encryptionId=668130e06e, topicName=Axumin)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=37d0457, createdName=yhj-time, createdTime=Tue May 09 06:02:00 CST 2017, time=2017-05-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839433, encodeId=824c1839433f6, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Mon Apr 03 15:02:00 CST 2017, time=2017-04-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=138067, encodeId=b94913806e3b, content=拜读，好文, beContent=null, objectType=article, channel=null, level=null, likeNumber=106, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzdAIB7UwTkHt6fQkBP8ictliaXtc5gCUmYdAW1sAETC2nhO3q6YjRHkUibyOCtP8ibmXNObTyd63A076/0, createdBy=d4111948983, createdName=1e10c84am36(暂无匿称), createdTime=Fri Sep 30 14:38:02 CST 2016, time=2016-09-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=95268, encodeId=5f47952680e, content=有前景，值得学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=103, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=a37a1710612, createdName=oo902, createdTime=Sun Jul 31 11:36:00 CST 2016, time=2016-07-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=89144, encodeId=242889144fe, content=研究复发的新思路, beContent=null, objectType=article, channel=null, level=null, likeNumber=186, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f5b11304786, createdName=ljh0111, createdTime=Thu Jun 09 22:37:00 CST 2016, time=2016-06-09, status=1, ipAttribution=)]
    2016-07-31 oo902

    有前景，值得学习

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=1780262, encodeId=5d931e80262bb, content=<a href='/topic/show?id=668130e06e' target=_blank style='color:#2F92EE;'>#Axumin#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=107, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3070, encryptionId=668130e06e, topicName=Axumin)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=37d0457, createdName=yhj-time, createdTime=Tue May 09 06:02:00 CST 2017, time=2017-05-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839433, encodeId=824c1839433f6, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Mon Apr 03 15:02:00 CST 2017, time=2017-04-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=138067, encodeId=b94913806e3b, content=拜读，好文, beContent=null, objectType=article, channel=null, level=null, likeNumber=106, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzdAIB7UwTkHt6fQkBP8ictliaXtc5gCUmYdAW1sAETC2nhO3q6YjRHkUibyOCtP8ibmXNObTyd63A076/0, createdBy=d4111948983, createdName=1e10c84am36(暂无匿称), createdTime=Fri Sep 30 14:38:02 CST 2016, time=2016-09-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=95268, encodeId=5f47952680e, content=有前景，值得学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=103, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=a37a1710612, createdName=oo902, createdTime=Sun Jul 31 11:36:00 CST 2016, time=2016-07-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=89144, encodeId=242889144fe, content=研究复发的新思路, beContent=null, objectType=article, channel=null, level=null, likeNumber=186, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f5b11304786, createdName=ljh0111, createdTime=Thu Jun 09 22:37:00 CST 2016, time=2016-06-09, status=1, ipAttribution=)]
    2016-06-09 ljh0111

    研究复发的新思路

    0

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