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FDA批准诺华的Gilenya用于儿童和青少年复发型多发性硬化症

2018-05-14 MedSci MedSci原创

Gilenya儿童和青少年复发型多发性硬化症
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美国监管机构已批准诺华公司的Gilenya治疗儿童和青少年复发型多发性硬化症（RMS），使其成为该患者群体首次针对疾病进行治疗。该批准基于10岁至18岁以下的RRMS患者的III期研究，结果表明Gilenya（芬戈莫德）使干扰素β-1a注射的年复发率降低约82％。此外，该药物的安全性被发现与以前在成人临床试验中所见的安全性一致。2010年，Gilenya在美国首次获得批准，用于欧洲成人患者复发性多


美国监管机构已批准诺华公司的Gilenya治疗儿童和青少年复发型多发性硬化症（RMS），使其成为该患者群体首次针对疾病进行治疗。

该批准基于10岁至18岁以下的RRMS患者的III期研究，结果表明Gilenya（芬戈莫德）使干扰素β-1a注射的年复发率降低约82％。

此外，该药物的安全性被发现与以前在成人临床试验中所见的安全性一致。

2010年，Gilenya在美国首次获得批准，用于欧洲成人患者复发性多发性硬化症的一线治疗。

儿科多发性硬化症通常在青少年时期被诊断出来，与成年患者相比，复发更频繁，也更严重。

"我们热切期待为MS患者提供一种经过验证的治疗方案，"儿科多发性硬化症联盟主席Elin Phillips说。"到目前为止，还没有大型的临床试验来评估治疗儿童和青少年疾病的治疗效果。"


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    2018-12-24 bugit

    #FDA批准#

    0

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    2018-08-18 jml2009

    #多发性#

    0

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    2018-06-03 lifestar

    #儿童和青少年#

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1839591, encodeId=dad618395911e, 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=29, 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 Dec 24 12:40:00 CST 2018, time=2018-12-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1889897, encodeId=a21e188989eb5, content=<a href='/topic/show?id=760c430895a' target=_blank style='color:#2F92EE;'>#多发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43089, encryptionId=760c430895a, topicName=多发性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=04d6114, createdName=jml2009, createdTime=Sat Aug 18 10:40:00 CST 2018, time=2018-08-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1937465, encodeId=4c9a193e46563, content=<a href='/topic/show?id=b3252822854' target=_blank style='color:#2F92EE;'>#儿童和青少年#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=28228, encryptionId=b3252822854, topicName=儿童和青少年)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=aa0e14, createdName=lifestar, createdTime=Sun Jun 03 14:40:00 CST 2018, time=2018-06-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1685841, encodeId=aaca168584100, content=<a href='/topic/show?id=05ff8021b0' target=_blank style='color:#2F92EE;'>#Gilenya#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8021, encryptionId=05ff8021b0, topicName=Gilenya)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6cc428292054, createdName=1194695146_61857356, createdTime=Tue Dec 18 16:40:00 CST 2018, time=2018-12-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1983006, encodeId=2ddb1983006c3, content=<a href='/topic/show?id=a7a7e359478' target=_blank style='color:#2F92EE;'>#硬化症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73594, encryptionId=a7a7e359478, topicName=硬化症)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a691420, createdName=30397604, createdTime=Mon Dec 17 21:40:00 CST 2018, time=2018-12-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1968814, encodeId=a9dd19688142e, content=<a href='/topic/show?id=6e2d42514f8' target=_blank style='color:#2F92EE;'>#复发型多发性硬化症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=42514, encryptionId=6e2d42514f8, topicName=复发型多发性硬化症)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=52c7237, createdName=yahu, createdTime=Sat Mar 09 23:40:00 CST 2019, time=2019-03-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1282723, encodeId=86921282e235a, content=<a href='/topic/show?id=2df29190553' target=_blank style='color:#2F92EE;'>#诺华#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91905, encryptionId=2df29190553, topicName=诺华)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6f63175, createdName=nian.wang1982, createdTime=Wed May 16 12:40:00 CST 2018, time=2018-05-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=315133, encodeId=7c8b31513326, content=不错的文章值得拥有, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=eff51996281, createdName=1e1b8538m79(暂无匿称), createdTime=Mon May 14 22:56:52 CST 2018, time=2018-05-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=315127, encodeId=3d7931512ef9, content=不错的文章值得推荐, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=04f22055142, createdName=131****2916, createdTime=Mon May 14 22:36:11 CST 2018, time=2018-05-14, status=1, ipAttribution=)]
    2018-12-18 1194695146_61857356

    #Gilenya#

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=1839591, encodeId=dad618395911e, 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=29, 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 Dec 24 12:40:00 CST 2018, time=2018-12-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1889897, encodeId=a21e188989eb5, content=<a href='/topic/show?id=760c430895a' target=_blank style='color:#2F92EE;'>#多发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43089, encryptionId=760c430895a, topicName=多发性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=04d6114, createdName=jml2009, createdTime=Sat Aug 18 10:40:00 CST 2018, time=2018-08-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1937465, encodeId=4c9a193e46563, content=<a href='/topic/show?id=b3252822854' target=_blank style='color:#2F92EE;'>#儿童和青少年#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=28228, encryptionId=b3252822854, topicName=儿童和青少年)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=aa0e14, createdName=lifestar, createdTime=Sun Jun 03 14:40:00 CST 2018, time=2018-06-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1685841, encodeId=aaca168584100, content=<a href='/topic/show?id=05ff8021b0' target=_blank style='color:#2F92EE;'>#Gilenya#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8021, encryptionId=05ff8021b0, topicName=Gilenya)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6cc428292054, createdName=1194695146_61857356, createdTime=Tue Dec 18 16:40:00 CST 2018, time=2018-12-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1983006, encodeId=2ddb1983006c3, content=<a href='/topic/show?id=a7a7e359478' target=_blank style='color:#2F92EE;'>#硬化症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73594, encryptionId=a7a7e359478, topicName=硬化症)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a691420, createdName=30397604, createdTime=Mon Dec 17 21:40:00 CST 2018, time=2018-12-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1968814, encodeId=a9dd19688142e, content=<a href='/topic/show?id=6e2d42514f8' target=_blank style='color:#2F92EE;'>#复发型多发性硬化症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=42514, encryptionId=6e2d42514f8, topicName=复发型多发性硬化症)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=52c7237, createdName=yahu, createdTime=Sat Mar 09 23:40:00 CST 2019, time=2019-03-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1282723, encodeId=86921282e235a, content=<a href='/topic/show?id=2df29190553' target=_blank style='color:#2F92EE;'>#诺华#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91905, encryptionId=2df29190553, topicName=诺华)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6f63175, createdName=nian.wang1982, createdTime=Wed May 16 12:40:00 CST 2018, time=2018-05-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=315133, encodeId=7c8b31513326, content=不错的文章值得拥有, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=eff51996281, createdName=1e1b8538m79(暂无匿称), createdTime=Mon May 14 22:56:52 CST 2018, time=2018-05-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=315127, encodeId=3d7931512ef9, content=不错的文章值得推荐, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=04f22055142, createdName=131****2916, createdTime=Mon May 14 22:36:11 CST 2018, time=2018-05-14, status=1, ipAttribution=)]
    2018-12-17 30397604

    #硬化症#

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1839591, encodeId=dad618395911e, 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=29, 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 Dec 24 12:40:00 CST 2018, time=2018-12-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1889897, encodeId=a21e188989eb5, content=<a href='/topic/show?id=760c430895a' target=_blank style='color:#2F92EE;'>#多发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43089, encryptionId=760c430895a, topicName=多发性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=04d6114, createdName=jml2009, createdTime=Sat Aug 18 10:40:00 CST 2018, time=2018-08-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1937465, encodeId=4c9a193e46563, content=<a href='/topic/show?id=b3252822854' target=_blank style='color:#2F92EE;'>#儿童和青少年#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=28228, encryptionId=b3252822854, topicName=儿童和青少年)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=aa0e14, createdName=lifestar, createdTime=Sun Jun 03 14:40:00 CST 2018, time=2018-06-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1685841, encodeId=aaca168584100, content=<a href='/topic/show?id=05ff8021b0' target=_blank style='color:#2F92EE;'>#Gilenya#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8021, encryptionId=05ff8021b0, topicName=Gilenya)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6cc428292054, createdName=1194695146_61857356, createdTime=Tue Dec 18 16:40:00 CST 2018, time=2018-12-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1983006, encodeId=2ddb1983006c3, content=<a href='/topic/show?id=a7a7e359478' target=_blank style='color:#2F92EE;'>#硬化症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73594, encryptionId=a7a7e359478, topicName=硬化症)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a691420, createdName=30397604, createdTime=Mon Dec 17 21:40:00 CST 2018, time=2018-12-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1968814, encodeId=a9dd19688142e, content=<a href='/topic/show?id=6e2d42514f8' target=_blank style='color:#2F92EE;'>#复发型多发性硬化症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=42514, encryptionId=6e2d42514f8, topicName=复发型多发性硬化症)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=52c7237, createdName=yahu, createdTime=Sat Mar 09 23:40:00 CST 2019, time=2019-03-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1282723, encodeId=86921282e235a, content=<a href='/topic/show?id=2df29190553' target=_blank style='color:#2F92EE;'>#诺华#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91905, encryptionId=2df29190553, topicName=诺华)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6f63175, createdName=nian.wang1982, createdTime=Wed May 16 12:40:00 CST 2018, time=2018-05-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=315133, encodeId=7c8b31513326, content=不错的文章值得拥有, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=eff51996281, createdName=1e1b8538m79(暂无匿称), createdTime=Mon May 14 22:56:52 CST 2018, time=2018-05-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=315127, encodeId=3d7931512ef9, content=不错的文章值得推荐, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=04f22055142, createdName=131****2916, createdTime=Mon May 14 22:36:11 CST 2018, time=2018-05-14, status=1, ipAttribution=)]
    2019-03-09 yahu

    #复发型多发性硬化症#

    0

  7. [GetPortalCommentsPageByObjectIdResponse(id=1839591, encodeId=dad618395911e, 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=29, 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 Dec 24 12:40:00 CST 2018, time=2018-12-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1889897, encodeId=a21e188989eb5, content=<a href='/topic/show?id=760c430895a' target=_blank style='color:#2F92EE;'>#多发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43089, encryptionId=760c430895a, topicName=多发性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=04d6114, createdName=jml2009, createdTime=Sat Aug 18 10:40:00 CST 2018, time=2018-08-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1937465, encodeId=4c9a193e46563, content=<a href='/topic/show?id=b3252822854' target=_blank style='color:#2F92EE;'>#儿童和青少年#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=28228, encryptionId=b3252822854, topicName=儿童和青少年)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=aa0e14, createdName=lifestar, createdTime=Sun Jun 03 14:40:00 CST 2018, time=2018-06-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1685841, encodeId=aaca168584100, content=<a href='/topic/show?id=05ff8021b0' target=_blank style='color:#2F92EE;'>#Gilenya#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8021, encryptionId=05ff8021b0, topicName=Gilenya)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6cc428292054, createdName=1194695146_61857356, createdTime=Tue Dec 18 16:40:00 CST 2018, time=2018-12-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1983006, encodeId=2ddb1983006c3, content=<a href='/topic/show?id=a7a7e359478' target=_blank style='color:#2F92EE;'>#硬化症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73594, encryptionId=a7a7e359478, topicName=硬化症)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a691420, createdName=30397604, createdTime=Mon Dec 17 21:40:00 CST 2018, time=2018-12-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1968814, encodeId=a9dd19688142e, content=<a href='/topic/show?id=6e2d42514f8' target=_blank style='color:#2F92EE;'>#复发型多发性硬化症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=42514, encryptionId=6e2d42514f8, topicName=复发型多发性硬化症)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=52c7237, createdName=yahu, createdTime=Sat Mar 09 23:40:00 CST 2019, time=2019-03-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1282723, encodeId=86921282e235a, content=<a href='/topic/show?id=2df29190553' target=_blank style='color:#2F92EE;'>#诺华#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91905, encryptionId=2df29190553, topicName=诺华)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6f63175, createdName=nian.wang1982, createdTime=Wed May 16 12:40:00 CST 2018, time=2018-05-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=315133, encodeId=7c8b31513326, content=不错的文章值得拥有, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=eff51996281, createdName=1e1b8538m79(暂无匿称), createdTime=Mon May 14 22:56:52 CST 2018, time=2018-05-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=315127, encodeId=3d7931512ef9, content=不错的文章值得推荐, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=04f22055142, createdName=131****2916, createdTime=Mon May 14 22:36:11 CST 2018, time=2018-05-14, status=1, ipAttribution=)]
    2018-05-16 nian.wang1982

    #诺华#

    0

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    2018-05-14 1e1b8538m79(暂无匿称)

    不错的文章值得拥有

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    2018-05-14 131****2916

    不错的文章值得推荐

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