Neurology:迟发性脊髓性肌萎缩患儿接受Nusinersen长期疗效研究

2019-04-29 MedSci MedSci原创

长期Nusinersen治疗可显著改善迟发性脊髓性肌萎缩症患儿运动功能,稳定疾病活动状态

近日研究人员考察了儿童迟发性脊髓性肌萎缩症(SMA)患者神经鞘内注射Nusinersen的长期疗效。

本次研究为1B/2A期研究(ISIS-396443-CS2;NCT0103988),SMA患儿首次接受了Nusinersen治疗,有资格患者在扩展研究中继续接受治疗(ISS-396443-CS12;NCT 02052791)。1B/2A期研究为期253天、患者接受递增剂量(3、6、9、12毫克)考察,患儿年龄2-15岁,总计计划随访715天(参与者随访时间范围196-413天),单次剂量为12mg。研究的主要终点包括Hammersmith功能性运动量表(HFMSE)、上肢模块(ULM)、6分钟步行测试(6MWT)、复合肌肉动作电位(CMAP)和定量多点递增运动单位数评估。

28例儿童患者(SMAⅡ型11人,SMAⅢ型17人),治疗后患者平均HFMSE评分、ULM评分和6 MWT显著改善(HFMSE:SMA II型,10.8分;SMA III型,1.8分;ULM:SMA II型,4.0分;6 MWT:SMA III型,92.0米),平均CMAP值保持相对稳定。未发生因不良事件导致的停药。

长期Nusinersen治疗可显著改善迟发性脊髓性肌萎缩症患儿运动功能,稳定疾病活动状态。

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encodeId=f5e71514455b2, content=<a href='/topic/show?id=1ae010211143' target=_blank style='color:#2F92EE;'>#髓性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=16, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=102111, encryptionId=1ae010211143, topicName=髓性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ae8810654266, createdName=more is better!, createdTime=Wed May 01 04:15:00 CST 2019, time=2019-05-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1553493, encodeId=1ac015534936c, content=<a href='/topic/show?id=3b409e02804' target=_blank style='color:#2F92EE;'>#长期疗效#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97028, encryptionId=3b409e02804, topicName=长期疗效)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fe2a14383573, createdName=gjsgj, createdTime=Wed May 01 04:15:00 CST 2019, time=2019-05-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032146, encodeId=83291032146da, content=谢谢梅斯提供这么好的信息,学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Mon Apr 29 16:15:00 CST 2019, time=2019-04-29, status=1, ipAttribution=)]
  5. [GetPortalCommentsPageByObjectIdResponse(id=2034415, encodeId=e134203441505, content=<a href='/topic/show?id=45eb94588cd' target=_blank style='color:#2F92EE;'>#迟发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=94588, encryptionId=45eb94588cd, topicName=迟发性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f14236, createdName=经常头晕, createdTime=Thu Nov 28 23:15:00 CST 2019, time=2019-11-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2000761, encodeId=13f72000e610c, content=<a href='/topic/show?id=d5df12695e6' target=_blank style='color:#2F92EE;'>#Neurol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=18, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12695, encryptionId=d5df12695e6, topicName=Neurol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8217292, 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objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13151, encryptionId=09481315139, topicName=Nusinersen)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f98e185, createdName=psybestwish, createdTime=Thu Nov 07 22:15:00 CST 2019, time=2019-11-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1503119, encodeId=6d1d15031198a, content=<a href='/topic/show?id=a71481058ca' target=_blank style='color:#2F92EE;'>#肌萎缩#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=81058, encryptionId=a71481058ca, topicName=肌萎缩)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=eebd9606217, createdName=neizongke, createdTime=Wed May 01 04:15:00 CST 2019, time=2019-05-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1514455, encodeId=f5e71514455b2, content=<a href='/topic/show?id=1ae010211143' target=_blank style='color:#2F92EE;'>#髓性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=16, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=102111, encryptionId=1ae010211143, topicName=髓性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ae8810654266, createdName=more is better!, createdTime=Wed May 01 04:15:00 CST 2019, time=2019-05-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1553493, encodeId=1ac015534936c, content=<a href='/topic/show?id=3b409e02804' target=_blank style='color:#2F92EE;'>#长期疗效#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97028, encryptionId=3b409e02804, topicName=长期疗效)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fe2a14383573, createdName=gjsgj, createdTime=Wed May 01 04:15:00 CST 2019, time=2019-05-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032146, encodeId=83291032146da, content=谢谢梅斯提供这么好的信息,学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Mon Apr 29 16:15:00 CST 2019, time=2019-04-29, status=1, ipAttribution=)]
    2020-02-29 anminleiryan
  6. 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  7. 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  8. 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  9. 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  10. 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May 01 04:15:00 CST 2019, time=2019-05-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032146, encodeId=83291032146da, content=谢谢梅斯提供这么好的信息,学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Mon Apr 29 16:15:00 CST 2019, time=2019-04-29, status=1, ipAttribution=)]
    2019-04-29 内科新手

    谢谢梅斯提供这么好的信息,学到很多

    0