Baidu
map

消化

订阅

MedSci主页 / 所有栏目 / 消化

早产儿坏死性小肠结肠炎：IBT和FDA就III期研究的设计达成一致

2019-05-21 不详 网络

坏死性小肠结肠炎早产儿FDA
关注

IBT已经与美国食品和药品监督管理局（FDA）就如何设计IBP-9414的III期研究进行了长时间的磋商。目前，FDA现以书面形式通知IBT，对IBT的试验设计表示满意

IBT已经与美国食品和药品监督管理局（FDA）就如何设计IBP-9414的III期研究进行了长时间的磋商。目前，FDA现以书面形式通知IBT，对IBT的试验设计表示满意。IBT计划在即将进行的III期研究中评估IBP-9414对早产儿消化系统疾病（如坏死性小肠结肠炎）的影响，因为早产儿的一个严重的医疗问题是他们不能正常摄取营养。

85%的坏死性小肠结肠炎发生于早产儿。病因不清，患儿肠道的血供减少可能导致肠壁的损伤，使正常存在于肠道的细菌侵袭受损的肠壁，然后进入婴儿的血液，引起感染（败血症）。如果损伤了肠壁全层，肠壁穿孔，肠道内容物漏进腹腔就会引起腹膜炎。这种疾病往往是致命的。


原始出处：

http://www.firstwordpharma.com/node/1641984#axzz5oW6BiU1G

本文系梅斯医学（MedSci）原创编译整理，转载需授权!

版权声明：
本网站所有内容来源注明为“梅斯医学”或“MedSci原创”的文字、图片和音视频资料，版权均属于梅斯医学所有。非经授权，任何媒体、网站或个人不得转载，授权转载时须注明来源为“梅斯医学”。其它来源的文章系转载文章，或“梅斯号”自媒体发布的文章，仅系出于传递更多信息之目的，本站仅负责审核内容合规，其内容不代表本站立场，本站不负责内容的准确性和版权。如果存在侵权、或不希望被转载的媒体或个人可与我们联系，我们将立即进行删除处理。
在此留言
评论区 (5)
#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=1916105, encodeId=6548191610509, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Mon Mar 23 11:21:00 CST 2020, time=2020-03-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2021345, encodeId=15f7202134574, content=<a href='/topic/show?id=69d595e421' target=_blank style='color:#2F92EE;'>#III期研究#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9574, encryptionId=69d595e421, topicName=III期研究)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/qXbLjJB4FSzhQS3C5qQFMJkqicRIJFL6zHFwwhv0I95nzA6xicevQcEica0gk4A58UkbMMriadAgTY2b7N7Yd0ZsQg/132, createdBy=910c2500152, createdName=HinsMax, createdTime=Tue Feb 25 19:21:00 CST 2020, time=2020-02-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1362947, encodeId=1d87136294e1e, content=<a href='/topic/show?id=b723414321c' target=_blank style='color:#2F92EE;'>#坏死#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=41432, encryptionId=b723414321c, topicName=坏死)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c0e3195, createdName=millore, createdTime=Thu May 23 00:21:00 CST 2019, time=2019-05-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1591629, encodeId=eff7159162959, content=<a href='/topic/show?id=253f4143849' target=_blank style='color:#2F92EE;'>#坏死性小肠结肠炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=107, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=41438, encryptionId=253f4143849, topicName=坏死性小肠结肠炎)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=660517960040, createdName=doctor-chen9588, createdTime=Thu May 23 00:21:00 CST 2019, time=2019-05-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594594, encodeId=aad51594594ec, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Thu May 23 00:21:00 CST 2019, time=2019-05-23, status=1, ipAttribution=)]
    2020-03-23 juliusluan78

    #III#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1916105, encodeId=6548191610509, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Mon Mar 23 11:21:00 CST 2020, time=2020-03-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2021345, encodeId=15f7202134574, content=<a href='/topic/show?id=69d595e421' target=_blank style='color:#2F92EE;'>#III期研究#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9574, encryptionId=69d595e421, topicName=III期研究)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/qXbLjJB4FSzhQS3C5qQFMJkqicRIJFL6zHFwwhv0I95nzA6xicevQcEica0gk4A58UkbMMriadAgTY2b7N7Yd0ZsQg/132, createdBy=910c2500152, createdName=HinsMax, createdTime=Tue Feb 25 19:21:00 CST 2020, time=2020-02-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1362947, encodeId=1d87136294e1e, content=<a href='/topic/show?id=b723414321c' target=_blank style='color:#2F92EE;'>#坏死#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=41432, encryptionId=b723414321c, topicName=坏死)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c0e3195, createdName=millore, createdTime=Thu May 23 00:21:00 CST 2019, time=2019-05-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1591629, encodeId=eff7159162959, content=<a href='/topic/show?id=253f4143849' target=_blank style='color:#2F92EE;'>#坏死性小肠结肠炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=107, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=41438, encryptionId=253f4143849, topicName=坏死性小肠结肠炎)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=660517960040, createdName=doctor-chen9588, createdTime=Thu May 23 00:21:00 CST 2019, time=2019-05-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594594, encodeId=aad51594594ec, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Thu May 23 00:21:00 CST 2019, time=2019-05-23, status=1, ipAttribution=)]
    2020-02-25 HinsMax

    #III期研究#

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1916105, encodeId=6548191610509, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Mon Mar 23 11:21:00 CST 2020, time=2020-03-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2021345, encodeId=15f7202134574, content=<a href='/topic/show?id=69d595e421' target=_blank style='color:#2F92EE;'>#III期研究#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9574, encryptionId=69d595e421, topicName=III期研究)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/qXbLjJB4FSzhQS3C5qQFMJkqicRIJFL6zHFwwhv0I95nzA6xicevQcEica0gk4A58UkbMMriadAgTY2b7N7Yd0ZsQg/132, createdBy=910c2500152, createdName=HinsMax, createdTime=Tue Feb 25 19:21:00 CST 2020, time=2020-02-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1362947, encodeId=1d87136294e1e, content=<a href='/topic/show?id=b723414321c' target=_blank style='color:#2F92EE;'>#坏死#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=41432, encryptionId=b723414321c, topicName=坏死)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c0e3195, createdName=millore, createdTime=Thu May 23 00:21:00 CST 2019, time=2019-05-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1591629, encodeId=eff7159162959, content=<a href='/topic/show?id=253f4143849' target=_blank style='color:#2F92EE;'>#坏死性小肠结肠炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=107, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=41438, encryptionId=253f4143849, topicName=坏死性小肠结肠炎)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=660517960040, createdName=doctor-chen9588, createdTime=Thu May 23 00:21:00 CST 2019, time=2019-05-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594594, encodeId=aad51594594ec, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Thu May 23 00:21:00 CST 2019, time=2019-05-23, status=1, ipAttribution=)]
    2019-05-23 millore

    #坏死#

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1916105, encodeId=6548191610509, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Mon Mar 23 11:21:00 CST 2020, time=2020-03-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2021345, encodeId=15f7202134574, content=<a href='/topic/show?id=69d595e421' target=_blank style='color:#2F92EE;'>#III期研究#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9574, encryptionId=69d595e421, topicName=III期研究)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/qXbLjJB4FSzhQS3C5qQFMJkqicRIJFL6zHFwwhv0I95nzA6xicevQcEica0gk4A58UkbMMriadAgTY2b7N7Yd0ZsQg/132, createdBy=910c2500152, createdName=HinsMax, createdTime=Tue Feb 25 19:21:00 CST 2020, time=2020-02-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1362947, encodeId=1d87136294e1e, content=<a href='/topic/show?id=b723414321c' target=_blank style='color:#2F92EE;'>#坏死#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=41432, encryptionId=b723414321c, topicName=坏死)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c0e3195, createdName=millore, createdTime=Thu May 23 00:21:00 CST 2019, time=2019-05-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1591629, encodeId=eff7159162959, content=<a href='/topic/show?id=253f4143849' target=_blank style='color:#2F92EE;'>#坏死性小肠结肠炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=107, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=41438, encryptionId=253f4143849, topicName=坏死性小肠结肠炎)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=660517960040, createdName=doctor-chen9588, createdTime=Thu May 23 00:21:00 CST 2019, time=2019-05-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594594, encodeId=aad51594594ec, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Thu May 23 00:21:00 CST 2019, time=2019-05-23, status=1, ipAttribution=)]
    2019-05-23 doctor-chen9588

    #坏死性小肠结肠炎#

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=1916105, encodeId=6548191610509, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Mon Mar 23 11:21:00 CST 2020, time=2020-03-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2021345, encodeId=15f7202134574, content=<a href='/topic/show?id=69d595e421' target=_blank style='color:#2F92EE;'>#III期研究#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9574, encryptionId=69d595e421, topicName=III期研究)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/qXbLjJB4FSzhQS3C5qQFMJkqicRIJFL6zHFwwhv0I95nzA6xicevQcEica0gk4A58UkbMMriadAgTY2b7N7Yd0ZsQg/132, createdBy=910c2500152, createdName=HinsMax, createdTime=Tue Feb 25 19:21:00 CST 2020, time=2020-02-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1362947, encodeId=1d87136294e1e, content=<a href='/topic/show?id=b723414321c' target=_blank style='color:#2F92EE;'>#坏死#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=41432, encryptionId=b723414321c, topicName=坏死)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c0e3195, createdName=millore, createdTime=Thu May 23 00:21:00 CST 2019, time=2019-05-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1591629, encodeId=eff7159162959, content=<a href='/topic/show?id=253f4143849' target=_blank style='color:#2F92EE;'>#坏死性小肠结肠炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=107, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=41438, encryptionId=253f4143849, topicName=坏死性小肠结肠炎)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=660517960040, createdName=doctor-chen9588, createdTime=Thu May 23 00:21:00 CST 2019, time=2019-05-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594594, encodeId=aad51594594ec, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Thu May 23 00:21:00 CST 2019, time=2019-05-23, status=1, ipAttribution=)]
    2019-05-23 智智灵药

    #III期#

    0

相关资讯

Lancet：婴儿的肠道菌群可预测坏死性小肠结肠炎的发生

肠道细菌可能会诱发或防止早产儿发生坏死性小肠结肠炎，一种严重的疾病导致早产。

JAMA：对于极低出生体重儿，严重贫血增加了坏死性小肠结肠炎的风险

关于红细胞（RBC）输血和贫血而引起坏死性小肠结肠炎（NEC）的数据是相互矛盾的。这些关联还没有前瞻性评估，计算那些反复，随时间变化的风险。原始出处：Ravi M. Patel,Andrea Knezevic,Neeta Shenvi,et al.Association of Red Blood Cell Transfusion, Anemia, and Necrotizing Enterocol

2016新生儿坏死性小肠结肠炎小肠造瘘术后临床治疗专家共识发布

小肠造瘘术是新生儿坏死性小肠结肠炎(necrotizing enterocolitis，NEC)常见的手术方式之一，改善了危重NEC患儿的预后。但由于解剖生理的改变，术后易出现肠液大量丢失、营养物质消化吸收障碍，导致营养不良，水、电解质紊乱等临床问题，在治疗上极具挑战性。规范化的治疗可减少并发症的发生，改善预后，因此，就NEC小肠造瘘术后营养治疗、药物治疗、关瘘时机等问题经讨论形成如下专家共识。全

Baidu
map
Baidu
map
Baidu
map