Diabetes Care：人类胰岛移植完成III期临床根治1型糖尿病已见曙光！

2016-04-22 生物谷生物谷

最新临床试验结果表明进行胰岛移植能够帮助1型糖尿病患者预防低血糖症，低血糖会导致病人出现痉挛，意识丧失，严重者甚至发生死亡，对生命造成威胁。研究人员发现这种治疗对于遭受过严重低血糖症的病人非常有效。这项III期临床试验由美国国立卫生研究院NIAID和NIDDK两个研究所共同资助，同时该试验的设计也得到了美国FDA的认可，从一定程度上为纯化人类胰岛细胞的商品化应用提供了保证。

最新临床试验结果表明进行胰岛移植能够帮助1型糖尿病患者预防低血糖症，低血糖会导致病人出现痉挛，意识丧失，严重者甚至发生死亡，对生命造成威胁。研究人员发现这种治疗对于遭受过严重低血糖症的病人非常有效。

这项III期临床试验由美国国立卫生研究院NIAID和NIDDK两个研究所共同资助，同时该试验的设计也得到了美国FDA的认可，从一定程度上为纯化人类胰岛细胞的商品化应用提供了保证。相关结果在线发表在国际学术期刊Diabetes Care上。

1型糖尿病是由于自身免疫系统攻击负责胰岛素合成的胰岛细胞而导致的一种先天性糖尿病，1型糖尿病患者需要终生使用胰岛素进行治疗，帮助控制血糖，但是在胰岛素治疗过程中，病人会经常出现血糖波动，甚至出现低血糖症。

低血糖症通常伴随震颤，出汗以及心悸等症状，需要及时进食进水提升血糖水平。而有些人感受不到这些早期症状--这也叫做低血糖症意识损伤，这样的人由于无法及时进行自我治疗，很容易发生危险。行为治疗或连续血糖监测系统能够帮助许多存在意识损伤的人预防低血糖症，但并非对所有人有效，因此仍然有许多人存在低血糖症风险。

这项研究共包含48名参与者，这些参与者都存在低血糖症意识损伤，同时也经历过严重的低血糖症。研究人员通过标准化流程从已故的人类供体身上获得了纯化的胰岛细胞，通过门静脉注射对参与者进行了胰岛移植，所有研究参与者都至少接受过一次胰岛移植。接受移植的患者们需要终生服用免疫抑制药物，防止免疫系统排斥移植细胞。

首次移植一年之后，88%的参与者没有再发生过严重的低血糖症，他们体内建立了近乎正常的血糖水平，并且恢复了低血糖症意识。两年之后，71%的参与者仍然能够达到移植成功的标准。

研究人员表示，只需要很少数量具备胰岛素合成分泌功能的胰岛细胞就能够帮助恢复低血糖症意识，但是有些人还需要使用胰岛素帮助完全控制血糖水平，这些人适合再次接受胰岛细胞移植。参与者中有25人接受了第二次胰岛细胞移植，1人接受了第三次胰岛细胞移植，一年之后，52%的参与者不再需要胰岛素治疗。

来自NIDDK的Griffin P.Rodgers表示："虽然这项技术仍处于试验阶段，在使用的时候需要慎重考虑，但是它为病人带来的希望是无法否认的，同时也令人振奋鼓舞。毕竟即使拥有最好的医护条件，仍有大约30%的1型糖尿病病人无法意识到血糖的急剧下降。"

对于无法安全控制1型糖尿病的病人来说，胰岛移植技术为预防严重的低血糖症带来了真正的希望，但是免疫抑制药物会带来一些明显的副作用，因此这项技术目前仅适用于进行了合理的糖尿病控制但是仍然经常出现严重低血糖症的病人，或者已经进行过肾脏移植目前正在服用免疫抑制药物的病人，该组正在进行另外一项III期临床试验。

MedSci小编注：这篇研究重点关注胰岛移植后，对1型糖尿病患者使用胰岛治疗后的低血糖反应，这方面同样具有良好的缓解作用。可能是因为胰岛移植后，胰岛素使用比例下降，从而也从某种程度上减轻了低血糖的反应。同时，移植的胰岛可能具有生物反馈的作用，也不会导致过度的低血糖

原始出处：

Bernhard J. Hering1, et al.Phase 3 Trial of Transplantation of Human Islets in Type 1 Diabetes Complicated by Severe Hypoglycemia.Diabetes Care April 18, 2016 doi: 10.2337/dc15-1988

Krishnamurthy B, Selck C, Chee J, Jhala G, Kay TW. Analysis of antigen specific T cells in diabetes - Lessons from pre-clinical studies and early clinical trials. J Autoimmun. 2016 Apr 12. pii: S0896-8411(16)30031-2.

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2017-03-03 医生2402

#I期临床#

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2016-10-03 木头人513

#Diabetes#

41 0
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2016-10-11 juliusluan78

#III#

45 0
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2016-12-07 yangpeizhi

#曙光#

41 0
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2016-12-01 ms5439512287675881

#BET#

31 0
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2016-08-21 哈夫

中国砖家何在

61 0
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encryptionId=58476021257, topicName=曙光)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=180c33737541, createdName=yangpeizhi, createdTime=Wed Dec 07 16:23:00 CST 2016, time=2016-12-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1759661, encodeId=c9f71e5966137, content=<a href='/topic/show?id=9bea33520d' target=_blank style='color:#2F92EE;'>#BET#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3352, encryptionId=9bea33520d, topicName=BET)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=9a1a37427546, createdName=ms5439512287675881, createdTime=Thu Dec 01 08:23:00 CST 2016, time=2016-12-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=102023, encodeId=c60b10202355, content=中国砖家何在, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/08/03/49a8b8e59b1110232178c436948997ae.jpg, createdBy=90151681386, createdName=哈夫, createdTime=Sun Aug 21 16:54:00 CST 2016, time=2016-08-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1637318, encodeId=1556163e31819, content=<a href='/topic/show?id=afda591646' target=_blank style='color:#2F92EE;'>#DIA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5916, encryptionId=afda591646, topicName=DIA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=987022654425, createdName=ms9608593228839890, createdTime=Sat Apr 23 19:23:00 CST 2016, time=2016-04-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1661175, encodeId=049e16611e5dd, content=<a href='/topic/show?id=e5548386534' target=_blank style='color:#2F92EE;'>#胰岛移植#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=83865, encryptionId=e5548386534, topicName=胰岛移植)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=e75025222144, createdName=晓辰, createdTime=Fri May 20 03:23:00 CST 2016, time=2016-05-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1749603, encodeId=c6941e496038d, content=<a href='/topic/show?id=be7c8385345' target=_blank style='color:#2F92EE;'>#胰岛#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=83853, encryptionId=be7c8385345, topicName=胰岛)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a7a536274692, createdName=baoya, createdTime=Sun Aug 14 20:23:00 CST 2016, time=2016-08-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=85400, encodeId=c43e8540090, content=还有一段很长的路要走, beContent=null, objectType=article, channel=null, level=null, likeNumber=132, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=172d1721528, createdName=QQ6709219e, createdTime=Wed May 11 00:13:00 CST 2016, time=2016-05-11, status=1, ipAttribution=)]
2016-04-23 ms9608593228839890

#DIA#

29 0
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topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/08/03/49a8b8e59b1110232178c436948997ae.jpg, createdBy=90151681386, createdName=哈夫, createdTime=Sun Aug 21 16:54:00 CST 2016, time=2016-08-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1637318, encodeId=1556163e31819, content=<a href='/topic/show?id=afda591646' target=_blank style='color:#2F92EE;'>#DIA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5916, encryptionId=afda591646, topicName=DIA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=987022654425, createdName=ms9608593228839890, createdTime=Sat Apr 23 19:23:00 CST 2016, time=2016-04-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1661175, encodeId=049e16611e5dd, content=<a href='/topic/show?id=e5548386534' target=_blank style='color:#2F92EE;'>#胰岛移植#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=83865, encryptionId=e5548386534, topicName=胰岛移植)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=e75025222144, createdName=晓辰, createdTime=Fri May 20 03:23:00 CST 2016, time=2016-05-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1749603, encodeId=c6941e496038d, content=<a href='/topic/show?id=be7c8385345' target=_blank style='color:#2F92EE;'>#胰岛#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=83853, encryptionId=be7c8385345, topicName=胰岛)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a7a536274692, createdName=baoya, createdTime=Sun Aug 14 20:23:00 CST 2016, time=2016-08-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=85400, encodeId=c43e8540090, content=还有一段很长的路要走, beContent=null, objectType=article, channel=null, level=null, likeNumber=132, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=172d1721528, createdName=QQ6709219e, createdTime=Wed May 11 00:13:00 CST 2016, time=2016-05-11, status=1, ipAttribution=)]
2016-05-20 晓辰

#胰岛移植#

39 0
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createdBy=0045169, createdName=木头人513, createdTime=Mon Oct 03 15:23:00 CST 2016, time=2016-10-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1915895, encodeId=67d61915895ce, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Tue Oct 11 06:23:00 CST 2016, time=2016-10-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1725137, encodeId=5e121e25137c5, content=<a href='/topic/show?id=58476021257' target=_blank style='color:#2F92EE;'>#曙光#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=60212, encryptionId=58476021257, topicName=曙光)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=180c33737541, createdName=yangpeizhi, createdTime=Wed Dec 07 16:23:00 CST 2016, time=2016-12-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1759661, encodeId=c9f71e5966137, content=<a href='/topic/show?id=9bea33520d' target=_blank style='color:#2F92EE;'>#BET#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3352, encryptionId=9bea33520d, topicName=BET)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=9a1a37427546, createdName=ms5439512287675881, createdTime=Thu Dec 01 08:23:00 CST 2016, time=2016-12-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=102023, encodeId=c60b10202355, content=中国砖家何在, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/08/03/49a8b8e59b1110232178c436948997ae.jpg, createdBy=90151681386, createdName=哈夫, createdTime=Sun Aug 21 16:54:00 CST 2016, time=2016-08-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1637318, encodeId=1556163e31819, content=<a href='/topic/show?id=afda591646' target=_blank style='color:#2F92EE;'>#DIA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5916, encryptionId=afda591646, topicName=DIA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=987022654425, createdName=ms9608593228839890, createdTime=Sat Apr 23 19:23:00 CST 2016, time=2016-04-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1661175, encodeId=049e16611e5dd, content=<a href='/topic/show?id=e5548386534' target=_blank style='color:#2F92EE;'>#胰岛移植#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=83865, encryptionId=e5548386534, topicName=胰岛移植)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=e75025222144, createdName=晓辰, createdTime=Fri May 20 03:23:00 CST 2016, time=2016-05-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1749603, encodeId=c6941e496038d, content=<a href='/topic/show?id=be7c8385345' target=_blank style='color:#2F92EE;'>#胰岛#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=83853, encryptionId=be7c8385345, topicName=胰岛)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a7a536274692, createdName=baoya, createdTime=Sun Aug 14 20:23:00 CST 2016, time=2016-08-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=85400, encodeId=c43e8540090, content=还有一段很长的路要走, beContent=null, objectType=article, channel=null, level=null, likeNumber=132, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=172d1721528, createdName=QQ6709219e, createdTime=Wed May 11 00:13:00 CST 2016, time=2016-05-11, status=1, ipAttribution=)]
2016-08-14 baoya

#胰岛#

30 0
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encryptionId=58476021257, topicName=曙光)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=180c33737541, createdName=yangpeizhi, createdTime=Wed Dec 07 16:23:00 CST 2016, time=2016-12-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1759661, encodeId=c9f71e5966137, content=<a href='/topic/show?id=9bea33520d' target=_blank style='color:#2F92EE;'>#BET#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3352, encryptionId=9bea33520d, topicName=BET)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=9a1a37427546, createdName=ms5439512287675881, createdTime=Thu Dec 01 08:23:00 CST 2016, time=2016-12-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=102023, encodeId=c60b10202355, content=中国砖家何在, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/08/03/49a8b8e59b1110232178c436948997ae.jpg, createdBy=90151681386, createdName=哈夫, createdTime=Sun Aug 21 16:54:00 CST 2016, time=2016-08-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1637318, encodeId=1556163e31819, content=<a href='/topic/show?id=afda591646' target=_blank style='color:#2F92EE;'>#DIA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5916, encryptionId=afda591646, topicName=DIA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=987022654425, createdName=ms9608593228839890, createdTime=Sat Apr 23 19:23:00 CST 2016, time=2016-04-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1661175, encodeId=049e16611e5dd, content=<a href='/topic/show?id=e5548386534' target=_blank style='color:#2F92EE;'>#胰岛移植#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=83865, encryptionId=e5548386534, topicName=胰岛移植)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=e75025222144, createdName=晓辰, createdTime=Fri May 20 03:23:00 CST 2016, time=2016-05-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1749603, encodeId=c6941e496038d, content=<a href='/topic/show?id=be7c8385345' target=_blank style='color:#2F92EE;'>#胰岛#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=83853, encryptionId=be7c8385345, topicName=胰岛)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a7a536274692, createdName=baoya, createdTime=Sun Aug 14 20:23:00 CST 2016, time=2016-08-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=85400, encodeId=c43e8540090, content=还有一段很长的路要走, beContent=null, objectType=article, channel=null, level=null, likeNumber=132, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=172d1721528, createdName=QQ6709219e, createdTime=Wed May 11 00:13:00 CST 2016, time=2016-05-11, status=1, ipAttribution=)]
2016-05-11 QQ6709219e

还有一段很长的路要走

132 0

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Diabetes Care：人类胰岛移植完成III期临床根治1型糖尿病已见曙光！

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内分泌科

Diabetes Care：人类胰岛移植完成III期临床 根治1型糖尿病已见曙光！

相关资讯

科室

工具

服务

Diabetes Care：人类胰岛移植完成III期临床根治1型糖尿病已见曙光！