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Lancet :胰岛素用量增加导致心血管事件及患者死亡率升高,谬论or事实?

2016-12-27 赛诺菲医学部 菲糖新动

2016年11月,The Lancet Diabetes & Endocrinology 杂志发表了一项回顾性队列研究,主要在2型糖尿病(T2DM)患者中,对高剂量胰岛素治疗与患者死亡风险及主要不良心血管事件(MACE)发生率之间的相关性进行了探讨,其结果进一步验证了胰岛素用于2型糖尿病治疗总体安全性较好。 既往多项观察性研究表明胰岛素疗效的剂量依赖性会增加T2DM的管理风险,而UKPDS

2016年11月,The Lancet Diabetes & Endocrinology 杂志发表了一项回顾性队列研究,主要在2型糖尿病(T2DM)患者中,对高剂量胰岛素治疗与患者死亡风险及主要不良心血管事件(MACE)发生率之间的相关性进行了探讨,其结果进一步验证了胰岛素用于2型糖尿病治疗总体安全性较好。

既往多项观察性研究表明胰岛素疗效的剂量依赖性会增加T2DM的管理风险,而UKPDS、ORIGIN等随机对照试验则显示胰岛素并不会增加总死亡率,且其自身也无心脏毒性。


为进一步探究T2DM患者胰岛素治疗的相对安全性,Gamble JM教授团队对英国临床实践研究数据库中的医疗保健记录进行分析。研究纳入数据库中2001年1月1日-2012年12月31日期间起始二甲双胍治疗后加用胰岛素,且使用胰岛素超过6个月的患者。主要终点为全因死亡率和MACE* ,利用多元COX回归模型评估死亡率和主要不良心血管事件的相对差异,并通过边际结构模型降低由于既往治疗所导致的时间依赖性混杂因素。

*:MACE定义为首次出现非致死性心肌梗死、非致死性卒中或任何心血管相关的死亡。

校正时间依赖性协变量后,胰岛素剂量与死亡率之间的相关性减弱

该研究共纳入在基层保健诊所就诊的6,072例年龄≥30岁的T2DM患者,患者起始二甲双胍单药治疗后加用胰岛素治疗。研究期间共691例患者死亡,粗死亡率为31人/1000人·年,不同胰岛素剂量组(<25U、25~50U、50~75U、75~100U、>100U)的粗死亡率相似。校正基线协变量后,较高剂量胰岛素组(>25U)与死亡率增加显著相关(P趋势=0.006)。但进一步校正时间依赖性协变量后(如血糖控制、体重、低血糖事件发生频次、心血管事件变化等),胰岛素剂量与死亡率之间的相关性明显减弱,仅胰岛素剂量最高的两组与死亡率增加相关。而利用边际结构模型进行分析后,胰岛素剂量与全因死亡率无显著相关性。

不同校正/统计方法所得的全因死亡率风险比(HR)


较高胰岛素剂量未增加MACE风险

医院情况统计信息数据库/英国国家统计局(HES/ONS)相关性研究为该试验的亚队列研究,对3599例受试者(58%源患者)进行了心血管相关结局的分析,其结果显示,研究过程中共发生548次MACE,较高胰岛素剂量(>50U)与MACE增加无显著相关性,仅发现胰岛素剂量与心血管死亡有显著的相关性。

胰岛素剂量与MACE及心血管相关死亡的相关性


作者见解

在考量胰岛素剂量和死亡率两者相关性的研究中,如何处理多种混杂因素对于获取精确的研究结果起着至关重要的作用,差之毫厘则谬以千里。本研究利用边际结构模型和常规COX回归模型进行数据校正,边际结构模型最主要的优势在于可同时对时间依赖性协变量及外界混杂因素进行校正,而常规COX回归模型则用于校正时间依赖性混杂因素与中间变量。基于上述方法,本研究证明了胰岛素在T2DM治疗中的总体安全性,且不会增加MACE风险。研究结果或可帮助理解在非随机对照试验与随机对照试验中,胰岛素的剂量依赖作用与死亡率及心血管结局相关性存在矛盾的一些潜在原因。作者认为,在使用胰岛素过程中所观察到的一些负面效应可能正是由于残留的混杂因素所导致。

原始出处:

Gamble JM, Chibrikov E, Twells LK, et al. Lancet Diabetes Endocrinol 2016 Nov 16.

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    2017-10-21 howi
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    2017-02-07 baoya
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  5. [GetPortalCommentsPageByObjectIdResponse(id=1983495, encodeId=c1231983495ac, content=<a href='/topic/show?id=628553048e3' target=_blank style='color:#2F92EE;'>#患者死亡#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=53048, encryptionId=628553048e3, topicName=患者死亡)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=12de429, createdName=sunylz, createdTime=Wed Jul 26 21:39:00 CST 2017, time=2017-07-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1828733, encodeId=1f051828e33fa, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Sat Oct 21 12:39:00 CST 2017, time=2017-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1749676, encodeId=aed11e4967620, content=<a href='/topic/show?id=be7c8385345' target=_blank style='color:#2F92EE;'>#胰岛#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, 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=Tue Feb 07 21:39:00 CST 2017, time=2017-02-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1643436, encodeId=bdb41643436c1, content=<a href='/topic/show?id=6236895092b' target=_blank style='color:#2F92EE;'>#血管事件#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=89509, encryptionId=6236895092b, topicName=血管事件)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f99523187183, createdName=hukaixun, createdTime=Sat Jul 22 18:39:00 CST 2017, time=2017-07-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=168895, encodeId=bb7416889544, content=谢谢分享,学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=136, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=fe261399236, createdName=xyfg98, createdTime=Sun Jan 08 21:06:45 CST 2017, time=2017-01-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=166170, encodeId=c9cc1661e0ad, content=棒棒哒????????, beContent=null, objectType=article, channel=null, level=null, likeNumber=82, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=76491981781, createdName=1e184d7bm65(暂无匿称), createdTime=Tue Dec 27 22:51:26 CST 2016, time=2016-12-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=166149, encodeId=7b621661494c, content=看来不能随便用, beContent=null, objectType=article, channel=null, level=null, likeNumber=90, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=62d381629, createdName=yafeiliutjh, createdTime=Tue Dec 27 20:54:10 CST 2016, time=2016-12-27, status=1, ipAttribution=)]
    2017-01-08 xyfg98

    谢谢分享,学习了

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1983495, encodeId=c1231983495ac, content=<a href='/topic/show?id=628553048e3' target=_blank style='color:#2F92EE;'>#患者死亡#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=53048, encryptionId=628553048e3, topicName=患者死亡)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=12de429, createdName=sunylz, createdTime=Wed Jul 26 21:39:00 CST 2017, time=2017-07-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1828733, encodeId=1f051828e33fa, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Sat Oct 21 12:39:00 CST 2017, time=2017-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1749676, encodeId=aed11e4967620, content=<a href='/topic/show?id=be7c8385345' target=_blank style='color:#2F92EE;'>#胰岛#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, 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=Tue Feb 07 21:39:00 CST 2017, time=2017-02-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1643436, encodeId=bdb41643436c1, content=<a href='/topic/show?id=6236895092b' target=_blank style='color:#2F92EE;'>#血管事件#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=89509, encryptionId=6236895092b, topicName=血管事件)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f99523187183, createdName=hukaixun, createdTime=Sat Jul 22 18:39:00 CST 2017, time=2017-07-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=168895, encodeId=bb7416889544, content=谢谢分享,学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=136, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=fe261399236, createdName=xyfg98, createdTime=Sun Jan 08 21:06:45 CST 2017, time=2017-01-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=166170, encodeId=c9cc1661e0ad, content=棒棒哒????????, beContent=null, objectType=article, channel=null, level=null, likeNumber=82, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=76491981781, createdName=1e184d7bm65(暂无匿称), createdTime=Tue Dec 27 22:51:26 CST 2016, time=2016-12-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=166149, encodeId=7b621661494c, content=看来不能随便用, beContent=null, objectType=article, channel=null, level=null, likeNumber=90, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=62d381629, createdName=yafeiliutjh, createdTime=Tue Dec 27 20:54:10 CST 2016, time=2016-12-27, status=1, ipAttribution=)]
    2016-12-27 1e184d7bm65(暂无匿称)

    棒棒哒????????

    0

  7. [GetPortalCommentsPageByObjectIdResponse(id=1983495, encodeId=c1231983495ac, content=<a href='/topic/show?id=628553048e3' target=_blank style='color:#2F92EE;'>#患者死亡#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=53048, encryptionId=628553048e3, topicName=患者死亡)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=12de429, createdName=sunylz, createdTime=Wed Jul 26 21:39:00 CST 2017, time=2017-07-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1828733, encodeId=1f051828e33fa, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Sat Oct 21 12:39:00 CST 2017, time=2017-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1749676, encodeId=aed11e4967620, content=<a href='/topic/show?id=be7c8385345' target=_blank style='color:#2F92EE;'>#胰岛#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, 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=Tue Feb 07 21:39:00 CST 2017, time=2017-02-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1643436, encodeId=bdb41643436c1, content=<a href='/topic/show?id=6236895092b' target=_blank style='color:#2F92EE;'>#血管事件#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=89509, encryptionId=6236895092b, topicName=血管事件)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f99523187183, createdName=hukaixun, createdTime=Sat Jul 22 18:39:00 CST 2017, time=2017-07-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=168895, encodeId=bb7416889544, content=谢谢分享,学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=136, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=fe261399236, createdName=xyfg98, createdTime=Sun Jan 08 21:06:45 CST 2017, time=2017-01-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=166170, encodeId=c9cc1661e0ad, content=棒棒哒????????, beContent=null, objectType=article, channel=null, level=null, likeNumber=82, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=76491981781, createdName=1e184d7bm65(暂无匿称), createdTime=Tue Dec 27 22:51:26 CST 2016, time=2016-12-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=166149, encodeId=7b621661494c, content=看来不能随便用, beContent=null, objectType=article, channel=null, level=null, likeNumber=90, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=62d381629, createdName=yafeiliutjh, createdTime=Tue Dec 27 20:54:10 CST 2016, time=2016-12-27, status=1, ipAttribution=)]
    2016-12-27 yafeiliutjh

    看来不能随便用

    0

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