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胡大一：如何评价随机临床试验中他汀的剂量 设计？科学？游戏？还是“陷阱”？

2016-12-07 “胡大一大夫”微信号 “胡大一大夫”微信号

胡大一评价随机临床试验他汀剂量设计
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2013年11月美国心脏病学学院（ACC）和美国心脏协会（AHA）发布了胆固醇新指南，其中最重大的变化是取消LDL-C治疗目标值，改为推荐四类需使用他汀药物治疗的人群和大、中两种他汀剂量，做出如此在临床上难以执行的建议基于高质量随机临床试验（RCT）的证据。那么RCT的他汀剂量是如何设计的？基于科学? 还是游戏? 甚至“陷阱”？以4S 为代表的5 项有里程碑意义的他汀类药物RCT 使用ACC/

2013年11月美国心脏病学学院（ACC）和美国心脏协会（AHA）发布了胆固醇新指南，其中最重大的变化是取消LDL-C治疗目标值，改为推荐四类需使用他汀药物治疗的人群和大、中两种他汀剂量，做出如此在临床上难以执行的建议基于高质量随机临床试验（RCT）的证据。那么RCT的他汀剂量是如何设计的？基于科学? 还是游戏? 甚至“陷阱”？以4S 为代表的5 项有里程碑意义的他汀类药物RCT 使用ACC/AHA新指南所列的中小剂量与安慰剂的对比，两组间的LDL-C差别都在30%以上，从而显示出总死亡率下降，心血管病死亡率下降，非致命心肌梗死与卒中下降，对PCI 与CABG 的需求明显减少，而且安全性好，与安慰剂比无显著差别。RCT结束后，长期随访表明，早期使用他汀长期获益。到降LDL-C 作用更强的阿托伐他汀上市时，在大多数领域从科学到伦理已不允许设安慰剂对照组。科学家的研究兴趣与制药企业的市场营销策略不谋而合指向“强化降脂，更多获益”。制药企业支持的RCT基本原则是不触及安全底线的前提下，追求效果，并且希望入组患者不过多，随访时间不过长的情况下，获取有统计学显著差异的阳性结果。因为对照组使用他汀

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  1. 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07 22:22:25 CST 2016, time=2016-12-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=161038, encodeId=049d16103814, content=大师才能做出来的, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20151226/IMG567EB873985DE3928.jpg, createdBy=ea941622301, createdName=inter158, createdTime=Wed Dec 07 22:21:15 CST 2016, time=2016-12-07, status=1, ipAttribution=)]
    2017-03-15 ms117281293605716

    #随机临床试验#

    0

  2. 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    2017-05-20 1249842em20(暂无昵称)

    #游戏#

    0

  3. 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07 22:22:25 CST 2016, time=2016-12-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=161038, encodeId=049d16103814, content=大师才能做出来的, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20151226/IMG567EB873985DE3928.jpg, createdBy=ea941622301, createdName=inter158, createdTime=Wed Dec 07 22:21:15 CST 2016, time=2016-12-07, status=1, ipAttribution=)]
    2016-12-23 飘飘爱

    很特别

    0

  4. 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07 22:22:25 CST 2016, time=2016-12-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=161038, encodeId=049d16103814, content=大师才能做出来的, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20151226/IMG567EB873985DE3928.jpg, createdBy=ea941622301, createdName=inter158, createdTime=Wed Dec 07 22:21:15 CST 2016, time=2016-12-07, status=1, ipAttribution=)]
    2016-12-18 李东泽

    很好，不错，以后会多学习

    0

  5. 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07 22:22:25 CST 2016, time=2016-12-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=161038, encodeId=049d16103814, content=大师才能做出来的, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20151226/IMG567EB873985DE3928.jpg, createdBy=ea941622301, createdName=inter158, createdTime=Wed Dec 07 22:21:15 CST 2016, time=2016-12-07, status=1, ipAttribution=)]
    2016-12-11 sunlong28

    赞一个～

    0

  6. 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07 22:22:25 CST 2016, time=2016-12-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=161038, encodeId=049d16103814, content=大师才能做出来的, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20151226/IMG567EB873985DE3928.jpg, createdBy=ea941622301, createdName=inter158, createdTime=Wed Dec 07 22:21:15 CST 2016, time=2016-12-07, status=1, ipAttribution=)]
    2016-12-09 仁心济世

    #胡大一#

    0

  7. 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07 22:22:25 CST 2016, time=2016-12-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=161038, encodeId=049d16103814, content=大师才能做出来的, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20151226/IMG567EB873985DE3928.jpg, createdBy=ea941622301, createdName=inter158, createdTime=Wed Dec 07 22:21:15 CST 2016, time=2016-12-07, status=1, ipAttribution=)]
    2016-12-09 huagfeg

    #评价#

    0

  8. 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07 22:22:25 CST 2016, time=2016-12-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=161038, encodeId=049d16103814, content=大师才能做出来的, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20151226/IMG567EB873985DE3928.jpg, createdBy=ea941622301, createdName=inter158, createdTime=Wed Dec 07 22:21:15 CST 2016, time=2016-12-07, status=1, ipAttribution=)]
    2016-12-07 艳阳天2016

    现在越来越关注胡教授的文章

    0

  9. 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07 22:22:25 CST 2016, time=2016-12-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=161038, encodeId=049d16103814, content=大师才能做出来的, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20151226/IMG567EB873985DE3928.jpg, createdBy=ea941622301, createdName=inter158, createdTime=Wed Dec 07 22:21:15 CST 2016, time=2016-12-07, status=1, ipAttribution=)]
    2016-12-07 inter158

    科学家的研究兴趣与制药企业的市场营销策略不谋而合指向“强化降脂，更多获益”。

    0

  10. 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07 22:22:25 CST 2016, time=2016-12-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=161038, encodeId=049d16103814, content=大师才能做出来的, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20151226/IMG567EB873985DE3928.jpg, createdBy=ea941622301, createdName=inter158, createdTime=Wed Dec 07 22:21:15 CST 2016, time=2016-12-07, status=1, ipAttribution=)]
    2016-12-07 inter158

    大师才能做出来的

    0

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