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Circulation：新降血脂药研发陷入困境（附点评）

2011-06-01 MedSci原创 MedSci原创

Circulation降血脂药
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MedSci评：以往Meta分析多针对已发表的文献，而本例Meta分析主要针对II和III期临床试验成果（当然不少也是以文献形式发表）。这表明循证医学的数据来源是多样的，这给我们提供很好地启示。 　　 　　Circulation杂志2011年4月25日发表的一项循证医学Meta研究表明，单独采用鲨烯合酶抑制剂拉帕司他醋酸盐（lapaquistat acetate），或联合他汀类药物抑制鲨烯合酶

MedSci评：以往Meta分析多针对已发表的文献，而本例Meta分析主要针对II和III期临床试验成果（当然不少也是以文献形式发表）。这表明循证医学的数据来源是多样的，这给我们提供很好地启示。 　　 　　Circulation杂志2011年4月25日发表的一项循证医学Meta研究表明，单独采用鲨烯合酶抑制剂拉帕司他醋酸盐（lapaquistat acetate），或联合他汀类药物抑制鲨烯合酶，可剂量依赖性地有效降低低密度脂蛋白胆固醇（LDL-C）。然而，该药可导致丙氨酸氨基转移酶水平升高和罕见胆红素升高，潜在的肝脏安全性隐患导致其研发被终止。 　　该研究汇总了12项临床Ⅱ期和Ⅲ期临床研究（n=6151）的结果，研究因拉帕司他潜在的肝脏危险而被迫在高级阶段暂停。这些研究持续6至96周，均为针对血脂异常患者的随机、双盲、平行、安慰剂或活性药对照临床试验，治疗方案包括拉帕司他单药或与其他降脂药物联合治疗，包含一项持续96周的大规模安全性研究（n=2121）。多数研究均采用拉帕司他100 mg/d。结果采用LDL-C的百分率变化、次要的脂类/代谢变量和总安全性进行测量。 　　研究显示，拉帕司

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    2011-12-19 ms2536978994064944

    #困境#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1707172, encodeId=745c1e0717254, content=<a href='/topic/show?id=fedc406085d' target=_blank style='color:#2F92EE;'>#困境#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=40608, encryptionId=fedc406085d, topicName=困境)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=0a4631370697, createdName=ms2536978994064944, createdTime=Mon Dec 19 21:40:00 CST 2011, time=2011-12-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1992990, encodeId=68271992990f9, content=<a href='/topic/show?id=29c598209ca' target=_blank style='color:#2F92EE;'>#降血脂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98209, encryptionId=29c598209ca, topicName=降血脂)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIW7uIr5ebYvJohUq0dkkVV05uF9jPpeyCrlcx904mUdMI9UKqpO3bt4GkgYBNdv485qT2NsVE27w/132, createdBy=023c2500122, createdName=ms8543593053280928, createdTime=Tue Apr 17 12:40:00 CST 2012, time=2012-04-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1299709, encodeId=e6e11299e09cc, content=<a href='/topic/show?id=ed5ee332423' target=_blank style='color:#2F92EE;'>#研发#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73324, encryptionId=ed5ee332423, topicName=研发)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=aea0290, createdName=lqvr, createdTime=Fri Jun 03 13:40:00 CST 2011, time=2011-06-03, status=1, ipAttribution=)]
    2012-04-17 ms8543593053280928

    #降血脂#

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1707172, encodeId=745c1e0717254, content=<a href='/topic/show?id=fedc406085d' target=_blank style='color:#2F92EE;'>#困境#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=40608, encryptionId=fedc406085d, topicName=困境)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=0a4631370697, createdName=ms2536978994064944, createdTime=Mon Dec 19 21:40:00 CST 2011, time=2011-12-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1992990, encodeId=68271992990f9, content=<a href='/topic/show?id=29c598209ca' target=_blank style='color:#2F92EE;'>#降血脂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98209, encryptionId=29c598209ca, topicName=降血脂)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIW7uIr5ebYvJohUq0dkkVV05uF9jPpeyCrlcx904mUdMI9UKqpO3bt4GkgYBNdv485qT2NsVE27w/132, createdBy=023c2500122, createdName=ms8543593053280928, createdTime=Tue Apr 17 12:40:00 CST 2012, time=2012-04-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1299709, encodeId=e6e11299e09cc, content=<a href='/topic/show?id=ed5ee332423' target=_blank style='color:#2F92EE;'>#研发#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73324, encryptionId=ed5ee332423, topicName=研发)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=aea0290, createdName=lqvr, createdTime=Fri Jun 03 13:40:00 CST 2011, time=2011-06-03, status=1, ipAttribution=)]
    2011-06-03 lqvr

    #研发#

    0