NEJM:奥贝胆酸可显著降低原发性胆汁性胆管炎患者碱性磷酸酶及总胆红素的水平

2016-08-18 MedSci MedSci原创

原发性胆汁性胆管炎(以前称为原发性胆汁性肝硬化)尽管接受熊去氧胆酸治疗,仍可进展为肝硬化和死亡。碱性磷酸酶和胆红素的水平与肝移植或死亡的风险密切相关。奥贝胆酸,一种法尼酯X受体激动剂,在这种疾病的治疗上具有潜在的益处。 在此为期12个月的双盲安慰剂对照3期试验中,研究人员随机分配了217名对熊去氧胆酸治疗反应不足或出现副作用的患者分别接受10毫克的奥贝胆酸(10毫克组),5毫克的奥贝胆酸,如

原发性胆汁性胆管炎(以前称为原发性胆汁性肝硬化)尽管接受熊去氧胆酸治疗,仍可进展为肝硬化和死亡。碱性磷酸酶和胆红素的水平与肝移植或死亡的风险密切相关。奥贝胆酸,一种法尼酯X受体激动剂,在这种疾病的治疗上具有潜在的益处。

在此为期12个月的双盲安慰剂对照3期试验中,研究人员随机分配了217名对熊去氧胆酸治疗反应不足或出现副作用的患者分别接受10毫克的奥贝胆酸(10毫克组),5毫克的奥贝胆酸,如果适用调整至10毫克(5–10 mg组),或安慰剂组。主要研究终点是碱性磷酸酶的水平小于1.67倍正常范围上限,从基线减少至少15%,以及总胆红素水平正常。

最终216名患者接受随机分组,93%的患者曾接受熊去氧胆酸治疗。与安慰剂组(10%)相比,5-10毫克组(46%)和10毫克组(47%)的患者发生主要研究终点的比例较高(组间P<0.001)。与安慰剂组患者相比,5-10毫克组和10毫克组患者碱性磷酸酶的水平显著降低(最小二乘均值分别为−113和−130 U每升,VS.−14 U每升;组间P<0.001),总胆红素的水平也显著降低(分别为−0.02和−0.05毫克每分升[−0.3和−0.9微摩尔每升],VS. 0.12毫克每分升[ 2微摩尔每升];组间P<0.001)。

治疗第12个月时,无论是治疗组还是安慰剂组,肝纤维化的无创性指标并没有显著差异。与安慰剂组相比,奥贝胆酸治疗组皮肤瘙痒更常见(5-10 mg组为56%, 10毫克组为68%,安慰剂组为38%)。5-10 mg组出现严重不良事件发生率为16%,10毫克组为11%,安慰剂组为4%。

总而言之,与安慰剂组相比,奥贝胆酸联合熊去氧胆酸或仅作为单药治疗原发性胆汁性胆管炎患者治疗12个月可使得碱性磷酸酶及总胆红素的水平显著低于基线时期。但是奥贝胆酸治疗也有更多的严重不良事件。

原始出处:

Frederik Nevens, Pietro Andreone, et al., A Placebo-Controlled Trial of Obeticholic Acid in Primary Biliary Cholangitis. N Engl J Med 2016; 375:631-643August 18, 2016DOI: 10.1056/NEJMoa1509840.

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level=null, likeNumber=1, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160817/IMG57B3C3F6DC2FD8753.jpg, createdBy=81321934679, createdName=1e0d99ddm02(暂无匿称), createdTime=Sun Aug 21 16:42:00 CST 2016, time=2016-08-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=101479, encodeId=04c81014e9bf, content=值得学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTLMzGpMQ8w4I7FpiblCXNcmI6O7TDINutbaicEUpoYFR1rWqn3kTbulfMhT0iaPFurLz2ddEcWe3BiciaQ/0, createdBy=5f6e1724878, createdName=136****0753赵, createdTime=Sat Aug 20 15:16:00 CST 2016, time=2016-08-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1379008, encodeId=679d13e900893, content=<a 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    2016-08-26 李东泽

    这篇资讯写的真好,带给我们新知识,启发新思维,不论是科研还是临床工作都有很大的帮助。。。

    0

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    2016-08-26 李东泽

    这篇资讯写的真好,带给我们新知识,启发新思维,不论是科研还是临床工作都有很大的帮助。。。

    0

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href='/topic/show?id=8f633e1073d' target=_blank style='color:#2F92EE;'>#原发性胆汁性胆管炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=37107, encryptionId=8f633e1073d, topicName=原发性胆汁性胆管炎)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ec53439, createdName=zhty5337, createdTime=Sat Aug 20 09:58:00 CST 2016, time=2016-08-20, status=1, ipAttribution=)]
    2016-08-21 1e0d99ddm02(暂无匿称)

    赞一个,学习!

    0

  7. [GetPortalCommentsPageByObjectIdResponse(id=1846499, encodeId=ac431846499df, content=<a href='/topic/show?id=d3a33e0306d' target=_blank style='color:#2F92EE;'>#原发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=37030, encryptionId=d3a33e0306d, topicName=原发性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8e4c53, createdName=jiyangfei, createdTime=Mon May 29 18:58:00 CST 2017, time=2017-05-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1722121, encodeId=2d3e1e22121a9, content=<a href='/topic/show?id=bfd452e73d3' target=_blank style='color:#2F92EE;'>#总胆红素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=52773, encryptionId=bfd452e73d3, topicName=总胆红素)], attachment=null, authenticateStatus=null, createdAvatar=null, 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level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160817/IMG57B3C3F6DC2FD8753.jpg, createdBy=81321934679, createdName=1e0d99ddm02(暂无匿称), createdTime=Sun Aug 21 16:43:00 CST 2016, time=2016-08-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=102003, encodeId=8e8a1020033c, content=了解一下!!?, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160817/IMG57B3C3F6DC2FD8753.jpg, createdBy=81321934679, createdName=1e0d99ddm02(暂无匿称), createdTime=Sun Aug 21 16:42:00 CST 2016, time=2016-08-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=102004, encodeId=605810200467, content=学习了,赞一个!, beContent=null, objectType=article, channel=null, level=null, likeNumber=1, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160817/IMG57B3C3F6DC2FD8753.jpg, createdBy=81321934679, createdName=1e0d99ddm02(暂无匿称), createdTime=Sun Aug 21 16:42:00 CST 2016, time=2016-08-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=101479, encodeId=04c81014e9bf, content=值得学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTLMzGpMQ8w4I7FpiblCXNcmI6O7TDINutbaicEUpoYFR1rWqn3kTbulfMhT0iaPFurLz2ddEcWe3BiciaQ/0, createdBy=5f6e1724878, createdName=136****0753赵, createdTime=Sat Aug 20 15:16:00 CST 2016, time=2016-08-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1379008, encodeId=679d13e900893, content=<a href='/topic/show?id=8f633e1073d' target=_blank style='color:#2F92EE;'>#原发性胆汁性胆管炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=37107, encryptionId=8f633e1073d, topicName=原发性胆汁性胆管炎)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ec53439, createdName=zhty5337, createdTime=Sat Aug 20 09:58:00 CST 2016, time=2016-08-20, status=1, ipAttribution=)]
    2016-08-21 1e0d99ddm02(暂无匿称)

    了解一下!!?

    0

  8. [GetPortalCommentsPageByObjectIdResponse(id=1846499, encodeId=ac431846499df, content=<a href='/topic/show?id=d3a33e0306d' target=_blank style='color:#2F92EE;'>#原发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=37030, encryptionId=d3a33e0306d, topicName=原发性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8e4c53, createdName=jiyangfei, createdTime=Mon May 29 18:58:00 CST 2017, time=2017-05-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1722121, encodeId=2d3e1e22121a9, content=<a href='/topic/show?id=bfd452e73d3' target=_blank style='color:#2F92EE;'>#总胆红素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=52773, encryptionId=bfd452e73d3, topicName=总胆红素)], attachment=null, authenticateStatus=null, createdAvatar=null, 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level=null, likeNumber=1, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160817/IMG57B3C3F6DC2FD8753.jpg, createdBy=81321934679, createdName=1e0d99ddm02(暂无匿称), createdTime=Sun Aug 21 16:42:00 CST 2016, time=2016-08-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=101479, encodeId=04c81014e9bf, content=值得学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTLMzGpMQ8w4I7FpiblCXNcmI6O7TDINutbaicEUpoYFR1rWqn3kTbulfMhT0iaPFurLz2ddEcWe3BiciaQ/0, createdBy=5f6e1724878, createdName=136****0753赵, createdTime=Sat Aug 20 15:16:00 CST 2016, time=2016-08-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1379008, encodeId=679d13e900893, content=<a href='/topic/show?id=8f633e1073d' target=_blank style='color:#2F92EE;'>#原发性胆汁性胆管炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=37107, encryptionId=8f633e1073d, topicName=原发性胆汁性胆管炎)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ec53439, createdName=zhty5337, createdTime=Sat Aug 20 09:58:00 CST 2016, time=2016-08-20, status=1, ipAttribution=)]
    2016-08-21 1e0d99ddm02(暂无匿称)

    学习了,赞一个!

    0

  9. [GetPortalCommentsPageByObjectIdResponse(id=1846499, encodeId=ac431846499df, content=<a href='/topic/show?id=d3a33e0306d' target=_blank style='color:#2F92EE;'>#原发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=37030, encryptionId=d3a33e0306d, topicName=原发性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8e4c53, createdName=jiyangfei, createdTime=Mon May 29 18:58:00 CST 2017, time=2017-05-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1722121, encodeId=2d3e1e22121a9, content=<a href='/topic/show?id=bfd452e73d3' target=_blank style='color:#2F92EE;'>#总胆红素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=52773, encryptionId=bfd452e73d3, topicName=总胆红素)], attachment=null, authenticateStatus=null, createdAvatar=null, 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createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzUn81b5CF5ibVPib8jWI92iciaxmqGHlwruOnK4SVZykd4iahqo1hicklIibyZoxm55X7EM8BW9eX1h1hQ2/0, createdBy=8aa81937526, createdName=李东泽, createdTime=Fri Aug 26 11:32:00 CST 2016, time=2016-08-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=104024, encodeId=7818104024ab, content=这篇资讯写的真好,带给我们新知识,启发新思维,不论是科研还是临床工作都有很大的帮助。。。, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzUn81b5CF5ibVPib8jWI92iciaxmqGHlwruOnK4SVZykd4iahqo1hicklIibyZoxm55X7EM8BW9eX1h1hQ2/0, createdBy=8aa81937526, createdName=李东泽, createdTime=Fri Aug 26 01:07:00 CST 2016, time=2016-08-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=102005, encodeId=c61a10200565, content=赞一个,学习!, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160817/IMG57B3C3F6DC2FD8753.jpg, createdBy=81321934679, createdName=1e0d99ddm02(暂无匿称), createdTime=Sun Aug 21 16:43:00 CST 2016, time=2016-08-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=102003, encodeId=8e8a1020033c, content=了解一下!!?, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160817/IMG57B3C3F6DC2FD8753.jpg, createdBy=81321934679, createdName=1e0d99ddm02(暂无匿称), createdTime=Sun Aug 21 16:42:00 CST 2016, time=2016-08-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=102004, encodeId=605810200467, content=学习了,赞一个!, beContent=null, objectType=article, channel=null, level=null, likeNumber=1, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160817/IMG57B3C3F6DC2FD8753.jpg, createdBy=81321934679, createdName=1e0d99ddm02(暂无匿称), createdTime=Sun Aug 21 16:42:00 CST 2016, time=2016-08-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=101479, encodeId=04c81014e9bf, content=值得学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTLMzGpMQ8w4I7FpiblCXNcmI6O7TDINutbaicEUpoYFR1rWqn3kTbulfMhT0iaPFurLz2ddEcWe3BiciaQ/0, createdBy=5f6e1724878, createdName=136****0753赵, createdTime=Sat Aug 20 15:16:00 CST 2016, time=2016-08-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1379008, encodeId=679d13e900893, content=<a href='/topic/show?id=8f633e1073d' target=_blank style='color:#2F92EE;'>#原发性胆汁性胆管炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=37107, encryptionId=8f633e1073d, topicName=原发性胆汁性胆管炎)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ec53439, createdName=zhty5337, createdTime=Sat Aug 20 09:58:00 CST 2016, time=2016-08-20, status=1, ipAttribution=)]
    2016-08-20 136****0753赵

    值得学习

    0

  10. 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createdBy=18f733165481, createdName=slcumt, createdTime=Wed Mar 15 02:58:00 CST 2017, time=2017-03-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1809365, encodeId=d7e9180936567, content=<a href='/topic/show?id=5eba834e876' target=_blank style='color:#2F92EE;'>#胆汁性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=83478, encryptionId=5eba834e876, topicName=胆汁性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=hb2008ye, createdTime=Fri Jul 14 05:58:00 CST 2017, time=2017-07-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=104433, encodeId=2828104433da, content=这篇资讯写的真好,带给我们新知识,启发新思维,不论是科研还是临床工作都有很大的帮助。。。, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, 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