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EMA:审定血管紧张素Ⅱ受体阻滞剂(ARB)无致癌风险

2011-10-24 MedSci原创 MedSci原创

  2011年10月20日,与美国FDA在今年6月的决定相似,欧洲药监局(EMA)发布了人用药品委员会(CHMP)对血管紧张素Ⅱ受体阻滞剂(ARB)的评审结果,认为使用ARB与癌症危险升高无关。ARB的效益风险比仍是阳性的。   EMA的评审源自去年一项荟萃分析得出的有争议的结果,该分析指出服用ARB的患者新发癌症尤其是肺癌危险升高7.2%,高于服用安慰剂或其他心脏药物的6%。   CHMP回

  2011年10月20日,与美国FDA在今年6月的决定相似,欧洲药监局(EMA)发布了人用药品委员会(CHMP)对血管紧张素Ⅱ受体阻滞剂(ARB)的评审结果,认为使用ARB与癌症危险升高无关。ARB的效益风险比仍是阳性的。

  EMA的评审源自去年一项荟萃分析得出的有争议的结果,该分析指出服用ARB的患者新发癌症尤其是肺癌危险升高7.2%,高于服用安慰剂或其他心脏药物的6%。

  CHMP回顾了所有有关服用ARB患者癌症风险的数据,包括荟萃分析。结果发现,荟萃分析所提供的证据较弱,数据的质量有几个问题,尤其是研究中的患者缺乏长期随访,并可能存在发表文章的偏倚,分析似乎更多纳入了提示与癌症有关的研究。

  不过,针对EMA的评审结论,去年因发表荟萃分析而使此话题成为热点的美国研究者IIke Sipahi表示,对EMA和FDA失望。他认为,两个部门均有机会要求公司提供患者水平的数据以便分析药物剂量、患者依从性和暴露时间的分析,但他们都没有这样做。EMA只是回顾了现有文献,而且这种回顾也是不完全的,后来发表的几项研究是支持IIke Sipahi的观点的。

  链接:

  EMA Review Concludes: No Cancer Risk With ARBs

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    2012-05-27 zhyy88
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    2012-08-17 sjq027
  5. [GetPortalCommentsPageByObjectIdResponse(id=2023307, encodeId=16a6202330e6a, content=<a href='/topic/show?id=bb29865199d' target=_blank style='color:#2F92EE;'>#致癌风险#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=93, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=86519, encryptionId=bb29865199d, topicName=致癌风险)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=19ad38, createdName=lq1767, createdTime=Sat Feb 04 23:46:00 CST 2012, time=2012-02-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1995093, encodeId=9581199509378, content=<a href='/topic/show?id=347538040cf' target=_blank style='color:#2F92EE;'>#受体阻滞剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=38040, encryptionId=347538040cf, topicName=受体阻滞剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=hb2008ye, createdTime=Thu Jun 28 18:46:00 CST 2012, time=2012-06-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2085676, encodeId=4d4d20856e626, content=<a href='/topic/show?id=723a9e69383' target=_blank style='color:#2F92EE;'>#阻滞剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97693, encryptionId=723a9e69383, topicName=阻滞剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=40be178, createdName=zhyy88, createdTime=Sun May 27 17:46:00 CST 2012, time=2012-05-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2061298, encodeId=b707206129897, content=<a href='/topic/show?id=e6e1e15509f' target=_blank style='color:#2F92EE;'>#癌风险#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=71550, encryptionId=e6e1e15509f, topicName=癌风险)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d58a435, createdName=sjq027, createdTime=Fri Aug 17 08:46:00 CST 2012, time=2012-08-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1317174, encodeId=471b131e1740b, content=<a href='/topic/show?id=74916e0414' target=_blank style='color:#2F92EE;'>#EMA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6704, encryptionId=74916e0414, topicName=EMA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a35a460, createdName=fengyi812, createdTime=Wed Oct 26 13:46:00 CST 2011, time=2011-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1370750, encodeId=4c6513e075041, content=<a href='/topic/show?id=9c39864991e' target=_blank style='color:#2F92EE;'>#致癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=86499, encryptionId=9c39864991e, topicName=致癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2c25323, createdName=jambiya, createdTime=Wed Oct 26 13:46:00 CST 2011, time=2011-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1589276, encodeId=89c615892e6d0, content=<a href='/topic/show?id=fb0389e4373' target=_blank style='color:#2F92EE;'>#血管紧张素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=89743, encryptionId=fb0389e4373, topicName=血管紧张素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=5ce517702394, createdName=xiongliangxl, createdTime=Wed Oct 26 13:46:00 CST 2011, time=2011-10-26, status=1, ipAttribution=)]
    2011-10-26 fengyi812
  6. [GetPortalCommentsPageByObjectIdResponse(id=2023307, encodeId=16a6202330e6a, content=<a href='/topic/show?id=bb29865199d' target=_blank style='color:#2F92EE;'>#致癌风险#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=93, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=86519, encryptionId=bb29865199d, topicName=致癌风险)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=19ad38, createdName=lq1767, createdTime=Sat Feb 04 23:46:00 CST 2012, time=2012-02-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1995093, encodeId=9581199509378, content=<a href='/topic/show?id=347538040cf' target=_blank style='color:#2F92EE;'>#受体阻滞剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=38040, encryptionId=347538040cf, topicName=受体阻滞剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=hb2008ye, createdTime=Thu Jun 28 18:46:00 CST 2012, time=2012-06-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2085676, encodeId=4d4d20856e626, content=<a href='/topic/show?id=723a9e69383' target=_blank style='color:#2F92EE;'>#阻滞剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97693, encryptionId=723a9e69383, topicName=阻滞剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=40be178, createdName=zhyy88, createdTime=Sun May 27 17:46:00 CST 2012, time=2012-05-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2061298, encodeId=b707206129897, content=<a href='/topic/show?id=e6e1e15509f' target=_blank style='color:#2F92EE;'>#癌风险#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=71550, encryptionId=e6e1e15509f, topicName=癌风险)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d58a435, createdName=sjq027, createdTime=Fri Aug 17 08:46:00 CST 2012, time=2012-08-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1317174, encodeId=471b131e1740b, content=<a href='/topic/show?id=74916e0414' target=_blank style='color:#2F92EE;'>#EMA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6704, encryptionId=74916e0414, topicName=EMA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a35a460, createdName=fengyi812, createdTime=Wed Oct 26 13:46:00 CST 2011, time=2011-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1370750, encodeId=4c6513e075041, content=<a href='/topic/show?id=9c39864991e' target=_blank style='color:#2F92EE;'>#致癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=86499, encryptionId=9c39864991e, topicName=致癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2c25323, createdName=jambiya, createdTime=Wed Oct 26 13:46:00 CST 2011, time=2011-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1589276, encodeId=89c615892e6d0, content=<a href='/topic/show?id=fb0389e4373' target=_blank style='color:#2F92EE;'>#血管紧张素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=89743, encryptionId=fb0389e4373, topicName=血管紧张素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=5ce517702394, createdName=xiongliangxl, createdTime=Wed Oct 26 13:46:00 CST 2011, time=2011-10-26, status=1, ipAttribution=)]
    2011-10-26 jambiya
  7. [GetPortalCommentsPageByObjectIdResponse(id=2023307, encodeId=16a6202330e6a, content=<a href='/topic/show?id=bb29865199d' target=_blank style='color:#2F92EE;'>#致癌风险#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=93, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=86519, encryptionId=bb29865199d, topicName=致癌风险)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=19ad38, createdName=lq1767, createdTime=Sat Feb 04 23:46:00 CST 2012, time=2012-02-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1995093, encodeId=9581199509378, content=<a href='/topic/show?id=347538040cf' target=_blank style='color:#2F92EE;'>#受体阻滞剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=38040, encryptionId=347538040cf, topicName=受体阻滞剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=hb2008ye, createdTime=Thu Jun 28 18:46:00 CST 2012, time=2012-06-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2085676, encodeId=4d4d20856e626, content=<a href='/topic/show?id=723a9e69383' target=_blank style='color:#2F92EE;'>#阻滞剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97693, encryptionId=723a9e69383, topicName=阻滞剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=40be178, createdName=zhyy88, createdTime=Sun May 27 17:46:00 CST 2012, time=2012-05-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2061298, encodeId=b707206129897, content=<a href='/topic/show?id=e6e1e15509f' target=_blank style='color:#2F92EE;'>#癌风险#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=71550, encryptionId=e6e1e15509f, topicName=癌风险)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d58a435, createdName=sjq027, createdTime=Fri Aug 17 08:46:00 CST 2012, time=2012-08-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1317174, encodeId=471b131e1740b, content=<a href='/topic/show?id=74916e0414' target=_blank style='color:#2F92EE;'>#EMA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6704, encryptionId=74916e0414, topicName=EMA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a35a460, createdName=fengyi812, createdTime=Wed Oct 26 13:46:00 CST 2011, time=2011-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1370750, encodeId=4c6513e075041, content=<a href='/topic/show?id=9c39864991e' target=_blank style='color:#2F92EE;'>#致癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=86499, encryptionId=9c39864991e, topicName=致癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2c25323, createdName=jambiya, createdTime=Wed Oct 26 13:46:00 CST 2011, time=2011-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1589276, encodeId=89c615892e6d0, content=<a href='/topic/show?id=fb0389e4373' target=_blank style='color:#2F92EE;'>#血管紧张素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=89743, encryptionId=fb0389e4373, topicName=血管紧张素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=5ce517702394, createdName=xiongliangxl, createdTime=Wed Oct 26 13:46:00 CST 2011, time=2011-10-26, status=1, ipAttribution=)]
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