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FDA:面对生物恐怖袭击,批准炭疽疫苗用于炭疽暴露后的保护

2015-11-28 MedSci MedSci原创

FDA近日宣布批准BioThrax添加一个新的适应症,用于18-65岁个人在疑似或确诊炭疽杆菌暴露后阻止炭疽病发作。临床医生应该推荐BioThrax疫苗和抗生素治疗联合使用。

FDA近日批准一种已经使用了45年的疫苗用于炭疽杆菌暴露后的保护。

FDA1970年批准炭疽疫苗吸附剂BioThrax(紧急生物防御措施)用于存在高危暴露风险的个体预防炭疽。FDA近日宣布批准BioThrax添加一个新的适应症,用于18-65岁个人在疑似或确诊炭疽杆菌暴露后阻止炭疽病发作。临床医生应该推荐BioThrax疫苗和抗生素治疗联合使用。

个体吸入炭疽孢子后如果没有及时治疗,炭疽通常是致命的。

FDA的决定在一定程度上是基于对暴露于炭疽的兔子的研究。使用疫苗和抗生素治疗暴露于炭疽的兔子,兔子的存活率在70%和100%之间,具体数值取决于疫苗剂量。在另外两个研究中只使用抗生素治疗暴露于炭疽杆菌的兔子,兔子存活率分别下降到44%和23%。

另一项由联邦政府实施的研究观察人体对BioThrax的抗体反应和疫苗的安全性。200例健康成年人在4周疗程内接受3次皮下注射疫苗。大多数受试者中抗体反应达到兔子研究生存率的70%。

这项人体研究的不良反应与用于预防炭疽目的使用的不良反应相似。紧张、疼痛、注射部位红肿和上肢运动受限是疫苗注射区域的主要不良反应。最常见的全身性不良反应是肌痛、头痛和疲劳。

原始出处:

Anthrax Vaccine Approved for Postexposure Protection. Medscape. November 24,2015.


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  1. [GetPortalCommentsPageByObjectIdResponse(id=54709, encodeId=a24f54e09f2, content=好东西,值得分享,学习了!, beContent=null, objectType=article, channel=null, level=null, likeNumber=124, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=69b61619007, createdName=andruhn, createdTime=Fri Jan 08 20:07:00 CST 2016, time=2016-01-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=51529, encodeId=ae785152970, content=不知道是什么的事物都会让人恐慌, beContent=null, objectType=article, channel=null, level=null, likeNumber=128, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=fe261399236, createdName=xyfg98, createdTime=Sun Jan 03 21:34:00 CST 2016, time=2016-01-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=44225, encodeId=c5244422538, content=感觉中国人对炭疽知之甚少, beContent=null, objectType=article, channel=null, level=null, likeNumber=139, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://login.medsci.cn/upload/avatar/e3b78fdf1c4d3e2e9ec6e03f643df0e2/6ca494c7b27a25fdde0721c5dac778d7.jpg, createdBy=2e441664544, createdName=鲜花飞鸟, createdTime=Mon Nov 30 22:38:00 CST 2015, time=2015-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=44191, encodeId=62dc44191bb, content=恐怖分子引起太大的恐慌, beContent=null, objectType=article, channel=null, level=null, likeNumber=116, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=974f1667182, createdName=杨晨舟, createdTime=Mon Nov 30 17:05:00 CST 2015, time=2015-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=44160, encodeId=ea5944160a0, content=额额。。, beContent=null, objectType=article, channel=null, level=null, likeNumber=171, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=59d01634640, createdName=tennian, createdTime=Mon Nov 30 12:42:00 CST 2015, time=2015-11-30, status=1, ipAttribution=)]
    2016-01-08 andruhn

    好东西,值得分享,学习了!

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=54709, encodeId=a24f54e09f2, content=好东西,值得分享,学习了!, beContent=null, objectType=article, channel=null, level=null, likeNumber=124, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=69b61619007, createdName=andruhn, createdTime=Fri Jan 08 20:07:00 CST 2016, time=2016-01-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=51529, encodeId=ae785152970, content=不知道是什么的事物都会让人恐慌, beContent=null, objectType=article, channel=null, level=null, likeNumber=128, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=fe261399236, createdName=xyfg98, createdTime=Sun Jan 03 21:34:00 CST 2016, time=2016-01-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=44225, encodeId=c5244422538, content=感觉中国人对炭疽知之甚少, beContent=null, objectType=article, channel=null, level=null, likeNumber=139, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://login.medsci.cn/upload/avatar/e3b78fdf1c4d3e2e9ec6e03f643df0e2/6ca494c7b27a25fdde0721c5dac778d7.jpg, createdBy=2e441664544, createdName=鲜花飞鸟, createdTime=Mon Nov 30 22:38:00 CST 2015, time=2015-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=44191, encodeId=62dc44191bb, content=恐怖分子引起太大的恐慌, beContent=null, objectType=article, channel=null, level=null, likeNumber=116, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=974f1667182, createdName=杨晨舟, createdTime=Mon Nov 30 17:05:00 CST 2015, time=2015-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=44160, encodeId=ea5944160a0, content=额额。。, beContent=null, objectType=article, channel=null, level=null, likeNumber=171, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=59d01634640, createdName=tennian, createdTime=Mon Nov 30 12:42:00 CST 2015, time=2015-11-30, status=1, ipAttribution=)]
    2016-01-03 xyfg98

    不知道是什么的事物都会让人恐慌

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=54709, encodeId=a24f54e09f2, content=好东西,值得分享,学习了!, beContent=null, objectType=article, channel=null, level=null, likeNumber=124, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=69b61619007, createdName=andruhn, createdTime=Fri Jan 08 20:07:00 CST 2016, time=2016-01-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=51529, encodeId=ae785152970, content=不知道是什么的事物都会让人恐慌, beContent=null, objectType=article, channel=null, level=null, likeNumber=128, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=fe261399236, createdName=xyfg98, createdTime=Sun Jan 03 21:34:00 CST 2016, time=2016-01-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=44225, encodeId=c5244422538, content=感觉中国人对炭疽知之甚少, beContent=null, objectType=article, channel=null, level=null, likeNumber=139, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://login.medsci.cn/upload/avatar/e3b78fdf1c4d3e2e9ec6e03f643df0e2/6ca494c7b27a25fdde0721c5dac778d7.jpg, createdBy=2e441664544, createdName=鲜花飞鸟, createdTime=Mon Nov 30 22:38:00 CST 2015, time=2015-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=44191, encodeId=62dc44191bb, content=恐怖分子引起太大的恐慌, beContent=null, objectType=article, channel=null, level=null, likeNumber=116, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=974f1667182, createdName=杨晨舟, createdTime=Mon Nov 30 17:05:00 CST 2015, time=2015-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=44160, encodeId=ea5944160a0, content=额额。。, beContent=null, objectType=article, channel=null, level=null, likeNumber=171, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=59d01634640, createdName=tennian, createdTime=Mon Nov 30 12:42:00 CST 2015, time=2015-11-30, status=1, ipAttribution=)]
    2015-11-30 鲜花飞鸟

    感觉中国人对炭疽知之甚少

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=54709, encodeId=a24f54e09f2, content=好东西,值得分享,学习了!, beContent=null, objectType=article, channel=null, level=null, likeNumber=124, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=69b61619007, createdName=andruhn, createdTime=Fri Jan 08 20:07:00 CST 2016, time=2016-01-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=51529, encodeId=ae785152970, content=不知道是什么的事物都会让人恐慌, beContent=null, objectType=article, channel=null, level=null, likeNumber=128, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=fe261399236, createdName=xyfg98, createdTime=Sun Jan 03 21:34:00 CST 2016, time=2016-01-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=44225, encodeId=c5244422538, content=感觉中国人对炭疽知之甚少, beContent=null, objectType=article, channel=null, level=null, likeNumber=139, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://login.medsci.cn/upload/avatar/e3b78fdf1c4d3e2e9ec6e03f643df0e2/6ca494c7b27a25fdde0721c5dac778d7.jpg, createdBy=2e441664544, createdName=鲜花飞鸟, createdTime=Mon Nov 30 22:38:00 CST 2015, time=2015-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=44191, encodeId=62dc44191bb, content=恐怖分子引起太大的恐慌, beContent=null, objectType=article, channel=null, level=null, likeNumber=116, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=974f1667182, createdName=杨晨舟, createdTime=Mon Nov 30 17:05:00 CST 2015, time=2015-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=44160, encodeId=ea5944160a0, content=额额。。, beContent=null, objectType=article, channel=null, level=null, likeNumber=171, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=59d01634640, createdName=tennian, createdTime=Mon Nov 30 12:42:00 CST 2015, time=2015-11-30, status=1, ipAttribution=)]
    2015-11-30 杨晨舟

    恐怖分子引起太大的恐慌

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=54709, encodeId=a24f54e09f2, content=好东西,值得分享,学习了!, beContent=null, objectType=article, channel=null, level=null, likeNumber=124, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=69b61619007, createdName=andruhn, createdTime=Fri Jan 08 20:07:00 CST 2016, time=2016-01-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=51529, encodeId=ae785152970, content=不知道是什么的事物都会让人恐慌, beContent=null, objectType=article, channel=null, level=null, likeNumber=128, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=fe261399236, createdName=xyfg98, createdTime=Sun Jan 03 21:34:00 CST 2016, time=2016-01-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=44225, encodeId=c5244422538, content=感觉中国人对炭疽知之甚少, beContent=null, objectType=article, channel=null, level=null, likeNumber=139, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://login.medsci.cn/upload/avatar/e3b78fdf1c4d3e2e9ec6e03f643df0e2/6ca494c7b27a25fdde0721c5dac778d7.jpg, createdBy=2e441664544, createdName=鲜花飞鸟, createdTime=Mon Nov 30 22:38:00 CST 2015, time=2015-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=44191, encodeId=62dc44191bb, content=恐怖分子引起太大的恐慌, beContent=null, objectType=article, channel=null, level=null, likeNumber=116, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=974f1667182, createdName=杨晨舟, createdTime=Mon Nov 30 17:05:00 CST 2015, time=2015-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=44160, encodeId=ea5944160a0, content=额额。。, beContent=null, objectType=article, channel=null, level=null, likeNumber=171, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=59d01634640, createdName=tennian, createdTime=Mon Nov 30 12:42:00 CST 2015, time=2015-11-30, status=1, ipAttribution=)]
    2015-11-30 tennian

    额额。。

    0

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