FDA警告!儿童孕妇慎用这11种药物

2016-12-16 医学界麻醉频道 医学界麻醉频道

导读:2016年12月14日,FDA发布了一个关于孕妇及婴幼儿慎用全麻药及镇静药物的警告。随着麻醉技术的快速发展,临床上已经能常规、安全的给予婴幼儿、新生儿、孕妇各种手术麻醉支持。全球每年有数百万的新生儿或儿童在外科手术和影像学检查中接受全身麻醉药麻醉。但近日FDA发布警告:妊娠末三个月的孕妇或3岁以下儿童在手术中重复或长时间(>3小时)使用全麻药和镇静药,可能会影响胎儿及儿童的大脑发育。FDA要

导读:2016年12月14日,FDA发布了一个关于孕妇及婴幼儿慎用全麻药及镇静药物的警告。

随着麻醉技术的快速发展,临床上已经能常规、安全的给予婴幼儿、新生儿、孕妇各种手术麻醉支持。全球每年有数百万的新生儿或儿童在外科手术和影像学检查中接受全身麻醉药麻醉。

近日FDA发布警告:妊娠末三个月的孕妇或3岁以下儿童在手术中重复或长时间(>3小时)使用全麻药和镇静药,可能会影响胎儿及儿童的大脑发育。

FDA要求在全麻药和镇静药物的药品标签上增加相关的警告,并表示会持续关注这类药物对儿童和孕妇的影响,并会及时向公众通告。FDA还呼吁医疗专业人员、患者、家长、照看者积极上报麻醉剂和镇静药物引起的不良反应。

下列药物均需修改药品标签:



点击查看大图

FDA建议:使用任何麻醉药物前都需要考虑风险和获益

医疗保健专业人员,在给幼儿和孕妇麻醉时,应选择适当的麻醉方法并权衡利弊,尤其是在给3岁以下的幼儿麻醉超过3小时,或程序复杂时,需与患儿家长、照看者或孕妇本人充分沟通,详细告知他们关于麻醉剂和镇静药物的潜在利弊,以及选择合适的手术时机。

家长及照看者需要与儿童健康专业人员沟通讨论,麻醉剂和镇静药物对脑部发育的潜在影响,以及合适的手术或用药时机,延迟手术或用药可能对幼儿带来的危害。孕妇同样需要跟医生等专业医疗人员沟通,并详细讨论相关的问题及担忧。

FDA发布这个警告的依据是什么?

既往幼龄动物试验中,使用全麻药或镇静药物超过3小时,会增加大脑神经元细胞凋亡,并导致长期的认知缺陷。且全麻药和镇静药物对大脑发育的不良影响在很多动物(物种从扁形虫到非人灵长类动物)身上都能到了证实。

而在人体幼儿试验中也发现了一些支持既往动物研究结果的证据,尤其在生命早期重复多次或长时间此类药物暴露,会对婴幼儿的行为和认知造成不良影响。值得一提的是,近期人体试验显示,全麻药和镇静剂单次,短时间的暴露对于婴幼儿的行为和认知不会造成不良影响。(该结果与动物试验结果一致)

一些流行病学研究还发现在儿童时期麻醉药物的暴露和神经发育的不良预后相关。特别是麻醉药物长时间或重复的暴露可能会造成认知和行为缺陷,包括神经发育迟缓的诊断,学习障碍,注意缺陷多动障碍。然而,值得一提的是,认知和行为障碍究竟是受到麻醉药物的影响还是手术本身的影响,又或者是一些未知因素的影响,目前还不得而知。

FDA也表示,目前所有的儿童试验都有局限性,关于早期麻醉药物的暴露是否会影响儿童大脑发育,尤其是长时间和重复暴露,以及对体质较弱的儿童有何影响,以及这些不良影响是否会影响到儿童后期的行为和认知,这些均有待于进一步的研究。

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    2021-08-02 ms812711744394816

    吸入静脉都不行,没的用啦?

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1004717, encodeId=74a31004e1777, content=吸入静脉都不行,没的用啦?, beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201210/017ce76ad1014a7ab78fda1719777146/e1909743852a42449a457ef64bb5bfe8.jpg, createdBy=26641794232, createdName=ms812711744394816, createdTime=Mon Aug 02 18:33:37 CST 2021, time=2021-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=163275, encodeId=493b1632e589, content=好资料,学习下, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOgo3iaicb1Imgk1yIfnvr6oXzibcAFB6puAyNJXbzWhNuLqaFYBVRWjh7rghkvFLPxMAfD5ib3nXwVD/0, createdBy=bed21972958, createdName=wxl882001, createdTime=Fri Dec 16 13:02:39 CST 2016, time=2016-12-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=163243, encodeId=fda316324352, content=给孕妈妈们再加一重压力啦, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2d5a1812418, createdName=ms8253890721363845, createdTime=Fri Dec 16 12:04:14 CST 2016, time=2016-12-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=163239, encodeId=5012163239ea, content=棒棒哒???????, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=76491981781, createdName=1e184d7bm65(暂无匿称), createdTime=Fri Dec 16 11:45:28 CST 2016, time=2016-12-16, status=1, ipAttribution=)]
    2016-12-16 wxl882001

    好资料,学习下

    0

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    2016-12-16 ms8253890721363845

    给孕妈妈们再加一重压力啦

    0

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    2016-12-16 1e184d7bm65(暂无匿称)

    棒棒哒???????

    0

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