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含德拉马尼治疗方案在成人和儿童（≥6岁）耐药结核病患者中的“同情用药”

2020-03-23 MedSci原创 MedSci原创

耐药结核病德拉马尼
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大冢公司开展的“同情使用”（CU）计划于2014年启动，向治疗选择有限的MDR-TB患者提供德拉马尼。我们将呈现2014年2月1日至2019年2月28日期间入组患者的安全性和初

大冢公司开展的“同情使用”（CU）计划于2014年启动，向治疗选择有限的MDR-TB患者提供德拉马尼。我们将呈现2014年2月1日至2019年2月28日期间入组患者的安全性和初步疗效结果。
方法
纳入的患者为年龄≥6岁且体重>20公斤的MDR-TB患者。体重≥35kg的患者德拉马尼服用剂量为100 mg，每日两次（BID），体重在20-35公斤之间的患者则为50mg BID，作为联合治疗的一部分，与适当的联合方案联合治疗24周。
结果
共计199例患者开始启用含德拉马尼的治疗方案。 治疗伊始，患者平均年龄为35岁，38%（76/199）的患者是女性。31/199（16%）为儿童，其中9/31（29%）的儿童患者服用50 mg BID德拉马尼。122/199 (61%)的患者为广泛耐药结核病（XDR-TB），66/199（33%）合并HIV感染，平均CD4计数为289，105/199（53%）的患者同时接受德拉马尼和贝达喹啉治疗。截至2019年2月28日，155/199（78%）例患者完成德拉马尼的24周治疗。
78%（121/155）的患者启动德拉马尼治疗前痰培养阳性，其中96/121（79%）的患者在结束德拉马尼治疗时达到了痰培养阴转。89%（16/18）的儿童患者、77%（60/78）的XDR-TB患者，91%（39/43）合并HIV感染的患者实现了24周的痰培养阴转。
最常报告的AE为恶心、呕吐、和QTcF间期延长。55/199例患者报告了156例严重不良事件（SAE），包括18例死亡。34%的SAE与德拉马尼相关。在儿童组中，3例患者报告了8例SAE，其中1例患者发生5例SAE，均与德拉马尼相关。 德拉马尼治疗期间无患儿死亡。

 

结论
总体而言，CU项目中含德拉马尼的方案用于成人和儿童是有效的，且耐受性良好

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    2020-07-14 zhangjiqing

    #治疗方案#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1905128, encodeId=4c931905128e2, content=<a href='/topic/show?id=21f66464823' target=_blank style='color:#2F92EE;'>#治疗方案#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64648, encryptionId=21f66464823, topicName=治疗方案)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5ee4187, createdName=zhangjiqing, createdTime=Tue Jul 14 22:11:37 CST 2020, time=2020-07-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1746221, encodeId=3e4d1e46221dd, content=<a href='/topic/show?id=6b49e865466' target=_blank style='color:#2F92EE;'>#结核病患者#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=78654, encryptionId=6b49e865466, topicName=结核病患者)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=395f25, createdName=爆笑小医, createdTime=Wed Oct 28 10:11:37 CST 2020, time=2020-10-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1969833, encodeId=a9d0196983309, content=<a href='/topic/show?id=59ed5084328' target=_blank style='color:#2F92EE;'>#德拉马尼#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=50843, encryptionId=59ed5084328, topicName=德拉马尼)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=743d308, createdName=baoya, createdTime=Tue Sep 29 19:11:37 CST 2020, time=2020-09-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=381226, encodeId=805e381226b5, content=好棒, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200315/6c52e73f687745e5b92987fb63ac6545/路径.png, createdBy=fb822254669, createdName=Ahui, createdTime=Wed Apr 01 15:42:20 CST 2020, time=2020-04-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1254334, encodeId=df6d12543346e, content=<a href='/topic/show?id=f30ae86297d' target=_blank style='color:#2F92EE;'>#结核#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=78629, encryptionId=f30ae86297d, topicName=结核)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dfa37, createdName=huhuaidong387, createdTime=Wed Mar 25 00:11:37 CST 2020, time=2020-03-25, status=1, ipAttribution=)]
    2020-10-28 爆笑小医

    #结核病患者#

    0

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    2020-09-29 baoya

    #德拉马尼#

    0

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    2020-04-01 Ahui

    好棒

    0

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    2020-03-25 huhuaidong387

    #结核#

    0

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