Lancet Neurol:Patisiran治疗遗传性转甲状腺素蛋白淀粉样变性长期效果及安全性研究

2020-11-17 MedSci原创 MedSci原创

在为期12个月的长期研究中,遗传性转甲状腺素蛋白淀粉样变性患者接受Patisiran治疗后可维持临床改善,且安全性良好

遗传性转甲状腺素蛋白淀粉样变性是一种罕见的、遗传性、进行性疾病,由转甲素(TTR)基因突变引起。Patisiran是一种可抑制TTR产生的RNA干扰疗法,具有潜在的遗传性转甲状腺素蛋白淀粉样变性伴多发性神经病治疗作用。近日研究人员评估了Patisiran长期治疗的安全性和有效性。
 
OLE(III期)试验在19个国家的43家医院或临床中心开展,先前完成了APOLLO(III期)或OLE(II期)研究并耐受Patisiran治疗的患者参与,每3周静脉注射Patisiran 0.3 mg/kg,并计划持续5年。研究的疗效评估包括多发性神经病得分(改良神经病变损害评分+7[mNIS+7])、生活质量、自主神经症状、营养状况、残疾、行走状态、运动功能和心脏应激。
 
在2018年9月24日的数据截止时,来自APOLLO-Patisiran组的137名患者中有126名(92%)、来自APOLLO-安慰剂组49名患者中有38名(78%)以及II期OLEL-Patisiran组的全部25名(100%)完成了12个月的评估。患者在使用Patisiran治疗后,mNIS+7的改善得以持续(APOLLO-Patisiran组平均变化-4.0; II期OLE-patisiran组平均变化为-4.7)。总体而言,211名患者中有204名(97%)报告了不良事件,82名(39%)报告了严重不良事件,23名(11%)死亡。APOLLO-安慰剂组的严重不良事件率为57%,而APOLLO-Patisiran组为35%,而II期OLEL-Patisiran组为24%。最常见的治疗相关不良事件是轻中度输液相关反应。APOLLO-安慰剂组死亡率为27%,而APOLLO-Patisiran组仅为7%,II期OLE-Patisiran组无患者死亡。
 
在为期12个月的长期研究中,遗传性转甲状腺素蛋白淀粉样变性患者接受Patisiran治疗后可维持临床改善,且安全性良好。
 
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    2021-06-05 howi
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    2021-05-26 yinhl1978
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    2021-01-12 ms1000001802106630

    受教了

    0

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2020, time=2020-11-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=900322, encodeId=0832900322d8, content=学习了,谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7c592194322, createdName=1209e435m98(暂无昵称), createdTime=Wed Nov 18 23:28:40 CST 2020, time=2020-11-18, status=1, ipAttribution=)]
  8. 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2020, time=2020-11-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=900322, encodeId=0832900322d8, content=学习了,谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7c592194322, createdName=1209e435m98(暂无昵称), createdTime=Wed Nov 18 23:28:40 CST 2020, time=2020-11-18, status=1, ipAttribution=)]
    2020-11-19 huangdf
  9. 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  10. 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2020, time=2020-11-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=900322, encodeId=0832900322d8, content=学习了,谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7c592194322, createdName=1209e435m98(暂无昵称), createdTime=Wed Nov 18 23:28:40 CST 2020, time=2020-11-18, status=1, ipAttribution=)]
    2020-11-18 1209e435m98(暂无昵称)

    学习了,谢谢分享

    0

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