广大偏头痛患者的福利——新型药物加兰珠单抗带来希望!

2021-04-22 MedSci原创 MedSci原创

本研究表明,加兰珠单抗对发作性偏头痛或慢性偏头痛的患者是安全有效的。

偏头痛(Migraine)是一种出现反复轻度或重度头痛的慢性疾病,通常伴有各种自主神经系统症状。通常这种头痛为单侧性质(仅涉及一侧头部),并伴有搏动,可持续2-72小时。相关症状可能包括恶心、呕吐、对光线更加敏感、对声音更加敏感,且肢体活动会加重疼痛的感觉。

其中,三分之一的偏头痛患者均能感到病症先兆:短暂的视觉、感觉、语言或肢体障碍都意味着头痛即将发作,被称为先兆性偏头痛。而更多的患者主要为无先兆性。

目前,普遍认为偏头痛的病因是环境因素和遗传因素的综合作用所致。其中,近7成患者都有遗传因素的原因。同时,激素水平的波动也可能是一个因素:在青春期之前,受到偏头痛影响的男童比女童要稍多;但在此之后,受到偏头痛影响的女性则比男性要多出两至三倍。同时,通常在怀孕期间,偏头痛的影响会减弱。

尽管目前有治疗偏头痛的预防性药物可用于减少偏头痛发作的频率,但许多患者对这些治疗没有反应或无法忍受。一项回顾法国、德国、日本和美国偏头痛患者治疗的研究表明,43%的偏头痛预防性药物治疗患者有药物失败或更换药物的病史。

基础研究发现,降钙素基因相关肽(CGRP)的物质已显示出可通过扩大大脑中的血管而参与偏头痛的发生。为此,礼来公司研发了CGRP抑制剂相关药物加兰珠单抗Galcanezumab用于治疗偏头痛。近期,荷兰奈梅亨医院的神经病学专家对该药疗效进行了全面的研究、报道。

CONQUER是一项多中心、随机、双盲、安慰剂对照的3b期试验,在12个国家(比利时、加拿大、捷克、法国、德国、匈牙利、日本、荷兰、韩国、西班牙、英国和美国)的64个医院、诊所或研究中心进行。纳入年龄在18-75岁之间、患有阵发性或慢性偏头痛的患者。所有偏头痛发病年龄在50岁之前,且有记录的预防性药物治疗失败史。

患者按1:1的比例随机接受皮下注射安慰剂或加兰珠单抗(每月120mg,为期3个月)。通过互动式网络回复系统,对偏头痛频率分层。主要终点是所有被随机分配并接受至少一剂研究药物的患者,在3个月的治疗期间,每月偏头痛天数从基线的总体平均变化。

在2018.09.10-2019.03.12期间,462名患有发作性(269[58%])或慢性(193[42%])偏头痛的参与者被随机分配并接受至少一次注射安慰剂(n=230)或加兰珠单抗(n=232)。总的来说,加兰珠单抗治疗的患者在1-3个月内的偏头痛天数与安慰剂相比有明显的减少。

与基线相比,加兰珠单抗组每月偏头痛天数平均减少4.1天,而安慰剂组比基线平均减少1.0天(组间差异-3.1[95%CI:-3.9~-2.3])。加兰珠单抗和安慰剂的治疗突发不良事件的类型和数量相似。安慰剂组与加兰珠单抗组分别有53%、51%的患者报告了治疗突发的不良事件。

综上,本研究表明,加兰珠单抗对发作性偏头痛或慢性偏头痛的患者是安全有效的。

 

参考文献:

Safety and efficacy of galcanezumab in patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER): a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial. https://doi.org/10.1016/S1474-4422(20)30279-9

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    2021-04-23 ZJYYY7

    加拦珠单抗

    0

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    2021-04-23 ZJYYY7

    !可以可以

    0

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    2021-04-23 ZJYYY7

    好东西 鞋习

    0

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    2021-04-23 12186752m54暂无昵称

    学习

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1486366, encodeId=134a14863664d, content=<a href='/topic/show?id=865a582869a' target=_blank style='color:#2F92EE;'>#新型药物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58286, encryptionId=865a582869a, topicName=新型药物)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fca58121482, createdName=ms1260584454294838, createdTime=Sat Apr 24 13:18:37 CST 2021, time=2021-04-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=959715, encodeId=ad58959e15fb, content=加拦珠单抗, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201214/b3170121d995432ea306ae3a7809cc05/2cfb236f361b4d3c80ef8fdef4301832.jpg, createdBy=8ad35400531, createdName=ZJYYY7, createdTime=Fri Apr 23 10:33:45 CST 2021, time=2021-04-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=959714, encodeId=9141959e1422, content=!可以可以, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201214/b3170121d995432ea306ae3a7809cc05/2cfb236f361b4d3c80ef8fdef4301832.jpg, createdBy=8ad35400531, createdName=ZJYYY7, createdTime=Fri Apr 23 10:33:20 CST 2021, time=2021-04-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=959713, encodeId=9f1d959e135c, content=好东西 鞋习, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201214/b3170121d995432ea306ae3a7809cc05/2cfb236f361b4d3c80ef8fdef4301832.jpg, createdBy=8ad35400531, createdName=ZJYYY7, createdTime=Fri Apr 23 10:33:04 CST 2021, time=2021-04-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=959653, encodeId=697f95965383, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210319/11a5cd980a9d460da3309d2f9b731d89/6bc10897e4c7451ab7a1b02b57b06c50.jpg, createdBy=9c9c2261743, createdName=12186752m54暂无昵称, createdTime=Fri Apr 23 06:51:45 CST 2021, time=2021-04-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=959603, encodeId=4f7895960349, content=学习了,谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7c592194322, createdName=1209e435m98(暂无昵称), createdTime=Thu Apr 22 22:33:01 CST 2021, time=2021-04-22, status=1, ipAttribution=)]
    2021-04-22 1209e435m98(暂无昵称)

    学习了,谢谢分享

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