Lancet infect dis:巴洛沙韦早期干预对流感并发症的预防效果

2020-06-22 医刀 MedSci原创

单剂量巴洛沙韦在改善高危门诊患者的流感症状方面具有优于安慰剂的疗效,与奥司他韦的疗效相当。巴洛沙韦的安全性和安慰剂的不相上下。

巴洛沙韦marboxil(以下称巴洛沙韦)是流感帽依赖性核酸内切酶的选择性抑制剂,已于2018年在美国和日本获准用于治疗12岁以上健康人群的单纯性流感。本研究旨在评估巴洛沙韦在具有高流感相关并发症风险的门诊患者中的疗效。

这是一个双盲的安慰剂和奥司他韦为对照的试验,在多个国家地区的551个地点招募12岁及以上的、具有临床诊断的流感样疾病(症状持续<48h)、并至少具有一个与流感相关的并发症的危险因素(如>65岁)的门诊患者。主要终点是在意向治疗人群中,流感症状得以改善的时间(TTIIS)。

2017年1月11日-2018年3月30日,共招募了2184位患者,随机分至巴洛沙韦组(730人)、安慰剂组(729人)或奥司他韦组(725人)。校正后的意向治疗人群共包含1163人:巴洛沙韦组 388人、安慰剂组 386人、奥司他韦组 389人。

在1163位患者中,557位(48%)患者为甲型H3N2流感,484位(42%)患者为乙型流感,80人(7%)为甲型H1N1流感,14位患者为混合感染,另外28位为未分型流感病毒感染。奥司他韦组的中位TTIIS为81.0h (95% CI 69.4~91.5),与巴洛沙韦组的7.7h(-7.9~22.7)存在明显差距。巴洛沙韦组不良反应发生率为25%,安慰剂组和奥司他韦组的分别是30%和28%。巴洛沙韦组报告了5例重度不良反应,安慰剂组和奥司他韦组分别有9例和8例;安慰剂组有1例高血压和1例恶心、奥司他韦组有2例转氨酶升高被认定为与治疗有关。携带Ile38Thr、Ile38Met或Ile38Asn突变的聚合酶酸性蛋白对巴洛沙韦的敏感性降低,在巴洛沙韦组的发生率为5%(15例)。

单剂量巴洛沙韦在改善高危门诊患者的流感症状方面具有优于安慰剂的疗效,与奥司他韦的疗效相当。巴洛沙韦的安全性和安慰剂的不相上下。本研究结果支持对有高流感并发症风险的患者进行早期治疗,以加快临床康复并减少并发症。

原始出处:

Michael G lson,et al. Early treatment with baloxavir marboxil in high-risk adolescent and adult outpatients with uncomplicated influenza (CAPSTONE-2): a randomised, placebo-controlled, phase 3 trial. The Lanct Infectious Disease. June 08,2020.

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    2021-06-06 howi
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    2021-01-09 zb1235672

    学习了

    0

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    2021-05-03 丁鹏鹏
  5. [GetPortalCommentsPageByObjectIdResponse(id=1830707, encodeId=6dd71830e07e6, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Sun Jun 06 15:45:51 CST 2021, time=2021-06-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2013406, encodeId=72ad201340660, content=<a href='/topic/show?id=7d69598468' target=_blank style='color:#2F92EE;'>#Dis#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5984, encryptionId=7d69598468, topicName=Dis)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c689267, createdName=cmj8wellington, createdTime=Thu Oct 15 15:45:51 CST 2020, time=2020-10-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=915069, encodeId=ff8b915069b0, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=59321624668, createdName=zb1235672, createdTime=Sat Jan 09 22:13:56 CST 2021, time=2021-01-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1758253, encodeId=b14f1e58253ab, content=<a href='/topic/show?id=84ba49031f9' target=_blank style='color:#2F92EE;'>#并发#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=49031, encryptionId=84ba49031f9, topicName=并发)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a27e37327108, createdName=丁鹏鹏, createdTime=Mon May 03 16:45:51 CST 2021, time=2021-05-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1668670, encodeId=15b416686e0b5, content=<a href='/topic/show?id=4929593e57f' target=_blank style='color:#2F92EE;'>#早期干预#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59375, encryptionId=4929593e57f, topicName=早期干预)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=7ab126374998, createdName=gao_jian4226, createdTime=Mon Jul 13 15:45:51 CST 2020, time=2020-07-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=799405, encodeId=45c4e99405bf, content=<a href='/topic/show?id=021b65306fb' target=_blank style='color:#2F92EE;'>#流感#</a>一粒药搞定, beContent=null, objectType=article, channel=null, level=null, likeNumber=431, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=65306, encryptionId=021b65306fb, topicName=流感)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=lovetcm, createdTime=Mon Jun 22 20:26:08 CST 2020, time=2020-06-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1033851, encodeId=769f1033851aa, content=顶刊就是不一样,质量很高,内容精彩!学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=goodbing, createdTime=Mon Jun 22 17:45:51 CST 2020, time=2020-06-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1047089, encodeId=85cb104e089fc, content=疗效只是效果的众多方面之一,还要看对患者的获益,包括生活质量等因素共同决定效果的, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=CHANGE, createdTime=Mon Jun 22 17:45:51 CST 2020, time=2020-06-22, status=1, ipAttribution=)]
  6. [GetPortalCommentsPageByObjectIdResponse(id=1830707, encodeId=6dd71830e07e6, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Sun Jun 06 15:45:51 CST 2021, time=2021-06-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2013406, encodeId=72ad201340660, content=<a href='/topic/show?id=7d69598468' target=_blank style='color:#2F92EE;'>#Dis#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5984, encryptionId=7d69598468, topicName=Dis)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c689267, createdName=cmj8wellington, createdTime=Thu Oct 15 15:45:51 CST 2020, time=2020-10-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=915069, encodeId=ff8b915069b0, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=59321624668, createdName=zb1235672, createdTime=Sat Jan 09 22:13:56 CST 2021, time=2021-01-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1758253, encodeId=b14f1e58253ab, content=<a href='/topic/show?id=84ba49031f9' target=_blank style='color:#2F92EE;'>#并发#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=49031, encryptionId=84ba49031f9, topicName=并发)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a27e37327108, createdName=丁鹏鹏, createdTime=Mon May 03 16:45:51 CST 2021, time=2021-05-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1668670, encodeId=15b416686e0b5, content=<a href='/topic/show?id=4929593e57f' target=_blank style='color:#2F92EE;'>#早期干预#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59375, encryptionId=4929593e57f, topicName=早期干预)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=7ab126374998, createdName=gao_jian4226, createdTime=Mon Jul 13 15:45:51 CST 2020, time=2020-07-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=799405, encodeId=45c4e99405bf, content=<a href='/topic/show?id=021b65306fb' target=_blank style='color:#2F92EE;'>#流感#</a>一粒药搞定, beContent=null, objectType=article, channel=null, level=null, likeNumber=431, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=65306, encryptionId=021b65306fb, topicName=流感)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=lovetcm, createdTime=Mon Jun 22 20:26:08 CST 2020, time=2020-06-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1033851, encodeId=769f1033851aa, content=顶刊就是不一样,质量很高,内容精彩!学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=goodbing, createdTime=Mon Jun 22 17:45:51 CST 2020, time=2020-06-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1047089, encodeId=85cb104e089fc, content=疗效只是效果的众多方面之一,还要看对患者的获益,包括生活质量等因素共同决定效果的, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=CHANGE, createdTime=Mon Jun 22 17:45:51 CST 2020, time=2020-06-22, status=1, ipAttribution=)]
    2020-06-22 lovetcm

    #流感#一粒药搞定

    0

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    2020-06-22 goodbing

    顶刊就是不一样,质量很高,内容精彩!学到很多

    0

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    2020-06-22 CHANGE

    疗效只是效果的众多方面之一,还要看对患者的获益,包括生活质量等因素共同决定效果的

    0

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早在1月初,武汉及其周边地区已经存在SARS-CoV-2社区传播。

美疾控中心:美国有些流感死亡病例可能实为新冠肺炎病例

美国疾病控制和预防中心主任罗伯特·雷德菲尔德11日说,美国存在新冠肺炎死亡病例被误认为是流感死亡病例的情况。

JAMA:美国社区流行的轻度流感样病人中,或有5%是新冠肺炎患者

目前,SARS-CoV-2的检测依旧只能通过公共卫生实验室进行,而且这些有限的检测资源也是优先用于有明显症状或较高患病风险的人群,例如前往疫区旅行的人。因此,有轻度疾病和没有危险因素的人的社区传播发病

打了流感疫苗,为什么还是会感染?

流感病毒主要通过打喷嚏、咳嗽和说话产生的飞沫实现从人到人的传播。

npj Vaccines: 通用流感疫苗前进一大步,人体病毒攻击临床试验取得积极结果

近日,来自NIAID的研究人员公布了一项候选通用流感疫苗FLU-v在人体病毒攻击IIb期临床试验结果