NEJM:麻疹疫苗采用皮下注射方式更优

2015-04-20 姜英浩译 MedSci原创

麻疹在目前仍然具有很高的发病率和死亡率,而雾化吸入式疫苗可以作为一种无须注射的麻疹免疫手段。现有的报道中,关于麻疹雾化吸入式疫苗对儿童的免疫能力产生的数据不够统一,因此在2015年4月16日新英格兰医学杂志上在线发表的一篇论文中,研究人员进行了一项临床研究对其进行验证。 在这项开放式非劣效性试验中,作者纳入了印度的9.0~11.9个月的,符合接受了首剂量的麻疹疫苗条件的儿童。将这些儿童随

麻疹在目前仍然具有很高的发病率和死亡率,而雾化吸入式疫苗可以作为一种无须注射的麻疹免疫手段。现有的报道中,关于麻疹雾化吸入式疫苗对儿童的免疫能力产生的数据不够统一,因此在2015416日新英格兰医学杂志上在线发表的一篇论文中,研究人员进行了一项临床研究对其进行验证。

在这项开放式非劣效性试验中,作者纳入了印度的9.0~11.9个月的,符合接受了首剂量的麻疹疫苗条件的儿童。将这些儿童随机分配至雾化吸入组及皮下注射组。主要评估指标为免疫91天后受试者抗麻疹抗体的血清阳性水平以及不良反应的出现情况。非劣效性边际为5 %

共有1001例儿童被分至雾化疫苗组,1003例被分至皮下注射组。免疫91天后,仍有1956名(97.6 %)儿童被跟踪随访,但331名儿童的结果由于标本解冻从而数据丢失。在方案数据分析人群中,1560例儿童(77.8 %)的数据是可以进行评估的。在第91天时,雾化组共有662例(85.4%; 95% confidence interval [CI], 82.5 to 88.0)、皮下注射组743例(94.6%; 95% CI, 92.7 to 96.1)为血清阳性,差异为-9.2 %95% CI, −12.2 to −6.3)。在全分析集中,得到的结果也类似(雾化组673/788 [85.4%];皮下注射组754/96 [94.7%]在第91天血清阳性, 差异−9.3 % [95% CI, −12.3 to −6.4])。未发生由于疫苗免疫而造成的严重不良反应。

因此作者得出结论,雾化吸入式麻疹疫苗能够产生致免疫力,但以血清阳性产生率为指标时,在预设的边际下,雾化吸入式免疫方法不优于常规的皮下注射免疫。

原文出处:

Nicola Low, Ashish Bavdekar, Lakshmanan Jeyaseelan, et al. A Randomized, Controlled Trial of an Aerosolized Vaccine against Measles. NEJM. 2015.4.16.

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  1. [GetPortalCommentsPageByObjectIdResponse(id=1355551, encodeId=671c13555515f, content=<a href='/topic/show?id=0ff310302082' target=_blank style='color:#2F92EE;'>#麻疹#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103020, encryptionId=0ff310302082, topicName=麻疹)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Wed Apr 22 06:36:00 CST 2015, time=2015-04-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1372222, encodeId=427a13e22226b, content=<a href='/topic/show?id=1a6de1930e8' target=_blank style='color:#2F92EE;'>#皮下注射#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=71930, encryptionId=1a6de1930e8, topicName=皮下注射)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c838337, createdName=zhlpower, createdTime=Wed Apr 22 06:36:00 CST 2015, time=2015-04-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=21498, encodeId=0f9f2149803, content=有用, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=cspcsp, createdTime=Mon Apr 20 22:55:00 CST 2015, time=2015-04-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=21466, encodeId=083d2146698, content=雾化吸入效果也不错啊。不一定要注射, beContent=null, objectType=article, channel=null, level=null, likeNumber=85, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=58.33.143.**, createdTime=Mon Apr 20 21:17:00 CST 2015, time=2015-04-20, status=1, ipAttribution=)]
    2015-04-22 zhaojie88
  2. [GetPortalCommentsPageByObjectIdResponse(id=1355551, encodeId=671c13555515f, content=<a href='/topic/show?id=0ff310302082' target=_blank style='color:#2F92EE;'>#麻疹#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103020, encryptionId=0ff310302082, topicName=麻疹)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Wed Apr 22 06:36:00 CST 2015, time=2015-04-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1372222, encodeId=427a13e22226b, content=<a href='/topic/show?id=1a6de1930e8' target=_blank style='color:#2F92EE;'>#皮下注射#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=71930, encryptionId=1a6de1930e8, topicName=皮下注射)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c838337, createdName=zhlpower, createdTime=Wed Apr 22 06:36:00 CST 2015, time=2015-04-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=21498, encodeId=0f9f2149803, content=有用, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=cspcsp, createdTime=Mon Apr 20 22:55:00 CST 2015, time=2015-04-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=21466, encodeId=083d2146698, content=雾化吸入效果也不错啊。不一定要注射, beContent=null, objectType=article, channel=null, level=null, likeNumber=85, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=58.33.143.**, createdTime=Mon Apr 20 21:17:00 CST 2015, time=2015-04-20, status=1, ipAttribution=)]
  3. [GetPortalCommentsPageByObjectIdResponse(id=1355551, encodeId=671c13555515f, content=<a href='/topic/show?id=0ff310302082' target=_blank style='color:#2F92EE;'>#麻疹#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103020, encryptionId=0ff310302082, topicName=麻疹)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Wed Apr 22 06:36:00 CST 2015, time=2015-04-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1372222, encodeId=427a13e22226b, content=<a href='/topic/show?id=1a6de1930e8' target=_blank style='color:#2F92EE;'>#皮下注射#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=71930, encryptionId=1a6de1930e8, topicName=皮下注射)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c838337, createdName=zhlpower, createdTime=Wed Apr 22 06:36:00 CST 2015, time=2015-04-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=21498, encodeId=0f9f2149803, content=有用, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=cspcsp, createdTime=Mon Apr 20 22:55:00 CST 2015, time=2015-04-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=21466, encodeId=083d2146698, content=雾化吸入效果也不错啊。不一定要注射, beContent=null, objectType=article, channel=null, level=null, likeNumber=85, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=58.33.143.**, createdTime=Mon Apr 20 21:17:00 CST 2015, time=2015-04-20, status=1, ipAttribution=)]
    2015-04-20 cspcsp

    有用

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1355551, encodeId=671c13555515f, content=<a href='/topic/show?id=0ff310302082' target=_blank style='color:#2F92EE;'>#麻疹#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103020, encryptionId=0ff310302082, topicName=麻疹)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Wed Apr 22 06:36:00 CST 2015, time=2015-04-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1372222, encodeId=427a13e22226b, content=<a href='/topic/show?id=1a6de1930e8' target=_blank style='color:#2F92EE;'>#皮下注射#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=71930, encryptionId=1a6de1930e8, topicName=皮下注射)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c838337, createdName=zhlpower, createdTime=Wed Apr 22 06:36:00 CST 2015, time=2015-04-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=21498, encodeId=0f9f2149803, content=有用, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=cspcsp, createdTime=Mon Apr 20 22:55:00 CST 2015, time=2015-04-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=21466, encodeId=083d2146698, content=雾化吸入效果也不错啊。不一定要注射, beContent=null, objectType=article, channel=null, level=null, likeNumber=85, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=58.33.143.**, createdTime=Mon Apr 20 21:17:00 CST 2015, time=2015-04-20, status=1, ipAttribution=)]
    2015-04-20 58.33.143.**

    雾化吸入效果也不错啊。不一定要注射

    0