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JAMA:促红细胞生成素治疗不能改善极度早产儿的神经发育状况

2016-05-18 崔倩 译 MedSci原创

极度早产儿有早产儿脑病和长期神经发育延迟的危险。促红细胞生成素治疗是在动物实验和人体临床研究中具有神经保护作用。原始出处:Giancarlo Natalucci,Beatrice Latal,Brigitte Koller,et al.Effect of Early Prophylactic High-Dose Recombinant Human Erythropoietin in Very Pr

极度早产儿有早产儿脑病和长期神经发育延迟的危险。促红细胞生成素治疗是在动物实验和人体临床研究中具有神经保护作用。

该研究的目的是确定在2年矫正年龄时,早产儿早期预防性应用大剂量重组人促红细胞生成素(rhEPO)是否能改善神经发育结局。

来自瑞士的研究人员招募了在妊娠期26周0天和31周6天出生的极度早产儿,在瑞士进行了一项随机、双盲、安慰剂对照试验,于2005年和2012年完成。神经发育评估在2014年完成。

受试者被随机分配接受rhEPO(3000IU/kg)或安慰剂(生理盐水,0.9%),3小时以内静脉注射,在出生后12至18小时,36至42小时进行。

主要成果是认知发展,在2年矫正年龄时通过贝利婴幼儿发展量表第二版(BSID-II)智力发育指数评价(MDI;标准,100[SD,15],数值越大表明有更好的功能)。组之间的最小临床差异是5分(0.3 SD)。次要终点是运动发展(通过运动发育指数评估),脑瘫,听力或视力障碍,和人体生长参数。

在随机分配的448名早产儿组(平均胎龄,29.0周[范围:26.0-30.9];264名[59%]为女孩;平均出生体重1210克[范围:490-2290]),228名被随机分配接受rhEPO,220名接受安慰剂。在平均年龄23.6个月时365(81%)名婴儿的神经发育结果的数据可用。在意向处理分析中,平均MDI在rhEPO组(93.5[SD16.0] [95%CI,91.2至95.8])和安慰剂组(94.5[SD 17.8]之间无统计学显著差异 [95 %CI,90.8至98.5])(差异,-1.0[95%CI,-4.5至2.5]; P=0.56)。组间的次要终点没有差异。

在接受预防性早期大剂量rhEP神经保护的极度早产儿中,与接受安慰剂的婴儿相比,在2年时的神经发育结局无统计学显著差异。后续的认知和身体的问题,可能直到以后的生活需要才会变得明显。

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  6. [GetPortalCommentsPageByObjectIdResponse(id=1985391, encodeId=301e19853910f, content=<a href='/topic/show?id=6597e717313' target=_blank style='color:#2F92EE;'>#红细胞生成素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77173, encryptionId=6597e717313, topicName=红细胞生成素)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/qXbLjJB4FSzhQS3C5qQFMJkqicRIJFL6zHFwwhv0I95nzA6xicevQcEica0gk4A58UkbMMriadAgTY2b7N7Yd0ZsQg/132, createdBy=910c2500152, createdName=HinsMax, createdTime=Thu Dec 29 02:52:00 CST 2016, time=2016-12-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2019404, encodeId=416d20194040e, content=<a href='/topic/show?id=87756168030' target=_blank style='color:#2F92EE;'>#极度早产儿#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=61680, encryptionId=87756168030, topicName=极度早产儿)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Jr8S1dfvNyP22t32IFDXJXnpd5AGlDibiajL5cl3pxj7OPCeAeibLhzOmZn5Q2Oicc6uKOCnxGNOggdLtI3hIW7huQ/132, createdBy=66e52500008, createdName=Tamikia, createdTime=Sat Oct 22 10:52:00 CST 2016, time=2016-10-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2030584, encodeId=fa382030584d9, content=<a href='/topic/show?id=bb752e110f9' target=_blank style='color:#2F92EE;'>#促红细胞生成素治疗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=27110, encryptionId=bb752e110f9, topicName=促红细胞生成素治疗)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/vLodSSFTQLpHtfwJicWJibSWH7pbiauxvpCMvQIv0N9Oes8vHkDkCIW2HNDkt7icUq3RCZiaDcHR9Rap17fFySRbiaFg/132, createdBy=9f202500205, createdName=ms3297076796458174, createdTime=Fri Feb 03 01:52:00 CST 2017, time=2017-02-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1281934, encodeId=fddf128193466, content=<a href='/topic/show?id=3dece71531e' target=_blank style='color:#2F92EE;'>#红细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77153, encryptionId=3dece71531e, topicName=红细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c22f171, createdName=kord1982, createdTime=Thu May 19 23:52:00 CST 2016, time=2016-05-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1345598, encodeId=3e56134559890, content=<a href='/topic/show?id=37c9e4238b9' target=_blank style='color:#2F92EE;'>#神经发育#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=74238, encryptionId=37c9e4238b9, topicName=神经发育)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d7532500500, createdName=12499e01m47暂无昵称, createdTime=Thu May 19 23:52:00 CST 2016, time=2016-05-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1347097, encodeId=2a30134e097aa, content=<a href='/topic/show?id=88713e938c1' target=_blank style='color:#2F92EE;'>#发育#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=37938, encryptionId=88713e938c1, topicName=发育)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f4c124, createdName=neurowu, createdTime=Thu May 19 23:52:00 CST 2016, time=2016-05-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1419942, encodeId=ad42141994225, content=<a href='/topic/show?id=c7d9e716941' target=_blank style='color:#2F92EE;'>#红细胞生成#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77169, encryptionId=c7d9e716941, topicName=红细胞生成)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=489d3549369, createdName=许安, createdTime=Thu May 19 23:52:00 CST 2016, time=2016-05-19, status=1, ipAttribution=)]
    2016-05-19 neurowu
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