JAMA:难治性紧迫性尿失禁——A型肉毒杆菌毒素OR骶神经调节?

2016-10-05 MedSci MedSci原创

关于难治性紧迫性尿失禁女性的治疗缺乏骶神经调节与A型肉毒杆菌毒素治疗对比的研究。本研究旨在对比A型肉毒杆菌毒素与骶神经调节的效果。 采用多中心开放标签随机试验研究设计,2012年2月至2015年1月在美国9个医疗中心进行,涉及381名难治性急迫性尿失禁的女性。分别接受膀胱逼尿肌内注射200 UA型肉毒杆菌毒素(n= 192)或骶神经调节(n=189 )。 主要研究结果为基线时期至治疗6

关于难治性紧迫性尿失禁女性的治疗缺乏骶神经调节与A型肉毒杆菌毒素治疗对比的研究。本研究旨在对比A型肉毒杆菌毒素与骶神经调节的效果。

采用多中心开放标签随机试验研究设计,2012年2月至2015年1月在美国9个医疗中心进行,涉及381名难治性急迫性尿失禁的女性。分别接受膀胱逼尿肌内注射200 UA型肉毒杆菌毒素(n= 192)或骶神经调节(n=189 )。

主要研究结果为基线时期至治疗6个月患者每日急迫性尿失禁发生次数的变化。次要终点包括膀胱过度活动症问卷简表(SF)的得分变化,膀胱过度活动症满意度问卷,以及不良事件的发生。

研究共纳入364名女性(平均[SD]年龄,63[11.6]岁),A型肉毒杆菌毒素组(190名)女性治疗后6个月内每天紧迫性尿失禁发作的次数较骶神经电刺激组(174名)明显降低(-3.9 vs−3.3次/天;平均差,0.63;95% CI,0.13-1.14;P = 0.01)。


与骶神经调节治疗相比,A型肉毒杆菌毒素组参与者膀胱过度活动症症状问卷SF的改善程度较大(−46.7 vs−38.6;平均差,8.1;95% CI,3-13.3;P = 0.002);治疗满意度的改善也较大(67.7 vs 59.8;平均差,7.8;95% CI,1.6-14.1;P =0.01)和治疗认可度较大(78.1 vs 67.6;平均差;10.4,95% CI,4.3-16.5;P<0.001)。

在舒适度(67.6 vs 70.2;平均差,−2.5;95% CI,−8.1~3;P =0.36),不良反应(88.4 vs 85.1;平均差,3.3;95% CI,−1.9~8.5;P =0.22),与治疗偏好(92% VS 89%;风险差异,−3%;95% CI,−16%~10%;P = 0.49)上两组并无明显差异。

A型肉毒杆菌毒素组尿路感染的发生率较骶神经调节组高(35% vs 11%;风险差异,−23%;95% CI,−33%~13%;P< 0.001)。A型肉毒杆菌毒素治疗第1个月和第6个月需要自我导尿的患者比例分别为8%和2%。神经调节装置修复和移除的发生率为3%。

总而言之,难治性紧迫性尿失禁的女性中,与骶神经调节治疗相比,A型肉毒杆菌毒素治疗患者每日紧迫性尿失禁发作的次数较少,虽然具有统计学意义但是临床意义并不确定。此外,A型肉毒杆菌毒素治疗的泌尿道感染风险较高,且需要暂时自我导尿。

原始出处:

Cindy L. Amundsen, et al., OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in WomenA Randomized Clinical Trial
. JAMA. 2016;316(13):1366-1374. doi:10.1001/jama.2016.14617.
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  5. 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topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=90f31612316, createdName=xiaotaiyang1, createdTime=Thu Oct 06 16:55:43 CST 2016, time=2016-10-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=140932, encodeId=86c414093268, content=可以一试!, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20161003/IMG57F1CE4724D2E2574.jpg, createdBy=c2eb1960303, createdName=drmike, createdTime=Thu Oct 06 13:02:23 CST 2016, time=2016-10-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=140931, encodeId=d5561409318c, content=A型肉毒杆菌毒素治疗的泌尿道感染风险较高!!, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20161003/IMG57F1CE4724D2E2574.jpg, createdBy=c2eb1960303, createdName=drmike, createdTime=Thu Oct 06 13:02:01 CST 2016, time=2016-10-06, status=1, ipAttribution=)]
    2016-10-07 freve
  6. 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  7. 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createdAvatar=http://cacheapi.medsci.cn/resource/upload/20161003/IMG57F1CE4724D2E2574.jpg, createdBy=c2eb1960303, createdName=drmike, createdTime=Thu Oct 06 13:02:01 CST 2016, time=2016-10-06, status=1, ipAttribution=)]
    2016-10-06 忠诚向上

    好好学习

    0

  8. 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topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=90f31612316, createdName=xiaotaiyang1, createdTime=Thu Oct 06 16:55:43 CST 2016, time=2016-10-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=140932, encodeId=86c414093268, content=可以一试!, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20161003/IMG57F1CE4724D2E2574.jpg, createdBy=c2eb1960303, createdName=drmike, createdTime=Thu Oct 06 13:02:23 CST 2016, time=2016-10-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=140931, encodeId=d5561409318c, content=A型肉毒杆菌毒素治疗的泌尿道感染风险较高!!, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20161003/IMG57F1CE4724D2E2574.jpg, createdBy=c2eb1960303, createdName=drmike, createdTime=Thu Oct 06 13:02:01 CST 2016, time=2016-10-06, status=1, ipAttribution=)]
    2016-10-06 xiaotaiyang1

    了解一下

    0

  9. 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topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=90f31612316, createdName=xiaotaiyang1, createdTime=Thu Oct 06 16:55:43 CST 2016, time=2016-10-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=140932, encodeId=86c414093268, content=可以一试!, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20161003/IMG57F1CE4724D2E2574.jpg, createdBy=c2eb1960303, createdName=drmike, createdTime=Thu Oct 06 13:02:23 CST 2016, time=2016-10-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=140931, encodeId=d5561409318c, content=A型肉毒杆菌毒素治疗的泌尿道感染风险较高!!, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20161003/IMG57F1CE4724D2E2574.jpg, createdBy=c2eb1960303, createdName=drmike, createdTime=Thu Oct 06 13:02:01 CST 2016, time=2016-10-06, status=1, ipAttribution=)]
    2016-10-06 drmike

    可以一试!

    0

  10. 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createdAvatar=http://cacheapi.medsci.cn/resource/upload/20161003/IMG57F1CE4724D2E2574.jpg, createdBy=c2eb1960303, createdName=drmike, createdTime=Thu Oct 06 13:02:01 CST 2016, time=2016-10-06, status=1, ipAttribution=)]
    2016-10-06 drmike

    A型肉毒杆菌毒素治疗的泌尿道感染风险较高!!

    0

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