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JAMA:对于艰难梭菌感染——冷冻粪便菌群移植(FMT)不比新鲜FMT效果差

2016-01-13 崔倩 译 MedSci原创

艰难梭菌感染(CDI)是医疗保健和社区设置的主要负担。CDI复发是因为有限的治疗方案,与其相关的临床和感染控制问题尤其令人关注。粪便菌群移植(FMT)是一种很有前途的,但并没有应用的干预措施。原始出处:Christine H. Lee,Theodore Steiner,Elaine O. Petrof,et al.Frozen vs Fresh Fecal Microbiota Transplan

艰难梭菌感染(CDI)是医疗保健和社区设置的主要负担。CDI复发是因为有限的治疗方案,与其相关的临床和感染控制问题尤其令人关注。粪便菌群移植(FMT)是一种很有前途的,但并没有应用的干预措施。

该研究的目的是确定对于复发或难治的CDI患者,冷冻-解冻(冷冻,实验性的)FMT是否不劣于新鲜(标准的)FMT在临床方面的效果,以及评估这两种类型的FMT的安全性。

该随机、双盲、非劣效性试验招募了232例复发性或难治性CDI成人患者,该研究在2012年7月和2014年9月间在加拿大6个学术医疗中心进行。患者被随机分配灌肠法接受冷冻(n=114  )或新鲜(n= 118)的FMT。主要观察指标是在13周时不复发腹泻的临床效果和不良事件。非劣效性界限定在15%。

总共有219名患者(冷冻FMT组n=108,新鲜FMT组n=111)被纳入改良的意向性治疗(mITT)人群中,符合方案人群包括178例患者(冷冻FMT:n=91,新鲜的FMT:n=87)。在符合方案人群中,临床诊断治疗解决的患者为FMT冷冻组83.5%,新鲜FMT组85.1%(差异,-1.6%,[95%Cl,-10.5%至∞];对于非劣效性P=0.01)。在nITT人群中临床诊断治疗解决FMT冷冻组为75.0%,,新鲜FMT组为70.3%(差异,4.7%[95%Cl,-5.2%至∞];非劣效性P<0.001)。在两个治疗组之间的不利或严重不良事件的比例没有差异。

在成人复发性或难治性CDI患者中,与新鲜FMT相比,采用冷冻FMT并没有导致更坏的临床腹泻结果。由于提供冷冻FMT具有潜在优势,其用途在此设置中是一个合理的选择。

原始出处:


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    2018-07-29 owlhealth

    不错了,学习啦

    0

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    2016-01-14 yb6560
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    2016-01-14 Homburg
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