Randomised clinical trial: faecal microbiota transplantation by colonoscopy plus vancomycin for the treatment of severe refractory Clostridium difficile infection-single versus multiple infusions
Randomised clinical trial: faecal microbiota transplantation by colonoscopy plus vancomycin for the treatment of severe refractory Clostridium difficile infection-single versus multiple infusions
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DOI：
10.1111/apt.14816
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发表时间：
2018-07-01
影响因子：
7.6
通讯作者：
Cammarota, G.
中科院分区：
文献类型：
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作者：
Ianiro, G.;Masucci, L.;Cammarota, G.
背景：粪便微生物群移植（FMT）是一种针对复发性艰难梭菌感染的高效治疗方法。FMT在治疗抗生素难治的严重艰难梭菌感染中的疗效证据少得多。Aim：比较两种与万古霉素相关的基于FMT的方案在治愈抗生素难治的严重艰难梭菌感染受试者中的疗效。Methods：将抗生素难治的严重艰难梭菌感染受试者随机分配至以下两个治疗组之一：（1）FMT-S，包括通过结肠镜检查进行单次粪便输注，随后进行14天万古霉素疗程，（2）FMT-M，包括多次粪便输注加14天万古霉素疗程。在FMT-M组中，所有受试者均接受至少两次输注，而伪膜性结肠炎受试者接受进一步输注，直至伪膜消失。主要结果是治愈难治性严重艰难梭菌infection.Results：56例受试者，每个治疗组28例。FMT-S组和FMT-M组分别有21例和28例患者治愈（符合方案分析和意向治疗分析分别为75%和100%; P = 0.01）。没有严重的不良事件与任何两个治疗protocols observed.Conclusions：一个假膜驱动的FMT协议组成的多次粪便输液和伴随万古霉素是显着更有效的比一个单一的粪便移植，其次是万古霉素在治愈严重的艰难梭菌感染难治性抗生素。
Background: Faecal microbiota transplantation (FMT) is a highly effective treatment against recurrent Clostridium difficile infection. Far less evidence exists on the efficacy of FMT in treating severe Clostridium difficile infection refractory to antibiotics.Aim: To compare the efficacy of two FMT-based protocols associated with vancomycin in curing subjects with severe Clostridium difficile infection refractory to antibiotics.Methods: Subjects with severe Clostridium difficile infection refractory to antibiotics were randomly assigned to one of the two following treatment arms: (1) FMT-S, including a single faecal infusion via colonoscopy followed by a 14-day vancomycin course, (2) FMT-M, including multiple faecal infusions plus a 14-day vancomycin course. In the FMT-M group, all subjects received at least two infusions, while those with pseudomembranous colitis underwent further infusions until the disappearance of pseudomembranes. The primary outcome was the cure of refractory severe Clostridium difficile infection.Results: Fifty six subjects, 28 in each treatment arm, were enrolled. Twenty one patients in the FMT-S group and 28 patients in the FMT-M group were cured (75%vs 100%, respectively, both in per protocol and intention-to-treat analyses; P = 0.01). No serious adverse events associated with any of the two treatment protocols were observed.Conclusions: A pseudomembrane-driven FMT protocol consisting of multiple faecal infusions and concomitant vancomycin was significantly more effective than a single faecal transplant followed by vancomycin in curing severe Clostridium difficile infection refractory to antibiotics.