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多次粪菌移植治疗艰难梭菌感染更有效

发布日期:2018-06-13来源:热心肠日报发布人:梦缘徽州

原标题:随机临床试验:结肠镜粪菌移植加万古霉素治疗严重难治性艰难梭菌感染——单次对多次灌输

① 56名严重难治性艰难梭菌感染患者随机分为2组,1组接受单次结肠镜粪菌移植+万古霉素治疗(FMT-S),1组接受多次结肠镜粪菌移植+万古霉素治疗(FMT-M);

② FMT-M组的患者均至少接受2次粪菌移植,伪膜性结肠炎患者接受多次粪菌移植直至伪膜消失;

③ FMT-S组的治愈率为75%,FMT-M组的治愈率为100%,后者显著高于前者,2组均无严重不良事件发生;

④ 比起单次粪菌移植+万古霉素,多次粪菌移植+万古霉素在严重难治性艰难梭菌感染的治疗中更有效。

Randomised clinical trial: faecal microbiota transplantation by colonoscopy plus vancomycin for the treatment of severe refractory Clostridium difficile infection-single versus multiple infusions

DOI: 10.1111/apt.14816

Abstract:
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. Clinical-Trials.gov registration number: NCT03427229.

First Authors:
G Ianiro

Correspondence:
G Cammarota

All Authors:
G Ianiro,L Masucci,G Quaranta,C Simonelli,L R Lopetuso,M Sanguinetti,A Gasbarrini,G Cammarota

5/30/18Article