新英格兰医学杂志2014-01-10 12:19 AM

Duodenal Infusion of Donor Feces for Recurrent Clostridium difficile 十二指肠注入供体粪便用以治疗复发性难辨梭状芽孢杆菌感染

Abstract Background Recurrent Clostridium difficile infection is difficult to treat, and failure rates for antibiotic therapy are high. We studied the effect of duodenal infusion of donor feces in patients with recurrent C. difficile infection. 背景 复发性难辨梭状芽孢杆菌感染很难治疗,而且抗生素治疗的失败率很高。 我们研究了为患者进行十二指肠注射供体粪便来治疗复发性难辨梭状芽孢杆菌感染的效果。 Methods We randomly assigned patients to receive one of three therapies: an initial vancomycin regimen (500 mg orally four times per day for 4 days), followed by bowel lavage and subsequent infusion of a solution of donor feces through a nasoduodenal tube; a standard vancomycin regimen (500 mg orally four times per day for 14 days); or a standard vancomycin regimen with bowel lavage. The primary end point was the resolution of diarrhea associated with C. difficile infection without relapse after 10 weeks. 方法 我们随机给病患分配下面三种治疗方法中的一种:开始进行万古霉素治疗(每天口服4次,每次500毫克,共服用4天),接着进行肠灌洗并随后通过一个十二指肠管输入供体粪便溶液;标准的万古霉素治疗方案(每天四次,每次500毫升,共14天);或者是一个标准的万古霉素加灌洗肠方案。 主要结点是伴随复发性难辨梭状芽孢杆菌感染的腹泻的治愈并在10周后没有复发。 Results The study was stopped after an interim analysis. Of 16 patients in the infusion group, 13 (81%) had resolution of C. difficile–associated diarrhea after the first infusion. The 3 remaining patients received a second infusion with feces from a different donor, with resolution in 2 patients. Resolution of C. difficile infection occurred in 4 of 13 patients (31%) receiving vancomycin alone and in 3 of 13 patients (23%) receiving vancomycin with bowel lavage (P<0.001 for both comparisons with the infusion group). No significant differences in adverse events among the three study groups were observed except for mild diarrhea and abdominal cramping in the infusion group on the infusion day. After donor-feces infusion, patients showed increased fecal bacterial diversity, similar to that in healthy donors, with an increase in Bacteroidetes species and clostridium clusters IV and XIVa and a decrease in Proteobacteria species. 结果 研究在一个中期分析之后停止。 16个注射小组的患者,13个在第一次注射后其复发性难辨梭状芽孢杆菌感染导致的腹泻被治愈,治愈率达81%。 留下的三个患者接受了第二次其他供体提供的粪便注射, 其中2人治愈。 13个只进行万古霉素治疗的患者中,4个患者的由复发性难辨梭状芽孢杆菌感染导致的腹泻被治愈,治愈率为31%。 13个进行万古霉素加肠灌洗治疗的患者中,3个患者的由复发性难辨梭状芽孢杆菌感染导致的腹泻被治愈,治愈率为23%(两组注射小组进行对比的话P<0.001)。 除了注射小组在注射日出现轻微的腹泻和腹部绞痛,三个小组在不良反应上没有显著的差异。 在供体粪便注射之后,患者的粪便细菌多样性上升,变得和健康的粪便提供者相似,伴随着杆菌菌种和梭菌菌簇 IV和XIV上升以及蛋白菌菌种下降。 Conclusions The infusion of donor feces was significantly more effective for the treatment of recurrent C. difficile infection than the use of vancomycin. 结论 和使用万古霉素相比,注射供体粪便来治疗复发性难辨梭状芽孢杆菌感染的效果要显著得多。

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