Maintaining remission of ulcerative colitis with the probiotic Escherichia coli Nissle 1917 is as effective as with standard mesalazine
Maintaining remission of ulcerative colitis with the probiotic Escherichia coli Nissle 1917 is as effective as with standard mesalazine
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DOI：
10.1136/gut.2003.037747
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发表时间：
2004-11-01
期刊：
影响因子：
24.5
通讯作者：
Schulze, J
中科院分区：
文献类型：
--
作者：
Kruis, W;Fric, P;Schulze, J
背景和目的：存在证据表明肠菌群在炎症性肠病中的致病作用。益生菌含有生物微生物，对宿主产生健康影响。我们比较了维持益生菌制剂大肠杆菌Nissle 1917的疗效，并用美沙嗪在溃疡性结肠炎患者中建立了治疗疗法。患者和方法：总共招募了327例患者，并分配了一项双盲型试验，要么接受双盲试验。益生菌药物200 mg每天一次（n = 162）或美沙嗪500 mg每天三次（n = 165）。该研究持续了12个月，并通过临床和内窥镜活动指数（Rachmilewitz）以及组织学评估患者。该研究的主要目的是确认两种药物在预防复发中的等效疗效。分析：根据E Coli Nissle 1917组和38/112的40/110（36.4％）患者的复发显示了40/110（36.4％）的复发（38/112）（美沙嗪组的33.9％）（显着的等效性P = 0.003）。亚组分析表明，治疗组的持续时间和疾病定位或审前治疗之间没有差异。安全性和耐受性对两组都非常好，并且没有不同。结论：益生菌药物E Coli Nissle 1917在维持与金标准美沙美嗪在溃疡性结肠炎患者中的缓解方面显示出疗效和安全性。益生菌治疗的有效性进一步强调了肠菌群的致病意义。
Background and aim: Evidence exists for the pathogenic role of the enteric flora in inflammatory bowel disease. Probiotics contain living microorganisms which exert health effects on the host. We compared the efficacy in maintaining remission of the probiotic preparation Escherichia coli Nissle 1917 and established therapy with mesalazine in patients with ulcerative colitis.Patients and methods: In total, 327 patients were recruited and assigned to a double blind, double dummy trial to receive either the probiotic drug 200 mg once daily ( n = 162) or mesalazine 500 mg three times daily ( n = 165). The study lasted for 12 months and patients were assessed by clinical and endoscopic activity indices (Rachmilewitz) as well as by histology. The primary aim of the study was to confirm equivalent efficacy of the two drugs in the prevention of relapses.Results: The per protocol analysis revealed relapses in 40/110 (36.4%) patients in the E coli Nissle 1917 group and 38/112 (33.9%) in the mesalazine group ( significant equivalence p = 0.003). Subgroup analyses showed no differences between the treatment groups in terms of duration and localisation of disease or pretrial treatment. Safety profile and tolerability were very good for both groups and were not different.Conclusions: The probiotic drug E coli Nissle 1917 shows efficacy and safety in maintaining remission equivalent to the gold standard mesalazine in patients with ulcerative colitis. The effectiveness of probiotic treatment further underlines the pathogenetic significance of the enteric flora.