Double-blind comparison of an oral Escherichia coli preparation and mesalazine in maintaining remission of ulcerative colitis
Double-blind comparison of an oral Escherichia coli preparation and mesalazine in maintaining remission of ulcerative colitis
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DOI：
10.1046/j.1365-2036.1997.00225.x
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发表时间：
1997-10-01
影响因子：
7.6
通讯作者：
Stolte, M
中科院分区：
文献类型：
--
作者：
Kruis, W;Schutz, E;Stolte, M
背景：氨基水杨酸盐被用作维持溃疡性结肠炎缓解的标准治疗。到目前为止，还没有其他有效的替代品。根据肠环境图有助于溃疡性结肠炎的病理生理学的假设，进行试验以测试用非致病性大肠杆菌的口服制剂进行益生菌治疗的效果。coli.Methods:共有120名非活动期溃疡性结肠炎患者被纳入一项双盲、双模拟研究，比较美沙拉秦500 mg t.d.s.一种活大肠杆菌的口服制剂。大肠杆菌Nissle菌株研究目的是评估两种治疗模式下临床活性指数（CAI）的等效性，并比较复发率、无复发时间和总体评估。结果：两个治疗组之间CAI的开始和结束评分无显著差异（P = 0.12）。美沙拉秦组复发率为11.3%，E. coli Nissle 1917（N.S.）生命表分析显示，美沙拉秦的无复发时间为103 +/- 4天，E. coli Nissle 1917（N.S.）两组的总体评估相似。耐受性的治疗是优秀的，并没有不同，没有严重的不良事件reported.Conclusions：从这个初步研究的结果，益生菌治疗似乎提供了另一种选择溃疡性结肠炎的维持治疗。提供了额外的支持，为溃疡性结肠炎的肠道环境的病理生理作用的假设。
Background: Aminosalicylates are used as standard treatment for maintaining remission in ulcerative colitis. As yet, there is no other existing alternative with proven efficacy. In light of the hypothesis that the intestinal environment map contribute to the pathophysiology of ulcerative colitis, a trial was conducted to test the effects of probiotic treatment with an oral preparation of non-pathogenic E. coli.Methods: A total of 120 patients with inactive ulcerative colitis were included in a double-blind, double-dummy study comparing mesalazine 500 mg t.d.s. to an oral preparation of viable E. coli strain Nissle (Serotype 06: K5: H1) for 12 weeks with regard to their efficacy in preventing a relapse of the disease, Study objectives were to assess the equivalence of the clinical activity index (CAI) under the two treatment modalities and to compare relapse rates, relapse-free times and global assessment,Results: The start and end scores of the CAI demonstrated no significant difference (P = 0.12) between the two treatment groups. Relapse rates were 11.3% under mesalazine and 16.0% under E. coli Nissle 1917 (N.S.). Life table analysis showed a relapse-free time of 103 +/- 4 days for mesalazine and 106 +/- 5 days for E. coli Nissle 1917 (N.S.). Global assessment was similar for both groups. Tolerability to the treatment was excellent and did not differ, No serious adverse events were reported.Conclusions: From the results of this preliminary study, probiotic treatment appears to offer another option for maintenance therapy of ulcerative colitis. Additional support is provided for the hypothesis of a pathophysiological role for the intestinal environment in ulcerative colitis.