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Clinical Trial
. 2005 Apr;128(4):856-61.
doi: 10.1053/j.gastro.2005.01.010.

Ornidazole for prophylaxis of postoperative Crohn's disease recurrence: a randomized, double-blind, placebo-controlled trial

Affiliations
Clinical Trial

Ornidazole for prophylaxis of postoperative Crohn's disease recurrence: a randomized, double-blind, placebo-controlled trial

Paul Rutgeerts et al. Gastroenterology. 2005 Apr.

Abstract

Background & aims: Crohn's disease almost inevitably recurs after ileocolonic resection, and effective prophylactic therapy has not been identified. We investigated the efficacy and safety of ornidazole, a nitroimidazole antibiotic, for the prevention of clinical recurrence of Crohn's disease after curative ileocolonic resection in a placebo-controlled double-blind clinical trial VSports手机版. .

Methods: Eighty patients were randomized to ornidazole 1 g/day or placebo started within 1 week of resection and continued for 1 year. The primary end point was the proportion of patients with clinical recurrence at 1 year. Secondary end points were endoscopic recurrence at 3 months and 12 months after resection. V体育安卓版.

Results: Two patients in the ornidazole group withdrew consent and were not dosed. Ornidazole significantly reduced the clinical recurrence rate at 1 year from 15 of 40 (37. 5%) patients in the placebo group to 3 of 38 (7. 9%) patients in the ornidazole group (Fisher exact test, 8. 03; P = . 0046; odds ratio, 0 V体育ios版. 14; 95% confidence interval, 0. 037-0. 546). Ornidazole reduced endoscopic recurrence at 12 months from 26 of 33 (79%) in the placebo group to 15 of 28 (53. 6%) in the ornidazole group (chi2 , 4. 37; P = . 037; odds ratio, 0. 31; 95% confidence interval, 0. 10-0. 94). Endoscopic recurrence at 3 and 12 months predicted clinical recurrence. Significantly more patients in the ornidazole group dropped out from the study because of side effects (P = . 041). .

Conclusions: Ornidazole 1 g/day is effective for the prevention of recurrence of Crohn's disease after ileocolonic resection. VSports最新版本.

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