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Randomized Controlled Trial
. 2010 Aug;105(8):1820-9.
doi: 10.1038/ajg.2010.84. Epub 2010 Mar 9.

Newly developed antibiotic combination therapy for ulcerative colitis: a double-blind placebo-controlled multicenter trial (VSports最新版本)

Affiliations
Randomized Controlled Trial

Newly developed antibiotic combination therapy for ulcerative colitis: a double-blind placebo-controlled multicenter trial

Toshifumi Ohkusa et al. Am J Gastroenterol. 2010 Aug.

Abstract (VSports app下载)

Objectives: Fusobacterium varium may contribute to ulcerative colitis (UC). We conducted a double-blind placebo-controlled multicenter trial to determine whether antibiotic combination therapy induces and/or maintains remission of active UC. VSports手机版.

Methods: Patients with chronic mild-to-severe relapsing UC were randomly assigned to oral amoxicillin 1500 mg/day, tetracycline 1500 mg/day, and metronidazole 750 mg/day, vs. placebo, for 2 weeks, and then followed up. The primary study end point was clinical response (Mayo score at 3 months after treatment completion) and secondary end points were clinical and endoscopic score improvements at 12 months. Anti-F. varium antibodies were measured by enzyme-linked immunosorbent assay V体育安卓版. .

Results: Treatment and placebo groups each had 105 subjects. At the primary end point, response rates were significantly greater with antibiotics than with placebo (44. 8 vs. 22 V体育ios版. 8%, P=0. 0011). Endoscopic scores significantly improved at 3 months (P=0. 002 vs. placebo). Remission rates were 19. 0% (antibiotics) vs. 15. 8% (placebo) at 3 months (P=0. 59). At the secondary end point, response rates were significantly greater with antibiotics than with placebo (49. 5 vs. 21. 8%, respectively, P<0. 0001). Endoscopic scores were significantly improved at 12 months after antibiotic treatment (P=0. 002 vs. placebo). Remission rates had improved to 26. 7% with antibiotics vs. 14. 9% for placebo, at 12 months (P=0. 041). F. varium antibody titers decreased in responders but not in nonresponders, and more in the antibiotic than in the placebo group. More pretreatment steroid-dependent UC patients discontinued corticosteroids after treatment completion (6 months: 28. 6 vs. 11. 8%, respectively, P=0. 046; 9 months: 34. 7 vs. 13. 7%, respectively, P=0. 019; and 12 months: 34. 7 vs. 13. 7%, respectively, P=0. 019). These effects were greater in the subanalysis of the active group (Mayo scores of 6-12) than in that of total cases (0-12). No serious drug-related toxicities occurred. .

Conclusions: The 2-week triple antibiotic therapy produced improvement, remission, and steroid withdrawal in active UC more effectively than a placebo. VSports最新版本.

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