Newly Developed Antibiotic Combination Therapy for Ulcerative Colitis: A Double-Blind Placebo-Controlled Multicenter Trial

作者：Toshifumi Ohkusa, Kimitoshi Kato, Shuichi Terao, Toshimi Chiba, Katsuhiro Mabe, Kazunari Murakami, Yuji Mizokami, Toshiro Sugiyama, Akinori Yanaka, Yoshiaki Takeuchi, Shigeru Yamato, Akira Yokoyama, Isao Okayasu, Sumio Watanabe, Hisao Tajiri, Nobuhiro Sato · 发表于：The American Journal of Gastroenterology · 年份：2010 · DOI：10.1038/ajg.2010.84 · 被引用次数：139 · 研究领域：Gut microbiota and health、Inflammatory Bowel Disease、Clostridium difficile and Clostridium perfringens research

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. 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. 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. 22.8%, 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 no...