Thia Kelvin T, Mahadevan Uma, Feagan Brian G, Wong Cindy, Cockeram Alan, Bitton Alain, Bernstein Charles N, Sandborn William J
Miles & Shirley Fiterman Center for Digestive Diseases, Mayo Clinic, Rochester, Minnesota 55905, USA.
Inflamm Bowel Dis. 2009 Jan;15(1):17-24. doi: 10.1002/ibd.20608.
Although metronidazole and ciprofloxacin are used to treat perianal Crohn's disease (CD), no placebo-controlled trials have been performed.
We performed a placebo-controlled pilot trial to evaluate the efficacy and safety of metronidazole and ciprofloxacin in patients with perianal CD. Twenty-five patients with CD and actively draining perianal fistulas were randomized to receive ciprofloxacin 500 mg, metronidazole 500 mg, or placebo twice daily for 10 weeks. Remission and response of perianal fistulas were defined as closure of all fistulas and closure of at least 50% of fistulas that were draining at baseline, respectively. The primary endpoint was remission at 10 weeks.
Ten patients were randomized to ciprofloxacin, 7 to metronidazole, and 8 to placebo. Remission at week 10 occurred in 3 patients (30%) treated with ciprofloxacin, no patients (0%) treated with metronidazole, and 1 patient (12.5%) treated with placebo (P = 0.41). Response at week 10 occurred in 4 patients (40%) treated with ciprofloxacin, 1 patient (14.3%) treated with metronidazole, and 1 patient (12.5%) treated with placebo (P = 0.43). Termination of the trial prior to week 10 occurred in 1 patient (10%) treated with ciprofloxacin, 5 patients (71.4%) treated with metronidazole, and 1 patient (12.5%) treated with placebo (P < 0.02). No serious adverse events occurred.
Remission and response occurred more frequently in patients treated with ciprofloxacin but the differences were not significant in this pilot study. Ciprofloxacin was well tolerated.
尽管甲硝唑和环丙沙星用于治疗肛周克罗恩病（CD），但尚未进行过安慰剂对照试验。
我们进行了一项安慰剂对照试验，以评估甲硝唑和环丙沙星对肛周CD患者的疗效和安全性。25例患有CD且肛周瘘管有活动性引流的患者被随机分为三组，分别每日两次接受500mg环丙沙星、500mg甲硝唑或安慰剂治疗，为期10周。肛周瘘管的缓解和反应分别定义为所有瘘管闭合以及基线时有引流的瘘管至少50%闭合。主要终点为10周时的缓解情况。
10例患者被随机分配至环丙沙星组，7例至甲硝唑组，8例至安慰剂组。10周时，接受环丙沙星治疗的患者中有3例（30%）达到缓解，接受甲硝唑治疗的患者中无（0%）达到缓解，接受安慰剂治疗的患者中有1例（12.5%）达到缓解（P = 0.41）。10周时，接受环丙沙星治疗的患者中有4例（40%）有反应，接受甲硝唑治疗的患者中有1例（14.3%）有反应，接受安慰剂治疗的患者中有1例（12.5%）有反应（P = 0.43）。在10周前试验终止的情况：接受环丙沙星治疗的患者中有1例（10%），接受甲硝唑治疗的患者中有5例（71.4%），接受安慰剂治疗的患者中有1例（12.5%）（P < 0.02）。未发生严重不良事件。
接受环丙沙星治疗的患者缓解和有反应的情况更频繁，但在这项初步研究中差异不显著。环丙沙星耐受性良好。
