Prantera C, Zannoni F, Scribano M L, Berto E, Andreoli A, Kohn A, Luzi C
Division of Gastroenterology, Ospedale Nuovo Regina Margherita, Rome, Italy.
Am J Gastroenterol. 1996 Feb;91(2):328-32.
Bacteria in the gut lumen may play a role in the etiology and/or the symptoms of Crohn's disease (CD). Although various antibacterial drugs have been employed in clinical practice, few controlled trials have been conducted, and those had conflicting results. The aim of this study was to investigate the efficacy and the safety of a combination of metronidazole and ciprofloxacin, compared with methylprednisolone, in treating 41 consecutive patients with active CD.
Eligible patients, 13 men and 28 women, mean age 38 yr, were randomly allocated to receive, for 12 wk, ciprofloxacin 500 mg twice daily plus metronidazole 250 mg four times daily or methylprednisolone 0.7-l mg/kg/day, with variable tapering to 40 mg, followed by tapering of 4 mg weekly.
Ten of the 22 antibiotic patients (45.5%) and 12 of the 19 steroid patients (63%) obtained clinical remission (Crohn's Disease Activity Index < or = 150) at the end of the 12-wk study (p = NS). Five patients on antibiotics (22.7%) and five patients on steroids (26.3%) were considered treatment failures because of deterioration or persistent symptoms. Six patients receiving antibiotics (27.3%) and two on steroids (10.6%) were withdrawn from the trial because of side effects. One patient on antibiotics was not compliant.
metronidazole and ciprofloxacin could be an alternative to steroids in treating the acute phase of CD.
肠道腔内的细菌可能在克罗恩病（CD）的病因和/或症状中起作用。尽管临床实践中已使用多种抗菌药物，但很少有对照试验，且结果相互矛盾。本研究的目的是比较甲硝唑和环丙沙星联合使用与甲泼尼龙在连续治疗41例活动期CD患者中的疗效和安全性。
符合条件的患者共41例，其中男性13例，女性28例，平均年龄38岁，随机分配接受为期12周的治疗，一组为每日两次服用500mg环丙沙星加每日四次服用250mg甲硝唑，另一组为每日服用0.7-1mg/kg甲泼尼龙，剂量逐渐减至40mg，然后每周减4mg。
在为期12周的研究结束时，22例使用抗生素组中的10例（45.5%）和19例使用类固醇组中的12例（63%）实现了临床缓解（克罗恩病活动指数≤150）（p=无显著性差异）。5例使用抗生素的患者（22.7%）和5例使用类固醇的患者（26.3%）因病情恶化或症状持续而被视为治疗失败。6例接受抗生素治疗的患者（27.3%）和2例接受类固醇治疗的患者（10.6%）因副作用退出试验。1例使用抗生素的患者未依从治疗。
甲硝唑和环丙沙星在治疗CD急性期时可作为类固醇的替代药物。
