Young G P, Ward P B, Bayley N, Gordon D, Higgins G, Trapani J A, McDonald M I, Labrooy J, Hecker R
Gastroenterology. 1985 Nov;89(5):1038-45. doi: 10.1016/0016-5085(85)90206-9.
A randomized double-blind study was carried out in patients with unresolving antibiotic-associated colitis due to Clostridium difficile, to compare the effect of bacitracin (80,000 U/day) with vancomycin (500 mg/day) on the resolution of symptoms, clearance of organism, and prevention of relapse. Forty-two patients with colitis, 9 of whom had a pseudomembrane, were randomized, 21 patients to each treatment group. The two groups were comparable in age, disease severity, and antibiotic exposure. For a 50% reduction in stool frequency the mean times (+/- SE) were 4.1 +/- 0.4 days for bacitracin and 4.2 +/- 0.4 days for vancomycin. Sixteen patients (76%) had symptom resolution after 7 days of treatment with bacitracin, compared with 18 patients (86%) given vancomycin. Patients who failed to respond were crossed over (blind) to the alternative antibiotic, but tended to be refractory to the alternative medication as well. Vancomycin-treated patients had negative toxin (83% vs. 53%, p = 0.04) and negative stool cultures (81% vs. 52%, p = 0.02) more frequently than did those patients given bacitracin. Similar numbers of patients in each group had symptomatic relapse during 1 mo of follow-up, but most of them relapsed yet again after blinded crossover therapy. Although bacitracin was significantly less effective than vancomycin in clearing C. difficile from the stools, both were of similar value in the control of symptoms in a group of patients with predominantly nonpseudomembranous colitis. In view of its low cost, bacitracin is a reasonable first-line alternative to vancomycin in the treatment of antibiotic-associated colitis.
对因艰难梭菌引起的抗生素相关性结肠炎未缓解的患者进行了一项随机双盲研究，以比较杆菌肽（80,000单位/天）与万古霉素（500毫克/天）对症状缓解、病原体清除及预防复发的效果。42例结肠炎患者，其中9例有假膜，被随机分组，每组21例。两组在年龄、疾病严重程度及抗生素暴露情况方面具有可比性。对于粪便频率降低50%，杆菌肽组的平均时间（±标准误）为4.1±0.4天，万古霉素组为4.2±0.4天。用杆菌肽治疗7天后，16例患者（76%）症状缓解，而给予万古霉素的患者为18例（86%）。无反应的患者交叉（盲法）接受另一种抗生素治疗，但对另一种药物也往往难治。万古霉素治疗的患者毒素阴性（83%对53%，p = 0.04）和粪便培养阴性（81%对52%，p = 0.02）的频率高于给予杆菌肽的患者。每组中相似数量的患者在1个月的随访期间有症状复发，但大多数患者在盲法交叉治疗后再次复发。尽管杆菌肽在从粪便中清除艰难梭菌方面明显不如万古霉素有效，但在一组主要为非假膜性结肠炎的患者中，两者在症状控制方面价值相似。鉴于其成本低，杆菌肽是治疗抗生素相关性结肠炎时替代万古霉素的合理一线药物。
