Goodgame R W, Kimball K, Akram S, Ike E, Ou C N, Sutton F, Graham D
Department of Medicine, Texas Children's Hospital, Baylor College of Medicine, Houston, TX 77030, USA.
Aliment Pharmacol Ther. 2001 Dec;15(12):1861-6. doi: 10.1046/j.1365-2036.2001.01099.x.
A mycobacterial infection may be the cause of Crohn's disease in some patients. Measurement of intestinal permeability may identify Crohn's disease patients with a high likelihood of relapse and may quantify the severity of intestinal injury.
To assess the effect of 3 months of clarithromycin and ethambutol on the disease activity and intestinal permeability in patients with Crohn's disease at high risk of relapse.
Patients with Crohn's disease, with a lactulose-mannitol permeability test above 0.03, were randomly assigned to receive either clarithromycin, 500 mg twice daily, and ethambutol, 15 mg/kg daily, or identically appearing placebo for 3 months in addition to their regular therapy. The Harvey-Bradshaw index and the lactulose-mannitol test were assessed in a blind fashion every 3 months for 12 months.
Thirty-one patients were randomized to receive either drugs (n=15) or placebo (n=16). The groups were similar in age, sex, duration of disease, location of disease, past complications and disease severity. Specifically, there was no difference between the drug or placebo groups in the mean Harvey-Bradshaw index (4.8 vs. 4.4), number with active disease (33% vs. 44%) and mean lactulose-mannitol test (0.06 vs. 0.10). During the 12-month follow-up period, there were no consistent, statistically significant differences in the mean Harvey-Bradshaw index or lactulose-mannitol test between treatment and placebo groups. Individual patients showed either improvement or worsening of these indices, but these were not related to study medication. Specifically, no 'cures' were noted with anti-mycobacterial treatment.
Three months of treatment with clarithromycin and ethambutol does not benefit Crohn's disease patients who are receiving standard medical therapy.
在某些患者中，分枝杆菌感染可能是克罗恩病的病因。测量肠道通透性可识别出复发可能性高的克罗恩病患者，并可量化肠道损伤的严重程度。
评估3个月的克拉霉素和乙胺丁醇对复发风险高的克罗恩病患者疾病活动度和肠道通透性的影响。
克罗恩病患者，乳果糖-甘露醇通透性试验值高于0.03，除常规治疗外，随机分配接受每日两次500毫克克拉霉素和每日15毫克/千克乙胺丁醇，或外观相同的安慰剂，为期3个月。每3个月以盲法评估哈维-布拉德肖指数和乳果糖-甘露醇试验，共12个月。
31例患者随机接受药物治疗（n = 15）或安慰剂治疗（n = 16）。两组在年龄、性别、病程、病变部位、既往并发症和疾病严重程度方面相似。具体而言，药物组和安慰剂组在平均哈维-布拉德肖指数（4.8对4.4）、活动性疾病患者数量（33%对44%）和平均乳果糖-甘露醇试验值（0.06对0.10）方面无差异。在12个月的随访期内，治疗组和安慰剂组在平均哈维-布拉德肖指数或乳果糖-甘露醇试验方面没有一致的、具有统计学意义的差异。个别患者这些指标有改善或恶化，但与研究用药无关。具体而言，抗分枝杆菌治疗未观察到“治愈”病例。
对于接受标准药物治疗的克罗恩病患者，3个月的克拉霉素和乙胺丁醇治疗并无益处。
