INFLAMMATION AND INFLAMMATORY BOWEL DISEASE Budesonide treatment of collagenous colitis: a randomised, double blind, placebo controlled trial with morphometric analysis
INFLAMMATION AND INFLAMMATORY BOWEL DISEASE Budesonide treatment of collagenous colitis: a randomised, double blind, placebo controlled trial with morphometric analysis
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炎症和炎症性肠病 布地奈德治疗胶原性结肠炎：一项采用形态测量分析的随机、双盲、安慰剂对照试验
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发表时间：
2002
期刊：
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通讯作者：
J. Fallingborg
中科院分区：
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作者：
O. Bonderup;J. B. Hansen;L. Birket;V. Vestergaard;P. S. Teglbjærg;J. Fallingborg
背景：胶原性结肠炎以腹泻、淋巴细胞性炎症和大肠粘膜上皮下胶原层增厚为特征。目前还没有建立这种疾病的标准治疗方法。目的：探讨口服布地奈德(Entocort，AstraZeneca)治疗胶原性结肠炎的临床和组织学疗效。患者：20例胶原性结肠炎(胶原层10μm)和腹泻(每天4次大便和/或大便重量200g/天)。方法：布地奈德治疗的随机、双盲、安慰剂对照试验。患者随机服用安慰剂或布地奈德，为期8周。记录治疗前后的大便频率和大便重量。治疗前后分别进行乙状结肠镜检查，并在固定部位取材进行形态计量学分析。结果：10名患者随机服用布地奈德，10名患者服用安慰剂。接受布地奈德治疗的所有10名患者都有临床反应，而安慰剂组只有2名患者有临床反应(p<；0.001)。布地奈德组大便重量从574g/d减少到200g/d，大便次数从6.2/d减少到1.9/d(p<；0.01)。乙状结肠黏膜组织学炎症分级和胶原层厚度明显减轻。炎症分级和胶原层厚度与大便重量呈正相关。没有副作用的报道。10例患者中有8例在停止治疗后8周内症状复发。结论：布地奈德治疗胶原性结肠炎疗效高，耐受性好。停止八周的治疗后，复发的风险很高。
Background: Collagenous colitis is characterised by diarrhoea, lymphocytic inflammation, and a thickened subepithelial collagen layer in the colorectal mucosa. No standard treatment of the disease is established. Aims: To investigate the clinical and histological effect of oral budesonide (Entocort, AstraZeneca) in the treatment of collagenous colitis. Patients: Twenty patients with collagenous colitis (collagen layer >10 μm) and diarrhoea (>4 stools/ day and/or stool weight >200 g/day). Methods: A randomised, double blind, placebo controlled trial of budesonide treatment. Patients were randomised to placebo or budesonide for eight weeks. Stool frequency and stool weight were registered before and after treatment. Sigmoidoscopy was performed before and after treatment, and biopsies at fixed locations were obtained for morphometric analysis. Results: Ten patients were randomised to budesonide and 10 to placebo. All 10 patients receiving budesonide had a clinical response compared with two in the placebo group (p<0.001). In the budesonide group, stool weight was reduced from 574 g/day to 200 g/day and stool frequency was reduced from 6.2/day to 1.9/day (p<0.01). The histological inflammation grade in the sigmoid mucosa and the thickness of the collagen layer were significantly reduced. A correlation between the grade of inflammation as well as collagen layer thickness and stool weight was found. No side effects were reported. Eight of 10 patients had relapse of symptoms within eight weeks after stopping treatment. Conclusions: Budesonide is a highly effective and well tolerated treatment of collagenous colitis. There is a high risk of relapse after stopping eight weeks of treatment.