Budesonide in collagenous colitis: A double-blind placebo-controlled trial with histologic follow-up

被引:158
作者
Baert, F
Schmit, A
D'Haens, G
Dedeurwaerdere, F
Louis, E
Cabooter, M
De Vos, M
Fontaine, F
Naegels, S
Schurmans, P
Stals, H
Geboes, K
Rutgeerts, P
机构
关键词
D O I
10.1053/gast.2002.30295
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
Background & Aims: Collagenous colitis (CC) is a well-described entity causing chronic diarrhea and characteristic histologic findings. Several treatment options have been suggested, but no controlled data are available. We conducted a placebo-controlled trial to show the clinical and histologic effects of budesonide in CC. Methods: Twenty-eight patients were randomly assigned to receive placebo (n = 14) or budesonide 9 mg daily (n = :14) for 8 weeks. Patients were evaluated clinically, and blinded biopsy specimens were analyzed from fixed locations at weeks 0 and 8. Clinical response was defined as a decrease of at least 50% in the disease activity score (number of bowel movements in the last 7 days). At week 8, nonresponders received open-label budesonide for the next 8-week period; responders discontinued treatment and were followed up. Results: Three patients discontinued the study prematurely. Intention-to-treat analysis showed clinical response in 8 of 14 patients in the budesonide group compared with 3 of 14 responders for placebo (P = 0.05) after 8 weeks of blinded therapy, together with improved stool consistency. Histologically, there was no change in the mean thickness of the Collagen band but a significant decrease of the lamina propria infiltrate in the budesonide group (P < 0.001). Conclusions: Budesonide is efficacious in inducing short-term clinical response in CC with significant reduction of the histologic infiltrate in the lamina propria.
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页码:20 / 25
页数:6
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