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

被引:160
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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共 21 条
[1]  
ALKAHATIB O, 1998, GASTROENTEROLOGY, V114, pA198
[2]  
Aviles PM, 1996, MED CLIN-BARCELONA, V106, P317
[3]   Lymphocytic colitis: a distinct clinical entity? A clinicopathological confrontation of lymphocytic and collagenous colitis [J].
Baert, F ;
Wouters, K ;
D'Haens, G ;
Hoang, P ;
Naegels, S ;
D'Heygere, F ;
Holvoet, J ;
Louis, E ;
Devos, M ;
Geboes, K .
GUT, 1999, 45 (03) :375-381
[4]   RANITIDINE, DIARRHEA, AND LYMPHOCYTIC COLITIS [J].
BEAUGERIE, L ;
PATEY, N ;
BROUSSE, N .
GUT, 1995, 37 (05) :708-711
[5]   DRUG-INDUCED LYMPHOCYTIC COLITIS [J].
BEAUGERIE, L ;
LUBOINSKI, J ;
BROUSSE, N ;
COSNES, J ;
CHATELET, FP ;
GENDRE, JP ;
LEQUINTREC, Y .
GUT, 1994, 35 (03) :426-428
[6]   Ticlopidine induced colitis: a histopathological study including apoptosis [J].
Berrebi, D ;
Sautet, A ;
Flejou, JF ;
Dauge, MC ;
Peuchmaur, M ;
Potet, F .
JOURNAL OF CLINICAL PATHOLOGY, 1998, 51 (04) :280-283
[7]   Collagenous colitis: A retrospective study of clinical presentation and treatment in 163 patients [J].
Bohr, J ;
Tysk, C ;
Eriksson, S ;
Abrahamsson, H ;
Jarnerot, G .
GUT, 1996, 39 (06) :846-851
[8]  
Fine K, 1999, GASTROENTEROLOGY, V116, pA880
[9]   Efficacy of open-label bismuth subsalicylate for the treatment of microscopic colitis [J].
Fine, KD ;
Lee, EL .
GASTROENTEROLOGY, 1998, 114 (01) :29-36
[10]   Therapy of prednisone-refractory collagenous colitis with budesonide [J].
Lanyi, B ;
Dries, V ;
Dienes, EP ;
Kruis, W .
INTERNATIONAL JOURNAL OF COLORECTAL DISEASE, 1999, 14 (01) :58-61