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Effect of budesonide enema on remission and relapse rate in distal ulcerative colitis and proctitis.

Abstract：

BACKGROUND:Glucocorticosteroid enemas are equally effective as 5-ASA enemas in the treatment of active distal ulcerative colitis (UC). With the introduction of budesonide, the risk of systemic side effects may be reduced. We investigated whether budesonide enema, 2 mg/100 ml, administered twice daily (b.i.d.) could increase the remission rate in comparison with the once daily (o.d.) standard regimen. Furthermore, we evaluated whether 2 mg budesonide enema, given twice weekly, could have a relapse preventing effect. METHODS:149 patients with active distal UC were treated in a controlled, double-blind multicentre study with two parallel groups: placebo enema in the morning and budesonide enema in the evening (i.e. 2 mg/day) or budesonide enema b.i.d. (i.e. 4 mg/day) until remission (absence of clinical symptoms and endoscopic healing) or at most 8 weeks. Patients in remission were randomized to either budesonide enema or placebo enema twice weekly for 24 weeks or until relapse. RESULTS:The remission rates at 4 weeks were 33% for o.d. and 41% for b.i.d. regimens (NS) and correspondingly 51% and 54% at 8 weeks (NS). The b.i.d. group had an increased frequency of impaired adrenal function, 32% versus 4.8% (P = 0.001). The relapse rates during maintenance treatment with budesonide enema and placebo were 15% versus 24% after 8 weeks, 31% versus 27% after 16 weeks and 41% versus 51% after 24 weeks (NS). CONCLUSION:Budesonide enema 2 mg o.d. appears to be the optimal dosage in active distal UC. We could not show that budesonide enema twice weekly is sufficient to maintain remission.

journal_name

Scand J Gastroenterol

journal_title

Scandinavian journal of gastroenterology

authors

Lindgren S,Löfberg R,Bergholm L,Hellblom M,Carling L,Ung KA,Schiöler R,Unge P,Wallin C,Ström M,Persson T,Suhr OB

doi

10.1080/00365520212512

subject

Has Abstract

pub_date

2002-06-01 00:00:00

pages

705-10

issue

6

eissn

0036-5521

issn

1502-7708

journal_volume

37

pub_type

临床试验,杂志文章,多中心研究,随机对照试验

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