[Budesonide foam as a new therapeutic principle in distal ulcerative colitis in comparison with mesalazine enema. An open, controlled, randomized and prospective multicenter pilot study].

Abstract:

:Budesonide is a locally acting steroid with a high first-pass metabolism in the liver and low systemic effects. We performed the first pilot study comparing budesonide foam (1 mg/50 ml b.i.d.) with mesalazine enemas (4 g/60 ml o.d.). 33 patients from 3 centres were enrolled in this open randomized clinical trial. 16 patients got budesonide foam and 17 got mesalazine enemas. The drugs were administered for 4 weeks. Histological index (HI) and endoscopic index (EI) were assessed at day 1 and day 28, clinical activity index (CAI) at day 1, 14 and 28. For patients with left-sided colitis and proctosigmoiditis improvement was defined as decrease in CAI of > or = 2 points. For patients with proctitis improvement was defined as decrease in HI of > or = 1 point. The primary efficacy evaluation was performed with the intention to treat population (n = 32). Improvement was found in 67% of the patients in the budesonide group compared to 71% in the mesalazine group. There was no statistically significant difference between the groups. Adverse events were mild and rare in both groups. Both treatments had no significant influence on plasma cortisol. In this pilot study for distal ulcerative colitis budesonide foam is as safe and effective as mesalazine enema.

journal_name

Z Gastroenterol

authors

Rufle W,Frühmorgen P,Huber W,Kimmig JM

doi

10.1055/s-2000-14869

subject

Has Abstract

pub_date

2000-04-01 00:00:00

pages

287-93

issue

4

eissn

0044-2771

issn

1439-7803

journal_volume

38

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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  • [The public health political status of alcohol drinking in West Germany].

    abstract::During the last years the per-capita-consumption of pure alcohol in the Federal Republic of Germany is slightly decreasing. In 1986 every person consumed an average of 11.5 litres of pure alcohol (146.4 litres of beer, 23.3 litres of wine and 6.1 litres of spirits). The amount of the alcohol addicts must be estimated ...

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  • [Reliability of the diagnosis of chronic pancreatitis].

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    doi:

    authors: Lankisch PG,Staritz M,Freise J

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    doi:

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  • [Diagnosis, staging and therapy of gastric cancer].

    abstract::In spite of a continuously decreasing incidence in Western countries, gastric cancer remains a major health problem world-wide and a leading cause of cancer-related deaths. The molecular pathogenesis of the vast majority of sporadic tumours has not yet been clarified in detail, while for some familial cancer types cau...

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    authors: Horak W,Polterauer P,Renner F,Silberbauer K,Rauhs R,Mühlbacher F,Funovics J

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