Continuous Infusion : A Randomized, Double-Blind TrialVersus: A Randomized, Double-Blind Trial Bolus Administration of Steroids in Severe Attacks of Ulcerative Colitis: A Randomized, Double-Blind Trial

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Abstract

BACKGROUND

In patients with severe attacks of ulcerative colitis (UC), IV steroids represent the first-line treatment, leading to clinical improvement in approximately 50–60% of patients.

AIM

The aim of this study was to prospectively compare the efficacy and safety of different modalities of steroid administration, and to evaluate predictors of failure to therapy.

MATERIALS

In a single-center, double-blind trial, consecutive patients with a severe attack of UC received

METHODS

1 mg/kg/day of 6-methyl-prednisolone administered randomly by either a bolus injection (group A) or continuous infusion (group B).

RESULTS

Sixty-six patients were enrolled (35 men, mean age 38 ± 15, range 18–75 yr), 15 of them at their first attack of UC; in the remaining cases, the mean duration of disease was 4.5 ± 5 yr. At inclusion, forty patients (60%) had pancolitis and the remainder had left-sided colitis. Overall, thirty-three patients (50%) underwent clinical remission after 7 days of treatment: 16 of 32 in group A and 17 of 34 in group B. Thirty-one patients eventually underwent total colectomy (12 in group A and 9 in group B), which was carried out by the first month in 10 patients (5 in each group). Twenty-eight patients (15 in group A and 13 in group B) experienced steroid-related adverse reactions. All differences between groups were not statistically significant. Previous use of steroids (OR 13.6, CI 2–86) and active smoking (OR 11.6, CI 1.4–107) were independent predictors of nonresponse.

CONCLUSIONS

In severe attacks of UC, methyl-prednisolone given as a continuous infusion was no better than bolus administration in terms of efficacy and safety.

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