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Clinical Trial
. 1993 Apr;7(2):155-8.
doi: 10.1111/j.1365-2036.1993.tb00084.x.

Oral tobramycin in ulcerative colitis: effect on maintenance of remission

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Clinical Trial

VSports - Oral tobramycin in ulcerative colitis: effect on maintenance of remission

VSports手机版 - A J Lobo et al. Aliment Pharmacol Ther. 1993 Apr.

Abstract

Oral tobramycin for 7 days has been shown to be of benefit as an adjunct to conventional medication in acute ulcerative colitis. Eighty-one patients (40 who had received tobramycin; 41 placebo) who had been enrolled in a double-blind placebo-controlled trial of this drug in acute disease were subsequently followed to determine whether this short-term benefit persisted. Relapse was defined as a liquid stool frequency of three times daily with rectal bleeding. Results were analysed by the log-rank test on Kaplan-Meier survival curves. Treatment failure was defined as a lack of response by the end of the acute trial period, or subsequent relapse. In a second analysis, only those entering remission at the end of the acute trial were considered, and followed to relapse. Although at the start of the follow-up period significantly fewer patients in the tobramycin group had failed (failed: tobramycin 9, placebo 24; not failed tobramycin 31; placebo 17; P = 0. 001), the failure-free survival curves subsequently converged and did not differ significantly. After 1 and 2 years, the failure-free survival rates were 40% (S. E. = 7. 8%) and 20% (S. E. = 6. 3%) for the tobramycin group and 24% (S. E. = 6. 7%) and 12% (S. E. = 5. 1%) for the placebo group. When only those entering remission were considered, there was no significant difference in the relapse rates in the two groups VSports手机版. Benefit from tobramycin is therefore short-lived and may reflect short-term changes in the faecal flora. .

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