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Minerva Chirurgica 1999 September;54(9):635-46

language: Italian

Topical treatment of ulcerative colitis. A multicentre trial with beclomethasone dipropionate foam

Arcidiacono R., Zanasi G., Pirone Z., Borzio M., Milano G., Cestari L., Ravelli P., Terraroli C., de Franchis R., Vecchi M., Galeone M., Toti G. L., Cacioli D., Luminari L., Giannelli C., Gioiemi A., Russello D., Di Blasi M., Di Stefano A., Russo A., Aprile G., Biraghi M.


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Background and aims. The use of steroids was recently extended to the various forms of ulcerative rectocolitis by the introduction of topical formulations, above all steroids with an hepatic ''first Pass'' devoid of systemic interference. The aim of this study was to evaluate the efficacy and tolerability of Beclomethasone dipropionate (BDP) in a rectal foam formulation, in the treatment of patients suffering from ulcerative colitis.
Methods. The experimental protocol took the form of a 28-day open prospective trial using BDP rectal foam in patients suffering from ulcerative colits. Endoscopic, histological, clinical and tolerability parameters were evaluated. The centres taking part in the trial collocted data for 60 cases out of a total of 80 patients enrolled in the study, of both sexes and aged between 20 and 81 years old, suffering from proctosigmoiditis (46.7%) and ulcerative rectocolitis (53.3%).
Results. Endoscopic parameters showed an improvement after 28 days of treatment in 74.5% of patients; a clinical improvement was achieved in 65.2% of cases. In percentage terms of the mean value of all the improved parameters, histological parameters were altered in 56.9% of patients. With regard to tolerability, 82% of patients judged the treatment to be good/excellent.
Conclusions. In conclusion, in line with recent reports regarding other pharmaceutical forms of BDP, including the use of rectal foam, these data confirm the efficacy and tolerability of this molecule and emphasise the validity of its use in the treatment of ulcerative colitis and proctosigmoiditis.

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