[The topical therapy of ulcerative colitis. A multicenter study with beclomethasone dipropionate foam].
OBJECTIVE
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 colitis. Endoscopic, histological, clinical and tolerability parameters were evaluated. The centres taking part in the trial collected 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.
Arcidiacono
R
R
Servizio di Gastroenterologia ed Endoscopia Digestiva, Ospedale Niguarda Ca' Granda, Milano.
Zanasi
G
G
Pirone
Z
Z
Borzio
M
M
Borzio
F
F
Milano
G
G
Cestari
L
L
Ravelli
P
P
Terraroli
C
C
de Franchis
R
R
Vecchi
M
M
Galeone
M
M
Toti
G L
GL
Cacioli
D
D
Luminari
L
L
Giannelli
C
C
Gioiemi
A
A
Russello
D
D
Di Blasi
M
M
Di Stefano
A
A
Russo
A
A
Aprile
G
G
Biraghi
M
M
D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D001507:Beclomethasone / Q000008:administration & dosage*; D016009:Chi-Square Distribution; D003093:Colitis, Ulcerative / Q000175:diagnosis / Q000188:drug therapy* / Q000473:pathology; D003113:Colonoscopy; D005260:Female; D005938:Glucocorticoids; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012074:Remission Induction
D000893:Anti-Inflammatory Agents; D005938:Glucocorticoids; D001507:Beclomethasone