[5-aminosalicylic acid enema (Pentasa) versus hydrocortisone acetate foam (Proctocort) for the treatment of outbreaks of proctitis and cryptogenetic proctosigmoiditis. A comparative randomized multicenter trial].
The therapeutic efficacy of 1 g 5-aminosalicylic acid enema was compared with that of 90 mg hydrocortisone acetate foam following daily rectal administration to patients with idiopathic proctitis or proctosigmoiditis during two weeks. A total of 199 patients (103 5-aminosalicylic acid, 96 hydrocortisone acetate) were included in a randomized, multicenter trial. Endoscopic and clinical remission was seen in 67 and 69 percent of the 5-aminosalicylic acid-treated and in 50 and 45 percent of the hydrocortisone acetate-treated patients (P less than 0.05), respectively. Mild side effects were seen in 10.7 percent of the 5-aminosalicylic acid-treated patients and in 3.1 percent of the hydrocortisone acetate-treated patients (P = 0.05). After 2 weeks, 5-aminosalicylic acid enemas are more effective than hydrocortisone foam for topical treatment of patients with idiopathic proctitis or proctosigmoiditis.
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Service de Gastroentérologie, Hôpital Saint-Lazare, Paris.
Rambaud
J C
JC
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000636:Aminosalicylic Acids / Q000009:adverse effects / Q000627:therapeutic use*; D004733:Enema / Q000379:methods*; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008297:Male; D019804:Mesalamine; D008875:Middle Aged; D011349:Proctitis / Q000188:drug therapy*; D011350:Proctocolitis / Q000188:drug therapy*
D000636:Aminosalicylic Acids; C021650:hydrocortisone acetate; D019804:Mesalamine; D006854:Hydrocortisone
Lavement d'acide 5-aminosalicylique (Pentasa) versus mousse d'acétate d'hydrocortisone (Proctocort) dans le traitement des poussées de rectite et rectosigmoïdite cryptogénétique. Essai comparatif randomisé multicentrique.