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Titolo:
Multicentre randomized placebo-controlled trial of ursodeoxycholic acid with or without colchicine in symptomatic primary biliary cirrhosis
Autore:
Almasio, PL; Floreani, A; Chiaramonte, M; Provenzano, G; Battezzati, P; Crosignani, A; Podda, M; Todros, L; Rosina, F; Saccoccio, G; Manenti, F; Ballardini, G; Bianchi, FP; Scheuer, PJ; Davies, SE; Craxi, A;
Indirizzi:
Univ Palermo, Ist Clin Med, Cattedra Gastroenterol, Dipartimento Biomed Med Interna & Specialist, I-90127 Palermo, Italy Univ Palermo Palermo ItalyI-90127 & Specialist, I-90127 Palermo, Italy Univ Padua, Dipartimento Sci Chirurg & Gastroenterol, Padua, Italy Univ Padua Padua Italy imento Sci Chirurg & Gastroenterol, Padua, Italy Univ Aquila, Dipartimento Sanita Pubbl & Med Interna, Unita Operat Gastroenterol, I-67100 Laquila, Italy Univ Aquila Laquila Italy I-67100 Gastroenterol, I-67100 Laquila, Italy Univ Milan, Osped San Paolo, Dipartimento Med Interna, Milan, Italy Univ Milan Milan Italy an Paolo, Dipartimento Med Interna, Milan, Italy Univ Turin, Azienda Osped Molinette, Dipartimento Gastroenterol, Turin, Italy Univ Turin Turin Italy inette, Dipartimento Gastroenterol, Turin, Italy Univ Modena, Dept Med Interna, I-41100 Modena, Italy Univ Modena Modena Italy I-41100 Dept Med Interna, I-41100 Modena, Italy Univ Bologna, Ist Clin Med Gen & Terapia Med, Cattedra Med Interna 1, Bologna, Italy Univ Bologna Bologna Italy Med, Cattedra Med Interna 1, Bologna, Italy Royal Free Hosp, Dept Histopathol, London NW3 2QG, England Royal Free Hosp London England NW3 2QG topathol, London NW3 2QG, England
Titolo Testata:
ALIMENTARY PHARMACOLOGY & THERAPEUTICS
fascicolo: 12, volume: 14, anno: 2000,
pagine: 1645 - 1652
SICI:
0269-2813(200012)14:12<1645:MRPTOU>2.0.ZU;2-X
Fonte:
ISI
Lingua:
ENG
Soggetto:
DOUBLE-BLIND; BILE-ACIDS; THERAPY;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
33
Recensione:
Indirizzi per estratti:
Indirizzo: Almasio, PL Univ Palermo, Ist Clin Med, Cattedra Gastroenterol, Dipartimento Biomed Med Interna & Specialist, Piazza Clin 2, I-90127 Palermo, Italy Univ Palermo Piazza Clin 2 Palermo Italy I-90127 lermo, Italy
Citazione:
P.L. Almasio et al., "Multicentre randomized placebo-controlled trial of ursodeoxycholic acid with or without colchicine in symptomatic primary biliary cirrhosis", ALIM PHARM, 14(12), 2000, pp. 1645-1652

Abstract

Aim: To establish the efficacy of combination therapy with ursodeoxycholicacid (UDCA) and colchicine in patients with symptomatic primary biliary cirrhosis (PBC), defined by the presence of liver cirrhosis, pruritus or bilirubin exceeding 2 mg/mL. Methods: A total of 90 patients were randomly assigned to ursodeoxycholic acid 500 mg/daily plus placebo (UDCA group, n=44), or ursodeoxycholic acid at the same dosage plus colchicine, 1 mg/daily (UDCA/C group, n=46). The two groups were comparable for age, sex, stage of disease, severity of pruritus, bilirubin, and Mayo score. All patients underwent clinical, ultrasonographic, and biochemical examinations at entry and then every 6 months up to 3 years of follow-up. Patients with cirrhosis underwent endoscopy every 12 months. In a sub-group of patients without cirrhosis, who consented, liver biopsy was repeated at the end of the study. Results: The number of treatment failures (i.e. dead, orthotopic liver transplantation (OLT), complications of cirrhosis, doubling of bilirubin, untreatable pruritus) was 11 (25%) in the UDCA group and four (9%) in the UDCA/C group (P < 0.05). No significant differences were observed in terms of improvement of liver enzymes related to cholestasis and cytolysis and of amelioration of pruritus. The Mayo score values increased less above the baseline values at 24 and 36 month-intervals in the UDCA/C group than in the UDCAgroup. Histological evaluation at baseline and at the end of the study wasavailable for 15 patients with pre-cirrhotic stage. A significant reduction in histological grading score was observed in patients from the UDCA/C group, whereas no changes in these histological scores were observed in the UDCA group. Conclusions: The addition of colchicine to ursodeoxycholic acid in patients with symptomatic primary biliary cirrhosis results in a small but significant reduction of disease progress.

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Documento generato il 02/12/20 alle ore 17:42:41