Multicentre randomized placebo-controlled trial of ursodeoxycholic acid with or without colchicine in symptomatic primary biliary cirrhosis

Autor:	P.L. Almasio, Andrea Crosignani, Giuseppe Provenzano, Maria Chiaramonte, Federico Manenti, Annarosa Floreani, L. Todros, Giorgio Ballardini, P. J. Scheuer, Pier Maria Battezzati, Fb Bianchi, Floriano Rosina, Antonio Craxì, S. E. Davies, Mauro Podda, G. Saccoccio
Rok vydání:	2000
Předmět:	medicine.medical_specialty Cirrhosis Hepatology medicine.diagnostic_test business.industry Biliary cirrhosis Gastroenterology Placebo-controlled study medicine.disease Placebo Ursodeoxycholic acid Primary biliary cirrhosis Cholestasis Liver biopsy Internal medicine medicine Pharmacology (medical) business medicine.drug
Zdroj:	Alimentary Pharmacology & Therapeutics. 14:1645-1652
ISSN:	0269-2813
DOI:	10.1046/j.1365-2036.2000.00869.x
Popis:	Aim: To establish the efficacy of combination therapy with ursodeoxycholic acid (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
Databáze:	OpenAIRE
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