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Titolo:
Long-term effects of ursodeoxycholic acid in primary biliary cirrhosis: results of a double-blind controlled multicentric trial
Autore:
Pares, A; Caballeria, L; Rodes, J; Bruguera, M; Rodrigo, L; Garcia-Plaza, A; Berenguer, J; Rodriguez-Martinez, D; Mercader, J; Velicia, R;
Indirizzi:
Univ Barcelona, Hosp Clin, Oviedo, Spain Univ Barcelona Oviedo SpainUniv Barcelona, Hosp Clin, Oviedo, Spain Univ Oviedo, Hosp Cent Asturias, E-33080 Oviedo, Spain Univ Oviedo Oviedo Spain E-33080 sp Cent Asturias, E-33080 Oviedo, Spain Hosp Ramon y Cajal, E-28034 Madrid, Spain Hosp Ramon y Cajal Madrid Spain E-28034 n y Cajal, E-28034 Madrid, Spain Hosp La Fe, E-46009 Valencia, Spain Hosp La Fe Valencia Spain E-46009Hosp La Fe, E-46009 Valencia, Spain Hosp Xeral Cies, Vigo, Spain Hosp Xeral Cies Vigo SpainHosp Xeral Cies, Vigo, Spain Hosp Virgen Arrixaca, Murcia, Spain Hosp Virgen Arrixaca Murcia SpainHosp Virgen Arrixaca, Murcia, Spain Hosp Rio Hortega, Valladolid, Spain Hosp Rio Hortega Valladolid SpainHosp Rio Hortega, Valladolid, Spain
Titolo Testata:
JOURNAL OF HEPATOLOGY
fascicolo: 4, volume: 32, anno: 2000,
pagine: 561 - 566
SICI:
0168-8278(200004)32:4<561:LEOUAI>2.0.ZU;2-G
Fonte:
ISI
Lingua:
ENG
Soggetto:
URSODIOL; DISEASE; STAGE;
Keywords:
cholestasis; liver histology; primary biliary cirrhosis; survival; therapy; ursodeoxycholic acid;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
26
Recensione:
Indirizzi per estratti:
Indirizzo: Pares, A Hosp Clin & Prov, Liver Unit, C Villarroel 170, Barcelona 08036, Spain Hosp Clin & Prov C Villarroel 170 Barcelona Spain 08036 6, Spain
Citazione:
A. Pares et al., "Long-term effects of ursodeoxycholic acid in primary biliary cirrhosis: results of a double-blind controlled multicentric trial", J HEPATOL, 32(4), 2000, pp. 561-566

Abstract

Background/Aims: The aim of this study was to assess the efficacy of ursodeoxycholic acid (UDCA) for primary biliary cirrhosis in a randomized, double-blind placebo-controlled trial. Methods: Consecutive patients (n=192) were randomized to receive 14-16 mg UDCA/kg/day or placebo. Patients underwent a complete history, physical examination, liver chemistries, immunological determinations and liver biopsy at entry and at the end of the trial, which lasted for at least 2 years. Patients were seen every 3 months and the median follow-up was 3.4 years (range 0.3 to 6.1 years). Results: Patients receiving UDCA (99) or placebo (93) were comparable withregard to age, sex, biochemical parameters and liver histology, UDCA treatment was associated with decreases in alkaline phosphatase, gammaglutamyl transferase, alanine aminotransferase, and cholesterol levels, effects whichwere conspicuous after 3 months of treatment and remained similar during the follow-up. During the study 31 patients (10 receiving UDCA and 21 placebo) discontinued the trial because of noncompliance (n=11), voluntary withdrawal (n=19) or adverse effects (n=1), Treatment failure (death or liver transplantation) was observed in 17 patients receiving UDCA and in 11 patientsreceiving placebo, Times to death or liver transplantation and to clinicalcomplications were not significantly different in patients receiving UDCA or placebo. Histological analysis indicates that UDCA improved portal inflammation and prevented histological stage progression. By contrast, histological stage as well as ductular proliferation and ductopenia progressed in patients receiving placebo. Conclusions: Although UDCA treatment did not significantly affect time to death or liver transplantation and to clinical complications, the effects on both cholestasis and liver histology suggest that UDCA is safe and may beuseful for preventing the progression of primary biliary cirrhosis.

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Documento generato il 26/01/20 alle ore 01:04:58