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Titolo:
A RANDOMIZED TRIAL COMPARING COLCHICINE AND URSODEOXYCHOLIC ACID COMBINATION TO URSODEOXYCHOLIC ACID IN PRIMARY BILIARY-CIRRHOSIS
Autore:
POUPON RE; HUET PM; POUPON R; BONNAND AM; VANNHIEU JT; ZAFRANI ES; BRESSONHADNI S; MIGUET JP; MATHIEUCHANDELIER C; DOFFOEL M; VETTER D; ZARSKI JP; PARIENTE EA; CAPRON JP; GRANGE JD; DAVID A; DEGOS F; BOUNIN M; DHUMEAUX D; ZAFRANI ES; MYARA A; GUECHOT J;
Indirizzi:
INSERM,U21,16 AVE PAUL VAILLANT COUTURIER F-94807 VILLEJUIF FRANCE HOP ST LUC MONTREAL PQ H2X 1P1 CANADA HOP ST ANTOINE F-75571 PARIS FRANCE SERV ANAT & CYTOL PATHOL CRETEIL FRANCE HOP TENON F-75970 PARIS FRANCE HOP ST JOSEPH,SERV BIOCHIM F-75674 PARIS FRANCE HOP ST ANTOINE,SERV BIOCHIM A F-75571 PARIS FRANCE
Titolo Testata:
Hepatology
fascicolo: 5, volume: 24, anno: 1996,
pagine: 1098 - 1103
SICI:
0270-9139(1996)24:5<1098:ARTCCA>2.0.ZU;2-L
Fonte:
ISI
Lingua:
ENG
Soggetto:
PLACEBO-CONTROLLED TRIAL; D-PENICILLAMINE; DOUBLE-BLIND; PREDNISOLONE TREATMENT; INTERNATIONAL TRIAL; AZATHIOPRINE; PHARMACOKINETICS; CYCLOSPORINE; MULTICENTER; PROGNOSIS;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Citazioni:
40
Recensione:
Indirizzi per estratti:
Citazione:
R.E. Poupon et al., "A RANDOMIZED TRIAL COMPARING COLCHICINE AND URSODEOXYCHOLIC ACID COMBINATION TO URSODEOXYCHOLIC ACID IN PRIMARY BILIARY-CIRRHOSIS", Hepatology, 24(5), 1996, pp. 1098-1103

Abstract

The efficacy of colchicine combined with ursodeoxy-cholic acid (UDCA)and UDCA alone in the treatment of patients with nonadvanced primary biliary cirrhosis (PBC) was evaluated in a 2-year controlled study, Seventy-four patients with PBC who had been treated previously with UDCA(at least 8 months) but still had ab normal Liver test results, especially elevated alkaline phosphatase activity, were randomized to be administered colchicine (1 mg/d, 5 days per week) (n = 37) or a placebo (n = 37), In addition, the patients were treated with UDCA (13-15 mg .kg(-1) . day(-1)). The patients underwent clinical examination and liver tests every 6 months and upper endoscopy and liver biopsy at entryand at 2 years. Procollagen type III aminoterminal peptide (PIIINP), hyaluronic acid, and sulfobromophthalein (BSP) elimination kinetics were determined at entry and after 2 years, After 2 years of treatment, relative to UDCA, colchicine combined with UDCA did not significantly improve symptoms, laboratory findings (serum bilirubin level, alkalinephosphatase and alanine transaminase [ALT] activities, immunoglobulin[Ig] M level), serum markers of fibrosis, or histological features, except lobular inflammation, Colchicine did tend to slightly reduce theprogression of esophageal varices; however, the difference was not significant, BSP elimination kinetics (45-minute retention percentage) was significantly improved when treated with colchicine, During the 2-year study, the only clinical complications were variceal bleeding in one patient administered colchicine and two administered the placebo. Two patients died from nonliver causes, One severe adverse effect (peripheral neuromyopathy) was observed in a colchicine-treated patient, Inconclusion, this study suggests that colchicine appears to provide a slight advantage relative to UDCA alone in patients with nonadvanced PBC.

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Documento generato il 26/11/20 alle ore 19:52:13