Treatment of primary sclerosing cholangitis with low-dose ursodeoxycholic acid: results of retrospective Italian multicentric survey.

BACKGROUND: Data concerning the usefulness and type of drugs employed to treat patients with primary sclerosing cholangitis are controversial. Ursodeoxycholic acid has been shown to be a useful agent, however the drug dosage and its effect on the clinical course are still under debate. AIM: To evaluate the efficacy of low-dose ursodeoxycholic acid in the treatment of primary sclerosing cholangitis. METHODS: We retrospectively analysed data from 86 patients with primary sclerosing cholangitis from eight centres in Italy between 1987 and 1997: 69 were treated with ursodeoxycholic acid (8-13 mg/kg/day), while 17 received symptomatic treatment and served as controls. The effect of therapy was evaluated by standard liver function tests and symptom analysis. RESULTS: Ursodeoxycholic acid treatment was associated with significant improvement in serum alkaline phosphatase (735+/-833 vs. 519+/-448 U/l, p<0.001), gamma-glutamyl transpeptidase (401+/-352 vs. 234+/-235 U/l, p<0.001), aspartate aminotransferase (87+/-70 vs. 56+/-42 U/l, p=0.001), alanine aminotransferase (146+/-139 vs. 76+/-73 U/l, p<0.001), and total bilirubin (1.88+/-2.44 vs. 1.76+/-4.12 U/l, p=0.01); there was also amelioration of fatigue (p=0.007), jaundice (p=0.002), and body weight loss (p=0.002). CONCLUSIONS: Ursodeoxycholic acid, at a dose of 8-13 mg/kg/day was beneficial for the general condition and liver biochemistry of patients with primary sclerosing cholangitis; high-dose ursodeoxycholic acid treatment requires further evaluation

Home artificial nutrition: national guidelines of reference

The present regulations on home artificial nutrition (HAN) in Italy resemble leopard spots, with remarkable differences even in its organization. At present time, in 10% of our country (Piemonte, Veneto, and Molise) there is a specific regional law for HAN, in 65% there are general regional resolutions (Campania, Emilia Romagna, Friuli Venezia Giulia, Marche, Lazio, Liguria, Lombardia, Puglia, Toscana, Trentino Alto Adige, Umbria, and Val d'Aosta), and more than 25% of the country (Abruzzo, Basilicata, Calabria, Sardegna, and Sicilia) lacks efficient prescriptive instruments, which are necessary to appropriately start a HAN treatment with promptness. A difference in procedures can be found also within the same region. A significant problem is represented in general by a lack of a clinical-institutional point of reference assuming responsibility for the treatment. The-sum of these aspects inevitably leads to protracted hospitalization with an increase in national health care costs, and most notably the worsening of the patient's quality of life and that of his family. HAN, owing to the possibility of treating at home, clinically stable patients who would need to be hospitalized only for nutritional treatment, allows us to avoid a prolonged hospitalization, makes the patient's total family, social, and working reintegration easier and considerably reduces health care costs. After Decreto Delegate of 3 June 2003, a development committee was set up at the Direzione generale della valutazione dei Medicinali e della Farmacovigilanza of the Department of Health for formulation of the present document on HAN. Subsequently, the Agenziaper i Servizi Sanitari Regionali was entrusted by the Department of Health to formulate the clinical and organizational guidelines for HAN in order to include them in the "Manuale della Buona Pratica Clinica" (Manual of Good Clinical Practice) and to use them to promote a more homogeneous realization of HAN in the Italian Regions. The development committee, comprising specialists appointed by the Regions, decided on the elaboration of the present recommendations handbook. Now, in light of our work so far and being aware of the necessity for further efforts, we believe that this document can be presented in the relevant institutions to help toward reaching the declared targets in real terms and to represent a point of reference and a clinical and organizational direction for nutritional staff in the field