title: [Rationale for the use of bile salts after cholecystectomy: results of a controlled clinical study using tauroursodeoxycholic acid (TUDCA)].
abstract: Cholecystectomy causes alterations in bile composition. In particular it rises the proportion of highly detergent bile acids with the possible consequence of the manifestation of dyspepsia in a high percentage of patients: this is the well-known post-cholecystectomy syndrome. In this clinical trial we studied the activity and safety of tauroursodeoxycholic acid--TUDCA--(500 mg/die) in the prevention of dyspepsia in cholecystectomized patients, in comparison with no treated group. We enrolled 203 patients (101 TUDCA--group A--and 102 control-group B). The two groups were comparable for age (47.1 years in group A and 50.7 years in group B), sex (m/f: 28/73 and 37/65 in the two groups) and for other characteristics connected to surgical procedures. After operation all patients suffered from dyspepsia symptoms. In patients treated with TUDCA we registered a prompt regression in severity of symptoms when compared with no treated group: in fact we noted a significant difference only at the first control planned after one month from operation. No difference were registered at the other controls (two and three months after operation). Two patients in A and 3 in group B manifested adverse events. In conclusion, the treatment with TUDCA, a new hydrophilic bile acid, seems to contribute to the improvement of clinical course in cholecystectomized patients.
authors.affiliation: Ospedale Fatebenefratelli di Milano.
authors.forename: E
authors.initials: E
authors.lastname: Croce
authors.forename: M
authors.initials: M
authors.lastname: Golia
authors.forename: M
authors.initials: M
authors.lastname: Trignano
authors.forename: G
authors.initials: G
authors.lastname: Occhioni
authors.forename: J
authors.initials: J
authors.lastname: Pisano
authors.forename: R
authors.initials: R
authors.lastname: La Rocca
authors.forename: A
authors.initials: A
authors.lastname: Capomagi
authors.forename: A
authors.initials: A
authors.lastname: De Sanctis
authors.forename: M
authors.initials: M
authors.lastname: Morino
authors.forename: M
authors.initials: M
authors.lastname: Fornari
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002763:Cholecystectomy / Q000009:adverse effects; D004415:Dyspepsia / Q000209:etiology / Q000517:prevention & control*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007536:Isomerism; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000517:prevention & control*; D013655:Taurochenodeoxycholic Acid / Q000627:therapeutic use*
chemical_list: D013655:Taurochenodeoxycholic Acid; C031655:ursodoxicoltaurine
vernacular_title: Razionale all'utilizzo dei sali biliari nel paziente colecistectomizzato: risultati di uno studio clinico controllato con l'impiego dell'acido tauroursodesossicolico (TUDCA).