BACKGROUND/AIMS:To evaluate the efficacy and tolerability of a new 1-week triple therapy regimen consisting of pantoprazole, amoxycillin and metronidazole.METHODOLOGY:The study involved 51 Helicobacter pylori (H. pylori) positive patients (M:30, F:21, mean age: 52.5 years, range: 24-75) affected with duodenal ulcer in active phase. At baseline and 6 weeks after the completion of treatment, clinical assessment, endoscopy with gastric biopsies, rapid urease test, 13C urea breath test, and serum laboratory analyses were performed. All patients were treated with pantoprazole 40 mg once daily, plus amoxycillin 1 gram tid and metronidazole 250 mg tid for 1 week, and pantoprazole 40 mg once daily for a second week. A clinical diary for daily assessment of symptoms and side effects was completed by patients during the treatment period.RESULTS:Three patients were discontinued from the study. Six weeks after therapy, the ulcer was healed in 47 of 48 patients (97.9%, 95% CI = 93.9-100). The cure rates of H. pylori infection, expressed using both the intention-to-treat and per protocol analyses, were 80.4% (95% CI = 69.5-91.3) and 85.4% (95% CI = 75.4-95.4), respectively. The therapy led to a significant, rapid disappearance or reduction in daytime epigastric pain, from 68.8% on day 1 to 82.2% on day 3 (p < 0.001) and in nocturnal epigastric pain, from 80.6% on day 1 to 93.3% on day 3 (p < 0.001). After 2 weeks of treatment, the percentage of patients completely free of pain was 82.2% for daytime pain and 90.3% for nocturnal pain. A rapid improvement in acid regurgitation, heartburn, nausea and vomiting was also observed with a median value of symptom disappearance of 2 days. The percentages of patients completely symptom-free were 37.5% after 1 day, 54.1% after 3 days, 75% after 2 weeks, and 83.3% after 2 months. H. pylori-cured patients showed a significant decrease in the histological activity of both antral (p = 0.0001) and body (p < 0.008) gastritis. Mild to moderate adverse events were reported by 15 patients.CONCLUSIONS:One week triple therapy with pantoprazole in combination with amoxycillin and metronidazole, followed by a second week of pantoprazole, was well tolerated and highly effective for the 1) rapid improvement or resolution of symptoms; 2) healing of the DU; 3) eradication of H. pylori infection; and, 4) reduction of histological signs of chronic gastritis activity.

BACKGROUND/AIMS: Cholesterol (Ch) stones usually do not reform in the common duct after cholecystectomy (1).However, they can form after cholecystectomy, even if not primarily in the common duct, in a long cystic remnant (LCR) acting as a mini-gallbladder.In a recent prospective studyO) recurrent stones initially formed within LCR accounted for 17% of all postcholecystectomy stones.After the wide diffusion of laparoscopic cholecystectomy (LC), which deliberately leaves a long cystic stump, it is presumed that also the number of postcholecystectomy stones related to LCR is going to increase in the long-term period.Since these stones are mostly cholesterol, possible prophylaxis using bile acid therapy could be indicated in selected cases.PATIENTS AND METHODS.One hundred patients with a cystic stump larger than 15 mm after LC were enrolled between 1991 and 1994.Patients with a presumed residual LCR were selected among those showing a particularly long and tortuous cystic duct at i.v.cholangiography.In order to prevent Ch stone reformation in the LCR, 50 patients were treated by tauroursodeoxycholic acid (7 mg/kg/die).The remaining 50 patients didn't receive any treatment and were used as control group.Ultrasound examination was scheduled every year and cholangiography every 3 years.The minimum follow-up was 3 years, maximum 6 years.RESULTS Two patients, both belonging to the control group, were found with recurrent Ch stones, which likely had formed primarily in the cystic duct.In the former, a 56-year-old woman, a single ovoidal 8-mm-large Ch stone was found 36 months after LC; in the latter, a 49-year-old woman, 2 partly faceted Ch. stones, 5 mm in diameter, were found 51 months after LC.In both cases, stones were removed by endoscopic sphincterotomy.No patients belonging to the "treated group" had symptoms or evident stones.On the other hand, it must be stated that none of the patients of the "treated group" followed the scheduled prescriptions, but there were 21 of 50 dropouts because of non compliance and the remaining patients had only cyclical drug consumption.CONCLUSION These data, even if obtained from a prospective study with a follow-up of 3 to 6 years, are still insufficient to establish whether bile acid prophylaxis is effective to prevent cholesterol stone recurrence.Further data and larger numbers are required, in particular to detect which patients are the ideal candidates for this treatment.However, present findings suggest that: (i) cholesterol stones can reform in the cystic remnant both after open surgery and LC, partly irrespective of the length of the stump; (ii) the rate of recurrence is not predictable; (iii) causes facilitating stone recurrence are not yet completely elucidated.

Tauroursodeoxycholic acid has been proposed for the treatment of hepatobiliary disease, but data on the enrichment of biliary tauroursodeoxycholic acid pool and on changes of biliary lipids after administration of the compound are scarce. We studied the composition of biliary lipids in a series of 33 patients with radiolucent stones, before and after treatment with tauroursodeoxycholic acid, 3.5 - 16.6 mg/kg/day for 4 - 6 weeks. Duodenal bile was collected with the Entero-Test after gallbladder contraction. Tauroursodeoxycholic acid administration produced the following dose-dependent effects: a linear decrease of cholesterol saturation (r = 0.59, p < 0.001); a non-linear increase of the percent of ursodeoxycholic acid in bile (r = 0.59, p < 0.001); a non-linear increase of the fraction of ursodeoxycholate conjugated with taurine. At the dose of 11 mg/kg per day, cholesterol saturation was 80%, ursodeoxycholic acid represented about 45% of biliary bile acids, and about half of UDCA was conjugated with taurine. Biliary bile acids were repeatedly measured in 6 patients during long-term treatment with 9.7 - 12.1 mg/kg. The fraction of tauroursodeoxycholic acid decreased progressively from 67.6% +/- 10.5 to 29.1% +/- 5. Tauroursodeoxycholic acid is as effective as ursodeoxycholic acid on a molar basis in reducing biliary cholesterol saturation and in enriching bile with ursodeoxycholate. Moreover, tauroursodeoxycholic acid administration is associated with higher concentrations of tauroconjugates in the bile than those previously reported by feeding the free bile acid.