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Notes: Background : Triple therapy with proton pump inhibitor, clarithromycin and amoxicillin and, in the event of eradication failure, quadruple therapy with proton pump inhibitor, bismuth, tetracycline and metronidazole have been proposed in Maastricht as the optimal sequential treatment of Helicobacter pylori infection.Aim : To compare two second-line regimens with quadruple therapy.Methods : One hundred and eighty patients with a previous failed course of standard therapy were randomly given one of the following 7-day treatments: ranitidine bismuth citrate 400 mg b.d. plus amoxicillin 1 g b.d. and tinidazole 500 mg b.d. (RBCAT), pantoprazole 40 mg b.d. plus amoxicillin 1 g b.d. and levofloxacin 500 mg/day (PAL) and pantoprazole 40 mg b.d., bismuth citrate 240 mg b.d., tetracycline 500 mg q.d.s. and metronidazole 500 mg b.d. (PBTM). The eradication rate was assessed by 13C-urea breath test. Side-effects and compliance were evaluated by a standardized questionnaire and by counting returned medication.Results : The RBCAT, PAL and PBTM groups achieved mean intention-to-treat eradication rates of 85%, 63% and 83%, respectively (P 〈 0.05 for PAL vs. either RBCAT or PBTM). Compliance was optimal in all patients, although side-effects were more commonly observed in the PBTM group than in the other two patient groups (P 〈 0.0001).Conclusions : Both RBCAT and PBTM can be used as second-line therapies. Conversely, PAL did not achieve satisfactory eradication rates.

Notes: Background : Eradication rates of Helicobacter pylori with standard triple therapy are disappointing, and studies from several countries confirm this poor performance.Aim : To assess the eradication rate of a new sequential treatment regimen compared with conventional triple therapy for the eradication of H. pylori infection.Methods : One thousand and forty-nine dyspeptic patients were studied prospectively. H. pylori-infected patients were randomized to receive 10-day sequential therapy [rabeprazole (40 mg daily) plus amoxicillin (1 g twice daily) for the first 5 days, followed by rabeprazole (20 mg), clarithromycin (500 mg) and tinidazole (500 mg) twice daily for the remaining 5 days] or standard 7-day treatment [rabeprazole (20 mg), clarithromycin (500 mg) and amoxicillin (1 g) twice daily]. H. pylori status was assessed by histology, rapid urease test and 13C-urea breath test at baseline and 6 weeks or more after completion of treatment.Results : Higher eradication rates were found with the sequential regimen compared to the standard regimen (intention-to-treat: 92% vs. 74%, P 〈 0.0001; per protocol: 95% vs. 77%, P 〈 0.0001). Higher eradication rates were also seen in patients with peptic ulcer disease and non-ulcer dyspepsia. In both treatments, compliance was similar (〉 90%), as was the rate of side-effects, which were mild.Conclusions : This 10-day sequential treatment regimen achieves high eradication rates in peptic ulcer disease and non-ulcer dyspepsia.

Notes: Background:  13C breath test analysis requires accurate 13CO2 measurements.Aim:  To perform a multicentre study to evaluate the repeatability and reproducibility of breath 13CO2 analysis.Methods:  Two series of 25 paired randomly coded tubes (each consisting of 23 13CO2-enriched breath samples and two samples of standard reference pure CO2 with certified δ13CPDB) were sent to participating centres for 13CO2 measurement. Each series of tubes was analysed 10 days apart. The repeatability and reproducibility of 13C measurements was assessed by Mandel's k and h statistics.Results:  Twenty-two centres participated in the study: 18 showed good inter- and intra-laboratory variability, whilst four showed abnormally high inter- or intra-laboratory variability. Breath test results were also significantly affected by the accuracy of the 13C analytical procedures.Conclusions:  A low accuracy of 13C measurements may significantly affect the results of breath tests, leading to inappropriate clinical decisions. Standardization of 13C analysis is required to guarantee optimal 13C measurements and accurate 13C breath test results.

Notes: Triple therapy with proton pump inhibitor, clarythromycin, and amoxicillin has been proposed in Maastricht as the first-line treatment of H. pylori infection.〈section xml:id="abs1-2"〉〈title type="main"〉Aim:To determine whether ranitidine bismuth citrate (RBC) based regimens may be used as second-line treatments after ‘Maastricht therapy’ failure.〈section xml:id="abs1-3"〉〈title type="main"〉Methods:A total of 285 patients with H. pylori infection were given a 7-day treatment with pantoprazole 40 mg b.d., clarythromycin 500 mg b.d., and amoxicillin 1 g b.d. Patients who were still infected were randomly given one of the following 14-day treatments: RBC 400 mg b.d. plus amoxicillin 1 g b.d. and tinidazole 500 mg b.d. (RAT group), RBC 400 mg b.d. plus amoxicillin 1 g b.d. and clarythromycin 500 mg b.d. (RAC group), and RBC 400 mg b.d. plus clarythromycin 500 mg b.d. and tinidazole 500 mg b.d. (RCT group).〈section xml:id="abs1-4"〉〈title type="main"〉Results:The ‘Maastricht therapy’ achieved an eradication rate of 59% (95% CI: 54–65) on intention-to-treat analysis. The RAT, RAC, and RCT regimens achieved eradication rates of 81% (95% CI: 67–94), 43% (95% CI: 26–60), and 62% (95% CI: 44–80), respectively, on intention-to-treat analysis. Patient compliance was optimal in RAT and RAC groups.〈section xml:id="abs1-5"〉〈title type="main"〉Conclusion:RBC plus tinidazole and either amoxicillin or clarythromycin can be used as second-line therapies after failure of the Maastricht triple therapy.

Notes: Triple therapy with proton pump inhibitor, clarithromycin and amoxicillin has recently been proposed in Maastricht as first-line treatment for H. pylori infection.〈section xml:id="abs1-2"〉〈title type="main"〉Aim:To determine predictors of unsuccessful eradication.〈section xml:id="abs1-3"〉〈title type="main"〉Methods:Two hundred and forty-eight patients underwent endoscopy with biopsies for rapid urease test, histology and culture with antibiotic susceptibility tests, and 13C-UBT. All infected patients were given pantoprazole (40 mg b.d.), clarithromycin (500 mg b.d.) and amoxicillin (1 g b.d.) for 1 week. Eradication was assessed by UBT at 4–6 weeks after therapy.〈section xml:id="abs1-4"〉〈title type="main"〉Results:One hundred and sixty-two of 248 patients (65%) were infected. Culture was positive in 144 (89%). Prevalence rates of metronidazole, clarithromycin and amoxicillin resistance were 14, 8 and 3%, respectively. Eradication rates (95% CI) were 63% (54.7–70.6) by intention-to-treat analysis and 67% (59.4–75.4) by per protocol analysis. Drug compliance was excellent and side-effects were mild. Age ≥ 45 years (OR: 2.35, CI: 1.30–4.25), smoking (OR: 1.37, CI 1.01–1.87) and high pre-treatment UBT results (OR: 1.36, CI: 1.08–1.72) were independent predictors of eradication failure. Gender, endoscopic findings, alcohol intake, and clarithromycin and amoxicillin resistance did not predict treatment failure.〈section xml:id="abs1-5"〉〈title type="main"〉Conclusion:Despite the low prevalence of primary antibiotic resistance in our geographical area, triple therapy with pantoprazole, amoxicillin and clarithromycin achieves low eradication rates. Smoking, age and pre-treatment UBT results are predictors of potential eradication failure.

Notes: Background : The urea breath test is routinely used for diagnosing or confirming the eradication of Helicobacter pylori.Aim : To evaluate the appropriateness of urea breath test referrals.Methods : The age, sex, symptoms, endoscopic findings, use of non-steroidal anti-inflammatory drugs, family history of gastric cancer or H. pylori infection and concomitant diseases of patients referred for urea breath testing in a 1-year period were recorded. The appropriateness of urea breath test referrals was judged according to Maastricht guidelines.Results : One thousand, three hundred and twenty subjects (47 ± 16 years) were referred in 2001: 578 (43.8%) for the diagnosis and 742 (56.2%) for confirmation of the eradication of H. pylori. The urea breath test was considered to be appropriate in 836 (63.3%) patients, inappropriate in 192 (14.5%) and appropriate but avoidable in 292 (22.1%). The appropriateness ratios of urea breath test referrals were 4.6 and 9.0 (P 〈 0.0001) for general practitioners and gastroenterologists, respectively. Of the patients (n=230) with uninvestigated dyspepsia, who underwent urea breath testing according to a ‘test and treat’ strategy, 98 (42.6%) presented at least one risk factor for organic disease.Conclusions : In Italy, nearly 36% of urea breath test referrals are inappropriate or could be avoided if all dyspeptic patients with risk factors were referred for endoscopy or all dyspeptic patients undergoing endoscopy were tested for H. pylori infection with biopsy methods. Both general practitioners and, to a lesser extent, gastroenterologists require educational programmes to deal effectively with H. pylori.

Notes: Background: Aim of this work was to improve standardization of the 13C-urea breath test (13C-UBT) by evaluating the effect of drug administration, feeding and colonic ureolysis on the UBT results. Methods: Three different studies were performed. First, a 13C-UBT was performed in 41 Helicobacter pylori infected subjects before and after 1 day of therapy with sucralfate (5 g), colloidal bismuth (600 mg), amoxycillin (2.5 g) or omeprazole (40 mg). Second, a 13C-UBT was performed in 10 H. pylori-positive patients after an overnight fast and repeated 2 h after lunch. Finally, a 13C-UBT was carried out in seven healthy volunteers, with breath sampling prolonged to 6 h to investigate colonic bacterial ureolysis. Results: Even a short course of drugs specific for H. pylori may result in a falsely negative 13C-UBT. Feeding does not interfere with the 13C-UBT in infected subjects. No significant 13C-urea breakdown by colonic bacteria is observed during the 13C-UBT when it is prolonged to 6 h. Conclusion: The 13C-urea breath test is a sensitive clinical tool for the non-invasive diagnosis of H. pylori infection. It is unaffected by feeding or colonic ureolysis. However, false negative results are likely even after 1 day of therapy with bactericidal, ‘cytoprotective’ or antisecretory drugs.

Notes: Aim : To evaluate the efficacy of a long-term course of lamivudine monotherapy in patients with anti-HBe-positive chronic hepatitis B who relapsed after the first course of either lamivudine/interferon (n = 16; Group 1) or lamivudine (n = 20; Group 2).Methods : Biochemical and virological tests were performed every 3 months. At baseline and breakthrough, the region coding for the YMDD amino acid motif was sequenced.Results : The length of re-treatment averaged 24 months. The virological response peaked at 6 months (94.4%), and declined to 66.7% and 50% at 12 and 24 months, respectively. The rates of breakthrough were 2.9%, 31.4% and 48.6% at 6, 12 and 24 months, respectively. By the second year, responders amounted to 62.5% and 40% in Groups 1 and 2, respectively (P = 0.10). The 18 responders at month 24 are still on therapy after 25–51 months of treatment: 14 still maintain a response, nine from Group 1 and five from Group 2.Conclusions : Re-treatment with lamivudine can control viral replication. This effect is maintained for the initial 12 months in two-thirds of patients, but afterwards the duration of response lessens due to the development of viral resistance.

Notes: Background : Anti-Saccharomyces cerevisiae mannan antibodies have been proposed as a new serological marker associated with Crohn's disease. However, their clinical value is still unclear; furthermore, a standardization of anti-S. cerevisiae mannan measurements is lacking.Aim : In this study, we aimed to assess the correlation between anti-S. cerevisiae mannan detection and specific clinical features in Crohn's disease and ulcerative colitis. Moreover, we tested the concordance of four different anti-S. cerevisiae mannan assays.Materials and methods : Serum samples from 196 patients with Crohn's disease, 197 patients with ulcerative colitis and 100 unrelated healthy controls were tested for anti-S. cerevisiae mannan with a standard enzyme-linked immunosorbent assay method (Lille) by one of the authors (VP). Subsequently, 60 randomly selected serum samples (27 Crohn's disease, 28 ulcerative colitis and five healthy controls) were tested for anti-S. cerevisiae mannan with three different commercial kits.Results : With the Lille assay, anti-S. cerevisiae mannan were detected in 100 of 196 patients with Crohn's disease (51%; P 〈 0.0001 vs. controls), 32 of 197 patients with ulcerative colitis (16%; P 〈 0.02 vs. controls), and six of 100 controls (6%). No correlation between presence of anti-S. cerevisiae mannan and specific clinical features was found in both ulcerative colitis and Crohn's disease patients. The percentages of anti-S. cerevisiae mannan detected with four different assays ranged from 28 (Bouty) up to 43% (Inova), but these differences did not reach statistical significance. The concordance rate of anti-S. cerevisiae mannan detection in the four assays was very low (11 concordant results of 60 samples, 18.3%) (k = 0.15). No improvement of the concordance rate wasobtained by modifying the suggested cut-off values (k = 0.20).Conclusion : In this study, we confirm that anti-S. cerevisiae mannan are significantly more frequent in Crohn's disease patients compared with ulcerative colitis patients (P 〈 0.0001) and controls. However, no correlation with clinical features was found in both ulcerative colitis and Crohn's disease. The low prevalence of anti-S. cerevisiae mannan, at least in our population, and the low concordance rate between different assays, makes the clinical role of this marker questionable.