Objectives: Azithromycin, a new antibiotic chemically related to erythromycin, has been proposed for the cure of Helicobacter pylori, achieving high gastric tissue levels (above the MIC for H. pylori) after oral administration. The aim of the study was to establish whether azithromycin plus metronidazole in association with either omeprazole or bismuth subcitrate is useful in curing H. pylori infection of the stomach. Patients and Methods: The study involved 132 dispeptic patients who proved to be H. pylori infected by antral and corpus histology (Giemsa, modified) and rapid urease test (CLO test); the Sydney system was used to classify the gastritis. Sixty-three patients received bismuth subcitrate 120 mg q.i.d. for 14 days plus azithromycin 500 mg o.d. for the first 3 days plus metronidazole 250 mg q.i.d. for the first 7 days; 69 patients received omeprazole 40 mg for 14 days plus azithromycin 500 mg o.d. for the first 3 days plus metronidazole 250 mg q.i.d. for the first 7 days. Patients were well matched for common clinical variables. Cure of H. pylori infection was assessed by the same methods 2 months after completion of treatment. Results: Eleven patients dropped out of the study, only one reporting side effects (nausea, vomiting, and epigastric pain). Cumulative ''per protocol'' cure rate was 66.1% (CI 95%, 58.5-75.3%). There was no statistically significant difference between the two treatment groups: 58.9% (CI 95% 48.4-74.6%) versus 72.3% (CI 95%, 60.7-82.5%). Intention to treat does not substantially modify results. Few side effects were recorded. Cured patients showed a significant reduction in the activity of gastritis. Conclusion: azithromycin, combined with omeprazole and metronidazole, the cure rate of H. pylori was about 70%. The cure of H. pylori infection improves the activity of gastritis.

Background: Common etiopathogenic factors may explain the association of systemic sarcoidosis with inflammatory bowel disease. Methods: We report two cases of such an association: one of sarcoidosis that developed 2 years after proctocolectomy for ulcerative colitis and one of sarcoidosis and Crohn's colitis. Factors like increased cellular immunity or circulating immunocomplexes or autoantibodies may have a role. Exogenous agents or familiarity may also be involved. Conclusions: It is postulated that the association between sarcoidosis and inflammatory bowel disease (both ulcerative colitis and Crohn's disease) does not occur by chance alone and that the two conditions may share some genetic or immunologic alterations. The two diseases, however, follow an independent clinical course.

Contractor's risk management capability (RMC) reflects the sophistication of contractor's understanding of risk portfolio and how to manage those risks. This paper aims to develop a RMC assessment model for subway project contractors and to assess the current overall RMC of subway project contractors in mainland China. To achieve the objectives, a questionnaire survey was conducted and data were collected from 58 respondents. The empirical research findings showed that the overall RMC of subway project contractors can be regarded as between “low” and “medium”. In addition, currently in subway projects' area, contactor's risk analysis capability is relatively more mature than other capabilities. However, contractors' risk management attitude is relatively less mature than other capabilities. Assessing the current RMC of subway project contractors can be used to identify the priority or weakest areas needed for improvement.

A 6-month, open, randomized study was performed to evaluate different dosage regimens for maintenance therapy with omeprazole in patients refractory to treatment with standard histamine2 (H2)-blockers. One hundred two patients with gastric and/or duodenal ulcers, unhealed after 8 weeks of full-dose H2-antagonist treatment but healed after a further 4 to 8 weeks of omeprazole 20–40 mg/d, were randomized into four treatment groups: omeprazole 20 mg once daily (group A), omeprazole 20 mg every other day (group B), omeprazole 20 mg twice weekly (group C), and ranitidine 150 mg at bedtime (control). Endoscopic and clinical examinations were performed at 3 and 6 months and at every symptomatic relapse. Eleven patients dropped out for reasons of noncompliance. Relapses were detected in 14.8% of 27 cases in group A, 19.4% of 31 cases in group B, 42.9% of 21 cases in group C, and 66.7% of 12 controls. The better outcomes in groups A and B, as compared with group C and the control group were statistically significant. These findings confirm the efficacy of omeprazole in maintenance therapy for refractory ulcers and suggest that drug administration should be daily or every other day, as twice-weekly dosages are less effective.

This multicenter, prospective, randomized, open, long-term study compared the efficacy of sucralfate (1 g twice daily) versus ranitidine (150 mg once daily) versus no therapy in patients with gastric ulcer. The results at the end of the first of a scheduled 3-year follow-up are reported. Two hundred ninety patients with healed GU entered the 3-year, open study. Ninety patients were randomly assigned to receive sucralfate, 105 to receive ranitidine, and 95 to receive no treatment. The three groups proved well matched in terms of standard clinical data. Fifty patients were withdrawn from the study during the first year; a gastric neoplasm was diagnosed in four patients. At months 3, 6, and 12 of therapy, the remission rates were, respectively, 94.8%, 86.2%, and 79.6% with sucralfate; 98.9%, 91.6%, and 82.5% with ranitidine; and 89.3%, 80.7%, and 66.9% with no treatment. Sucralfate was as effective as ranitidine (P = NS), and both drugs produced higher cumulative remission rates than no treatment (P < 0.06 and P < 0.01, respectively). We conclude that 1 g of sucralfate twice daily was as effective as 150 mg of ranitidine once daily in maintaining GU remission for 1 year; both treatments led to a better outcome than no treatment.

Objective: To evaluate the safety and efficacy of nizatidine 150 mg as a maintenance therapy for gastric ulcer. Design: A 1-year prospective, multicentre, randomized, double-blind study versus placebo. All patients were examined every 3 months with endoscopy, clinical check-ups and blood tests. Setting: Outpatients followed-up by 22 endoscopic units in north-eastern Italy. Patients: Adult patients with an endoscopically documented healed gastric ulcer, obtained within 8 weeks by nizatidine 300 mg. Two hundred and forty-one patients entered the study: 123 treated with nizatidine 150 mg, 118 with placebo; one was excluded. Thirty-eight patients withdrew during follow-up, 202 concluded the study. Main outcome measures: Age, gender, height, weight, family history of ulcer disease, smoking habit, alcohol consumption, length of gastric ulcer history, previous ulcer treatment, number of ulcers, ulcer size and location, current drug therapy and common laboratory tests were taken into account. Results: Nizatidine proved significantly better than placebo in preventing gastric ulcer relapse, i.e. remission rate was 94 versus 79%, 81 versus 68%, 79 versus 640/o and 77 versus 52% after 3, 6, 9 and 12 months, respectively (P = 0.001). Antacid consumption, symptoms, compliance and adverse events were comparable in both groups; cigarette smoking was the major relapse risk factor in both treatment groups. Conclusion: Long-term nizatidine 150 mg per day proved safe and effective in containing gastric ulcer relapse compared with placebo: smoking habit is the most important risk factor in gastric ulcer relapse.

UNLABELLED Aim of the present study has been to investigate the possible modifications of peptic secretion after a period with H2 blockers and omeprazole, evaluating in the same patient pepsinogen group A levels in gastric mucosa and pepsin in gastric juice. 54 active duodenal ulcer were studied: during an upper gastrointestinal endoscopy a sample of gastric juice and one fundus biopsy were taken before and after four weeks 300 mg/daily ranitidine (23 patients), 40 mg/daily famotidine (7 patients), 300 mg/daily nizatidine (12 patients) therapy and 40 mg/daily omeprazole (12 patients) therapy. RESULTS H2-blockers and omeprazole treatment determines a non statistically significant decrease of pepsin in gastric juice and in pepsinogen group A in gastric mucosa.

A retrospective study of 31 consecutive bleeding duodenal ulcer (DU) patients and, as controls, 62 active DU subjects without bleeding episodes was conducted in order to ascertain whether bleeding DU patients have particular clinical or functional characteristics. The patients were followed for 15.6 and 17.4 months, respectively, after diagnosis. The following parameters were taken into account: sex, age, family history of ulcer, blood group (ABO system), ulcer pain, nonsteroidal anti-inflammatory drug (NSAID) consumption, cigarette smoking, alcohol and coffee consumption, ulcer site, fasting serum gastrin and pepsinogen group A, basal acid output (BAO), and maximal acid output (MAO). Statistics were gathered using the Student's t test and Fisher's exact test. Bleeding DU patients had less ulcer pain (P < 0.005) and used more NSAIDs (P < 0.05) than controls. All other clinical and functional data considered in both groups were comparable. Results showed that NSAID consumption was very dangerous in our DU patients even though bleeding episodes were observed. Usually no pain is felt immediately before hemorrhage, and cigarette smoking does not appear to affect this complication of DU.

Gastric bicarbonate secretion has been evaluated by Feldman's method in 48 duodenal-ulcer patients. The relationship between smoking, clinical ulcer outcome (healing and recurrence) and bicarbonate secretion has been analysed. Heavy smokers secreted higher bicarbonate ions than did non-smokers. High-relapsing patients produced lower bicarbonate output. These preliminary data suggest that an impaired gastric bicarbonate secretion is associated with smoking, a well-known ulcer-associated factor; further-more, it may single out high-relapsing duodenal ulcer patients.

Objective: The aim of this study was to evaluate the clinical correlations between group I pepsinogens (PGI) and pepsin concentrations (determined on tissue samples of gastric mucosa) and the gender, blood group, family history of ulcer, smoking habit, alcohol intake and previous bleeding episodes in peptic ulcer patients.Patients: The study involved 195 patients (43 with gastric ulcer, 152 with duodenal ulcer) showing endoscopic evidence of healed ulcer.Design: One biopsy sample was obtained from the upper part of the body of the stomach in each patient for the determination of PGI and pepsin concentrations. Statistical evaluation was based on Wilcoxon's test.Results: Gender, blood group and family history of ulcer did not modify PGI or pepsin levels, though duodenal ulcer patients with a history of bleeding showed increased PGI (30.65, range; 5.5-187.0 versus 17.35, 6.5-280.6) and pepsin (90.0, 10-215 versus 57.5, 6.8-230) concentrations.Conclusion: This study suggests that there is no correlation between genetically related factors, such as gender, blood group and family history, and peptic activity in the gastric mucosa but emphasized a relationship with bleeding which is an important complication in ulcer disease.

This multicenter, prospective, randomized, open, long-term study compares sucralfate (2 g daily) with ranitidine (150 mg daily) and no treatment in gastric ulcer (GU). We report the results of the second year of a scheduled 3-year follow-up, the outcome of the 1 st year has been reported earlier. The 24-month follow-up was completed by 142 patients who were continuously either treated with the drug randomly assigned at the beginning of the study or left untreated (i.e. 32 patients took 150 mg ranitidine at bedtime, 29 took 1 g sucralfate twice daily and 81 were left untreated, 23 of whom came from the ranitidine group, 19 from the sucralfate group and 39 from the untreated group). Seven patients dropped out and 26 subjects relapsed (5 under ranitidine, 4 under sucralfate and 17 untreated cases). Ranitidine versus previous ranitidine, sucralfate versus previous sucralfate and each one versus no treatment showed comparable relapse rates. An additional study, using Cox's models, showed that three variables have a significant correlation with relapse during the 1 st year of follow-up: therapy carried out (p = 0.0025), symptoms (p = 0.0047) and family history of ulcer (p = 0.0392). In conclusion, both ranitidine 150 mg and sucralfate 2 g proved effective in reducing GU relapse as compared with no treatment, an effect which does not seem to persist during the 2nd year of therapy, when the 'no treatment' option may be taken into account.

UNLABELLED:A substantial number of duodenal ulcer (DU) patients relapse despite maintenance treatment with antisecretory drugs. The influence of certain risk factors and the heterogeneity of the disease could explain such behavior. The present prospective, open study compares the one-year clinical outcome (with upper GI endoscopy at the beginning of the study, at 6 and 12 months, and at every symptomatic relapse) of four groups of DU subjects, consecutively recruited from December 1987 to December 1988, separated in accordance with whether or not a bleeding DU episode had previously occurred, and whether or not an evaluation of gastric acid secretion had been made. Thus, Group I (17 patients; 12 males, 5 females) included heavy smokers and/or gastric acid hypersecretors; Group II (13 patients; 12 males, 1 female) non- or light smokers non-hypersecretors; Group III (34 patients; 22 males, 12 females) subjects with unknown gastric acid secretion; Group IV (33 patients; 30 males, 3 females) previously bleeding DU patients. All patients, except those in Group II (who were left untreated), were given ranitidine 150 mg at bedtime. The outcome of Groups I+II was compared with that of Group III (considered as "standard therapy") and Group IV patients, the latter presumably with a low risk of relapse because of the low prevalence of smokers.STATISTICS:Chi-square test, Fisher's exact test, analysis of variance and the logrank test. During the year of follow-up, 27/97 patients withdrew from the study, while 18 had a DU relapse (remission rates 82.1% +/- 7.4% in Groups I+II, 70.5% +/- 8.4% in Group III, 87.5% +/- 5.9% in Group IV).(ABSTRACT TRUNCATED AT 250 WORDS)

The clinical course of gastric and duodenal ulcer and the efficacy of H2 blockers in ulcer healing and the prevention of relapse in cirrhotic liver patients were studied. Seventy-four cirrhotic patients with endoscopically proven acute gastric ulcer (30), duodenal ulcer (34) or a combination of both gastric and duodenal ulcers (10) were treated for six weeks with either Cimetidine 800 mg/daily (27) or Ranitidine 300 mg/daily (47). Of the 77 patients 49 (66.2%) were healed after therapy, 11 cases (14.8%) remained unhealed even after two additional cycles of the same treatment and four were lost to follow-up. After an endoscopically proven healing of the active ulcer, 51 patients took part in the long-term study over a mean period of 24 months: 21.5% of the 27 patients were treated with a maintenance dosage of H2 blockers and 29.1% of the 24 patients left without therapy relapsed during the first year. We conclude that the ulcer healing rate with H2 blockers is lower and the relapse rate higher in cirrhotic patients than in the general ulcer population.

Cimetidine 800 mg was compared with ranitidine 300 mg in single nighttime doses in the treatment of active duodenal ulcer. One hundred patients entered the study, 50 in each treatment group. The two treatment groups were comparable regarding the common clinical and biochemical parameters. Three patients dropped out: two in the cimetidine group and one in the ranitidine group. After six and 12 weeks of treatment 72% and 92% of patients, respectively, were healed in the cimetidine group, as opposed to 96% and 98% in the ranitidine group. The difference was statistically significant at the sixth week but not at the 12th week. No differences were found in the symptomatic improvement between the two drugs. Based on our results, we calculated that the 50 patients treated with ranitidine for six weeks spent a total of $945 more for therapy than the 50 cimetidine-treated patients. The choice of one drug rather than another should, in our opinion, be made on the basis of a cost/benefit evaluation, according to the current retail prices.