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    Sergio Vigneri

    Endoscopic studies were performed to determine whether changes occurred in the duodenum related to portal hypertension in patients with liver cirrhosis. The total of 271 patients studied were subdivided into three groups: 83 patients with... more
    Endoscopic studies were performed to determine whether changes occurred in the duodenum related to portal hypertension in patients with liver cirrhosis. The total of 271 patients studied were subdivided into three groups: 83 patients with liver cirrhosis and portal hypertension, 53 with liver cirrhosis but no portal hypertension, and 135 controls. In the duodenum of cirrhotic patients with portal hypertension several changes were observed on endoscopy that were also present in the other two groups. Atrophy and vascular malformations, however, were present only in the duodenum of cirrhotic patients with portal hypertension, although in only a few patients and with statistical significance only for vascular malformations (p less than 0.01, phi = 0.21). Eleven percent of the patients had more than one endoscopic finding, but the associations of findings were without statistical significance. No statistically significant correlation was observed between the clinical severity of cirrhosis or the severity of esophageal varices and the endoscopic findings. Finally, there was no statistically significant difference between the histological findings of duodenitis in the three groups of patients.
    Proton pump inhibitors (PPIs) are antisecretory agents that are widely used in the short- and long-term management of gastroesophageal reflux disease (GERD) to relieve symptoms, heal esophagitis, and prevent complications, such as... more
    Proton pump inhibitors (PPIs) are antisecretory agents that are widely used in the short- and long-term management of gastroesophageal reflux disease (GERD) to relieve symptoms, heal esophagitis, and prevent complications, such as strictures and Barrett’s esophagus. The total healthcare costs of GERD are high, especially for maintenance treatment. Therefore, the choice of cost-effective therapeutic options is an ineluctable challenge for public health authorities, third-party payers, and patients. In some European Union countries, a recent trend of public health authorities is to promote the choice of less expensive PPIs, regardless of their antisecretory potency – this in spite of the evidence that newer PPIs provide superior symptom relief and esophageal erosion healing compared to earlier drugs. Several large clinical trials have demonstrated the superiority of esomeprazole over other PPIs at standard doses for both initial and continuous maintenance therapy in patients with mode...
    Gastro-oesophageal reflux disease (GORD), characterized by frequent episodes of heartburn, imposes considerable burdens on both patients and health services. In addition to both patients and health services. In addition to... more
    Gastro-oesophageal reflux disease (GORD), characterized by frequent episodes of heartburn, imposes considerable burdens on both patients and health services. In addition to both patients and health services. In addition to gastrointestinal symptoms, GORD may precipitate a variety of extra-oesophageal complications, such as asthma and chest pain, which can significantly impair patients' quality of life. This paper aims to describe the impact of heartburn on patients' health-related quality of life (HRQL) in Italy. Consecutive patients from general practices and gastroenterology clinics who were experiencing heartburn were invited to complete a selection of standardized patient-reported outcomes instruments, including Italian translations of the Gastrointestinal Symptom Rating Scale (GSRS), Short-Form 36 (SF-36), Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD) and Hospital Anxiety and Depression (HAD) scale. Frequency and severity of heartburn in the preceding week were recorded. Assessments were completed by 152 patients (mean age, 47 years), of whom 60% were female. Sixty-one per cent had moderate symptoms and 74% had symptoms on three or more days in the previous week. Patients were most bothered by reflux, abdominal pain and indigestion. As a result of their symptoms, patients experienced impaired vitality, sleep disturbance and other alimentary problems. This led to impaired HRQL across all but one SF-36 domain. According to the HAD scale, 21% of patients were depressed and 19% were anxious. GORD substantially impairs many aspects of HRQL, including sleep, vitality and emotional health.
    GASTROENTEROLOGY 1999;117:746-747
    This study was carried out in order to compare the antisecretory effect of a single bedtime dose of roxatidine 150 mg and ranitidine 300 mg and to assess the relationship between the degree and the duration of acid suppression and the... more
    This study was carried out in order to compare the antisecretory effect of a single bedtime dose of roxatidine 150 mg and ranitidine 300 mg and to assess the relationship between the degree and the duration of acid suppression and the healing rates obtained in duodenal ulcer patients treated with the above regimens. Sixty-three patients with endoscopically proven ulcer underwent 24-h gastric pH-metry on day 0, day 1, and day 28 of treatment with both roxatidine and ranitidine. Ulcer healing was checked endoscopically after 4 weeks of therapy. RESULTS: Eight patients did not complete the study, leaving 55 patients eligible for final analysis, 28 in the roxatidine group and 27 in the ranitidine group. Duodenal ulcers were healed in 24--28 (85%) patients of the former and in 22--27 (81%) patients of the latter group (p minus sign NS). Gastric pH was significantly higher (p < 0.001) than basal values on days 1 and 28 with both H2-antagonists. The 24-h pH levels did not differ between day 1 and day 28 with both roxatidine and ranitidine. There was also do difference between the two active treatments. The pattern of gastric acidity significantly differed (p < 0.01) between responder (n = 46) and nonresponder (n = 9) patients to both H2-blockers, and this difference was mainly sustained by nocturnal pH. CONCLUSIONS: A bedtime close of roxatidine 150 mg and ranitidine 300 mg was able to heal more than 80% of duodenal ulcers within 4 weeks of treatment. The lack of tolerance to H2-blockers in duodenal ulcer patients contributes to this good result. The antisecretory effect of H2-antagonists is reduced in nonresponder patients with respect to responder patients and this is mainly due to an impaired control of nocturnal acidity.
    Published data on the regression of the extent of duodenal gastric metaplasia (DGM) after the eradication of Helicobacter pylori infection and the normalization of the organism-induced alterations in gastric physiology are scanty and... more
    Published data on the regression of the extent of duodenal gastric metaplasia (DGM) after the eradication of Helicobacter pylori infection and the normalization of the organism-induced alterations in gastric physiology are scanty and controversial. Therefore, we decided to assess the circadian pattern of gastric acidity and the degree of DGM before and one year after H. pylori eradication in a group of duodenal ulcer patients. Fifteen consecutive H. pylori-positive patients with endoscopically proven duodenal ulcer were recruited for this study. The diagnosis of H. pylori infection was based on CLO-test and histology, and DGM was assessed on four bulb biopsies taken before and one year after H. pylori eradication. At the same time, gastric pH was measured by 24-hr continuous intraluminal recording. H. pylori eradication was ascertained by means of concomitant negative CLO-test and histology performed both four weeks after the end of the eradicating treatment and at the one-year endo...
    A high prevalence of duodenal ulcer has been reported in patients with chronic pancreatitis. Data from previous studies on gastric acid secretion in these patients have provided conflicting results, and the potential role of H. pylori... more
    A high prevalence of duodenal ulcer has been reported in patients with chronic pancreatitis. Data from previous studies on gastric acid secretion in these patients have provided conflicting results, and the potential role of H. pylori infection has been poorly investigated. The aim of this study was to assess the circadian pattern of gastric acidity and the prevalence of H. pylori infection in a group of patients suffering from this disease. Thirty-five patients with chronic pancreatitis ascertained by means of pancreatic calcifications or ductal alterations revealed by ERCP were recruited for this prospective study. They underwent 24-hr gastric pH-metry with glass minielectrodes positioned in the gastric corpus, and their profile of gastric acidity was compared with that of 35 healthy subjects, matched for age and sex. H. pylori infection was diagnosed by means of serology. There was no statistical difference (P = NS) in gastric pH of circadian, nocturnal, daytime, and postprandial...
    In analogy with proton pump inhibitors, H2-antagonists may also be responsible for false-negative results on urea breath test for the detection of Helicobacter pylori. In this study we assessed the frequency and duration of false-negative... more
    In analogy with proton pump inhibitors, H2-antagonists may also be responsible for false-negative results on urea breath test for the detection of Helicobacter pylori. In this study we assessed the frequency and duration of false-negative urea breath tests in patients given different doses of ranitidine. A total of 120 consecutive dyspeptic patients infected with H. pylori on the basis of concomitant positive results of CLO-test, histology and urea breath test were recruited for this prospective, open, parallel-group study performed in an urban university gastroenterological clinic. They were randomized to receive an acute treatment with either ranitidine 300 mg once a day in the evening, ranitidine 300 mg once a day in the morning, ranitidine 150 mg b.i.d., or ranitidine 300 mg b.i.d. for 14 days. The urea breath test was performed on day 14 while patients were still taking ranitidine, and on day 21, 1 wk after completion of therapy. The test was repeated on day 28 in those patients who were still negative on day 21. Duplicate breath samples were collected after ingestion of 75 mg 13C-urea plus citric acid. A delta value >5/1000 was considered positive. Of 118 patients infected with H. pylori, 15 (13%) had a negative urea breath test on day 14. The false-negative results were equally distributed among the four groups of ranitidine dosage. Nine of these patients reverted to positive at 7 days and the remaining six at 14 days after completion of therapy. Our study shows that ranitidine negatively affects the results of urea breath testing, independent of the given dosage. Patients undergoing this examination for H. pylori diagnosis should discontinue use of H2-antagonists 2 wk before testing.
    Whether patients with typical gastroesophageal reflux disease (GERD) symptoms and without alarm features should be treated empirically or undergo endoscopy first is a debated issue. In this study, our aim was to assess the efficacy, and... more
    Whether patients with typical gastroesophageal reflux disease (GERD) symptoms and without alarm features should be treated empirically or undergo endoscopy first is a debated issue. In this study, our aim was to assess the efficacy, and to compare the direct costs and impact on health-related quality of life (HRQL), of two treatment strategies (empirical vs endoscopy-oriented treatment) in a large population of patients with GERD. In total, 612 patients were randomized to either empirical treatment with esomeprazole 40 mg once daily (od) (group 1, N = 309) or endoscopy and treatment according to endoscopic findings (group 2, N = 303, esomeprazole 40 mg od in patients with reflux esophagitis and esomeprazole 20 mg od in patients without esophagitis) for 4 wk, followed by esomeprazole 20 mg od maintenance treatment in both groups. Direct costs and HRQL were analyzed in both treatment arms. At the end of the acute treatment phase (week 4), 267 patients in group 1 (86.4%) and 265 patients in group 2 (87.5%) were considered responders to treatment (intention-to-treat analysis, P= 0.878). Empirical treatment proved to be cost-effective by saving 38.72 euros per treated patient. At the end of the maintenance phase (week 24), a similar proportion of patients responded to treatment in the two groups (71.8%vs 68.3%, P= 0.389). HRQL improved from baseline to week 24 in both groups (difference between study groups not significant). In patients with GERD, empirical treatment with esomeprazole proved to be cost-effective compared with endoscopy-oriented treatment, and did not negatively affect patient HRQL. These results should be taken into account in the management of GERD patients in clinical practice.
    There is much experimental work on the occurrence of tolerance to the antisecretory effect of H2-receptor antagonists in healthy subjects, while data on its development in patients with duodenal ulcer are poor and conflicting. Moreover,... more
    There is much experimental work on the occurrence of tolerance to the antisecretory effect of H2-receptor antagonists in healthy subjects, while data on its development in patients with duodenal ulcer are poor and conflicting. Moreover, this phenomenon has not been studied previously with 24 h gastric pH-metry in patients with active duodenal ulcer. For these reasons, we carried out a prospective pharmacodynamic investigation in 48 patients with endoscopically proven duodenal ulcer using the well-established once daily dosing schedule of H2 blockers. They were studied by means of 24 h continuous endoluminal pH-metry which was performed before, on d1 and d28 after receiving an oral bedtime dose (2200 hours) of either roxatidine 150 mg or ranitidine 300 mg, given in randomized and single-blind fashion. Eight patients did not complete the study for various reasons and 82% of ulcers healed after 4 weeks of therapy. Gastric pH was higher (P < 0.001) on d1 and d28 than basal values during all time periods, but the evening, with both H2 blockers. There was no significant difference between pH values of d1 and d28 in any time interval with both roxatidine and ranitidine. There was also no difference in pharmacodynamic data between the two active treatments. We conclude that tolerance does not develop after 1 month's treatment with a bedtime dose of H2 antagonist in patients with active duodenal ulcer and therefore data gathered on this phenomenon in healthy subjects are not applicable to ulcer patients.
    ... Ospedale CSS-IRCCS, San Giovanni Rotondo, Italy 2 UO Gastroenterologia, Università di Bologna, Ospedale Castel S. Pietro Terme, Italy 3 ... of members of staff of companies which produce and distribute endoscopic devices, including Mr... more
    ... Ospedale CSS-IRCCS, San Giovanni Rotondo, Italy 2 UO Gastroenterologia, Università di Bologna, Ospedale Castel S. Pietro Terme, Italy 3 ... of members of staff of companies which produce and distribute endoscopic devices, including Mr Danilo Consolandi (Clinical Specialist ...
    This study was carried out in order to perform a combined prospective assessment of the individual pharmacodynamic response and of duodenal ulcer healing in patients treated with three different doses of omeprazole. Ninety-nine patients... more
    This study was carried out in order to perform a combined prospective assessment of the individual pharmacodynamic response and of duodenal ulcer healing in patients treated with three different doses of omeprazole. Ninety-nine patients with endoscopically proven duodenal ulcers were subdivided into three parallel groups of 33 cases, who were randomly assigned to receive orally at 0800 hr, in single blind fashion, either 10 mg, 20 mg, or 40 mg of omeprazole. All of them underwent continuous intragastric pH monitoring both in basal conditions and on the fifth day of each dose regimen; ulcer healing was then assessed endoscopically after four weeks of treatment. All three doses of omeprazole caused pH values to increase significantly (P < 0.001) over the whole 24-hr period. In patients treated with omeprazole 10 mg, the individual responses showed the highest variability: the acid inhibition, expressed in terms of time spent above pH 3.0, lasted for more than 16 hr in 42% of cases, for more than 8 hr in 28%, and for less than 6 hr in 30%. In patients treated with omeprazole 20 mg, the pharmacological response was more marked and uniform and lasted for more than 16 hr in 79% of cases; however, it is worth noting it lasted for less than 6 hr in three patients (10%). In patients treated with omeprazole 40 mg, the individual response was excellent (more than 16 hr) in 94% of cases, and it lasted for less than 6 hr in only one patient (3%).(ABSTRACT TRUNCATED AT 250 WORDS)
    ... MD, GIUSEPPE SANDRO MELA, MD, PATRIZIA ZENTILIN, MD, SERGIO VIGNERI, MD, PATRIZIA CUTELA, RAFFAELLA MELE, MD, and FRANCESCO DI MARIO, MD ... J Gastroenterol 24 (suppl 166):48-53, 1989 7. Fimmel CJ, Etienne A, Cilluffo T, Von Ritter C,... more
    ... MD, GIUSEPPE SANDRO MELA, MD, PATRIZIA ZENTILIN, MD, SERGIO VIGNERI, MD, PATRIZIA CUTELA, RAFFAELLA MELE, MD, and FRANCESCO DI MARIO, MD ... J Gastroenterol 24 (suppl 166):48-53, 1989 7. Fimmel CJ, Etienne A, Cilluffo T, Von Ritter C, Gasser T, Rey ...

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