bluuebunny/crossref_metadata_2025_split huggingface dataset:
One‐week therapy for Helicobacter pylori eradication: ranitidine bismuth citrate plus medium‐dose clarithromycin and either tinidazole or amoxycillin
Authors: Cammarota  , Cannizzaro  , Tursi  , Papa  , Gasbarrini  , Cuoco  , Cianei  , Armuzzi  , Fedeli  , Fedeli  , Gasbarrini  
Published: March 2003

Background:One‐week ranitidine bismuth citrate (RBC)‐based triple regimens may be effective for the eradication of Helicobacter pylori. We evaluated the efficacy of two short‐term RBC‐based eradicating therapies including RBC plus medium‐dose clarithromycin and either tinidazole or amoxycillin.Methods:Seventy consecutive patients, who underwent gastroscopy for dyspeptic symptoms and were found to be H. pylori‐positive, were randomly subdivided into two groups receiving either RBC 400 mg b.d. plus clarithromycin 250 mg t.d.s. and tinidazole 500 mg b.d. (group RBCCT) or RBC 400 mg b.d. plus clarithromycin 250 mg t.d.s. plus amoxycillin 1 g b.d. (group RBCCA). H. pylori status was evaluated by means of histology and rapid urease test at entry, and by 13C‐urea breath test alone 8 weeks after treatment.Results:Sixty‐nine out of 70 enrolled patients completed the study: 35/35 in group RBCCT and 34/35 in group RBCCA. One patient in group RBCCA was lost to follow‐up. In group RBCCT, at the end of treatment, 32 of 35 patients were H. pylori‐negative (per protocol analysis 91%, intention‐to‐treat analysis 91%; 95% CI: 77–98%). In group RBCCA, 31 of 34 patients returned H. pylori‐negative (per protocol 91%; 95% CI: 76–98%, intention‐to‐treat 89%; 95% CI: 73–97%). Slight side‐effects occurred in 3/35 patients (9%) in group RBCCT and in 3/34 (9%) in group RBCCA.Conclusions:One‐week regimens consisting of RBC plus clarithromycin and either tinidazole or amoxycillin, combine high eradication rates with modest side‐effects. No substantial difference was found between the two treatment regimens tested in this trial.
Addition of bismuth subnitrate to omeprazole plus amoxycillin improves eradication of Helicobacter pylori
Authors: Carvalho  , Fiorelli  , Jorge  , Silva C. M. F. Da , Nucci  , Ferraz  , Pedrazzoli  
Published: March 2003

Objective:To evaluate whether the addition of bismuth subnitrate to a dual oral therapy regimen with omeprazole plus amoxycillin could improve Helico‐bacter pylori eradication.Methods:Fifty consecutive Helicobacter pylori‐positive patients were randomly enrolled to receive either (A) bismuth subnitrate (300 mg q.d.s.), omeprazole (20 mg b.d.) and amoxycillin (500 mg q.d.s.), or (B) omeprazole (20 mg b.d.) and amoxycillin (500 mg q.d.s.). Both groups (n = 25 each) received the medication for 14 days. H. pylori status was reassessed 30 days after completion of the therapy in order to evaluate eradication rates.Results:Six patients were lost to follow‐up and therefore excluded from the study (three patients from each group). One patient from Group B withdrew from the study because of side‐effects. The addition of bismuth subnitrate to omeprazole and amoxycillin significantly improved its efficacy in eradicating H. pylori, with 72% (18/25) eradication in Group A and 52% (13/25) in Group B (P = 0.027). The addition of bismuth subnitrate to dual oral therapy was also capable of improving the healing of peptic ulcers when compared with dual oral therapy alone (100%, 8/8 vs. 58%, 4/7; P = 0.021).Conclusion:Our results demonstrate that the addition of bismuth subnitrate to dual oral therapy enhances H. pylori eradication, and improves healing of peptic ulcers.
Effects of oral clarithromycin and amoxycillin on interdigestive gastrointestinal motility of patients with functional dyspepsia and Helicobacter pylori gastritis
Authors: Bortolotti  , Brunelli  , Sarti  , Miglioli C.mari M. 
Published: March 2003

Background:Clarithromycin and amoxycillin are antibiotics commonly used in association for Helicobacter pylori eradication. Because this treatment, which lasts 1–2 weeks, is frequently associated with gastrointestinal symptoms, we investigated the effects of these antibiotics on gastrointestinal motility.Patients and methods:Gastroduodenal motility was recorded in 14 patients with functional dyspepsia and H. pylori gastritis by means of a low‐compliance manometric system with four recording ports in the stomach and four in the duodenum. Two tablets of clarithromycin 250 mg (seven patients, clarithromycin group) or one of amoxycillin 1 g (seven patients, amoxycillin group), ground and dissolved in 20 mL of water, were given randomly and in double‐blind manner 30 min after the end of the first activity front (AF) of the migrating motor complex (MMC) or, in the absence of AFs, after at least 200 min of recording. Recording continued until an AF was observed during the subsequent 200 min.Results:Clarithromycin administration was followed by a typical gastroduodenal AF in a significantly higher number of patients than for amoxycillin administration. In addition, the time lag between clarithromycin administration and the appearance of AFs was 48 min ± 8.5 (mean ± s.d.), significantly shorter than after amoxycillin (121 min ± 29). The clarithromycin‐related duodenal AFs showed a duration of 6.6 min ± 1.5, significantly longer than that of the spontaneous AFs (3.6 min ± 1.2, P < 0.01), while the amoxycillin‐related AFs were not significantly different from the spontaneous ones.Conclusion:Clarithromycin stimulated cyclic gastroduodenal motility, while amoxycillin was ineffective. It is likely that symptoms during the eradication treatment are due to this effect of clarithromycin.
Sleep‐related gastro‐oesophageal reflux: provocation with a late evening meal and treatment with acid suppression
Authors: Orr  , Harnish  
Published: March 2003

Background:Two studies were carried out in order to investigate the issue of meal‐provoked nocturnal gastro‐oesophageal reflux.Methods:In Experiment 1, 20 symptomatic reflux patients underwent both pH and polysomnographic monitoring on two nights. On one night, patients ate a non‐provocative meal prior to 19.00 hours, while on the other night patients consumed a late evening meal (21.00 hours). In Experiment 2, 17 symptomatic reflux patients were studied using pH and polysomnographic monitoring on two nights subsequent to a late evening provocative meal. On one night, patients received 75 mg of the H2‐antagonist ranitidine, while on another night they received a placebo. The data from 12 of the 17 patients studied were used in the analysis.Results:For Experiment 1, no significant differences in the number or duration of reflux events, acid exposure (total %), or polysomnographic measures of per cent of sleep stages between the two nights were observed. The results of the second experiment demonstrated that when given ranitidine, patients experienced significant decrease in acid contact time (total %), and mean duration of reflux events. Subjective reports of discomfort and sleep disturbance were also significantly improved on the drug night. However, significant differences in polysomnographic measures were not observed.Conclusions:Based on these results, we conclude that in some symptomatic reflux patients a late‐night non‐provocative meal may not increase the incidence of gastro‐oesophageal reflux, and that a low dose of an H2‐antagonist is effective in decreasing oesophageal acid contact time following a late evening provocative meal.
Insulin‐like growth factor I plays a role in gastric wound healing: evidence using a zinc derivative, polaprezinc, and an in vitro rabbit wound repair model
Authors: Watanabe  , Wang  , Hirose  , Kivilioto  , Osada  , Miwa  , Oide  , Kitamura  , Yoneta  , Seto  , Sato  
Published: March 2003

Background:Although the detailed mechanism is unclear, zinc and its derivative, polaprezinc, have been reported to accelerate gastric ulcer healing in vivo.Aim:To investigate the detailed cellular mechanism of polaprezinc on gastric epithelial cells and fibroblasts with special attention to insulin‐like growth factor I (IGF‐I).Methods:Isolated rabbit gastric epithelial cells formed a complete monolayer, from which a circular artificial wound with constant size was made. The restoration process was monitored by measuring wound size up to 48 h. Either polaprezinc, IGF‐I, fibroblast conditioned medium or neutralized medium conditioned by anti‐IGF‐I antibody was added at the time of wounding. The expression of mRNA of IGF‐I, hepatocyte growth factor (HGF) and transforming growth factor α (TGF‐α) in fibroblasts with or without polaprezinc treatment was tested using reverse transcription polymerase chain reaction (RT‐PCR). Gastric epithelial cell proliferation was also examined by bromodeoxyuridine (BrdU) staining.Results:IGF‐I and fibroblast conditioned medium treatment accelerated gastric epithelial restoration which included cell migration and proliferation. However, polaprezinc and neutralized conditioned medium treatment did not accelerate epithelial repair. RT‐PCR for growth factor mRNA revealed the IGF‐I mRNA expression in fibroblasts was increased after treatment with polaprezinc.Conclusion:Polaprezinc induced IGF‐I production from mesenchymal cells, resulting in stimulation of epithelial cell restoration through a paracrine pathway. IGF‐I may play an important role in gastric wound repair.
Foetal outcome in women with inflammatory bowel disease treated during pregnancy with oral mesalazine microgranules
Authors: Marteau  , Tennenbaum  , Elefant  , Lémann  , Cosnes  
Published: March 2003

Background:Little information is available about the safety of high doses of mesalazine during pregnancy.Aim:To study the fate of pregnancy and foetal outcome in women taking 1–4 g/day of mesalazine microgranules for inflammatory bowel disease.Patients and methods:Case reports were collected from the Pharmacovigilance Department of Ferring SA, France, from a survey conducted in three gastroenterology units, and from a teratology information service. The evolution of pregnancy and foetal outcome were assessed by questionnaire.Results:The study covered a total of 123 pregnancies (126 foetuses). Ninety‐six women took mesalazine during the first trimester, 85 during the second and 83 during the third. The mean daily dose was 2.1 ± 0.8 g; 86 women received <3 g/day (low‐dose group), 37 women received ≥3 g/day (high‐dose group). The following abnormalities were observed in the low‐dose and high‐dose groups, respectively: ectopic pregnancy (1/0), spontaneous abortions (1/1), foetal death (0/1), premature deliveries (3/5, P < 0.05), congenital malformations (3/1) and one case of lethal oxalosis. Abnormalities were not considered to be related to mesalazine.Conclusions:The use of oral mesalazine microgranules during pregnancy is safe at doses ≤ 2 g/day, and probably also at a dose of 3 g/day.
Review article: the safety and efficacy of alosetron, a 5‐HT3 receptor antagonist, in female irritable bowel syndrome patients
Authors: Mangel A.W. , Northcutt A.R. 
Published: March 2003

Irritable bowel syndrome (IBS) is one of the most common gastrointestinal‐related conditions. In this review, the safety and efficacy of alosetron, a potent and selective 5‐HT3 receptor antagonist, in the treatment of IBS are discussed.Alosetron has been shown to produce statistically significant improvements in abdominal pain, stool consistency, stool frequency and urgency in female IBS patients. By contrast, no consistent improvement has been seen in male IBS patients treated with alosetron. The only adverse event of note with alosetron was constipation, and this represents a class effect of 5‐HT3 receptor antagonists.In conclusion, alosetron is a safe and effective treatment for female IBS patients.
Review article: pharmacokinetic concerns in the selection of anti‐ulcer therapy
Authors: Lew  
Published: March 2003

Rabeprazole is a new, highly potent proton pump inhibitor (PPI) being introduced for the treatment of disorders of gastric acid hypersecretion. Rabeprazole joins other drugs in this class, such as omeprazole, pantoprazole, and lansoprazole, which share a common mechanism of action. Each of these drugs is a substituted benzimidazole, which inhibits activity of the H+, K+‐ATPase located on the apical surface of parietal cells, thereby preventing the secretion of gastric acid. As a result of structural and functional similarities, the PPIs share many pharmacokinetic features. They have comparable rates of absorption, maximum plasma concentrations, and total drug absorptions resulting in similar bioavailability after single‐dose administration. With multiple dosing, rabeprazole differs from omeprazole in that its pharmacokinetic profile does not change significantly over the course of therapy.All the PPIs are metabolized rapidly, resulting in short half‐lives. However, their duration of activity is much longer, due to the way in which they bind to H+, K+‐ATPase. All are metabolized by hepatic cytochrome P450 enzymes, although only omeprazole has demonstrated significant interactions with other drugs metabolized by this pathway.Rabeprazole, which has a low potential for interacting with drugs metabolized by cytochrome P450, does interfere with the absorption of digoxin and ketoconazole because of its antisecretory effects. The pharmacokinetics of rabeprazole are altered slightly in elderly subjects and in patients with renal and moderate hepatic disease. However, the pharmacokinetic findings suggest that no dosage adjustment is required in these special populations.
Optimal duration of therapy combining ranitidine bismuth citrate with clarithromycin and metronidazole in the eradication of Helicobacter pylori infection
Authors: SAVARINO  , ZENTILIN  , BISSO  , PIVARI  , BILARDI  , BIAGINI  , MELE  , MANSI  , TERMINI  , VIGNERI  , CELLE  
Published: March 2003

Background:Ranitidine bismuth citrate (RBC) co‐prescribed with clarithromycin and metronidazole for 1 week has been shown to be an effective eradicating regimen for Helicobacter pylori.Aim:To determine the optimal duration of this regimen.Methods:A series of 165 dyspeptic patients were recruited for this randomized, open, parallel‐group study. They were subdivided into three groups receiving RBC 400 mg b.d. plus clarithromycin 250 mg b.d. and metronidazole 500 mg b.d. for three different periods (4, 7 and 10 days). H. pylori infection was assessed by the concomitant positivity of CLO‐test and histology performed at the pre‐entry endoscopy. The bacterium was considered eradicated on the basis of a negative 13C‐urea breath test performed at least 28 days after the completion of treatment.Results:The three subgroups were well matched and 16 patients dropped out of the study for many reasons (six in the 4‐day, five in the 7‐day and five in the 10‐day treatment regimens). Intention‐to‐treat cure rates were 60%, 84% and 85%, and the per‐protocol rates 67%, 92% and 94% in the 4‐day, 7‐day and 10‐day treatment regimens, respectively. There was a significant difference, P = 0.003−0.006 on intention‐to‐treat and P = 0.001−0.002 on per protocol analysis between the 4‐day and the 7‐day and the 4‐day and the 10‐day periods, respectively. The 7‐day and 10‐day periods did not differ from each other. Side‐effects were reported in 9%, 14% and 20% of the 4‐, 7‐ and 10‐day regimens. They led to stopping treatment in four cases (one in the 7‐day and three in the 10‐day period). There was no statistical difference among them.Conclusions:Reducing the duration of RBC‐based triple therapy to 4 days provides a low and unacceptable rate of H. pylori eradication. As there is no difference between 7 and 10 days of treatment, 1 week represents the optimal time period for this kind of treatment, based on RBC plus two antibiotics.
Delta‐9‐tetrahydrocannabinol delays the gastric emptying of solid food in humans: a double‐blind, randomized study
Authors: McCALLUM  , SOYKAN  , SRIDHAR  , RICCI  , LANGE  , PLANKEY  
Published: March 2003

Background:Delta‐9‐tetrahydrocannabinol (THC), the active constituent of marijuana, is an effective agent in the prevention of chemotherapy‐induced nausea and vomiting.Aim:To determine the effect of THC on gastric emptying of a radiolabelled solid food in humans.Methods:Thirteen healthy volunteers underwent gastric emptying studies after receiving THC and placebo in a randomized double‐blind fashion on 2 separate days. THC, at a dose of 10 mg/m2 of body surface area, or placebo were administered.Results:Gastric emptying after THC was slower than placebo in all subjects. Mean percentage of isotope remaining in the stomach was significantly greater than after placebo from 30 min (85.5 ± 4.3% vs. 94.2 ± 1.4% placebo and THC, respectively, P < 0.05) to 120 min (45.6 ± 7.2% vs. 73.9 ± 7.1% placebo and THC, respectively, P < 0.001) after the test meal. No correlation was found between plasma THC levels and the delay in gastric emptying.Conclusions:THC at a dose used for preventing chemotherapy‐induced nausea and vomiting significantly delays gastric emptying of solid food in humans. Therefore, the anti‐emetic property of THC may be mediated through the central nervous system.
Nitric oxide‐releasing NSAIDs inhibit interleukin‐1β converting enzyme‐like cysteine proteases and protect endothelial cells from apoptosis induced by TNFα
Authors: FIORUCCI  , SANTUCCI  , FEDERICI  , ANTONELLI  , DISTRUTTI  , MORELLI  , RENZO  , COATA  , CIRINO  , SOLDATO  , MORELLI  
Published: March 2003

Background: Nitric oxide (NO)‐releasing NSAIDs are a new class of NSAID derivatives with markedly reduced gastrointestinal toxicity. Although it has been demonstrated that NO‐NSAIDs spare gastric mucosal blood flow, molecular determinants involved in this effect are unknown.Aim: To investigate the effect of aspirin, naproxen and flurbiprofen, and their NO‐derivatives, on gastric apoptosis and endothelial cell damage induced by tumour necrosis factor‐α (TNFα). In other systems, TNFα‐induced apoptosis is mediated by caspases, a growing family of cysteine proteases similar to the IL‐1β converting enzyme (ICE), and so we have investigated whether NO‐NSAIDs modulate ICE‐like endopeptidases.Methods: Rats were treated orally with aspirin, naproxen and flurbiprofen, or their NO‐releasing derivatives in equimolar doses, and were killed 3 h later to assess mucosal damage and caspase activity. Endothelial cells (HUVECs) were obtained from human umbilical cord by enzymatic digestion. Caspase 1 and 3 activities were measured by a fluorimetric assay using selective peptides as substrates and inhibitors. Apoptosis was quantified by ELISA specific for histone‐associated DNA fragments and by the terminal transferase nick‐end translation method (TUNEL).Results: In vivo NSAID administration caused a time‐dependent increase in gastric mucosal damage and caspase activity. NCX‐4016, NO‐naproxen and NO‐flurbiprofen did not cause any mucosal damage and prevented cysteine protease activation. NSAIDs and NO‐NSAIDs stimulated TNFα release. Exposure to TNFα resulted in a time‐ and concentration‐dependent HUVEC apoptosis, an effect that was prevented by pretreating the cells with NCX‐4016, NO‐naproxen, NO‐flurbiprofen, SNP or Z‐VAD.FMK, a pan‐caspase inhibitor. The activation of ICE‐like cysteine proteases was required to mediate TNFα‐induced apoptosis of HUVECs. Exogenous NO donors inhibited TNFα‐induced cysteine protease activation. Inhibition of caspase activity was due to S‐nitrosylation of ICE/CPP32‐like proteases. NO‐NSAIDs prevented IL‐1β release from endotoxin‐stimulated macrophages.Conclusions: NO‐releasing NSAIDs are a new class of non‐peptide caspase inhibitors. Inhibition of ICE‐like cysteine proteases prevents endothelial cell damage induced by pro‐inflammatory agents and might contribute to the gastro‐protective effects of NO‐NSAIDs.
A cortisol suppression dose–response comparison of budesonide in controlled ileal release capsules with prednisolone
Authors: Edsbäcker  , Nilsson  , Larsson  
Published: March 2003

Aim:To assess the systemic effect of oral budesonide, given as Entocort controlled ileal release capsules, over a dose range of 3–15 mg/day, compared with that of a moderate dose (20 mg/day) of prednisolone.Methods:Twenty four healthy subjects were given 3, 9 or 15 mg budesonide or 20 mg prednisolone once daily, or 4.5 mg budesonide b.d., or placebo for 5 days in a randomized, double‐blind crossover study. The area under the curve (AUC) of plasma cortisol concentration and the amount of cortisol excreted in the urine were monitored.Results:Both plasma and urine cortisol suppression showed a dose‐response for the daily doses of budesonide. Prednisolone, 20 mg, suppressed plasma cortisol (AUC) statistically significantly more than 15 mg budesonide (P = 0.014), and 3 mg budesonide statistically significantly more than placebo (P = 0.010). No difference in AUC was detected between 9 mg and 4.5 mg budesonide b.d. Similar results for budesonide vs. placebo were obtained from urine cortisol excretion data. However, prednisolone affected urine cortisol less than it affected plasma cortisol.ConclusionAfter 5 days of administration, budesonide controlled ileal release capsules, in both clinical (9 mg/day) and high doses (15 mg/day), affected plasma cortisol less than a moderate (20 mg/day) dose of prednisolone.
Impact of food intake on the antisecretory effect of low‐dose ranitidine and famotidine
Authors: NETZER  , ESCHENMOSER  , HALTER  , INAUEN  
Published: March 2003

Background: Over‐the‐counter status has recently been approved for low‐dose H2‐antagonists in several countries. Insufficient information is currently available on the effect of food in low‐dose H2‐antagonist therapy.Aim: Compare the antisecretory efficacy of low‐dose ranitidine and famotidine in fasting and non‐fasting volunteers.Methods: Twenty volunteers were randomized into a double‐blind, placebo‐controlled, multiple‐step crossover study comparing the antisecretory efficacy of 75 mg ranitidine, 10 mg famotidine and placebo over 12 h using intragastric pH‐metry. Two standard meals were given after 4 h and 8 h of medication. Fifteen volunteers also participated in a second study comparing the antisecretory effect of both drugs, both with and without meals.Results: In non‐fasting subjects, the percentage of time with pH > 4 was similarly elevated for both drugs compared with placebo over the first 8 h: ranitidine 39.3%, famotidine 29.5%, placebo 9.5% (P < 0.001); but not for the last 4 h after the second meal (P > 0.05). Comparing the first 4‐h period with the second, the percentage of pH > 4 was significantly reduced for both drugs in the second period in the subjects given food at the end of the initial 4‐h period (ranitidine 56.9% vs. 26.6%, P = 0.005; famotidine 46.6% vs. 13.3%, P < 0.001). It remained more or less constant, however, for the second 4‐h period in fasting subjects (ranitidine 41% vs. 28.1%, P = 0.46; famotidine 52.7% vs. 52.2%, P = 0.12).Conclusion: In non‐fasting volunteers both low‐dose H2‐antagonists had comparable antisecretory effects and were superior to placebo over the first 8 h of therapy. Both drugs achieved a slightly higher antisecretory effect without food intake compared to with food intake.