bluuebunny/crossref_metadata_2025_split huggingface dataset:
Long‐term safety of tegaserod in patients with constipation‐predominant irritable bowel syndrome
Authors: Tougas G. , Snape W. J. , Otten M. H. , Earnest D. L. , Langaker K. ‐E. , Pruitt R. E. , Pecher E. , Nault B. , Rojavin M. A. 
Published: March 2003

SummaryBackground : Tegaserod is a 5‐hydroxytryptamine‐4 receptor partial agonist. Oral administration causes gastrointestinal effects resulting in increased gastrointestinal motility and attenuation of visceral sensation.Aim : To determine the long‐term safety and tolerability of tegaserod in patients suffering from irritable bowel syndrome with constipation as the predominant symptom of altered bowel habits.Method : A multicentre, open‐label study with flexible dose titration of tegaserod in out‐patients suffering from constipation‐predominant irritable bowel syndrome.Results : A total of 579 patients with constipation‐predominant irritable bowel syndrome were treated with tegaserod. Of these, 304 (53%) completed the trial. The most common adverse events, classified as related to tegaserod for any dose, were mild and transient diarrhoea (10.1%), headache (8.3%), abdominal pain (7.4%) and flatulence (5.5%). Forty serious adverse events were reported in 25 patients (4.4% of patients) leading to discontinuation in six patients. There was one serious adverse event, acute abdominal pain, classified as possibly related to tegaserod. There were no consistent differences in adverse events between patients previously exposed to tegaserod and those treated de novo. No pattern‐forming tegaserod‐related abnormalities in haematological and biochemical laboratory tests, urinalysis, blood pressure, pulse rate or electrocardiograms were found.Conclusions : Tegaserod appears to be well tolerated in the treatment of patients with constipation‐predominant irritable bowel syndrome. The adverse event profile, clinical laboratory evaluations, vital signs and electrocardiogram recordings revealed no evidence of any unexpected adverse events, and suggest that treatment is safe over a 12‐month period.
Gabexate mesilate and/or octreotide in human immunodeficiency virus‐associated pancreatic abnormalities
Authors: Manfredi R. , Calza L. , Chiodo F. 
Published: March 2003

SummaryBackground : Human immunodeficiency virus (HIV)‐associated pancreatic alterations are frequent, but poorly investigated, notwithstanding their potential consequences on the course and management of HIV infection. No epidemiological or clinical data on pancreatic alterations have been published since the introduction of highly active antiretroviral therapy, and no indications of the pharmacological management of symptomatic or prolonged laboratory pancreatic abnormalities have been reported.Aim : To investigate the therapeutic role of gabexate mesilate and octreotide in HIV‐infected patients with elevated, symptomatic or instrumentally confirmed pancreatic anomalies persisting for more than 3 months.Methods and results : An open‐label, prospective, 5‐year case–control study was conducted involving 185 consecutive patients with pancreatic alterations. Treatment of patients with severe laboratory and/or clinical involvement with low‐dose gabexate mesilate and/or somatostatin was effective and safe and led to a lower recurrence rate and a better tolerability of concomitant drug regimens compared with supportive therapy taken by control patients. Combined gabexate–octreotide proved to be more active than single drug administration.Conclusions : Epidemiological and therapeutic data on the frequency, risk factors and clinical significance of pancreatic abnormalities during HIV infection are required, as are studies investigating the need for and choice of antisecretory and/or antiprotease compounds.
Risk of upper gastrointestinal bleeding in patients taking low‐dose aspirin for the prevention of cardiovascular diseases
Authors: Serrano P. , Lanas A. , Arroyo M. T. , Ferreira I. J. 
Published: March 2003

SummaryBackground : Most patients with vascular‐occlusive diseases benefit from low‐dose aspirin (75–325 mg/day). However, they have an increased risk of upper gastrointestinal bleeding (UGIB).Aims : To analyse the incidence and factors influencing the occurrence of UGIB in patients taking low‐dose aspirin for the prevention of cardiovascular diseases outside clinical trials.Methods : We studied 903 consecutive patients discharged on low‐dose aspirin from the Cardiology Department of a general hospital. Data were collected from medical charts and structured telephone interviews.Results : Forty‐one patients (4.5%) presented with UGIB requiring hospitalization during follow‐up (45 ± 22 months). The incidence of UGIB was uniform during follow‐up (1.2 UGIB per 100 patient years). Multivariate analysis showed that a history of peptic ulcer or UGIB [risk ratio: 3.1, 95% CI: (1.5–6.5)] and aspirin dose (per 100 mg/day) [1.8 (1.5–2.9)] was associated with higher risk of UGIB. On the other hand, antisecretory [0.22 (0.07–0.75)] and nitrovasodilator drugs [0.73 (0.55–0.96)] were associated with a decreased risk.Conclusions : Cardiovascular patients on long‐term low‐dose aspirin have a stable risk of major UGIB, which is higher than published controlled clinical trials. Antisecretory and nitrovasodilator drugs protect from UGIB, whereas previous peptic ulcer or UGIB and higher doses of aspirin increase the risk.
Long‐term prospective follow‐up of endoscopic oesophagitis in southern Chinese — prevalence and spectrum of the disease
Authors: Wong W.‐M. , Lam S. K. , Hui W. M. , Lai K. C. , Chan C. K. , Hu W. H. C. , Xia H. H. X. , Hui C. K. , Yuen M. F. , Chan A. O. O. , Wong B. C. Y. 
Published: March 2003

SummaryAims : To study the prevalence, clinical characteristics and long‐term outcome of oesophagitis in Chinese patients.Methods : Clinical and endoscopic data were collected prospectively from consecutive patients who underwent upper endoscopy between 1997 and 2001. Patients with endoscopic oesophagitis were graded according to the Los Angeles system and analysed according to their clinical presentation, endoscopic details, Helicobacter pylori status, non‐steroidal anti‐inflammatory drug history, co‐morbidity and mortality.Results : A total of 22 628 upper endoscopies were performed in 16 606 patients. Of these, 631 (3.8%) had endoscopic oesophagitis, 14 had benign oesophageal stricture (0.08%) and 10 had Barrett's oesophagus (0.06%). Most patients (94%) had either Los Angeles grade A or grade B oesophagitis. Patients who died during follow‐up had a significantly higher incidence of co‐morbid illness (100% vs. 63%, P < 0.001). By Cox regression analysis, the presence of gastrointestinal bleeding (P = 0.008), advanced age (P = 0.004) and the use of Ryle's tube (P = 0.043) were identified to be independent factors associated with mortality.Conclusions : Complicated gastro‐oesophageal reflux disease is uncommon in the Asian population. Advanced age, use of Ryle's tube and the presence of gastrointestinal bleeding are associated with a poor long‐term outcome, which is a reflection of the severe underlying co‐morbidity.
Comparison of efficacy and safety of two doses of two different polyethylene glycol‐based laxatives in the treatment of constipation
Authors: Chaussade S. , Minić M. 
Published: March 2003

SummaryAim : To compare standard and maximum daily doses of polyethylene glycol 3350 plus electrolytes (Transipeg) and polyethylene glycol 4000 (Forlax) in a multicentre, double‐blind, randomized, parallel‐group study.Methods : Ambulatory patients with idiopathic chronic constipation were randomized to receive Forlax (10 or 20 g) or Transipeg (5.9 or 11.8 g) for 1 month. The primary efficacy end‐point was stool frequency. Secondary efficacy parameters included stool consistency, date of occurrence of first motion, straining on defecation, rectal evacuation, abdominal pain and distension. Adverse events were recorded.Results : Stool frequency was significantly increased compared with baseline in all treatment groups (P = 0.0001). Most patients (≥ 67.3%) had their first stool within 1 day of starting treatment. Stool consistency significantly improved compared with baseline in all treatment groups (P = 0.0001). The percentage of patients with normal stool consistency was significantly higher for standard‐dose Transipeg vs. both maximum‐dose treatments (P < 0.01). Other secondary parameters were also significantly improved compared with baseline in all treatment groups (P = 0.0001). All medications were well tolerated.Conclusions : Standard‐dose Transipeg (5.9 g) normalized stool consistency with less semi‐liquid or liquid stools than maximum‐dose Transipeg and Forlax, with a non‐significant trend towards less semi‐liquid or liquid stools than standard‐dose Forlax.
Mercaptopurine metabolite results in clinical gastroenterology practice
Authors: Bloomfeld R. S. , Onken J. E. 
Published: March 2003

SummaryBackground : Azathioprine (AZA) and its active metabolite mercaptopurine (MP) are frequently used in the management of inflammatory bowel disease. Measurement of the AZA/MP metabolites, thioguanine (TG) and methylmercaptopurine (MMP), has been suggested as a means to optimize therapy with AZA/MP in inflammatory bowel disease.Aim : To evaluate the results of initial AZA/MP metabolite panels sent by gastroenterologists during the first year of its widespread availability.Methods : Initial AZA/MP metabolite panels sent by gastroenterologists to a single laboratory were reviewed and the metabolite panels were interpreted.Results : Initial metabolite levels were reviewed for 9187 patients. Noncompliance was detected in 263 patients (3%) and under‐dosing in 4260 patients (46%). 534 patients (6%) had levels that were consistent with preferential metabolism via the TPMT pathway. The therapeutic goal was achieved in 2444 patients (27%) and an additional 552 patients (6%) had appropriate TG levels but potential hepatotoxicity. 936 patients (10%) had potential TPMT deficiency, and 58 patients (1%) had potential TPMT absence and were at risk for leukopenia. 140 patients (2%) had too high a dose.Conclusions : Measurement of AZA/MP metabolites can be used by practising gastroenterologists to identify potential reasons for nonresponse to AZA or MP, and to identify patients at risk for certain drug‐related toxicities.
Risk factors for failure of Helicobacter pylori therapy — results of an individual data analysis of 2751 patients
Authors: Broutet N. , Tchamgoué S. , Pereira E. , Lamouliatte H. , Salamon R. , Mégraud F. 
Published: March 2003

SummaryAim : To study risk factors for failure of Helicobacter pylori eradication treatment.Methods : Individual data from 2751 patients included in 11 multicentre clinical trials carried out in France and using a triple therapy, were gathered in a unique database. The 27 treatment regimens were regrouped into four categories.Results : The global failure rate was 25.8%[95% CI: 24–27]. There was a difference in failure rate between duodenal ulcer patients and non‐ulcer dyspeptic patients, 21.9% and 33.7%, respectively (P < 10−6). In a random‐effect model, the risk factors identified for eradication failure in duodenal ulcer patients (n = 1400) were: to be a smoker, and to have received the group 4 treatment, while to receive a 10 day treatment vs. 7 days protected from failure. In non‐ulcer dyspeptic patients (n = 913), the group 2 treatment was associated with failure. In both groups, age over 60 was associated with successful H. pylori eradication. There were less strains resistant to clarithromycin in duodenal ulcer patients than in non‐ulcer dyspeptic patients. Clarithromycin resistance predicted failure almost perfectly.Conclusion : Duodenal ulcer and non‐ulcer dyspeptic patients should be managed differently in medical practice and considered independently in eradication trials.
Is eradication sufficient to heal gastric ulcers in patients infected with Helicobacter pylori? A randomized, controlled, prospective study
Authors: Higuchi K. , Fujiwara Y. , Tominaga K. , Watanabe T. , Shiba M. , Nakamura S. , Oshitani N. , Matsumoto T. , Arakawa T. 
Published: March 2003

SummaryBackground : In Helicobacter pylori infection, the effect of short‐term triple therapy with proton pump inhibitor plus two antibiotics on gastric ulcer healing is not well known.Aim : To compare 1‐week triple therapy with 8‐week proton pump inhibitor therapy on gastric ulcer healing in infected patients.Patients and methods : We randomly assigned 120 patients with H. pylori and gastric ulcers to proton pump inhibitor plus amoxicillin and clarithromycin for 1 week (n = 61) or proton pump inhibitor alone for 8 weeks (n = 59), with endoscopic assessment of ulcer healing 8 weeks after the start of treatment.Results : Triple therapy eradicated H. pylori in 51 patients [intention‐to‐treat, 84%; 95% confidence interval (CI), 75–93%]. At 8 weeks, gastric ulcers were healed in 30 patients given triple therapy (49%; 95% CI, 37–62%) and in 49 patients given proton pump inhibitor (83%; 95% CI, 73–93%, P < 0.001). Healing rates in the triple therapy and proton pump inhibitor‐only groups were 89% and 100%, respectively, for ulcers of < 1.0 cm in diameter, 54% and 77% for ulcers of 1.0 to < 1.5 cm in diameter, and 5% and 77% (P < 0.001) for ulcers of ≥ 1.5 cm in diameter.Conclusions : One‐week triple therapy healed most ulcers of < 1.0 cm, but not ulcers of ≥ 1.5 cm. Short‐term therapy is effective for gastric ulcers of < 1.0 cm, but, for larger ulcers, follow‐up therapy to suppress acid is needed.
Double‐blind, randomized, placebo‐controlled study of nitazoxanide in the treatment of fascioliasis in adults and children from northern Peru
Authors: Favennec L. , Jave Ortiz J. , Gargala G. , Lopez Chegne N. , Ayoub A. , Rossignol J. F. 
Published: March 2003

SummaryBackground : Human fascioliasis is a significant world‐wide health problem, and massive or repeated infections by Fasciola hepatica can lead to considerable morbidity.Aim : To evaluate the safety and efficacy of nitazoxanide, when compared with placebo, in the treatment of fascioliasis in adults and children from northern Peru.Methods : A double‐blind, placebo‐controlled study was carried out in 50 adults and 50 children infected with F. hepatica. The diagnosis of infection was based on the presence of F. hepatica eggs in one stool sample obtained before inclusion in the study. Patients were randomized to receive treatment with either a 7‐day course of nitazoxanide (100 mg b.d., age range 2–3 years; 200 mg b.d., age range 4–11 years; 500 mg b.d., age > 12 years) or matching placebo. Three post‐treatment stool examinations were carried out between 30 and 90 days after initiation of treatment.Results : The parasite was eliminated in 18 of 30 (60%) adults completing the study who received nitazoxanide vs. one of eight adults in the placebo group (P = 0.042), and similarly in 14 of 35 (40%) children completing the treatment vs. none of eight in the placebo group (P = 0.038). Only mild, transient adverse events were reported.Conclusions : A 7‐day course of nitazoxanide was effective in adults and children in the treatment of F. hepatica, when compared with placebo.
Sandostatin LAR (long‐acting octreotide acetate) for malignant carcinoid syndrome: a 3‐year experience
Authors: Garland J. , Buscombe J. R. , Bouvier C. , Bouloux P. , Chapman M. H. , Chow A. C. , Reynolds N. , Caplin M. E. 
Published: March 2003

SummaryBackground : Somatostatin analogues are the best therapy for controlling the symptoms of malignant carcinoid syndrome. Octreotide acetate given as subcutaneous injection up to three times daily, intramuscular Lanreotide injection given once per 1–2 weeks and monthly intramuscular Sandostatin LAR have demonstrated similar efficacy in short‐term studies.Aim : To assess the long‐term effect of Sandostatin LAR on the management of patients with malignant carcinoid syndrome.Methods : This was a 3‐year retrospective study. Twenty‐seven patients were assessed with a median follow‐up of 23 months. Thirteen patients were switched from subcutaneous octreotide and 14 patients were octreotide naive. All patients showed avid uptake on indium‐111 octreotide imaging.Results : Ten of the 13 patients previously on subcutaneous octreotide and 13 of the 14 patients who were octreotide naive had good symptom control on Sandostatin LAR. Over the period of follow‐up, many patients showed progression of their tumour and required additional therapies. Patients expressed a preference for monthly intramuscular Sandostatin LAR as opposed to daily subcutaneous injections of octreotide. Although Sandostatin LAR was difficult to administer in certain instances, overall it was well tolerated.Conclusions : Sandostatin LAR provides good long‐term symptomatic control in patients with malignant carcinoid syndrome; it is well tolerated and patients expressed improved satisfaction in their management.
Helicobacter DNA in bile: correlation with hepato‐biliary diseases
Authors: Fallone C. A. , Tran S. , Semret M. , Discepola F. , Behr M. , Barkun A. N. 
Published: March 2003

SummaryBackground : Helicobacter has been identified in isolated cases of hepato‐biliary diseases, but its role in the pathogenesis of these conditions remains unclear.Aim : To determine whether Helicobacter could be detected in bile obtained at endoscopic retrograde cholangiopancreatography, and to evaluate the prevalence of this infection in patients with hepato‐biliary diseases.Methods : Bile was collected from 125 patients with various hepato‐biliary diseases undergoing endoscopic retrograde cholangiopancreatography. Among them, 75 were diagnosed with biliary stones, 15 with pancreatico‐biliary malignancies and four with primary sclerosing cholangitis. The detection of Helicobacter in DNA extracted from these bile samples was performed using Helicobacter genus‐specific primers (capable of detecting 100–1000 organisms/mL).Results : Helicobacter was detected in all positive controls. Only three samples had polymerase chain reaction inhibitors. All remaining bile samples (122 patients with hepato‐biliary diseases) were negative for Helicobacter DNA.Conclusions : Helicobacter can be detected in bile samples using polymerase chain reaction. This infection, however, was not present in any of our patients diagnosed with gallstones or hepato‐biliary malignancies, raising doubt as to the possible association between Helicobacter and these entities. Given the low sample size of patients with primary sclerosing cholangitis, more studies are required to determine whether an association exists with this condition.
Second harmonic imaging improves trans‐abdominal ultrasound detection of biliary sludge in ‘idiopathic’ pancreatitis
Authors: Ierardi E. , Muscatiello N. , Nacchiero M. , Gentile M. , Margiotta M. , Marangi S. , De Francesco V. , Francavilla R. , Barone M. , Faleo D. , Panella C. , Francavilla A. , Cuomo R. 
Published: March 2003

SummaryBackground : Recently, biliary sludge has been strongly correlated with ‘idiopathic pancreatitis’. It is often diagnosed by trans‐abdominal ultrasonography, despite the low sensitivity of this investigation. New scanners, using second harmonic imaging, may improve the quality of the echographic picture.Aim : To verify the impact of this methodology on the detection of biliary sludge in patients with ‘idiopathic’ pancreatitis.Methods : Fifty patients with ‘idiopathic’ pancreatitis observed over a 18‐month period entered the study. Exclusion criteria were gall‐bladder stones, polyps, clinical conditions related to biliary sludge development and haemolytic disorders. Patients were assessed blind by two operators using either conventional ultrasonography or second harmonic imaging. The parameters of diagnostic quality of both examinations were evaluated using, as the gold standard, microscopic examination of the gall‐bladder content collected at endoscopy after cholecystokinin infusion.Results : An improvement in sensitivity, specificity, efficiency and negative predictive value was obtained by second harmonic imaging compared with conventional ultrasonography.Conclusions : Second harmonic imaging, in our experience, is a reliable non‐invasive tool for the diagnosis and follow‐up of biliary sludge in the course of ‘idiopathic’ pancreatitis.
Two mesalazine regimens in the prevention of the post‐operative recurrence of Crohn's disease: a pragmatic, double‐blind, randomized controlled trial
Authors: Caprilli R. , Cottone M. , Tonelli F. , Sturniolo G. , Castiglione F. , Annese V. , Papi C. , Viscido A. , Cammà C. , Corrao G. , Latella G. 
Published: March 2003

SummaryBackground : The role of mesalazine in preventing the clinical recurrence of Crohn's disease after surgery has been shown in a meta‐analysis of all published studies. No clear relationship, however, has been shown between dosage and response.Aim : To evaluate whether 4.0 g/day of mesalazine may offer therapeutic advantages over 2.4 g/day in the prevention of both endoscopic and clinical post‐operative recurrence of Crohn's disease.Methods : The study was a double‐blind, randomized, multi‐centre, prospective, controlled clinical trial. Two hundred and six patients, submitted to first or second intestinal resection for Crohn's disease limited to the terminal ileum, with or without involvement of the caecum/ascending colon, were enrolled. Of these, 101 were randomly allocated to receive 4.0 g/day of mesalazine (Asacol, Giuliani SpA, Milan, Italy) and 105 to receive 2.4 g/day, starting 2 weeks after surgery. The primary outcome was endoscopic recurrence, at 12 months after surgery. Three different degrees of endoscopic recurrence were evaluated (endoscopic scores: > 0, > 1 and > 2). The secondary outcome was clinical recurrence, defined as a Crohn's disease activity index of more than 150 points or an increase in the Crohn's disease activity index of 100 points or more. For statistical analysis, chi‐square, Wilcoxon and Cox regression model tests were used, when appropriate.Results : Eighty‐four patients in the 4.0 g/day group and 81 patients in the 2.4 g/day group were evaluable by endoscopy. Endoscopic recurrence of > 0 was significantly higher in the 2.4 g/day group than in the 4.0 g/day group (62% vs. 46%; P < 0.04). No difference was observed between the two groups with regard to the other two endoscopic outcomes (> 1 and > 2) or clinical recurrence.Conclusions : A 4.0 g/day regimen of mesalazine does not offer a clinically significant advantage over a 2.4 g/day regimen in the prevention of post‐operative endoscopic and clinical recurrence of Crohn's disease at 1 year of follow‐up.
The effect of introducer gauge, design and bevel direction on the deflection of spinal needles*
Authors: Ahn W‐S. , Bahk J‐H. , Lim Y‐J. , Kim Y‐C. 
Published: March 2003

SummaryThis study was performed to determine how the use of an introducer affects the extent to which a needle deflects during a spinal or combined spinal‐epidural injection. A polystyrene block was used to simulate the paraspinal area of the back. A line was drawn perpendicular to the edge of the block to use as a guide and to measure the deflection. The use of an introducer needle decreased the deflection in all the bevelled needles (p < 0.001). Depending on the direction of both the bevels, the deflection decreased as the introducer bevel was changed from the same direction, to right‐angles to bevel direction and then to a direction opposite to that of the spinal needle (p < 0.05). Deflection was decreased when a thick introducer was used (p < 0.001). The use of an introducer increased the deflection of the pencil‐point needle only in the deflection direction of the introducer (p < 0.001). The 18‐gauge Tuohy needle with a ‘backhole’ deflected more than the corresponding needle without a backhole (p < 0.001), and the spinal needle inserted through the Tuohy needle with a backhole deflected more (p = 0.002). Besides the tip type and gauge, the deflection of a spinal needle depends upon the use of introducer, its gauge and bevel direction. The deflection of a Tuohy needle depends upon its design, gauge and the presence of a backhole.