bluuebunny/crossref_metadata_2025_split huggingface dataset:
Effects of buffered and plain acetylsalicylic acid formulations with and without ascorbic acid on gastric mucosa in healthy subjects
Authors: Dammann H.‐G. , M. Saleki  , Torz M. , Schulz H.‐U. , Krupp S. , Schürer M. , Timm J. , Gessner U. 
Published: January 2004

SummaryBackground : The most frequently reported adverse events associated with acetylsalicylic acid intake are minor gastrointestinal complaints. Galenic modifications, such as buffered formulations with or without ascorbic acid, may improve the benefit–risk ratio by decreasing the local mucosal side‐effects of acetylsalicylic acid.Aim : To assess endoscopically‐proven gastrointestinal lesions and the amount of gastric microbleeding of four different buffered and plain acetylsalicylic acid formulations, one containing paracetamol.Methods : A randomized, four‐fold cross‐over study was performed in 17 healthy subjects who underwent serial oesophago‐gastro‐duodenoscopy before and after each course of 4‐day dosing. Gastric aspirates were collected for the determination of haemoglobin concentrations to detect microbleeding.Results : Buffered acetylsalicylic acid plus ascorbic acid yielded the lowest Lanza score, the lowest increase in the number of mucosal petechiae and the lowest increase in the amount of gastric microbleeding. Subjects receiving acetylsalicylic acid plus paracetamol plus caffeine showed the highest Lanza score of all treatments, and a considerably greater sum of petechiae in the oesophagus, stomach and duodenum compared with those receiving buffered acetylsalicylic acid plus ascorbic acid.Conclusions : The trial confirms that buffering of acetylsalicylic acid improves local gastric tolerability. Acetylsalicylic acid in combination with ascorbic acid shows significantly fewer gastric lesions and the lowest increase in gastric microbleeding compared with the other tested formulations.
Clinical course after stopping lamivudine in chronic hepatitis B patients with lamivudine‐resistant mutants
Authors: Wong V. W.‐S. , Chan H. L.‐Y. , Wong M. L. , Tam J. S.‐L. , Leung N. W.‐Y. 
Published: January 2004

SummaryBackground : The efficacy of lamivudine therapy in chronic hepatitis B is well established. However, drug‐resistant YMDD mutants emerge with extended therapy. This may result in the resurgence of viral replication, the return of hepatitis and histological deterioration.Aim : To study the safety of stopping lamivudine when the drug is no longer effective.Methods : In the 5‐year Asian Lamivudine Study, 34 patients from a single centre were included in this study. They had harboured YMDD mutants for at least 2 years. Lamivudine was discontinued and they were followed up at regular intervals. Clinical symptoms, liver biochemistry and viral serology were monitored.Results : In a median follow‐up of 20 months after stopping lamivudine (range, 7–39 months), 20 of the 34 patients (58.8%) had elevated alanine aminotransferase (ALT), 13 patients (38.2%) had elevated ALT one to five times the upper limit of normal and seven patients (20.6%) had an ALT flare (ALT more than five times the upper limit of normal with detectable hepatitis B virus DNA). There was no liver decompensation. ALT flare could be predicted by ALT over twice the upper limit of normal at the time of stopping lamivudine (P = 0.037).Conclusions : It is relatively safe to stop lamivudine after YMDD mutants have emerged. ALT levels greater than or equal to twice the upper limit of normal at the time of stopping lamivudine have a higher risk for ALT flare.
Personal view: to treat or not to treat? Helicobacter pylori and gastro‐oesophageal reflux disease — an alternative hypothesis
Authors: Axon A. T. R. 
Published: January 2004

Summary Helicobacter pylori causes acute on chronic gastritis and is responsible for most peptic ulcers and gastric cancer. However, recent papers have suggested that it may protect against gastro‐oesophageal reflux, Barrett's oesophagus and oesophageal cancer. Furthermore, the rapid increase in gastro‐oesophageal reflux disease, Barrett's oesophagus and adenocarcinoma of the oesophagus in the developed world has been attributed by some to the falling prevalence of H. pylori. These considerations have led to the suggestion that H. pylori infection should not necessarily be treated, especially in patients with gastro‐oesophageal reflux disease.Conversely, data from prospective randomized studies have shown that H. pylori eradication does not cause gastro‐oesophageal reflux disease in patients with duodenal ulcer or in the normal population, nor does it worsen the outcome of pre‐existing gastro‐oesophageal reflux disease. Therefore, although H. pylori is negatively associated with gastro‐oesophageal reflux disease, its eradication does not induce the disease.A hypothesis is presented suggesting that the increased prevalence of gastro‐oesophageal reflux disease is a result of rising acid secretion in the general population, which, in turn, is a consequence of the increased linear height (a predictor of acid secretion). The greater acid secretion could also explain the decline in the prevalence of H. pylori and perhaps account for the inverse relationship between H. pylori and gastro‐oesophageal reflux disease. These considerations are explored in discussing whether H. pylori infection should be treated in infected patients presenting with gastro‐oesophageal reflux disease.
The pathophysiology of faecal spotting in obese subjects during treatment with orlistat
Authors: Fox M. , Thumshirn M. , Menne D. , Stutz B. , Fried M. , Schwizer W. 
Published: January 2004

SummaryBackground : The intermittent loss of oil or liquid faeces (‘spotting’) is an adverse effect that occurs in obese patients during treatment with the lipase inhibitor orlistat; the pathophysiology is unknown.Aim : To investigate the effects of orlistat on anorectal sensorimotor function and continence.Methods : Obese subjects susceptible to spotting were identified by an unblind trial of orlistat. Obese spotters (n = 15) and non‐spotters (n = 16) completed a randomized, double‐blind, cross‐over trial of orlistat and placebo. Anorectal function was assessed by rectal barostat and anal manometry, together with a novel stool substitute retention test, a quantitative measurement of faecal continence.Results : Orlistat increased stool volume and raised faecal fat and water. Treatment had no effect on anorectal motor function, but rectal sensation was reduced; on retention testing, the volume retained was increased. Subjects susceptible to spotting had lower rectal compliance, heightened rectal sensitivity and weaker resting sphincter pressure than non‐spotters. On retention testing, gross continence was maintained; however, spotters lost small volumes of rectal contents during rectal filling.Conclusion : Treatment with orlistat has no direct adverse effects on anorectal function or continence. Spotting occurs during treatment with orlistat when patients with sub‐clinical anorectal dysfunction are exposed to increased stool volume and altered stool composition.
Implementation of a computer‐assisted monitoring system for the detection of adverse drug reactions in gastroenterology
Authors: Dormann H. , Criegee‐Rieck M. , Neubert A. , Egger T. , Levy M. , Hahn E. G. , Brune K. 
Published: January 2004

SummaryAim : To investigate the effectiveness of a computer monitoring system that detects adverse drug reactions (ADRs) by laboratory signals in gastroenterology.Methods : A prospective, 6‐month, pharmacoepidemiological survey was carried out on a gastroenterological ward at the University Hospital Erlangen‐Nuremberg. Two methods were used to identify ADRs. (i) All charts were reviewed daily by physicians and clinical pharmacists. (ii) A computer monitoring system generated a daily list of automatic laboratory signals and alerts of ADRs, including patient data and dates of events.Results : One hundred and nine ADRs were detected in 474 admissions (377 patients). The computer monitoring system generated 4454 automatic laboratory signals from 39 819 laboratory parameters tested, and issued 2328 alerts, 914 (39%) of which were associated with ADRs; 574 (25%) were associated with ADR‐positive admissions. Of all the alerts generated, signals of hepatotoxicity (1255), followed by coagulation disorders (407) and haematological toxicity (207), were prevalent. Correspondingly, the prevailing ADRs were concerned with the metabolic and hepato‐gastrointestinal system (61). The sensitivity was 91%: 69 of 76 ADR‐positive patients were indicated by an alert. The specificity of alerts was increased from 23% to 76% after implementation of an automatic laboratory signal trend monitoring algorithm.Conclusion : This study shows that a computer monitoring system is a useful tool for the systematic and automated detection of ADRs in gastroenterological patients.
Intestinal and extra‐intestinal cancer in Crohn's disease: follow‐up of a population‐based cohort in Copenhagen County, Denmark
Authors: Jess T. , Winther K. V. , Munkholm P. , Langholz E. , Binder V. 
Published: January 2004

SummaryAim : To determine the long‐term risk of intestinal and extra‐intestinal malignancies in Crohn's disease patients in Copenhagen County, Denmark.Methods : In Copenhagen County, a strictly population‐based cohort of 374 patients with Crohn's disease diagnosed between 1962 and 1987 was followed until 1997 in order to determine the long‐term risk of intestinal and extra‐intestinal malignancies. Information on cancer occurrence was provided by the Danish National Cancer Registry and confirmed by the examination of hospital files. The observed number of cases was compared with the expected number, calculated from individually computed person‐years at risk and 1995 cancer incidence rates for the background population.Results : The risk of small bowel adenocarcinoma was significantly increased, independent of age and gender (standardized morbidity ratio, 66.7; 95% confidence interval, 18.1–170.7). The risk of colorectal cancer was not increased, either in the total group of patients or in patients with colonic Crohn's disease exclusively (standardized morbidity ratio, 1.64; 95% confidence interval, 0.20–5.92). Extra‐intestinal cancer did not occur more frequently than expected.Conclusions : This population‐based study of patients with Crohn's disease revealed no increase in colorectal cancer risk, possibly due to maintenance treatment with 5‐aminosalicylic acid preparations and surgery in treatment failure. In contrast, the risk of small bowel cancer was increased more than 60‐fold, but the numbers were small. The risk of extra‐intestinal cancer was not increased and no lymphomas were observed.
Treatment of irritable bowel syndrome with herbal preparations: results of a double‐blind, randomized, placebo‐controlled, multi‐centre trial
Authors: Madisch A. , Holtmann G. , Plein K. , Hotz J. 
Published: January 2004

SummaryBackground : Herbal medications have been used in many countries for the treatment of patients with irritable bowel syndrome. Controlled data supporting the efficacy of these treatments in patients with irritable bowel syndrome are lacking.Aim : To assess the efficacy and safety of a commercially available herbal preparation (STW 5) (nine plant extracts), the research herbal preparation STW 5‐II (six plant extracts) and the bitter candytuft mono‐extract in patients with irritable bowel syndrome.Methods : Two hundred and eight patients with irritable bowel syndrome were recruited after standardized diagnostic work‐up into a double‐blind, placebo‐controlled, multi‐centre trial and were randomly assigned to receive one of four treatments: commercially available herbal preparation STW 5 (n = 51), research herbal preparation STW 5‐II (n = 52), bitter candytuft mono‐extract (n = 53) or placebo (n = 52). The main outcome variables were the changes in total abdominal pain and irritable bowel syndrome symptom scores.Results : Two hundred and three patients completed the trial. STW 5 and STW 5‐II were significantly better than placebo in reducing the total abdominal pain score (intention‐to‐treat: STW 5, P = 0.0009; STW 5‐II, P = 0.0005) and the irritable bowel syndrome symptom score (intention‐to‐treat: STW 5, P = 0.001; STW 5‐II, P = 0.0003) at 4 weeks. There were no statistically significant differences between the bitter candytuft mono‐extract group and the placebo group (P = 0.1473, P = 0.1207).Conclusions : The commercially available herbal preparation STW 5 and its research preparation STW 5‐II are both effective in alleviating irritable bowel syndrome symptoms.
An enema formulation of alicaforsen, an antisense inhibitor of intercellular adhesion molecule‐1, in the treatment of chronic, unremitting pouchitis
Authors: Miner P. , Wedel M. , Bane B. , Bradley J. 
Published: January 2004

SummaryBackground : Pouchitis is the major long‐term complication of ileal pouch‐anal anastomosis for ulcerative colitis. The incidence of pouchitis is as high as 50% several years after surgery. Two‐thirds of pouchitis patients suffer recurrence. Of those who recur, one‐quarter suffer from chronic, unremitting pouchitis. Current treatments for this disorder are disappointing.Aim : To determine whether a topically administered enema formulation of ISIS 2302 (alicaforsen), an antisense inhibitor of intercellular adhesion molecule‐1, can improve the clinical symptoms, endoscopic mucosal appearance and mucosal histology in patients with chronic, unremitting pouchitis, a disorder in which this molecule is over‐expressed.Methods : In an open‐label, uncontrolled study, 12 patients with chronic, unremitting pouchitis were treated with 240 mg alicaforsen antisense enema nightly for 6 weeks. Clinical evaluation and endoscopy were performed at baseline and at weeks 3, 6 and 10. Pouchoscopy with biopsy was carried out at baseline and at weeks 6 and 10. The primary end‐point was the reduction from baseline of the Pouchitis Disease Activity Index (PDAI) at week 6. Secondary end‐points included the PDAI at week 10. Safety was evaluated by analysing the adverse events, vital signs and laboratory parameters.Results : After 6 weeks of nightly alicaforsen enema, a statistically significant (n = 12, P = 0.001) reduction in the PDAI from baseline (11.42) to week 6 (6.83) was observed. Mean reductions in the endoscopy sub‐score from baseline (5.25) to week 3 (3.08) and week 6 (2.58) were statistically significant (P = 0.0039 and P = 0.0005, respectively). The mean reductions in clinical symptom sub‐score from baseline (3.75) to week 3 (2.33) and week 6 (2.25) were also statistically significant (P = 0.0156 and P = 0.0117, respectively). Ten of the 12 patients achieved a mucosal appearance score of 0 or 1 at endoscopy. Five of the 12 patients (42%) had a non‐statistically significant decrease in the histology component of their PDAI from baseline to week 6. By week 6, seven of the 12 patients (58%) were in remission, as defined by PDAI < 7, with a mean decrease from baseline in PDAI score of six points. The alicaforsen enemas were well tolerated and no serious side‐effects were noted.Conclusions : Antisense enema to intercellular adhesion molecule‐1 is safe and well tolerated. In an open‐label trial, it appeared to improve the PDAI score, clinical symptoms and endoscopic mucosal appearance. It may also improve the histology. In the light of the responses observed in this trial, a randomized, placebo‐controlled trial is warranted.
Systematic review: incidence of abdominal/pelvic surgery amongst patients using tegaserod in randomized controlled trials
Authors: Schoenfeld P. 
Published: January 2004

SummaryBackground : In the USA, tegaserod is contraindicated in patients with a history of bowel obstruction, abdominal adhesions or symptomatic gall‐bladder disease due to a non‐significant difference in abdominal surgery between tegaserod‐using and placebo‐using patients in Phase III trials.Aim : To calculate the incidence of abdominal and pelvic surgery in tegaserod‐using and placebo‐using patients in randomized controlled trials and to assess the possible association between medication and surgery, using pre‐specified criteria in a blind adjudication procedure.Methods : Primary study selection criteria included: (i) randomized controlled trial; (ii) comparison of tegaserod vs. placebo; and (iii) results reporting the incidence of abdominal and pelvic surgery. A panel of experts in epidemiology and functional bowel disorders reviewed the history of each patient who underwent surgery. Experts were blind with regard to whether patients used tegaserod or placebo. Using pre‐specified criteria, experts rated the likelihood of an association between medication use and surgery.Results : Thirteen randomized controlled trials (n =9857 patients) met the primary study selection criteria. No significant difference in the incidence of abdominal/pelvic surgery was identified between tegaserod‐using and placebo‐using patients: pelvic surgery, 0.16% vs. 0.19% (P = 0.80); abdominal surgery (non‐cholecystectomy), 0.15% vs. 0.19% (P = 0.61); cholecystectomy, 0.13% vs. 0.03% (P = 0.17); total abdominal/pelvic surgery, 0.44% vs. 0.41% (P = 1.00). Post‐adjudication, there was no significant difference in the incidence of abdominal/pelvic surgery between tegaserod‐using and placebo‐using patients.Conclusion : Data from randomized controlled trials demonstrate a similar incidence of abdominal/pelvic surgery in tegaserod‐using and placebo‐using patients.
Long‐term culture ofXenopuspresumptive ectoderm in a nutrient‐supplemented culture medium
Authors: Fukui Yasuto , Furue Miho , Myoishi Yasufumi , Sato J. Denry , Okamoto Tetsuji , Asashima Makoto 
Published: January 2004

Animal cap assay is a useful experimental model for investigating the activity of inducers in amphibian development. This assay has revealed that activin A is a potent mesoderm‐inducing factor. However, it has been very difficult to induce highly differentiated tissues such as cartilage in a 3–4 day culture period. It was recently reported that jaw cartilage was inducedin vitroin an animal cap that had been cultured for 14 days in Steinberg's solution using the sandwich culture method and activin A. Under these conditions, necrosis was occasionally observed in the explants. In this study, we have achieved long‐term animal cap cultures in a nutrient‐supplemented culture medium designated RDX. This medium was made by modifying the saline concentration of the RD medium previously developed as a basal medium for the serum‐free culture of various kinds of mammalian cells. The explants cultured in RDX grew more vigorously compared with those in Steinberg's solution. RDX medium promoted a wider variety of tissue induction and gene expression in the animal caps than Steinberg's solution, and also increased the frequency of cartilage induction. Therefore, the supplemental nutrients may support and promote the differentiation of cartilage. This long‐term culture method using RDX medium is useful for studying the differentiation of tissues or organs such as cartilagein vitro.
Influence of climate factors on emergency visits for childhood asthma attack
Authors: Hashimoto Mitsuo , Fukuda Taiki , Shimizu Tetsuya , Watanabe Shou , Watanuki Satoshi , Eto Yoshikatsu , Urashima Mitsuyoshi 
Published: January 2004

Abstract
Background
: Asthma attack shows strong seasonality. The purpose of the present study was to quantify the contribution of climate variables and other seasonal factors on the incidence of emergency visits for childhood asthma in Tokyo, Japan.
Methods
: The number of children who visited emergency rooms at Jikei university hospitals in Tokyo during 1998−2002 (5559 visits) was retrieved retrospectively from files from the Department of Pediatrics, and compared with 45 climate parameters from the Meteorological Agency using multiple regression models with a stepwise backward elimination approach.
Results
: The number of visits (3.7 ± 3.1) per night increased significantly when climate conditions showed a rapid decrease from higher barometric pressure, from higher air temperature and from higher humidity, as well as lower wind speed. The best‐fit model demonstrated that a 22% variation in the number of visits was explained by a linear relationship with 12 climate variables, which increased to 36% after adjusting for calendar month and day of the week. Moreover, when the number of asthma visits was cut off at nine per night, the area under the receiver operator characteristics curve was 0.91 (95% CI: 0.89−0.94) in the multiple logistic regression model using the same variables.
Conclusions
: These results suggest that these models might quantify contributions of specific climate conditions and other seasonal factors on the number of emergency visits per night for childhood asthma attack in Tokyo, Japan.
Neonatal urinary tract infections: Analysis of the patients and recurrences
Authors: Biyikli Nese Karaaslan , Alpay Harika , Ozek Eren , Akman Ipek , Bilgen Hulya 
Published: January 2004

Abstract
Background
: Early diagnosis and proper treatment, including long‐term follow up, are very important for neonatal urinary tract infections (UTI).
Methods
: The present study reports the analysis and long‐term follow‐up results of 71 newborns treated for UTI.
Results
: Forty‐one per cent of patients were preterm babies. Suspected sepsis and hyperbilirubinemia were the main presenting features. Community‐acquired and nasocomial UTI accounted for 63% and 37% of cases, respectively. The leading causative agents were Escherichia coli for community‐acquired UTI and Klebsiella pneumoniae for nasocomial UTI. The urosepsis rate was 5%. Abnormal ultrasonography findings were present in 23% and vesicoureteral reflux was present in 15% of babies. A total of 23% of patients showed renal photopenic areas on dimercaptosuccinic acid scan. The recurrence rate was 28% occurring between 1.5 and 12 months, in particular in the first 6 months. Most of the recurrences developed in patients with no predisposing abnormalities.
Conclusion
: Pediatric nephrologic follow‐up of babies experiencing UTI in the neonatal period is very important to identify the predisposing congenital abnormalities and scarred kidneys, to diagnose and to treat the recurrences earlier.
Management of thyroglossal duct cysts in children
Authors: TürkyiLmaz Zafer , Sönmez Kaan , Karabulut Ramazan , DemirĞoullari Billur , Sezer Cem , BaŞaklar A. Can , Kale Nuri 
Published: January 2004

Abstract
Background
: The recurrence rate of thyroglossal duct cysts removed by Sistrunk or other procedures is 4% and 50%, respectively. The aim of the present study was to explain the reasons for recurrence and misdiagnosis.
Methods
: Twenty‐seven children underwent surgery for thyroglossal cysts and fistulas during 1989−2000. Age, sex, length of history, presentation, preoperative investigations, operative findings, histopathology of the lesion and length of excised hyoid bone, postoperative complications and length of follow‐up were recorded. Statistical analysis was performed using Fisher's exact test with a significance level of P < 0.05.
Results
: Twenty‐three patients were primary referrals and four were secondary referrals having had previous surgery with misdiagnosis. The recurrence rate after a Sistrunk procedure was similar to the rate indicated in the literature (3.7%); however, no related special features could be identified such as inflammation (n = 12), perforation at surgery (n = 7), presentation with fistula (n = 4) or previous drainage of abscess (n = 5) (P > 0.05).
Conclusion
: Misdiagnosis is the most common cause of inadequate and inappropriate surgery, leading to recurrence of the lesion. The authors recommend a Sistrunk procedure for all cases of suspected thyroglossal duct cysts.