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Dent J.,Royal Adelaide Hospital | Vakil N.,University of Wisconsin - Madison | Jones R.,Kings College London | Bytzer P.,Koge University Hospital | And 4 more authors.
Gut | Year: 2010

Objective: The aim of this study was to determine the accuracy of the diagnosis of gastro-oesophageal reflux disease (GORD) by the Reflux Disease Questionnaire (RDQ), family practitioners, gastroenterologists and a test of esomeprazole therapy. Methods: This was a single-blind, single-arm study over 3-4 weeks from September 2005 to November 2006. Each symptom-based diagnostic assessment was made blinded to prior diagnoses. Patients were those presenting to their family practitioner with troublesome upper gastrointestinal symptoms (n=308). The RDQ was completed and a symptom-based diagnosis was made by the family practitioner. Placebo esomeprazole was started. Gastroenterologists made a symptom-based diagnosis and then performed endoscopy with 48 h oesophageal pH and symptom association monitoring to determine the presence/absence of GORD. Symptoms were recorded during treatment with 40 mg of esomeprazole for 2 weeks. The main outcome measure was RDQ scoring for the presence of GORD compared with symptom-based diagnosis by family physicians and gastroenterologists. Results: GORD was present in 203/308 (66%) patients. Only 49% of the patients with GORD selected either heartburn or regurgitation as the most troublesome symptom. Sensitivity and specificity, respectively, of the symptom-based diagnosis of GORD, were 62% and 67% for the RDQ, 63% and 63% for family practitioners, and 67% and 70% for gastroenterologists. Symptom response to esomeprazole was neither sensitive nor specific for the diagnosis of GORD. Conclusions: The RDQ, family practitioners and gastroenterologists have moderate and similar accuracy for diagnosis of GORD. Symptom response to a 2 week course of 40 mg of esomeprazole does not add diagnostic precision. Clinical trial number: NCT00291746.


Heslet L.,Serendex ApS | Bay C.,Copenhagen University | Nepper-Christensen S.,Koge University Hospital
International Journal of General Medicine | Year: 2012

Background: The current radiation threat from the Fukushima power plant accident has prompted rethinking of the contingency plan for prophylaxis and treatment of the acute radiation syndrome (ARS). The well-documented effect of the growth factors (granulocyte colony-stimulating factor [G-CSF] and granulocyte-macrophage colony-stimulating factor [GM-CSF]) in acute radiation injury has become standard treatment for ARS in the United States, based on the fact that growth factors increase number and functions of both macrophages and granulocytes. Methods: Review of the current literature. Results: The lungs have their own host defense system, based on alveolar macrophages. After radiation exposure to the lungs, resting macrophages can no longer be transformed, not even during systemic administration of growth factors because G-CSF/GM-CSF does not penetrate the alveoli. Under normal circumstances, locally-produced GM-CSF receptors transform resting macrophages into fully immunocompetent dendritic cells in the sealed-off pulmonary compartment. However, GM-CSF is not expressed in radiation injured tissue due to defervescence of the macrophages. In order to maintain the macrophage's important role in host defense after radiation exposure, it is hypothesized that it is necessary to administer the drug exogenously in order to uphold the barrier against exogenous and endogenous infections and possibly prevent the potentially lethal systemic infection, which is the main cause of death in ARS. Recommendation: Preemptive treatment should be initiated after suspected exposure of a radiation dose of at least -2 Gy by prompt dosing of 250-400 μg GM-CSF/m2 or 5 μg/kg G-CSF administered systemically and concomitant inhalation of GM-CSF - 300 mcg per day for at least 14-21 days. Conclusion: The present United States standard for prevention and treatment of ARS standard intervention should consequently be modified into the combined systemic administration of growth factors and inhaled GM-CSF to ensure the sustained systemic and pulmonary host defense and thus prevent pulmonary dysfunction. © 2012 Heslet et al, publisher and licensee Dove Medical Press Ltd.


Bytzer P.,Koge University Hospital | Jones R.,Kings College London | Vakil N.,University of Wisconsin - Medical School | Junghard O.,Astrazeneca | And 3 more authors.
Clinical Gastroenterology and Hepatology | Year: 2012

Background &Aims:The efficacy of proton-pump inhibitor (PPI) therapy often is assessed to determine whether patients' symptoms are acid-related and if patients have gastroesophageal reflux disease (GERD), although the accuracy of this approach is questionable. We evaluated the diagnostic performance of the PPI test, in conjunction with other tests, for the diagnosis of GERD.Methods:We analyzed data from the DIAMOND study, a multinational trial that compared the ability of the reflux disease questionnaire with that of symptom-based clinical diagnosis to identify GERD in primary care patients with frequent upper-gastrointestinal symptoms. Patients (n = 308) were given placebo and further evaluated by endoscopy, wireless esophageal pH-metry, and symptom association monitoring. Those with GERD (n = 197) were identified based on the presence of reflux esophagitis, esophageal pH level less than 4 for more than 5.5% of 24 hours, or positive results from symptom association monitoring (or a positive result from the PPI test in patients with borderline levels of esophageal acidity). All patients then were given single-blind therapy with esomeprazole (40 mg once daily) for 2 weeks and symptoms were recorded daily.Results:A positive response to the PPI test was observed in 69% of patients with GERD and in 51% of those without GERD. Response to placebo did not influence the diagnostic ability of the subsequent PPI test. More patients with reflux esophagitis had a positive result from the PPI test than patients without GERD (57% vs 35%;P= .002) or patients with GERD but no esophagitis. A clinical diagnosis by the primary care physician of an acid-related disease was not associated with response to PPIs.Conclusions:In a well-characterized population of primary care patients with frequent upper-gastrointestinal symptoms of any type, the PPI test has limited ability to identify patients with GERD, diagnosed by current standard tests. © 2012 AGA Institute.


Andersen S.A.W.,Copenhagen University | Aabenhus K.,Copenhagen University | Glad H.,Koge University Hospital | Sorensen M.S.,Copenhagen University
Otology and Neurotology | Year: 2014

Objective: To present a prospective ear surgery database and investigate the graft take-rate and prognostic factors for graft take-rate in tympanoplasty using the database.Study Design: Prospective database study.Setting: Tertiary referral center.Patients: A total of 1606 cases undergoing tympanoplasty types I to IV were registered in the database in the period from February 2004 to November 2013.Intervention: A total of 837 cases underwent myringoplasty/ tympanoplasty type I.Main Outcome Measure: Graft take-rate and prognostic factors (age, discharge at time of surgery, tuba function, technique, graft material, and revision surgery) for tympanoplasty type I were studied. A comparison with the graft take-rates for tympanoplasty types II to IV and/or cholesteatoma was made.Results: A user-friendly ear surgery database with fast data entry and direct import of audiometric data was developed. The graft take-rate was found to be 93.0% at 2 to 6 months and 86.6% at more than 12 months. Except for a discharging ear at the time of surgery, no significant differences using Χ2 test of association were found when comparing graft take-rates for different prognostic factors or more advanced tympanoplasty with or without cholesteatoma. A long-term graft take-rate overestimation of 6% was found if cases with defaulted follow-up because of early reperforation were not included.Conclusion: A prospective database can be used to study prognostic factors and reduce bias in reporting the graft take-rate. Prospective databases are needed for high-quality longitudinal studies but require a continuous and daily effort of involved surgeons and therefore need to be convenient and fast to use. Copyright © 2014 Otology & Neurotology, Inc.


Lodrup A.,Koge University Hospital | Lodrup A.,Diagnostic Center | Hallas J.,University of Southern Denmark | Bytzer P.,Koge University Hospital | Bytzer P.,Copenhagen University
Alimentary Pharmacology and Therapeutics | Year: 2015

Background Guidelines recommend that patients with gastro-oesophageal reflux disease are adequately treated with acid-suppressive therapy before undergoing anti-reflux surgery. Little is known of the use of acid-suppressive drugs before anti-reflux surgery. Aim To determine the use of proton pump inhibitors and H2-receptor antagonists in the year before anti-reflux surgery. Methods A nationwide retrospective study of all patients aged ≥18 undergoing first-time anti-reflux surgery in Denmark during 2000-2012 using data from three different sources: the Danish National Register of Patients, the Danish National Prescription Register, and the Danish Person Register. Results The study population thus included 2922 patients (median age: 48 years, 55.7% male). The annual proportion of patients redeeming ≥180 DDD of acid-suppressive therapy increased from 17.0% 5 years before anti-reflux surgery to 64.9% 1 year before. The probability for inadequate dosing 1 year before surgery (<180 DDD) was significantly increased for younger patients, patients operated in the period 2000-2003, patients who had not undergone pre-surgical manometry, pH- or impedance monitoring, and patients who had not redeemed prescriptions on NSAID or anti-platelet drugs. Conclusion Compliance with medical therapy should be evaluated thoroughly before planning anti-reflux surgery, as a high proportion of patients receive inadequate dosing of acid-suppressive therapy prior to the operation. © 2015 John Wiley & Sons Ltd.

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