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| 3. |
- Andersson, Mats, 1954, et al.
(författare)
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Characteristics of timed barium esophagogram in newly diagnosed idiopathic achalasia: clinical and manometric correlates
- 2007
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Ingår i: Acta Radiol. - : SAGE Publications. - 0284-1851 .- 1600-0455. ; 48:1, s. 2-9
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Tidskriftsartikel (refereegranskat)abstract
- PURPOSE: To describe timed barium esophagogram (TBE) characteristics in patients with newly diagnosed idiopathic achalasia, and to correlate these with clinical and manometric variables. MATERIAL AND METHODS: Forty-six consecutive patients with newly diagnosed achalasia were examined with TBE. Esophageal emptying was assessed using the height, area, and volume of the barium column. Subjective evaluation was performed according to a standardized protocol in all patients. Objective diagnostic evaluation included manometry. RESULTS: At the 1-min time point after contrast ingestion, the static parameters median height, maximum, and mean width of the barium column were 16.0, 4.4, and 3.3 cm, respectively. Emptying, expressed as volume of barium, showed significant inverse correlation with the resting and the maximal relaxing pressure of the lower esophageal sphincter (LES) (R = -0.34 and R = -0.54, respectively). There was also an inverse correlation between emptied volume at TBE and the duration of symptoms (R = -0.36), and between barium column width and postprandial chest pain (R = -0.44). CONCLUSION: All patients with newly diagnosed achalasia presented with delayed emptying of barium the esophagus at TBE. The estimated emptied volume of barium (related to the ingested volume) correlated inversely with the basal tone and the relaxation pressure of the LES. Including estimation of the volume of emptied barium at TBE resulted in closer correlation with manometric values of LES tone than using the parameters traditionally recorded.
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| 4. |
- Andersson, Mats, 1954, et al.
(författare)
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Evaluation of the response to treatment in patients with idiopathic achalasia by the timed barium esophagogram: results from a randomized clinical trial.
- 2009
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Ingår i: Diseases of the Esophagus. - : Oxford University Press (OUP). - 1442-2050 .- 1120-8694. ; 22:3, s. 264-73
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Tidskriftsartikel (refereegranskat)abstract
- To choose which treatment would be most effective for the individual patient with newly diagnosed achalasia is difficult for the tending physician. A diagnostic tool that would allow prediction of the symptomatic and functional response after treatment for achalasia is therefore needed. The timed barium esophagogram (TBE) is a method that allows objective assessment of esophageal emptying, but the value of TBE in the clinical management of achalasia remains to be clarified. The aim of this study was first, to assess the ability of TBE to predict symptoms and treatment failure during post-treatment follow-up. Second, to determine whether esophageal emptying as assessed by TBE differs after treatment with pneumatic dilatation or laparoscopic myotomy. Fifty-one patients with newly diagnosed achalasia were prospectively randomized to pneumatic dilatation (n = 26) or laparoscopic myotomy (n = 25). Evaluation with TBE was performed before (n = 46) and after treatment (n = 43). The median interval between treatment and post-treatment TBE was 6 months, and the median follow-up time after the post-treatment TBE was 18 months. Following therapeutic intervention, TBE parameters did not differ significantly between treatment groups. However, significant correlations were found between the height of the barium column at 1 min and the symptom scores at the end of follow up for 'dysphagia for liquids' (P < 0.05, rho = 0.47), 'chest pain' (P < 0.05, rho = 0.42), and the 'Watson dysphagia score' (P < 0.05, rho = 0.46). Patients with less than 50% improvement in this TBE-parameter (height at 1 min) post-treatment had a 40% risk of treatment failure during follow-up. In summary, pneumatic balloon dilatation and laparoscopic myotomy similarly affected esophageal function as assessed by TBE-emptying. Lack of improvement in barium-column height post-treatment was associated with an increased risk of treatment failure which should motivate close surveillance in order to detect symptomatic recurrence at an early stage.
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| 6. |
- Andersson, Olle, 1964, et al.
(författare)
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Development and validation of a laryngopharyngeal reflux questionnaire, the Pharyngeal reflux Symptom Questionnaire
- 2010
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Ingår i: Scandinavian Journal of Gastroenterology. - 0036-5521. ; 45:2, s. 147-159
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: To develop and validate the Pharyngeal Reflux Symptom Questionnaire (PRSQ), a comprehensive, disease-specific, self-administered questionnaire for laryngopharyngeal reflux (LPR) disease. MATERIAL AND METHODS: The PRSQ was developed based on empirical evidence from a literature review and expert input from physicians and patients and tested in a pilot study. In this validation study, a total of 228 patients were included and classified according to the Reflux Symptom Index (RSI) cut-off score. Patients with an RSI score > 13 were defined as abnormal, i.e. having LPR disease (n = 102), and those with a score between 0 and 13 were defined as normal controls (n = 126). Psychometric properties of the PRSQ were evaluated by exploring the factor structure and by evaluating internal consistency and item convergent and discriminant validity. Convergent and discriminant validity were determined by using the Laryngopharyngeal Reflux-Health Related Quality of Life questionnaire (LPR-HRQL), the RSI and the Short Form-36. RESULTS: The PRSQ was well accepted by the patients. Compliance was satisfactory and missing item rates were low. After item reduction, due to items not being conceptually relevant or scaling errors and/or low factor loadings, a construct was achieved with no scaling errors and high internal consistency (Cronbach's alpha 0.79-0.93). The correlations between the PRSQ and similar dimensions in the RSI and LPR-HRQL were generally strong. Discriminant validity was satisfactory as the questionnaire discriminated between patients with and without LPR disease. CONCLUSION: The PRSQ showed good psychometric properties and may become a valuable instrument for assessing LPR disease.
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| 7. |
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| 8. |
- Andersson, Olle, 1964, et al.
(författare)
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Validation of the Swedish translation of LPR-HRQL.
- 2010
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Ingår i: Medical science monitor. - 1234-1010. ; 16:10, s. CR480-CR487
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: The aim of this study was to adapt the Laryngopharyngeal Reflux Health- Related Quality of Life questionnaire (LPR-HRQL) to Swedish and evaluate its psychometric properties in patients with suspected laryngopharyngeal reflux (LPR). MATERIAL/METHODS: The psychometric validation included 228 patients with suspected LPR who had previously undergone a 2-level 24-hour pH examination and who answered a mail-distributed set of questionnaires. The patients were divided into 2 comparable groups according to the Reflux Symptom Index (RSI) cut-off score: 126 patients with RSI score between 0-13 (defined as normal) and 102 patients with RSI score >13 (defined as abnormal, i.e. having LPR disease). RESULTS: LPR-HRQL was adapted to Swedish using a formal forward-backward translation method with input from expert groups (patients and physicians). Psychometric properties of the Swedish version of LPR-HRQL were evaluated by using factor analysis to explore the factor structure. Convergent and discriminant validity was determined by using the questionnaires RSI and Short Form-36 (SF-36). The psychometric tests performed fulfilled the criteria for structural integrity, validity and reliability, mostly confirming the results obtained in the original LPR-HRQL version. CONCLUSIONS: The Swedish translated version of LPR-HRQL proved to be a statistically valid instrument with which to assess HRQL in patients with LPR disease, and will be further tested in prospective studies.
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| 9. |
- Bergquist, Henrik, 1969, et al.
(författare)
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Combined stent insertion and single high-dose brachytherapy in patients with advanced esophageal cancer - results of a prospective safety study.
- 2011
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Ingår i: Diseases of the esophagus. - : Oxford University Press (OUP). - 1442-2050 .- 1120-8694. ; Early View
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Tidskriftsartikel (refereegranskat)abstract
- Previous randomized studies comparing the two commonly used palliative treatments for incurable esophageal cancer, i.e. stent insertion and intraluminal brachytherapy, have revealed the pros and cons of each therapy. While stent treatment offers a more prompt effect, brachytherapy results in more long-lasting relief of dysphagia and a better health-related quality of life (HRQL) in those living longer. This prospective pilot study aimed to explore the feasibility and safety of combining these two regimes and incorporating a single high dose of internal radiation. Patients with newly diagnosed, incurable cancer of the esophagus and dysphagia were eligible for inclusion, and stent insertion followed by a single dose (12Gy) of brachytherapy was performed as a two-stage procedure. Clinical parameters including HRQL and adverse events were registered at inclusion, and 1, 2, 3, 6, and 12 months later. Twelve patients (nine males) with a median age of 73 years (range 54-85) were included. Stent insertion followed by a single dose of brachytherapy was successfully performed in all but one patient who was treated with stent only. Relief of dysphagia was achieved in the majority of cases (10/11, P < 0.05), but HRQL did not improve except for dysphagia-related items. Only minor adverse events, including chest pain, reflux, and restenosis, were reported. The median survival time after inclusion was 6.6 months. Our conclusion is that the combination of stent insertion and single high-dose brachytherapy seems to be a feasible and safe palliative regime in patients with advanced esophageal cancer. Randomized trials comparing the efficacy of this strategy to stent insertion or brachytherapy alone are warranted.
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| 10. |
- Bergquist, Henrik, 1969, et al.
(författare)
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Functional long-term outcome of a free jejunal transplant reconstruction following chemoradiotherapy and radical resection for hypopharyngeal and proximal oesophageal carcinoma
- 2004
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Ingår i: Digestive surgery. ; :21, s. 426-433
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND/AIMS: To evaluate the functional outcome of a reconstruction by a free vascularized jejunal transplant combined with a voice prosthesis after chemoradiotherapy and surgery for proximal oesophageal or hypopharyngeal cancer. METHODS: Seven patients (6 men, mean age 52 years, range 28-70) with squamous cell cancer in the proximal oesophagus (n = 6) or the hypopharynx received preoperative chemoradiotherapy (40.8 Gy, cisplatinum and 5-FU) followed by a circumferential pharyngolaryngectomy and resection of the proximal oesophagus. A single-stage reconstruction was carried out with a free jejunal transplant using a microsurgical technique. A tracheojejunal puncture and insertion of a voice prosthesis (Provox I) was performed after 3 months in suitable cases. RESULTS: All operations had a per- and postoperative uneventful course. Five patients were alive after a mean follow-up time of 5 years and 7 months after surgery (range 3 years 4 months to 7 years 10 months), while 2 patients died from metastases within 2 years after surgery. Postoperative examination showed histopathological down-staging in all cases. Relief of dysphagia was achieved in most cases. Good or average speech was recorded in 3 patients. CONCLUSION: Reconstruction after radical resection for proximal oesophageal and hypopharyngeal cancer can be carried out with low mortality, acceptable morbidity and a promising functional outcome.
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| 11. |
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| 12. |
- Bove, Mogens, 1949, et al.
(författare)
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Acid challenge to the esophageal mucosa: effects on local nitric oxide formation and its relation to epithelial functions
- 2005
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Ingår i: Dig Dis Sci. - : Springer Science and Business Media LLC. - 0163-2116 .- 1573-2568. ; 50:4, s. 640-8
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Tidskriftsartikel (refereegranskat)abstract
- To evaluate the effect of esophageal acid exposure on epithelial function, transmucosal potential, histopathological markers of acute tissue damage, and local nitric oxide production were examined in healthy volunteers treated with proton pump inhibitors (group I), patients with treated reflux disease (group II), and patients with untreated erosive reflux disease (group III). The participants were randomized to esophageal perfusion with either saline or HCl. Denominators of acute acid exposure were balloon cells in superficial layers and superficial densification. The nitric oxide concentrations in groups I to III increased from < 1, 10.0+/-10.0, and 20.6+/-19.9 ppb, respectively, to 300+/-80, 1360+/-1080, and 920+/-700 ppb after HCl infusion (P < 0.001). Inducible nitric oxide synthase was consistently expressed in the epithelium. Blood flow was lower among reflux patients but did not correlate with acid exposure or nitric oxide. Nitric oxide is formed following acid perfusion and predominantly in gastroesophageal reflux disease.
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| 13. |
- Bove, Mogens, 1949, et al.
(författare)
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Acid challenge to the human esophageal mucosa: effects on epithelial architecture in health and disease
- 2005
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Ingår i: Dig Dis Sci. - : Springer Science and Business Media LLC. - 0163-2116 .- 1573-2568. ; 50:8, s. 1488-96
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Tidskriftsartikel (refereegranskat)abstract
- The histological changes that occur in the squamous epithelium in response to acute acid challenge was examined in healthy controls and proton pump inhibitor-treated gastroesophageal reflux disease (GERD) patients and related to the state of untreated erosive GERD in a saline-controlled, randomized perfusion study. In the basal state a stepwise significant increase in the thickness of the basal cell layer, papillary length, and dilatation of intercellular spaces (DIS) was seen when the three groups were compared. Acid perfusion induced a slight increase in the height of the basal cell layer mainly in healthy volunteers; this layer appears to be reactive to acute acid challenge as well as to acid suppressive therapy. DIS increases promptly in response to acute acid exposure in the healthy epithelium but no changes were seen in the lengths of the papillae or regarding DIS in the GERD patients. A protective effect of luminal nitric oxide on DIS development is suggested.
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| 14. |
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| 15. |
- Bove, Mogens, 1949, et al.
(författare)
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Epithelial barrier integrity and intraluminal nitric oxide production in response to acid perfusion of the ferret oesophagus
- 2005
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Ingår i: Acta Physiol Scand. - 0001-6772. ; 183:2, s. 211-8
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Tidskriftsartikel (refereegranskat)abstract
- AIM: To evaluate the source and role of acid-induced intraluminal nitric oxide (NO) production in the oesophagus by studying how the exposure of the oesophagus to acid affects NO release, via the NO-producing enzyme NO synthase and its relation to changes in epithelial barrier integrity. METHODS: Ferrets were anaesthetized and their oesophagi were divided at both ends. The test subjects were pre-treated with the intravenous NO synthase inhibitors N(G)-nitro-L-arginine-methyl ester (L-NAME, 100 mg kg(-1)) and 1400W (12 mg kg(-1)). Untreated and N(G)-nitro-D-arginine-methyl ester pre-treated (D-NAME, 100 mg kg(-1)) animals served as controls. The oesophagus was then perfused with either HCl (0.1 m) or physiological saline for 20 min. The intraluminal NO concentration was determined before and after the acid/saline infusion while the transmucosal potential difference (PD) was monitored continuously. Oesophageal biopsies were examined for expression of inducible NO synthase using immunohistochemistry. RESULTS: The intraluminal NO concentration increased after acid exposure. This was blocked by L-NAME and 1400W, but not by D-NAME. The peak PD response was not affected by agents affecting NO synthesis, while the plateau response was attenuated by L-NAME, D-NAME and 1400W. Immunohistochemistry revealed inducible NO synthase expression in the epithelium. CONCLUSIONS: Exposing the ferret oesophageal mucosa to acid elicited an increase in juxtamucosal NO formation through the activation of inducible NO synthase. The corresponding electrophysiological observations suggested an association between mucosal NO production and epithelial integrity.
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| 20. |
- Engström, Cecilia, 1965, et al.
(författare)
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Manometric characteristics of the gastroesophageal junction after anterior versus posterior partial fundoplication
- 2005
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Ingår i: Diseases of the esophagus. - 1120-8694. ; 18:1, s. 31-6
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Tidskriftsartikel (refereegranskat)abstract
- How best to surgically treat GERD is an unresolved issue. To increase our insights into the fundoplication procedures, functional consequences for the gastroesophageal junction of an anterior or a posterior partial fundoplication were studied by manometry. Patients were randomly selected from a larger study in a randomised comparison between posterior and anterior partial fundoplications. The manometric studies were done 12 months after respective procedures in 24 patients. The motor characteristics of the esophagus and lower esophageal sphincter (LES) function were determined by use of sleeve catheter manometry. The manometric characteristics of the esophageal body were similar in the study groups except for the ramp pressure. This was significantly higher in patients with posterior partial fundoplications. The posterior group had significantly longer total length (P < 0.02) as well as longer intra-abdominal portions (P = 0.07) of the LES while the basal tone, albeit numerically higher, did not reach statistical significance. Water-swallow induced LES relaxations reached lower nadir values in the anterior group (1.7 vs 2.7 mmHg). Gas distension triggered few transient LES relaxations in both study groups while common cavities were more frequently observed in those having an anterior partial wrap (P < 0.01). A posterior partial fundoplication is followed by manometric characteristics suggesting a well functioning antireflux barrier with some obstruction to bolus passage as well as restricted venting of air from the stomach. The manometric mechanisms behind the inferior reflux control achieved by a Watson type of anterior partial wrap has now been further elucidated.
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| 23. |
- Kostic, Srdjan, 1958, et al.
(författare)
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Health economic evaluation of therapeutic strategies in patients with idiopathic achalasia: results of a randomized trial comparing pneumatic dilatation with laparoscopic cardiomyotomy
- 2007
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Ingår i: Surgical endoscopy. - 1432-2218 .- 0930-2794. ; 21:7, s. 1184-9
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: We have prospectively collected information concerning the costs incurred during the management of patients allocated to either forceful dilatation or to an immediate laparoscopic operation because of newly diagnosed achalasia. METHODS: Fifty-one patients with newly diagnosed achalasia were randomized to either pneumatic dilatation to a diameter of 30-40 mm or to a laparoscopic myotomy to which was added a posterior partial fundoplication. Follow-ups were scheduled at 1, 3, 6, and 12 months after inclusion. At each follow-up visit a study nurse interviewed the patients regarding symptoms and their quality of life (QoL) and a health economic questionnaire was completed. In the latter questionnaire, patients were asked to report the presence and character of contacts with the healthcare system since the last visit. RESULTS: In the dilatation group six patients (23%), including the patient who was operated on because of perforation, were classified as failures during the first 12 months of follow-up compared to one (4%) in the myotomy group (p = 0.047). Five of those classified as failures in the dilatation group subsequently had a surgical myotomy and the sixth patient was treated with repeated dilatations. The patient classified as failure in the myotomy group was treated with endoscopic dilatation. The initial treatment cost and the total costs were significantly higher for laparoscopic myotomy compared to a pneumatic dilatation-based strategy (p = 0.0002 and p = 0.0019, respectively). When the total costs were subdivided into the different resources used, we found that the single largest cost item for pneumatic dilatation was that for hospital stay and that for laparoscopic myotomy was the actual operative treatment (operating room time). The cost-effectiveness analysis, relating to the actual treatment failures, revealed that the cost to avoid one treatment failure (incremental cost-effectiveness ratio) amounted to 9239 euros. CONCLUSION: The current prospective, controlled clinical trial shows that despite a higher level of clinical efficacy of laparoscopic myotomy to prevent treatment failure in newly diagnosed achalasia, the cost effectiveness of pneumatic dilatation is superior, at least when a reasonable time horizon is applied.
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| 24. |
- Kostic, Srdjan, 1958, et al.
(författare)
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Pneumatic dilatation or laparoscopic cardiomyotomy in the management of newly diagnosed idiopathic achalasia. Results of a randomized controlled trial
- 2007
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Ingår i: World journal of surgery. - : Springer Science and Business Media LLC. - 0364-2313 .- 1432-2323. ; 31:3, s. 470-8
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: The most effective therapeutic strategy in newly diagnosed achalasia is yet to be established. Therefore we designed a study in which pneumatic dilatation was compared to laparoscopic cardiomyotomy to which was added a partial posterior fundoplication. PATIENTS AND RESULTS: A series of 51 patients (24 males, mean age 44 years) were randomly allocated to the therapeutic modalities (dilatation = 26, surgery = 25). All patients were followed for at least 12 months, and during that period the pneumatic dilatations strategy had significantly more treatment failures (P = 0.04). Only minor differences emerged between the study groups when symptoms, dysphagia scorings, and quality-of-life assessments were evaluated 12 months after initiation of therapy. CONCLUSIONS: Laparoscopic myotomy was found to be superior to an endoscopic balloon dilatation strategy in the treatment of achalasia when studied during the first 12 months after treatment.
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| 25. |
- Larsson, Helen, 1982, et al.
(författare)
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Grade of eosinophilia versus symptoms in patients with dysphagia and esophageal eosinophilia.
- 2016
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Ingår i: Diseases of the esophagus. - : Oxford University Press (OUP). - 1120-8694. ; 29:8, s. 971-976
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Tidskriftsartikel (refereegranskat)abstract
- The aim of this study was to assess whether the symptom severity and health-related quality of life (HRQL) of patients with dysphagia and esophageal eosinophilia correlate with disease activity as expressed by the number of eosinophils in the esophageal mucosa. This study included newly diagnosed (n = 58) or relapsed patients (n = 7), where 40% were diagnosed in connection with esophageal bolus impaction. The mean age was 45 years (19-88), and 74% were men. Symptoms and HRQL were recorded using the Watson Dysphagia Scale (WDS), the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Oesophageal Module 18 and the Short Form-36 Questionnaire. Histological samples gathered from the proximal and distal esophageal mucosa were stained using both hematoxylin and eosin (HE) and an immunohistochemical (IHC) technique against 'Eosinophil Major Basic Protein,' and the peak number of eosinophils per high-power field was assessed. More eosinophils were detected after IHC staining than HE staining (P < 0.001). No correlation was found between symptoms or the HRQL and the number of eosinophils. However, higher numbers of eosinophils at the proximal esophagus were found in patients with concomitant bolus impaction (IHC P < 0.05 and HE P < 0.05) and could serve as a risk marker.
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| 26. |
- Norder Grusell, E., et al.
(författare)
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Bacterial flora of the human oral cavity, and the upper and lower esophagus.
- 2013
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Ingår i: Diseases of the esophagus. - : Oxford University Press (OUP). - 1120-8694. ; 26:1, s. 84-90
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Tidskriftsartikel (refereegranskat)abstract
- This reference study aims to survey the bacterial flora of the healthy lower human esophagus and to compare it with that of the upper esophagus and oral mucosa. The use of biopsies, in addition to brush samples, allows inclusion of not only transient bacteria present on the surface but also bacteria residing in the epithelia, and the yield of the two methods can be compared. Forty patients scheduled for surgery for reasons with no known influence on esophageal flora and with no symptoms or endoscopic signs of esophageal disease were included. Samples were collected from the oral, upper esophageal, and lower esophageal mucosa using sealed brushes and biopsy forceps. Colonies cultivated on agar plates were classified and semiquantified. Twenty-three different bacterial species were identified, with similar strains present at the three sites. The most common group of bacteria was viridans streptococci, with an occurrence rate in brush samples and biopsies of 98% and 95%, respectively. The median number of species occurring in the oral cavity, upper esophagus, and lower esophagus was between 3 and 4 (range 0-7). The total number of species in the oral cavity was significantly higher when compared with either level in the esophagus, while the yields obtained by brush and biopsy sampling were highly correlated. Hence, the normal human esophagus is colonized with a resident bacterial flora of its own, which has similarities to that of the oral mucosa. There are diverse species that make up this flora, although in relatively low amounts. The most frequent inhabitants of the esophagus are streptococci, with an occurrence rate in brush samples and biopsies of 95-98%. Comparative studies of patients with eosinophilic esophagitis and gastroesophageal reflux disease are warranted.
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| 27. |
- Norder Grusell, E., et al.
(författare)
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The cultivable bacterial flora of the esophagus in subjects with esophagitis
- 2018
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Ingår i: Scandinavian Journal of Gastroenterology. - : Informa UK Limited. - 0036-5521 .- 1502-7708. ; 53:6, s. 650-656
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Tidskriftsartikel (refereegranskat)abstract
- Background: The healthy human esophagus is colonized by bacteria similar to that of the oral mucosa. However, little is known about the microbiome of the esophagus in esophagitis or the possible role of bacteria in the inflammatory response.Aim: To survey bacterial diversity and compare the microbiome of the esophagus in subjects with gastro-esophageal reflux disease (GERD) and eosinophilic esophagitis (EoE).Material and methods: Seventeen subjects diagnosed with GERD and 10 with EoE underwent endoscopic examination with brush sampling and biopsies from the oral cavity, upper and lower esophagus. The samples were cultivated on agar plates, and bacterial growth was identified to the genus or species level and semi-quantified.Results: Significantly higher numbers of bacterial groups or species were found in specimens from the lower esophagus in subjects with EoE compared to subjects with GERD (median 4 (range 1-7) vs. 2 (range 0-6), p<.0014). Sixteen vs. 14 different bacterial groups or species were found in subjects with GERD and EoE, respectively, mostly in sparse or very sparse amounts. Alfa-streptococci (viridans streptococci) were the most common bacteria in both groups. Streptococci were present in all of the EoE-subjects but only in approximately 75% in lower esophagus of the GERD-subjects, regardless of the sampling method.Conclusion: Subjects with GERD had significantly less bacterial diversity in both oral and esophageal samples than EoE-subjects. Whether this discrepancy might be explained by an effect on the protective mucosal biofilm by the acidic content of the reflux in subjects with GERD remains unclear.
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| 28. |
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| 29. |
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| 30. |
- Rydholm, H., et al.
(författare)
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Reducing Adverse Effects During Drug Development: The Example of Lesogaberan and Paresthesia
- 2016
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Ingår i: Clinical Therapeutics. - : Elsevier BV. - 0149-2918. ; 38:4, s. 946-960
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: Lesogaberan, a gamma-aminobutyric acid (GABA)(B) receptor agonist, was developed for the treatment of gastroesophageal reflux disease in patients with a partial response to proton pump inhibitor therapy. A high prevalence of paresthesia was observed in healthy individuals after dosing with lesogaberan in early-phase clinical trials. The aim of this review was to gain further insight into paresthesia caused by lesogaberan by summarizing the relevant preclinical and clinical data. Methods: This study was a narrative review of the literature and unpublished data. Findings: The occurrence of paresthesia may depend on the route or rate of drug administration; several studies were conducted to test this hypothesis, and formulations were developed to minimize the occurrence of paresthesia. Phase I clinical studies showed that, in healthy individuals, paresthesia occurred soon after administration of lesogaberan in a dose-dependent manner regardless of the route of administration. The occurrence of paresthesia could be decreased by fractionating the dose or reducing the rate of administration. These findings suggest that the initial rate of absorption plays an important part in the development of paresthesia. Modified-release formulations minimize the occurrence of paresthesia while retaining the anti-reflux activity of the drug, as measured by esophageal pH and the number of transient lower esophageal sphincter relaxations. Implications: The development of lesogaberan was halted because the effect on gastroesophageal reflux disease symptoms observed in Phase II studies was not considered clinically meaningful in the target patient population. Nevertheless, it is an example of successful formulation development designed to minimize the occurrence of a compound's adverse effect while retaining its pharmacodynamic action. (C) 2016 Elsevier HS Journals, Inc. All rights reserved.
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| 31. |
- Schiöler, Linus, 1977, et al.
(författare)
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Nocturnal GERD - a risk factor for rhinitis/rhinosinusitis : the RHINE study
- 2015
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Ingår i: Allergy. European Journal of Allergy and Clinical Immunology. - : Wiley. - 0105-4538 .- 1398-9995. ; 70:6, s. 697-702
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Tidskriftsartikel (refereegranskat)abstract
- BackgroundIt has been suggested that gastroesophageal reflux disease (GERD) is a risk factor for developing rhinitis/rhinosinusitis, but data are lacking. This is a prospective 10-year follow-up study of a large multicenter cohort from Northern Europe, evaluating the relationship between nocturnal GERD and noninfectious rhinitis (NIR). MethodsThe study comprised 5417 subjects born between 1945 and 1973, who answered a questionnaire in 1999-2001 and again in 2010-2012. Noninfectious rhinitis was defined as having nasal obstruction, secretion, and/or sneezing without having the common cold. Odds ratios for developing NIR in relation to age, gender, BMI, smoking, asthma, and nocturnal GERD were calculated. ResultsDuring the 10-year observation period, 1034 subjects (19.1%) developed NIR. Subjects reporting nocturnal gastroesophageal reflux in both 1999 and 2010 had more NIR in 2010 (2.8% vs 1.2%, P<0.001). There was a significant dose-response relationship between the number of reflux episodes/week in 1999 and the risk of having NIR in 2010, P=0.02. In the multiple regression adjusted for age, gender, BMI, tobacco smoke, and asthma, those with nocturnal GERD in 1999 (3 episodes of nocturnal gastroesophageal reflux symptoms per week) had an OR of 1.6 (95% CI 1.0-2.5, P=0.03) to develop NIR in 2010. Smoking was associated both with an increased risk of developing NIR (30.7% vs 24.0%, P<0.001) and with the development of nocturnal GERD. ConclusionThis large, population-based, 10-year study indicates that nocturnal GERD was a risk factor for noninfectious rhinitis/rhinosinusitis. GERD should therefore be considered in patients with rhinitis of known and unknown origin.
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