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- Kjellman, M., et al.
(författare)
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A Plasma Protein Biomarker Strategy for Detection of Small Intestinal Neuroendocrine Tumors
- 2021
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Ingår i: Neuroendocrinology. - : S. Karger AG. - 0028-3835 .- 1423-0194. ; 111:9, s. 840-849
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Tidskriftsartikel (refereegranskat)abstract
- Background: Small intestinal neuroendocrine tumors (SI-NETs) are difficult to diagnose in the early stage of disease. Current blood biomarkers such as chromogranin A (CgA) and 5-hydroxyindolacetic acid have low sensitivity (SEN) and specificity (SPE). This is a first preplanned interim analysis (Nordic non-interventional, prospective, exploratory, EXPLAIN study [NCT02630654]). Its objective is to investigate if a plasma protein multi-biomarker strategy can improve diagnostic accuracy (ACC) in SI-NETs. Methods: At the time of diagnosis, before any disease-specific treatment was initiated, blood was collected from patients with advanced SI-NETs and 92 putative cancer-related plasma proteins from 135 patients were analyzed and compared with the results of age- and sex-matched controls (n = 143), using multiplex proximity extension assay and machine learning techniques. Results: Using a random forest model including 12 top ranked plasma proteins in patients with SI-NETs, the multi-biomarker strategy showed SEN and SPE of 89 and 91%, respectively, with negative predictive value (NPV) and positive predictive value (PPV) of 90 and 91%, respectively, to identify patients with regional or metastatic disease with an area under the receiver operator characteristic curve (AUROC) of 99%. In 30 patients with normal CgA concentrations, the model provided a diagnostic SPE of 98%, SEN of 56%, and NPV 90%, PPV of 90%, and AUROC 97%, regardless of proton pump inhibitor intake. Conclusion: This interim analysis demonstrates that a multi-biomarker/machine learning strategy improves diagnostic ACC of patients with SI-NET at the time of diagnosis, especially in patients with normal CgA levels. The results indicate that this multi-biomarker strategy can be useful for early detection of SI-NETs at presentation and conceivably detect recurrence after radical primary resection.
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- Orme, L. C., et al.
(författare)
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Climatic impacts on an Arctic lake since 1300 AD : a multi-proxy lake sediment reconstruction from Prins Karls Forland, Svalbard
- 2023
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Ingår i: Journal of Paleolimnology. - : Springer Science and Business Media LLC. - 0921-2728 .- 1573-0417. ; 69:3, s. 249-266
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Tidskriftsartikel (refereegranskat)abstract
- On the remote Arctic archipelago of Svalbard, there is increasing evidence of environmental impacts from climate change. The analysis of lake sedimentary records can be used to assess how strongly these recent changes have altered lake ecosystems. Sediments deposited during the last millennium from Lake Blokkvatnet, Prins Karls Forland, were analysed using a multiproxy approach, including stable isotope and X-ray fluorescence analysis. The results were interpreted as reflecting variability of (1) soil organic matter inwash, and potentially catchment and lake primary production, and (2) catchment weathering and erosion. Organic content began increasing after 1920 AD to the present, likely in response to warming. Earlier peaks of a similar magnitude occurred on three occasions since 1300 AD, with evidence indicating that these may have coincided with multidecadal-scale periods with higher temperatures, reduced sea ice and negative phases of the North Atlantic Oscillation. Catchment weathering and fluvial erosion began to increase around 1800 AD and peaked during the early twentieth century, potentially due to rising temperatures in autumn and winter causing increased liquid water availability. The records suggest that similar levels of erosion and weathering occurred between approximately 1300 and 1600 AD, spanning the transition from the Medieval Climate Anomaly to the Little Ice Age.
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- Collins, J.W., et al.
(författare)
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Assessing intra-operative ergonomics and workload in robotic surgery using inertia measuring unit sensors and validated questionnaires
- 2016
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Ingår i: European urology. Supplement. - : Elsevier BV. - 1569-9056 .- 1878-1500. ; 15:7, s. 247-247
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Tidskriftsartikel (refereegranskat)abstract
- INTRODUCTION & OBJECTIVES: Robotic approaches have revolutionized radical prostatectomy surgery. The 3D vision and 10 fold magnification provide surgeons improved anatomical vision and more precise instrument control compared to open or laparoscopic techniques. However, the potential benefits of robotic techniques may have trade-offs in increased mental and physical demands for the surgeons. The assisting surgeon, also has the added workload of maintaining working postures that do not impede the robotic arms. This study implemented an innovative motion tracking tool along with validated workload questionnaires to assess the ergonomics and workload for both assisting and console surgeons during robotic surgery. MATERIAL & METHODS: Ten individual surgeons (6 console surgeons and 4 assistant surgeons) performed 15 robotic prostatectomy cases while wearing inertia measurement units (IMUs) to track neck, shoulder, and torso motion during each case. Postoperatively, participants completed a validated workload questionnaire (NASA-TLX). Analysis of variance was performed on all response variables that do not violate the assumption of normality to identify the impact of surgeon role (Console vs Assistant). RESULTS: Twenty-six questionnaires were completed from 13 assisting and 13 console surgeons over the 15 cases. Selfreported mental demand was 41% higher for surgeons at the console than assisting (p<0.05), but physical demand was not statistically different. Post-operative pain was reported highest for the right shoulder and neck and this was more frequently seen in the console surgeons. On IMU readings, the assisting surgeon experienced high neck flexion (>10 degrees) duration over 42% of the procedure compared to only 24% in the console surgeon. In general, surgeons posture on the console was primarily static resulting in fewer movements compared to assisting surgeons. Table 1 summarizes posture movements and durations of static postures. CONCLUSIONS: Postures were more ergonomic during console tasks than assisting by the operating table. However, the console constrains postures leading to static postural loads that have been associated with musculoskeletal symptoms for the neck, torso and shoulders.
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- Fan, X., et al.
(författare)
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Surgeons’ physical workload in open surgery versus robot-assisted surgery and nonsurgical tasks
- 2022
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Ingår i: Surgical Endoscopy. - : Springer Nature. - 0930-2794 .- 1432-2218. ; 36:11, s. 8178-8194
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Tidskriftsartikel (refereegranskat)abstract
- Background: Musculoskeletal disorders (MSDs) are common among surgeons, and its prevalence varies among surgical modalities. There are conflicting results concerning the correlation between adverse work exposures and MSD prevalence in different surgical modalities. The progress of rationalization in health care may lead to job intensification for surgeons, but the literature is scarce regarding to what extent such intensification influences the physical workload in surgery. The objectives of this study were to quantify the physical workload in open surgery and compare it to that in (1) nonsurgical tasks and (2) two surgeon roles in robot-assisted surgery (RAS). Methods: The physical workload of 22 surgeons (12 performing open surgery and 10 RAS) was measured during surgical workdays, which includes trapezius muscle activity from electromyography, and posture and movement of the head, upper arms and trunk from inertial measurement units. The physical workload of surgeons in open surgery was compared to that in nonsurgical tasks, and to the chief and assistant surgeons in RAS, and to the corresponding proposed action levels. Mixed-effects models were used to analyze the differences. Results: Open surgery constituted more than half of a surgical workday. It was associated with more awkward postures of the head and trunk than nonsurgical tasks. It was also associated with higher trapezius muscle activity levels, less muscle rest time and a higher proportion of sustained low muscle activity than nonsurgical tasks and the two roles in RAS. The head inclination and trapezius activity in open surgery exceeded the proposed action levels. Conclusions: The physical workload of surgeons in open surgery, which exceeded the proposed action levels, was higher than that in RAS and that in nonsurgical tasks. Demands of increased operation time may result in higher physical workload for open surgeons, which poses an increased risk of MSDs. Risk-reducing measures are, therefore, needed.
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| 20. |
- Gerdtsson, Axel, et al.
(författare)
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Validation of a prediction model for post-chemotherapy fibrosis in nonseminoma patients
- 2023
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Ingår i: Bju International. - 1464-4096 .- 1464-410X. ; 132:3, s. 329-336
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Tidskriftsartikel (refereegranskat)abstract
- Objective To validate Vergouwe's prediction model using the Swedish and Norwegian Testicular Cancer Group (SWENOTECA) RETROP database and to define its clinical utility. Materials and methods Vergouwe's prediction model for benign histopathology in post-chemotherapy retroperitoneal lymph node dissection (PCRPLND) uses the following variables: presence of teratoma in orchiectomy specimen; pre-chemotherapy level of alphafetoprotein; b-Human chorionic gonadotropin and lactate dehydrogenase; and lymph node size pre- and postchemotherapy. Our validation cohort consisted of patients included in RETROP, a prospective population-based database of patients in Sweden and Norway with metastatic nonseminoma, who underwent PC-RPLND in the period 2007-2014. Discrimination and calibration analyses were used to validate Vergouwe's prediction model results. Calibration plots were created and a Hosmer-Lemeshow test was calculated. Clinical utility, expressed as opt-out net benefit (NBopt-out), was analysed using decision curve analysis. Results Overall, 284 patients were included in the analysis, of whom 130 (46%) had benign histology after PC-RPLND. Discrimination analysis showed good reproducibility, with an area under the receiver-operating characteristic curve (AUC) of 0.82 (95% confidence interval 0.77-0.87) compared to Vergouwe's prediction model (AUC between 0.77 and 0.84). Calibration was acceptable with no recalibration. Using a prediction threshold of 70% for benign histopathology, NBopt-out was 0.098. Using the model and this threshold, 61 patients would have been spared surgery. However, only 51 of 61 were correctly classified as benign. Conclusions The model was externally validated with good reproducibility. In a clinical setting, the model may identify patients with a high chance of benign histopathology, thereby sparing patients of surgery. However, meticulous follow-up is required.
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| 21. |
- Gustafsson, P. M., et al.
(författare)
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Gastro-oesophageal reflux and severity of pulmonary disease in cystic fibrosis
- 1991
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Ingår i: Scandinavian Journal of Gastroenterology. - : Informa Healthcare. - 0036-5521 .- 1502-7708. ; 26:5, s. 449-456
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Tidskriftsartikel (refereegranskat)abstract
- The correlation between oesophageal dysfunction (OD), pathologic gastro-oesophageal reflux (GOR), and severity of pulmonary disease was studied in 12 patients with cystic fibrosis (CF). They were interviewed about symptoms of OD and underwent 24-h pH recording in the oesophagus, oesophageal manometry combined with reflux provocation tests, the acid perfusion test, the acid clearance test, lung function tests, and scoring of the chest radiograph. Six of the 12 patients reported symptoms of OD. Abnormal GOR, as shown by 24-h pH monitoring of the oesophagus, was found in eight of them. Altogether 9 of the 12 participants had at least one pathologic oesophagus test result. Results of radiologic examinations of the oesophagus, performed in six patients, were pathologic. The four patients with the best chest radiograph scores and the best lung function had significantly less signs and symptoms of OD and GOR than the other eight patients. We conclude that OD, GOR, and pulmonary disease covariate in CF.
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| 30. |
- Lindskog, Magnus, et al.
(författare)
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Ilixadencel, a Cell-based Immune Primer, plus Sunitinib Versus Sunitinib Alone in Metastatic Renal Cell Carcinoma: A Randomized Phase 2 Study
- 2022
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Ingår i: European Urology Open Science. - : Elsevier BV. - 2666-1691 .- 2666-1683. ; 40, s. 38-45
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Tidskriftsartikel (refereegranskat)abstract
- Background: The prognosis of patients with synchronous metastatic renal cell carcinoma (mRCC) is poor. Whereas single-agent tyrosine kinase inhibition (TKI) is clearly insufficient, the effects can be enhanced by combinations with immune checkpoint inhibitors. Innovative treatment options combining TKI and other immune-stimulating agents could prove beneficial. Objective: To evaluate the clinical effects on metastatic disease when two doses of allogeneic monocyte-derived dendritic cells (ilixadencel) are administrated intratumorally followed by nephrectomy and treatment with sunitinib compared with nephrectomy and sunitinib monotherapy, in patients with synchronous mRCC. Design, setting, and participants: A randomized (2:1) phase 2 multicenter trial enrolled 88 patients with newly diagnosed mRCC to treatment with the combination ilixadencel/sunitinib (ILIXA/SUN; 58 patients) or sunitinib alone (SUN; 30 patients).Outcome measurements and statistical analysis: The primary endpoints were 18mo survival rate and overall survival (OS). A secondary endpoint was objective response rate (ORR) assessed up to 18 mo after enrollment. Statistic evaluations included Kaplan-Meier estimates, log-rank tests, Cox regression, and stratified Cochran-Mantel-Haenszel tests.Results and limitations: The median OS was 35.6 mo in the ILIXA/SUN arm versus 25.3 mo in the SUN arm (hazard ratio 0.73, 95% confidence interval 0.42-1.27; p = 0.25), while the 18-mo OS rates were 63% and 66% in the ILIXA/SUN and SUN arms, respectively. The confirmed ORR in the ILIXA/SUN arm were 42.2% (19/45), including three patients with complete response, versus 24.0% (six/25) in the SUN arm (p = 0.13) without complete responses. The study was not adequately powered to detect modest differences in survival. Conclusions: The study failed to meet its primary endpoints. However, ilixadencel in combination with sunitinib was associated with a numerically higher, nonsignificant, confirmed response rate, including complete responses, compared with sunitinib monotherapy.Patient summary: We studied the effects of intratumoral vaccination with ilixadencel followed by sunitinib versus sunitinib only in a randomized phase 2 study. The combination treatment showed numerically higher numbers of confirmed responses, suggesting an immunologic effect.(c) 2022 The Author(s). Published by Elsevier B.V. on behalf of European Association of Urology. This is an open access article under the CC BY license (http://creativecommons. org/licenses/by/4.0/).
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| 31. |
- McCracken, Joselle M., et al.
(författare)
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3D-Printed Hydrogel Composites for Predictive Temporal (4D) Cellular Organizations and Patterned Biogenic Mineralization
- 2019
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Ingår i: Advanced Healthcare Materials. - : WILEY. - 2192-2640 .- 2192-2659. ; 8:1
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Tidskriftsartikel (refereegranskat)abstract
- Materials chemistries for hydrogel scaffolds that are capable of programming temporal (4D) attributes of cellular decision-making in supported 3D microcultures are described. The scaffolds are fabricated using direct-ink writing (DIW)-a 3D-printing technique using extrusion to pattern scaffolds at biologically relevant diameters (<= 100 mu m). Herein, DIW is exploited to variously incorporate a rheological nanoclay, Laponite XLG (LAP), into 2-hydroxyethyl methacrylate (HEMA)-based hydrogels-printing the LAP-HEMA (LH) composites as functional modifiers within otherwise unmodified 2D and 3D HEMA microstructures. The nanoclay-modified domains, when tested as thin films, require no activating (e.g., protein) treatments to promote robust growth compliances that direct the spatial attachment of fibroblast (3T3) and preosteoblast (E1) cells, fostering for the latter a capacity to direct long-term osteodifferentiation. Cell-to-gel interfacial morphologies and cellular motility are analyzed with spatial light interference microscopy (SLIM). Through combination of HEMA and LH gels, high-resolution DIW of a nanocomposite ink (UniH) that translates organizationally dynamic attributes seen with 2D gels into dentition-mimetic 3D scaffolds is demonstrated. These analyses confirm that the underlying materials chemistry and geometry of hydrogel nanocomposites are capable of directing cellular attachment and temporal development within 3D microcultures-a useful material system for the 4D patterning of hydrogel scaffolds.
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| 32. |
- McCracken, Joselle M., et al.
(författare)
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Ionic Hydrogels with Biomimetic 4D-Printed Mechanical Gradients : Models for Soft-Bodied Aquatic Organisms
- 2019
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Ingår i: Advanced Functional Materials. - : WILEY-V C H VERLAG GMBH. - 1616-301X .- 1616-3028. ; 29:28
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Tidskriftsartikel (refereegranskat)abstract
- Direct-ink writing (DIW), a rapidly growing and advancing form of additive manufacturing, provides capacities for on-demand tailoring of materials to meet specific requirements for final designs. The penultimate challenge faced with the increasing demand of customization is to extend beyond modification of shape to create 4D structures, dynamic 3D structures that can respond to stimuli in the local environment. Patterning material gradients is foundational for assembly of 4D structures, however, there remains a general need for useful materials chemistries to generate gray scale gradients via DIW. Here, presented is a simple materials assembly paradigm using DIW to pattern ionotropic gradients in hydrogels. Using structures that architecturally mimic sea-jelly organisms, the capabilities of spatial patterning are highlighted as exemplified by selectively programming the valency of the ion-binding agents. Spatial gradients, when combined with geometry, allow for programming the flexibility and movement of iron oxide nanoparticle-loaded ionotropic hydrogels to generate 4D-printed structures that actuate in the presence of local magnetic fields. This work highlights approaches to 4D design complexity that exploits 3D-printed gray-scale/gradient mechanics.
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| 33. |
- Nandakumar, Kutty Selva, 1965-, et al.
(författare)
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Streptococcal Endo-β-N-Acetylglucosaminidase Suppresses Antibody-Mediated Inflammation In Vivo
- 2018
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Ingår i: Frontiers in Immunology. - : Frontiers Media SA. - 1664-3224. ; 9
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Tidskriftsartikel (refereegranskat)abstract
- Endo-β-N-acetylglucosaminidase (EndoS) is a family 18 glycosyl hydrolase secreted by Streptococcus pyogenes. Recombinant EndoS hydrolyzes the β-1,4-di-N-acetylchitobiose core of the N-linked complex type glycan on the asparagine 297 of the γ-chains of IgG. Here, we report that EndoS and IgG hydrolyzed by EndoS induced suppression of local immune complex (IC)-mediated arthritis. A small amount (1 µg given i.v. to a mouse) of EndoS was sufficient to inhibit IgG-mediated arthritis in mice. The presence of EndoS disturbed larger IC lattice formation both in vitro and in vivo, as visualized with anti-C3b staining. Neither complement binding in vitro nor antigen-antibody binding per se were affected. Thus, EndoS could potentially be used for treating patients with IC-mediated pathology.
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| 34. |
- Suga, Mitsuo, et al.
(författare)
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Recent progress in scanning electron microscopy for the characterization of fine structural details of nano materials
- 2014
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Ingår i: Progress in Solid State Chemistry. - : Elsevier BV. - 0079-6786 .- 1873-1643. ; 42:1-2, s. 1-21
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Forskningsöversikt (refereegranskat)abstract
- Research concerning nano-materials (metal-organic frameworks (MOFs), zeolites, mesoporous silicas, etc.) and the nano-scale, including potential barriers for the particulates to diffusion to/from is of increasing importance to the understanding of the catalytic utility. of porous materials when combined with any potential super structures (such as hierarchically porous materials). However, it is difficult to characterize the structure of for example MOFs via X-ray powder diffraction because of the serious overlapping of reflections caused by their large unit cells, and it is also difficult to directly observe the opening of surface pores using ordinary methods. Electron-microscopic methods including high-resolution scanning electron microscopy (HRSEM) have therefore become imperative for the above challenges. Here, we present the theory and practical application of recent advances such as through-the-lens detection systems, which permit a reduced landing energy and the selection of high-resolution, topographically specific emitted electrons, even from electrically insulating nano-materials.
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| 35. |
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| 36. |
- Svenner, A., et al.
(författare)
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A simulator-based comparison of a novel 3d and a conventional 3d vision system-surgical performance and subjective ratings
- 2019
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Ingår i: Inventions. - : MDPI Multidisciplinary Digital Publishing Institute. - 2411-5134. ; 4:4
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Tidskriftsartikel (refereegranskat)abstract
- In laparoscopy, novel three-dimensional laparoscopic vision systems (3D LVS) without glasses (3D−) have been invented. While standard 3D LVS with glasses (3D+) have shown advantages over original two-dimensional systems, quantitative comparisons of surgical performance between 3D− and 3D+ systems are still lacking. The aim is to compare the systems in simulated robotic surgery tasks. In a crossover study, 18 medical students performed four basic laparoscopic tasks in the validated Simball Box simulator with authentic surgical instruments by using the 3D+ and 3D− systems. Performance was measured by the number of errors and the task’s duration. Subjective ratings of perceptions and preference were assessed after each test. There were significant, but still minor, advantages for the conventional 3D+ system regarding spatial orientation and sense of depth. Overall, ten and eight subjects preferred 3D+ and 3D− systems, respectively. No significant differences were found in performance, post-operative physicals or eye symptoms. The novel 3D− system was similar to the conventional 3D+ system regarding performance and overall preference, while there were minor advantages for the 3D+ system in the subjective ratings. Since the 3D− system is a new invention, it should have a higher potential of usability improvements.
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| 37. |
- Uhlin, F., et al.
(författare)
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Endopeptidase Cleavage of Anti-Glomerular Basement Membrane Antibodies in vivo in Severe Kidney Disease: An Open-Label Phase 2a Study
- 2022
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Ingår i: Journal of the American Society of Nephrology. - : Ovid Technologies (Wolters Kluwer Health). - 1046-6673 .- 1533-3450. ; 33:4, s. 829-838
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Tidskriftsartikel (refereegranskat)abstract
- Background The prognosis for kidney survival is poor in patients presenting with circulating anti-glomerular basement membrane (GBM) antibodies and severe kidney injury. It is unknown if treat-ment with an endopeptidase that cleaves circulating and kidney bound IgG can alter the prognosis.& nbsp;Methods An investigator-driven phase 2a one-arm study (EudraCT 2016-004082-39) was performed in 17 hospitals in five European countries. A single dose of 0.25 mg/kg of imlifidase was given to 15 adults with circulating anti-GBM antibodies and an eGFR < 15 ml/min per 1.73m(2). All patients received standard treatment with cyclophosphamide and corticosteroids, but plasma exchange only if autoantibodies rebounded. The primary outcomes were safety and dialysis independency at 6 months.& nbsp;Results At inclusion, ten patients were dialysis dependent and the other five had eGFR levels between 7 and 14 ml/min per 1.73m(2). The median age was 61 years (range 19-77), six were women, and six were also positive for anti-neutrophil cytoplasmic antibodies. Then 6 hours after imlifidase infusion, all patients had anti-GBM antibodies levels below the reference range of a prespecified assay. At 6 months 67% (ten out of 15) were dialysis independent. This is significantly higher compared with 18% (nine out of 50) in a historical control cohort (P < 0.001, Fisher's exact test). Eight serious adverse events (including one death) were reported, none assessed as probably or possibly related to the study drug.& nbsp;Conclusions In this pilot study, the use of imlifidase was associated with a better outcome compared with earlier publications, without major safety issues, but the findings need to be confirmed in a randomized controlled trial.
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| 38. |
- Wolkerstorfer, A., et al.
(författare)
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Natural course of sensitization to cow's milk and hen's egg in childhood atopic dermatitis : ETAC™ study group
- 2002
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Ingår i: Clinical and Experimental Allergy. - : Wiley. - 0954-7894 .- 1365-2222. ; 32:1, s. 70-73
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Tidskriftsartikel (refereegranskat)abstract
- Background: Sensitization to food allergens has been implicated in the pathogenesis of atopic diseases, in particular atopic dermatitis (AD). The aim of the present paper is to investigate the natural course of sensitization to egg and to cow's milk and its relationship with the severity of AD. Methods: The placebo intention-to-treat population of the ETAC™ (Early Treatment of the Atopic Child) study consisted of 397 children with AD aged 12-24 months (mean ± SD: 17.2 ± 4.1 months) who were followed for 18 months. All children were examined for objective SCORing Atopic Dermatitis (SCORAD) and specific IgE amongst other, to egg and to cow's milk at inclusion and after 3, 12 and 18 months. Fifteen patients were excluded from this analysis due to major protocol violations thus leaving 382 patients in the analysed population. Results: Sensitization to egg and to cow's milk was more common in atopic children with severe AD at all time-points. At inclusion, children sensitized to both egg and to cow's milk had the most severe AD (Kruskall-Wallis test P = 0.007). The degree of sensitization expressed in RAST classes was significantly related to the severity of AD. Furthermore, children sensitized to egg or to cow's milk at inclusion had a higher risk of persistence of AD (84% and 67%, respectively, vs. 57% in those not sensitized) and a higher objective SCORAD after 18 months follow-up. Conclusion: We found an association between severity of AD and sensitization to egg or to cow's milk. Moreover, sensitization to egg, and to a lesser extent cow's milk, indicates a worse outcome of AD in terms of persistence and severity of the disease.
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| 39. |
- Acquavella, J., et al.
(författare)
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Design and methods for a Scandinavian pharmacovigilance study of osteonecrosis of the jaw and serious infections among cancer patients treated with antiresorptive agents for the prevention of skeletal-related events
- 2016
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Ingår i: Clinical Epidemiology. - 1179-1349. ; 8, s. 267-272
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Tidskriftsartikel (refereegranskat)abstract
- Objective: Osteonecrosis of the jaw (ONJ) is a recognized complication of potent antiresorptive therapies, especially at the doses indicated to prevent skeletal complications for cancer patients with bone metastases. This paper describes the rationale and methods for a prospective, post-authorization safety study of cancer patients treated with antiresorptive therapies. Methods: As part of a comprehensive pharmacovigilance plan, developed with regulators' input, the study will estimate incidence of ONJ and of serious infections among adult cancer patients with bone metastases treated with denosumab (120 mg subcutaneously) or zoledronic acid (4 mg intravenously, adjusted for renal function). Patients will be identified using routinely collected data combined with medical chart review in Denmark, Sweden, and Norway. Followup will extend from the first administration of antiresorptive treatment to the earliest of death, loss-to-follow-up, or 5 years after therapy initiation. Results will be reported for three treatment cohorts: denosumab-naive patients, zoledronic acid-naive patients, and patients who switch from bisphosphonate treatment to denosumab. ONJ cases will be identified in three newly established national ONJ databases and adjudicated by the committee that functioned during the XGEVA (R) clinical trials program. Conclusion: This study will provide a real world counterpart to the clinical trial-estimated risks for ONJ and serious infections for cancer patients initiating denosumab or zoledronic acid. The establishment of ONJ databases in the three Scandinavian countries will have potential benefits outside this study for the elucidation of ONJ risk factors and the evaluation of ONJ treatment strategies.
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| 40. |
- Alsos, Inger Greve, et al.
(författare)
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Ancient sedimentary DNA shows rapid post-glacial colonisation of Iceland followed by relatively stable vegetation until the Norse settlement (Landnam) AD 870
- 2021
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Ingår i: Quaternary Science Reviews. - : Elsevier. - 0277-3791 .- 1873-457X. ; 259
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Tidskriftsartikel (refereegranskat)abstract
- Understanding patterns of colonisation is important for explaining both the distribution of single species and anticipating how ecosystems may respond to global warming. Insular flora may be especially vulnerable because oceans represent severe dispersal barriers. Here we analyse two lake sediment cores from Iceland for ancient sedimentary DNA to infer patterns of colonisation and Holocene vegetation development. Our cores from lakes Torfdalsvatn and Nykurvatn span the last c. 12,000 cal yr BP and c. 8600 cal yr BP, respectively. With near-centennial resolution, we identified a total of 191 plant taxa, with 152 taxa identified in the sedimentary record of Torfdalsvatn and 172 plant taxa in the sedimentary record of Nykurvatn. The terrestrial vegetation at Torfdalsvatn was initially dominated by bryophytes, arctic herbs such as Saxifraga spp. and grasses. Around 10,100 cal yr BP, a massive immigration of new taxa was observed, and shrubs and dwarf shrubs became common whereas aquatic macrophytes became dominant. At Nykurvatn, the dominant taxa were all present in the earliest samples; shrubs and dwarf shrubs were more abundant at this site than at Torfdalsvatn. There was an overall steep increase both in the local accumulated richness and regional species pool until 8000 cal yr BP, by which time 3/4 of all taxa identified had arrived. The period 4500-1000 cal yr BP witnessed the appearance of a a small number of bryophytes, graminoids and forbs that were not recorded in earlier samples. The last millennium, after human settlement of the island (Landnam), is characterised by a sudden disappearance of Juniperus communis, but also reappearance of some high arctic forbs and dwarf shrubs. Notable immigration during the Holocene coincides with periods of increased incidence of sea ice, and we hypothesise that this may have acted as a dispersal vector. Thus, although ongoing climate change might provide a suitable habitat in Iceland for a large range of species only found in the neighbouring regions today, the reduction of sea ice may in fact limit the natural colonisation of new plant species.
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| 41. |
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| 42. |
- Andersson, F, et al.
(författare)
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Comparison of the cost-effectiveness of budesonide and sodium cromoglycate in the management of childhood asthma in everyday clinical practice
- 2001
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Ingår i: Annals of Allergy, Asthma & Immunology. - 1081-1206 .- 1534-4436. ; 86:5, s. 537-544
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Tidskriftsartikel (refereegranskat)abstract
- Background: Budesonide and sodium cromoglycate are both recommended as maintenance therapy for childhood asthma. Objective: To compare the cost-effectiveness of these two treatment strategies in clinical practice, in an open-label, pharmacoeconomic clinical trial. Methods: Health economics were evaluated in 138 children. ages 5 to 11 years, with unstable asthma not previously treated with corticosteroids or cromones. The asthma was stabilized during 4 to 6 weeks with budesonide 200 to 400 mug twice daily. The children were then randomly allocated to one of the two treatment strategies aiming at maintaining asthma control for 12 months, budesonide 400 mug/day (N = 69) or sodium cromoglycate 60 mg/day (N = 69). If asthma control was judged unsatisfactory, the doses were increased or the children were switched to the alternate treatment. Results: In children continuing on the same treatment, the degree of asthma control was similar in the two groups at study end. To maintain asthma control, 42% of cromoglycate children switched to budesonide, and then experienced a 14% increase in symptom-free days. No budesonide patient had to switch therapy because of lack of asthma control. Although not statistically significant, total annual cost per patient was 24% (Swedish kronor 4195, US $487, Euro 485) lower in the budesonide than the cromoglycate group, mainly due to a lower cost for asthma medication. Conclusions: A budesonide strategy for continued maintenance treatment, after an initial period of stabilizing treatment with budesonide, resulted in lower costs and less drug switches than did a strategy with sodium cromoglycate.
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- Ehrenstein, V., et al.
(författare)
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Osteonecrosis of the jaw among patients with cancer treated with denosumab or zoledronic acid: Results of a regulator-mandated cohort postauthorization safety study in Denmark, Norway, and Sweden
- 2021
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Ingår i: Cancer. - : Wiley. - 0008-543X .- 1097-0142. ; 127:21, s. 4050-4058
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND Osteonecrosis of the jaw (ONJ) is an adverse effect of antiresorptive treatment. This study estimated incidence proportions and incidence rates of ONJ in cancer patients with bone metastases from solid tumors treated for the prevention of skeletal-related events in routine clinical practice. METHODS This cohort study in Denmark, Norway, and Sweden in 2011-2018 included 3 treatment cohorts: a denosumab inception cohort (DEIC), a zoledronic acid inception cohort (ZAIC), and a denosumab-switch cohort (DESC). The authors estimated 1- to 5-year incidence proportions and incidence rates of ONJ overall, by cancer site (breast, prostate, or other solid tumor), and by country. ONJ diagnoses were confirmed by adjudication. RESULTS There were 1340 patients in the DEIC, 1352 in the ZAIC, and 408 in the DESC. The median ages of the 3 cohorts were 70, 69, and 70 years, respectively; the proportions of men were 72.6%, 53.8%, and 48.3%, respectively; and the median follow-up was 19.8, 12.9, and 13.3 months, respectively. The 5-year incidence proportions of ONJ were 5.7% (95% confidence interval [CI], 4.4%-7.3%) in the DEIC, 1.4% (95% CI, 0.8%-2.3%) in the ZAIC, and 6.6% (95% CI, 4.2%-10.0%) in the DESC. The corresponding ONJ incidence rates per 100 person-years were 3.0 (95% CI, 2.3-3.7), 1.0 (95% CI, 0.6-1.5), and 4.3 (95% CI, 2.8-6.3). Incidence proportions and incidence rates were highest in patients with prostate cancer and in Denmark. CONCLUSIONS This study provides estimates of the risk of medically confirmed ONJ among patients initiating denosumab or zoledronic acid in routine clinical practice in 3 Scandinavian countries. The results varied by cancer site and by country. LAY SUMMARY Denosumab and zoledronic acid reduce the risk of bone fractures, pain, and surgery in patients with advanced cancers involving bone. Osteonecrosis of the jaw (ONJ)-death of a jawbone-is a known side effect of treatment with denosumab or zoledronic acid. The authors examined almost 2900 denosumab- or zoledronic acid-treated patients with cancer in Denmark, Norway, and Sweden. Over the course of 5 years, ONJ developed in 5.7% of the patients whose initial treatment was denosumab, in 1.4% of the patients whose initial treatment was zoledronic acid, and in 6.6% of the patients who switched from zoledronic acid to denosumab.
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