Årsrapport 2011 - Region Sjælland

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Etablering af aldersrelateret referenceinterval for D-dimer dimer hos raske ældre ldre 90 ÅRSRAPPORT 2011 Et projekt under Region Sjællands Sj llands Befolkningsundersøgelse Befolkningsunders gelse Reservelæge Christine Haase, Overlæge Maja Jørgensen, Ledende overlæge, klinisk forskningslektor, ph.d. Lise Bathum, Afdelingslæge, klinisk forskningslektor, ph.d. Christina Ellervik, Civilingenør, ph.d. Mikala Klok Jørgensen. Klinisk Biokemisk afdeling, Sygehus Syd. Resumé: Analyse af D-dimer i blodet anvendes bl.a. ved symptomer på dyb venetrombose eller lungeemboli. En forhøjet værdi understøtter mistanken og vil føre til yderligere undersøgelser i form af billeddiagnostik. Ældre mennesker, især over 60-70 år, har ofte forhøjet D-dimer, selvom de ikke har tromboembolisk sygdom. Der er derfor brug for et aldersrelateret referenceinterval således at venøs tromboemboli med større sikkerhed kan udelukkes hos ældre. Baggrund: D-dimer er en væsentlig analyse i den diagnostiske strategi ved mistanke om venøs tromboemboli, herunder dyb vene trombose (DVT) eller lungeemboli (LE). D-dimer indgår således sammen med et klinisk baseret pointsystem (Wells Score) til at vurdere, om patientens sandsynlighed for venøs tromboembolisk sygdom berettiger yderligere undersøgelser i form af billeddiagnostik. D-dimer dimer Ved at anvende en cut-off værdi for D-dimer på 0,5 FEU mg/l ved mistanke om DVT eller LE hos voksne, kan akut tromboembolisk sygdom udelukkes hos patienter med D-dimer < cut-off værdien, hvis patienten har lav klinisk sandsynlighed ifølge pointsystemet 1, 2 (For IL D-dimer test (ILS laboratories Scandinavia) er cut-off værdien på 0,23 FEU mg/l). Undersøgelser har imidlertid vist, at ældre, især over 60-70 år, i forvejen har en forhøjet D-dimer, og specificiteten af analysen er derfor faldende, jo ældre patienten er 3-7 . D-dimer stiger sandsynligvis allerede fra 40 års alderen hos raske 8 . Der er derfor brug for et aldersrelateret referenceinterval, således at mistanke om DVT og lungeemboli med større sikkerhed kan udelukkes hos de ældre. Referenceintervaller bør generelt baseres på raske personer og være køns- og aldersrelaterede, såfremt det er muligt 9 . Sammenhængen mellem D-dimer og forskellige kardiovaskulære risikofaktorer har været undersøgt i en række studier. Der er fundet sammenhæng mellem stigende D-dimer og bl.a. kolesterol, triglycerid, sænkning (SR), BMI samt rygning og køn (Kvinder). Alkohol og motion er formentlig associeret med lavere værdier af D-dimer 8, 10 . Desuden er det påvist, at østrogener øger risikoen for tromboembolisk sygdom Formål: Referencer: 1. Wells et al. NEJM 2003; 349: 1227-35 2. Wells et al. Ann Intern Med 2001; 135: 98-107 3. Douma RA, le Gal G, Söhne M, Righini M, Kamphuisen PW, Perrier A, Kruip MJ, Bounameaux H, Büller HR, Roy PM. Potential of an age adjusted D-dimer cut-off value to improve the exckusion of pulmonary embolism in older patients: a retrospective analysis of three large cohorts. BMJ. 2010 Mar 30;340:c1475. doi: 10.1136/bmj.c1475. 4. Harper PL, Theakston E, Ahmed J, Ockelford P. D-dimer concentration increases with age reducing the clinical value of the D-dimer assay in the elderly. Intern Med J. 2007 Sep;37(9):607-13. Epub 2007 Jun 2. 5. Righini M, Le Gal G, Perrier A, Bounameaux H. The challenge of diagnosing pulmonary embolism in elderly patients: Inluence of age on commenly used diagnostic tests and strategies. J Am Geriatr Soc. 2005 Jun;53(6):1039-45. Review. 6. Righini M, Goehring C, Bounameaux H, Perrier A. Effects of age on the performance of common diagnostic tests for pulmonary embolism. Am J Med. 2000 Oct 1;109(5):357-61. 7. Pieper CF, Rao KM, Currie MS, Harris TB, Chen HJ. Age, functional status, and racial differences in plasma D-dimer levels in communitydwelling elderly persons. J Gerontol A Biol Sci Med Sci. 2000 Nov;55(11):M649-57. 8. Tita-Nwa F, Bos A, Adjei A, Ershler WB, Longo DL, Ferrucci L. Correlates of D-dimer in older persons. Aging. Clin Exp Res. 2010 Feb;22(1):20-3. 9. Jones G, Barker A. Reference Intervals. Clin Biochem Rev Vol 29 Suppl (i) August 2008. 10. Lee AJ, Fowkes GR, Lowe GD, Rumley A. Determinants of fibrin D-dimer in the Edinburgh Artery Study. Arterioscler Thromb Vasc Biol. 1995 Aug;15(8):1094-7. 11. Lidegaard Ø, Løkkegaard E, Svendsen AL, Agger C. Hormonal contraception and risk of venous thromboembolism: national follow-up study. BMJ. 2009 Aug 13;339:b2890. doi: 10.1136/bmj.b2890 12. Olié V, Canonico M, Scarabin PY. Postmenopausal hormone therapy and venous thromboembolism. Thromb Res. 2011 Feb;127 Suppl 3:S26-9. Review. Der ønskes etablering af et aldersrelateret referenceinterval for D-dimer hos raske personer over 40 år, idet der planlægges aldersintervaller på 5 år. Desuden ønskes sammenhængen mellem lipidprofil, CRP og D-dimer undersøgt, samt om der kan påvises sammenhæng mellem D-dimer og p-pille- /hormonindtag, rygning, alkohol, motion og BMI. Herudover ønskes en sammenligning af 2 forskellige metoder til analyse af D-dimer, henholdsvis Liatest og IL D-dimer test. Materiale og Metoder: Projektet udføres i tilknytning til Region Sjællands Befolkningsundersøgelse i Næstved. Alle borgere, der deltager i Befolkningsundersøgelsen, besvarer et spørgeskema og får som led i undersøgelsen udtaget blodprøve. Lidt af blodet anvendes til analyse af D-dimer ved hjælp af to forskellige metoder, ”Liatest” og ”IL D-dimer test”, som anvendes på henholdsvis Slagelse og Roskilde sygehuse. Oplysninger om p-pille-/hormonindtag, ryg- Venstresidig DVT ning, alkohol, motion og BMI indhentes fra det spørgeskema, der udleveres og udfyldes som led i dataindsamlingen til Befolkningsundersøgelsen. Borgere i behandling med antitrombotisk medicin, med arvelig tendens til tromboembolisk sygdom og gravide udelukkes. Der forventes at indgå resultater fra 1000 raske deltagere i alderen 20 år og opefter. Resultater og Konklusion: De første prøver indsamles i september 2011. Der foreligger endnu ingen resultater. Incidens per 1000 per år 12 9 6 3 0 Incidens af DVT Kvinder Mænd 74 Alder Thromb Haemost 2000;83:657-60
The SLAMSHAM study A Randomized Placebo Controlled Study of Arthroscopic Partial Meniscectomy Kristoffer B Hare, L Stefan Lohmander, Ewa M Roos PURPOSE The overall purpose of this study is to test whether the benefit from arthroscopic partial meniscectomy in patients aged 35-55 with knee pain and a degenerative meniscus lesion, is due to surgery or the placebo effect. Demonstration of no additional benefit from this surgery may reduce the development of surgically-related osteoarthritis in middle-aged patients. BACKGROUND Osteoarthritis (OA) is the most common form of arthritis and the knee is one of the most affected joints. Meniscus lesions are associated with knee OA, but it is unclear whether as a risk factor or a sign of the disease. The current treatment for a degenerative meniscus tear is arthroscopic partial meniscectomy (APM) with 1 million procedure being performed per year in the US. There is strong evidence that APM puts the knee at high risk of later OA. Earlier studies have shown a placebo effect from surgery in subjects with established OA. The effect of APM in younger subjects with no or mild OA is unknown. kbhr@regionsjaelland.dk DESIGN The study is a double-blind randomized placebo-controlled multicentre trial. Patients referred from general practitioners will be screened. If eligible, oral and written information about the study including a 10 minute video will be given to the patients. If MRI confirms medial meniscus lesion the patient will be included in the study and randomized to meniscectomy or sham procedure. All patients will be seen at a 3 month, and 2 and 5 year follow-up (Flowchart). Referred from general practitioner Patients who meet the criteria of age are selected for further screening First Visit - Screened for eligibility Screening includes x-ray and clinical examination. All patients are given the KOOS score to fill out at home. Eligible patients are referred to an MRI and given written material and a information video about the study to view at home. Second visit MRI scan and functionality test Eligible Patients are informed by telephone of MRI findings and asked if they wish to participate in the study. Enrolled Enrolled patients are put through a functionality test immediately after enrolment and signed up for surgery Baseline At now all patients should have established a baseline including, a clinical examination, x-rays, MRI, functionality test and a KOOS score Arthroscopic Partial Meniscectomy 3 month follow-up Clinical examination, functionality test and KOOS score (filled out at home) 2 year follow-up Clinical examination, functionality test and KOOS score (filled out at home) 5 year follow-up Fixed-flexion radiography Randomization Will take place at the time of surgery Placebo procedure 3 month follow-up Clinical examination, functionality test and KOOS score (filled out at home) 2 year follow-up Clinical examination, functionality test and KOOS score (filled out at home) 5 year follow-up Fixed-flexion radiography Ineligible Informed of MRI findings by telephone. Refused to participate Enrolled in an observational cohort Observational Cohort No intervention 3 month follow-up Clinical examination, functionality test and KOOS score (filled out at home) 2 year follow-up Clinical examination, functionality test and KOOS score (filled out at home) 5 year follow-up Fixed-flexion radiography The study is approved by the The Regional Committee on Biomedical Research Ethics and consistent with the declaration of Helsinki. METHODS Participants Patients 35 -55 years of age with knee pain for more than 2 months without significant trauma and an MRI confirmed medial meniscus lesion. Patients must be eligible for outpatient surgery and will be excluded if they are in need of acute surgery e.g. locked knee or high-energy trauma. Patients with Kellgren-Lawrence grade 3 or 4 knee OA, or knee surgery within the last 2 years will also be excluded. Primary outcome The primary outcome at 2 years follow-up is KOOS 5, derived from a self-reported questionnaire, the Knee injury and Osteoarthritis Outcome Score (KOOS), comprising five different subscales; a) pain, b) other symptoms, c) activities in daily living, d) function in sport and recreation, e) knee-related quality of life (www.koos.nu). Secondary outcomes All five KOOS subscales are used as secondary outcomes. A physical function test will be performed after 3 and 24 months including a one-leg jump test, maximal number of knee bends in 30 seconds and isometric strength knee extension strength. Development of knee OA Fixed-flexion radiography, with use of SynaFlex®, will asses the long-term development of OA. ÅRSRAPPORT 2011 91
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FORSKNINGSRÅDET SYGEHUS SYD Årsra
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Indhold Forskningsrådet 2011 4 For
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Forord 2011 har været forandringer
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Stofskiftefunktion og vægtøgning
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Ca. 0,25 % af den nordeuropæiske b
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vidt der bør iværksættes screeni
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Akutafdelingen, Slagelse Sygehus Af
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Anæstesiologisk afdeling, Næstved
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Arbejdsmedicinsk klinik, Slagelse S
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Arbejds- og miljømedicinsk klinik,
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Gynækologisk/obstetrisk afdeling,
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Akutte tilstande og benigne ano-rek
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Klinisk Biokemisk afdeling, Næstve
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Klinisk Fysiologisk/nuklearmedicins
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Klinisk Mikrobiologisk afdeling, Re
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Lester CH, Olsen SS, Jakobsen L, Ar
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Klinisk Patologisk afdeling, Næstv
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Årsrapport 2011 - Region Sjælland

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