Download PDF
Pneumologie 2009; 63(1): 49-55
DOI: 10.1055/s-0028-1100823
Übersicht
© Georg Thieme Verlag KG Stuttgart · New York

Beurteilungs- und Prognosekriterien bei COPD[1]

Assessment and Outcome Parameters in COPDR.  Dierkesmann1 , A.  Gillissen2 , J.  Lorenz3 , H.  Magnussen4 , H.  Mitfessel5 , H.  Morr6 , M.  Pfeifer7 , G.  Schultze-Werninghaus8 , G.  Steinkamp9 , H.  Teschler10 , Th.  Voshaar11 , T.  Welte12 , H.  Worth13
  • 1Ehem. Direktor der Klinik Schillerhöhe, Gerlingen/Stuttgart
  • 2Robert Koch-Klinik, Thoraxzentrum des Klinikums St. Georg, Leipzig
  • 3Klinik für Pneumologie und Intensivmedizin, Klinikum Lüdenscheid
  • 4Krankenhaus Großhansdorf, Zentrum für Pneumologie und Thoraxchirurgie, Großhansdorf, Lehrstuhl für Innere Medizin-Pneumologie, Großhansdorf, Universität zu Lübeck
  • 5Praxis Remscheid
  • 6Pneumologische Klinik Waldhof Elgershausen, Greifenstein/Hessen
  • 7Klinik Donaustauf, Universität Regensburg
  • 8Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH, Medizinische Klinik III – Pneumologie, Allergologie, Schlaf- und Beatmungsmedizin, Bochum
  • 9Medizinisch-wissenschaftliches Publizieren, Hannover
  • 10Ruhrlandklinik Essen
  • 11Krankenhaus Bethanien Moers, Med. Klinik III, Schwerpunkt Pneumologie, Allergologie, Zentrum für Schlaf- und Beatmungsmedizin
  • 12Abt. Pneumologie, Medizinische Hochschule Hannover
  • 13Medizinische Klinik I, Klinikum Fürth
Further Information

Publication History

eingereicht 27.9. 2008

akzeptiert 13.10.2008

Publication Date:
09 January 2009 (online)

Also available at
   Permissions and Reprints

Zusammenfassung

Hintergrund: Bisher ist für Therapiestudien bei COPD kein einheitlicher Zielparameter definiert. Daher werden in dieser Übersicht häufig verwendete Parameter im Hinblick auf ihre Eignung als Beurteilungs- und Prognosekriterien bei COPD bewertet. Methodik: Recherche der aktuellen Literatur. Resultate: Empfohlen wird weiterhin der am besten evaluierte Lungenfunktionsparameter FEV1, ergänzt durch die Messung weiterer Funktionsparameter, wie FVC, IC/TLC und bei entsprechender Ausstattung RV/TLC, Kco, PaO2 und PaCO2. Zusätzliche Informationen zur Bestimmung der FEV1 geben die Erfassung von Dyspnoe, Lebensqualität und körperlicher Belastbarkeit, Häufigkeit und Schweregrad von Exazerbationen sowie die Mortalität. Schlussfolgerung: Bisher wurde keiner der zusätzlichen Parameter so gut evaluiert, dass er derzeit als Ersatz für die FEV1 als Standardparameter für die Beurteilung und Prognose der COPD dienen könnte.

Abstract

Background: A standard outcome parameter for pharmacological trials in COPD has not yet been defined. Therefore, it is the aim of this review to evaluate frequently used parameters for their eligibility as assessment and outcome parameters in COPD. Methods: A review of the actual scientific literature was performed. Results: It is recommended to continue to rely primarily on the FEV1, which has been used as a primary variable in the vast majority of trials. In addition, further parameters, such as FVC and IC/TLC should be determined. If available, additional information is provided by RV/TLC, Kco, PaO2 and PaCO2. FEV1 is not a surrogate parameter for dyspnoea, quality of life, and exercise tolerance, which should therefore be assessed separately. Frequency and severity of exacerbations and mortality are important outcome parameters in long-term trials. Complex indices, such as the BODE index, may be superior to single variables. Conclusions: No single additional parameter has been evaluated sufficiently in order to substitute FEV1 as the standard parameter for the assessment and outcome in COPD.

1 Ergebnisse des Expertentreffens „Luftschlösser”, 23. – 24. November 2007, Frankfurt am Main, mit Unterstützung der Boehringer Ingelheim Pharma GmbH & Co KG

Literatur

  • 1 Gross N J. Outcome measurements in COPD, are we schizophrenic?.  Chest. 2003;  123 1325-1327
    CrossrefPubMedGoogle Scholar
  • 2 Gillissen A, Buhl R, Kardos P. et al . Studienendpunkte bei der chronisch-obstruktiven Lungenerkrankung (COPD): “Minimal Clinically Important Difference”.  Pneumologie. 2008;  62 149-157
    Article in Thieme ConnectPubMedGoogle Scholar
  • 3 Cazzola M, MacNee W, Martinez F-J. et al . ATS/ERS Task Force on outcome of COPD. Outcomes for COPD pharmacological trials: from lung function to biomarkers.  Eur Respir J. 2008;  31 416-468
    CrossrefPubMedGoogle Scholar
  • 4 Franciosi L G, Page C P, Celli B R. et al . Marker of disease severity in chronic obstructive pulmonary disease.  Pulm Pharmacol Ther. 2006;  19 189-199
    CrossrefPubMedGoogle Scholar
  • 5 Rabe K F, Hurd S, Anzueto A. et al . Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary.  Am J Respir Crit Care Med. 2007;  176 532-555
    CrossrefPubMedGoogle Scholar
  • 6 Celli B R, Halbert R J, Isonaka S. et al . Population impact of different definitions of airway obstruction.  Eur Respir J. 2003;  22 268-273
    CrossrefPubMedGoogle Scholar
  • 7 Calverley P M, Burge P S, Spencer S. et al . Bronchodilator reversibility testing in chronic obstructive pulmonary disease.  Thorax. 2003;  58 659-664
    CrossrefPubMedGoogle Scholar
  • 8 Vandevoorde J, Verbanck S, Schuermans D. et al . Forced vital capacity and forced expiratory volumen in six seconds as predictors of reduced total lung capacity.  Eur Respir J. 2008;  31 391-395
    CrossrefPubMedGoogle Scholar
  • 9 Taube C, Holz O, Mücke M. et al . Airway response to inhaled hypertonic saline in patients with moderate to severe chronic obstructive pulmonary disease.  Am J Respir Crit Care Med. 2001;  164 1810-1815
    PubMedGoogle Scholar
  • 10 Cerveri I, Dore R, Corsico A. et al . Assessment of emphysema in COPD: a functional and radiologic study.  Chest. 2004;  125 1714-1718
    CrossrefPubMedGoogle Scholar
  • 11 Mohsenifar Z, Lee S M, Diaz P. et al . Single-breath diffusing capacity of the lung for carbon monoxide: a predictor of PaO2, maximum work rate, and walking distance in patients with emphysema.  Chest. 2003;  123 1394-1400
    CrossrefPubMedGoogle Scholar
  • 12 Adams A B, Cakar N, Marini J J. Static and dynamic pressure-volume curves reflect different aspects of respiratory system mechanics in experimental acute respiratory distress syndrome.  Respir Care. 2001;  46 686-693
    PubMedGoogle Scholar
  • 13 O'Donnell D E, Flüge T, Gerken F. et al . Effects of tiotropium on lung hyperinflation, dyspnoea and exercise tolerance in COPD.  Eur Respir J. 2004;  23 832-840
    PubMedGoogle Scholar
  • 14 Lane D J, Howell J B, Giblin B. Relation between airways obstruction and CO2 tension in chronic obstructive airways disease.  Br Med J. 1968;  3 (5620) 707-709
    CrossrefPubMedGoogle Scholar
  • 15 Fletcher E C, Donner C F, Midgren B. et al . Survival in COPD patients with a daytime PaO2 greater than 60 mm Hg with and without nocturnal oxyhemoglobin desaturation.  Chest. 1992;  101 649-655
    CrossrefPubMedGoogle Scholar
  • 16 Oga T, Nishimura K, Tsukino M. et al . The effects of oxitropium bromide on exercise performance in patients with stable chronic obstructive pulmonary disease. A comparison of three different exercise tests.  Am J Respir Crit Care Med. 2000;  161 1897-1901
    CrossrefPubMedGoogle Scholar
  • 17 Oga T, Nishimura K, Tsukino M. et al . Analysis of the factors related to mortality in chronic obstructive pulmonary disease: role of exercise capacity and health status.  AJRCCM. 2003;  167 544-549
    CrossrefPubMedGoogle Scholar
  • 18 Palange P, Antonucci R, Valli G. Exercise testing in the prognostic evaluation pf patients with lung and heart diseases.  In: Ward SA, Palange P (eds). Clinical exercise testing.  Eur Respir Mon. 2007;  40 195-207
    PubMedGoogle Scholar
  • 19 Bernard S, LeBlanc P, Whittom F. et al . Peripheral muscle weakness in patients with chronic obstructive pulmonary disease.  Am J Respir Crit Care Med. 1998;  158 629-634
    CrossrefPubMedGoogle Scholar
  • 20 Ottenheijm C A, Heunks L M, Sieck G C. et al . Diaphragm dysfunction in chronic obstructive pulmonary disease.  Am J Respir Crit Care Med. 2005;  172 200-205
    CrossrefPubMedGoogle Scholar
  • 21 Simonneau G, Galiè N, Rubin L J. et al . Clinical classification of pulmonary hypertension.  J Am Coll Cardiol. 2004;  43 5S-12S
    CrossrefPubMedGoogle Scholar
  • 22 Thabut G, Dauriat G, Stern J B. et al . Pulmonary hemodynamics in advanced COPD candidates for lung volume reduction surgery or lung transplantation.  Chest. 2005;  127 1531-1536
    CrossrefPubMedGoogle Scholar
  • 23 Kessler R, Faller M, Weitzenblum E. et al . “Natural history” of pulmonary hypertension in a series of 131 patients with chronic obstructive lung disease.  Am J Respir Crit Care Med. 2001;  164 219-224
    CrossrefPubMedGoogle Scholar
  • 24 Naeije R. Pulmonary hypertension and right heart failure in COPD.  Monaldi Arch Chest Dis. 2003;  59 250-253
    PubMedGoogle Scholar
  • 25 Kessler R, Faller M, Fourgaut G. et al . Predictive Factors of Hospitalization for Acute Exacerbation in a Series of 64 Patients with Chronic Obstructive Pulmonary Disease.  Am J Respir Crit Care Med. 1999;  159 158-164
    CrossrefPubMedGoogle Scholar
  • 26 Holverda S, Bogaard H J, Groepenhoff H. et al . Cardiopulmonary Exercise Test Characteristics in Patients with Chronic Obstructive Pulmonary Disease and Associated Pulmonary Hypertension.  Respiration. 2007 Oct 25;  [Epub ahead of print]
    PubMedGoogle Scholar
  • 27 DeMarco Jr F J, Wynne J W, Block A J. et al . Oxygen desaturation during sleep as a determinant of the “Blue and Bloated” syndrome.  Chest. 1981;  79 621-625
    CrossrefPubMedGoogle Scholar
  • 28 Sanders M H, Newman A B, Haggerty C L. et al . Sleep Heart Health Study. Sleep and Sleep-disordered Breathing in Adults with Predominantly Mild Obstructive Airway Disease.  AJRCCM. 2003;  167 7-14
    CrossrefPubMedGoogle Scholar
  • 29 McNicholas W T, Calverley P MA, Lee A. et al . Tiotropium Sleep Study in COPD Investigators. Long-acting inhaled anticholinergic therapy improves sleeping oxygen saturation in COPD.  Eur Respir J. 2004;  23 825-831
    CrossrefPubMedGoogle Scholar
  • 30 Marin J M, Carrizo S J, Vicente E. et al . Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study.  Lancet. 2005 Mar 19 – 25;  365 (9464) 1046-1053
    CrossrefPubMedGoogle Scholar
  • 31 Lavie P, Herer P, Lavie L. Mortality risk factors in sleep apnoea: a matched case-control study.  J Sleep Res. 2007;  16 128-134
    CrossrefPubMedGoogle Scholar
  • 32 Taube C, Lehnigk B, Paasch K. et al . Factor analysis of changes in dyspnea and lung function parameters after bronchodilation in Chronic Obstructive Pulmonary Disease.  Am J Respir Crit Care Med. 2000;  162 216-220
    CrossrefPubMedGoogle Scholar
  • 33 Schlecht N F, Schwartzman K, Bourbeau J. Dyspnea as clinical indicator in patients with chronic obstructive pulmonary disease.  Chron Respir Dis. 2005;  2 183-191
    CrossrefPubMedGoogle Scholar
  • 34 Vincken W, Noord J A van, Greefhorst A PM. et al . Dutch/Belgian Tiotropium Study Group. Improved health outcomes in patients with COPD during 1 yr's treatment with tiotropium.  Eur Respir J. 2002;  19 209-216
    CrossrefPubMedGoogle Scholar
  • 35 Casaburi R, Mahler D A, Jones P W. et al . A long-term evaluation of once-daily tiotropium in chronic obstructive pulmonary disease.  Eur Respir J. 2002;  19 217-224
    CrossrefPubMedGoogle Scholar
  • 36 O'Donnell D E, Voduc N, Fitzpatrick M. et al . Effect of salmeterol on the ventilatory response to exercise in chronic obstructive pulmonary disease.  Eur Respir J. 2004;  24 86-294
    CrossrefPubMedGoogle Scholar
  • 37 Hodder R V, White R J, Menjoge S S. et al . Effectiveness of Tiotropium or Salmeterol in COPD patients receiving inhaled steroids.  Am J Respir Crit Care Med. 2002;  165 A228
    PubMedGoogle Scholar
  • 38 Jones P W. Interpreting thresholds for a clinically significant change in health status in asthma and COPD.  Eur Respir J. 2002;  19 398-404
    CrossrefPubMedGoogle Scholar
  • 39 Calverley P M, Boonsawat W, Cseke Z. et al . Maintenance therapy with budesonide and formoterol in chronic obstructive pulmonary disease.  Eur Respir J. 2003;  22 912-919
    CrossrefPubMedGoogle Scholar
  • 40 Jones P W, Edin H M, Anderson J. Salmeterol/Fluticasone propionate combination improves health status in COPD patients.  Am J Resp Crit Care Med. 2002;  165 A111
    PubMedGoogle Scholar
  • 41 Aaron S D, Vandenheen K L, Fergusson D. et al . Canadian Thoracic Society/Canadian Respiratory Clinical Research Consortium. Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease.  Ann Intern Med. 2007;  146 545-555
    CrossrefPubMedGoogle Scholar
  • 42 Vijayasaratha K, Stockley R A. Reported and unreported exacerbations of COPD: analysis by diary cards.  Chest. 2008;  133 34-41
    CrossrefPubMedGoogle Scholar
  • 43 Burge S, Wedzicha J A. COPD exacerbations: definitions and classifications.  Eur Respir J. 2003;  21 46s-53s
    CrossrefPubMedGoogle Scholar
  • 44 Aaron S D, Fergusson D, Marks G B. et al . Canadian Thoracic Society/Canadian Respiratory Clinical Research Consortium. Counting, analyzing and reporting exacerbations of COPD in randomized, controlled trials.  Thorax. 2008;  63 122-128
    PubMedGoogle Scholar
  • 45 Cote C G, Dordelly L J, Celli B R. Impact of COPD exacerbations on patient-centered outcomes.  Chest. 2007;  131 696-704
    CrossrefPubMedGoogle Scholar
  • 46 Soler-Cataluña J J, Martínez-García M Á, Sánchez P R. et al . Severe acute exacerbations and mortality in patients with chronic obstructive pulmonary disease.  Thorax. 2005;  60 925-931
    CrossrefPubMedGoogle Scholar
  • 47 Niewoehner D E, Lokhnygina Y, Rice K. et al . Risk indexes for exacerbations and hospitalizations due to COPD.  Chest. 2007;  131 20-28
    CrossrefPubMedGoogle Scholar
  • 48 Ringbaek T, Seersholm N, Viskum K. Standardised mortality rates in females and males with COPD and asthma.  Eur Respir J. 2005;  25 891-895
    CrossrefPubMedGoogle Scholar
  • 49 Hansell A L, Walk J A, Soriano J B. What do chronic obstructive pulmonary disease patients die from? A multiple cause coding analysis.  Eur Respir J. 2003;  22 809-814
    CrossrefPubMedGoogle Scholar
  • 50 Ringbaek T, Viskum K. Is there any association between inhaled ipratropium and mortality in patients with COPD and asthma?.  Respir Med. 2003;  97 264-272
    CrossrefPubMedGoogle Scholar
  • 51 Zielinski J, MacNee W, Wedzicha J. et al . Causes of death in patients with COPD and chronic respiratory failure.  Monaldi Arch Chest Dis. 1997;  52 43-47
    PubMedGoogle Scholar
  • 52 Gudmundsson G, Gislason T, Lindberg E. et al . Mortality in COPD patients discharged from hospital: the role of treatment and co-morbidity.  Respir Res. 2006;  16 (7) 109
    PubMedGoogle Scholar
  • 53 Curkendall S M, Lanes S, de Luise C. et al . Chronic obstructive pulmonary disease severity and cardiovascular outcomes.  Eur J Epidemiol. 2006;  21 803-813
    CrossrefPubMedGoogle Scholar
  • 54 Sin D D, Wu L, Anderson J. et al . Inhaled corticosteroids and mortality in chronic obstructive pulmonary disease.  Thorax. 2005;  60 992-997
    CrossrefPubMedGoogle Scholar
  • 55 Calverley P MA, Anderson J A, Celli B. et al . TORCH investigators. Salmeterol and Fluticasone Propionate and Survival in Chronic Obstructive Pulmonary Disease.  N Engl J Med. 2007;  356 775-789
    CrossrefPubMedGoogle Scholar
  • 56 Kesten S, Jara M, Wentworth C. et al . Pooled clinical trial analysis of tiotropium safety.  Chest. 2006;  13 1695-1703
    PubMedGoogle Scholar
  • 57 Celli B R, Cote C G, Marin J M. et al . The body-mass index, airflow obstruction, dyspnea, and exercise capacity index in chronic obstructive pulmonary disease.  N Engl J Med. 2004;  350 1005-1012
    CrossrefPubMedGoogle Scholar
  • 58 Casanova C, Cote C, de Torres J P. et al . Inspiratory-to-total lung capacity ratio predicts mortality in patients with chronic obstructive pulmonary disease.  Am J Respir Crit Care Med. 2005;  171 591-597
    CrossrefPubMedGoogle Scholar
  • 59 Holguin F, Folch E, Redd S C. et al . Comorbidity and mortality in COPD-related hospitalizations in the United States, 1979 to 2001.  Chest. 2005;  128 2005-2011
    CrossrefPubMedGoogle Scholar
  • 60 Young R P, Hopkins R, Eaton T E. Forced expiratory volume in one second: not just a lung function test but a marker of premature death from all causes.  Eur Respir J. 2007;  30 616-622
    CrossrefPubMedGoogle Scholar
  • 61 Garcia-Aymerich J, Lange P, Benet M. et al . Regular physical activity reduces hospital admission and mortality in chronic obstructive pulmonary disease: a population based cohort study.  Thorax. 2006;  61 772-778
    CrossrefPubMedGoogle Scholar
  • 62 Watz H, Waschki B, Boehme C. et al . Extrapulmonary effects of chronic obstructive pulmonary disease on physical activity: a cross-sectional study.  Am J Respir Crit Care Med. 2008;  177 743-745
    CrossrefPubMedGoogle Scholar
  • 63 Wewel A R, Gellermann I, Schwertfeger I. et al . Intervention by phone calls raises domiciliary activity and exercise capacity in patients with severe COPD.  Respir Med. 2008;  102 20-26
    CrossrefPubMedGoogle Scholar
  • 64 Vogelmeier C, Buhl R, Criée C P. et al . Leitlinie der Deutschen Atemwegsliga und der Deutschen Gesellschaft für Pneumologie und Beatmungsmedizin zur Diagnostik und Therapie von Patienten mit chronisch obstruktiver Bronchitis und Lungenemphysem (COPD).  Pneumologie. 2007;  61 e1-e40
    Article in Thieme ConnectPubMedGoogle Scholar
  • 65 Nationale Versorgungsleitlinie COPD NVL. Deutscher Ärzte-Verlag 2007
    Google Scholar
  • 66 Casaburi R, Kufkafka D, Cooper C B. et al . Improvement in exercise tolerance with the combination of tiotropium and pulmonary rehabilitation in patients with COPD.  Chest. 2005;  127 809-817
    CrossrefPubMedGoogle Scholar
  • 67 Decramer M, Gosselink R, Bartsch P. et al . Effect of treatments on the progression of COPD: report of a workshop held in Leuven, 11 – 12 March 2004.  Thorax. 2005;  60 343-349
    CrossrefPubMedGoogle Scholar
  • 68 Dhein Y, Birkenmaier A, Otte B. et al . Evaluation of a structured education programme (AFBE) for patients with mild to moderate COPD under outpatient conditions.  Am J Respir Crit Care Med. 2002;  165 A420
    PubMedGoogle Scholar
  • 69 Tirimanna P R, Den Otter J J, Van Schayck C P. et al . Evaluation of the suitability of weekly peak expiratory flow rate measurements in monitoring annual decline in lung function among patients with asthma and chronic bronchitis.  Br J Gen Pract. 1996;  46 15-18
    PubMedGoogle Scholar
  • 70 Glaab T, Banik N, Rutschmann O T. et al . National survey of guideline-compliant COPD management among pneumologists and primary care physicians.  COPD. 2006;  3 141-148
    CrossrefPubMedGoogle Scholar
  • 71 Nishimura K, Izumi T, Tsukino M. et al . Dyspnea is a better predictor of 5-year survival than airway obstruction in patients with COPD.  Chest. 2002;  121 1434-1440
    CrossrefPubMedGoogle Scholar
  • 72 Burdon J G, Juniper E F, Killian K J. et al . The perception of breathlessness in asthma.  Am Rev Respir Dis. 1982;  126 825-828
    PubMedGoogle Scholar
  • 73 Guyatt G H, Sullivan M J, Thompson P J. et al . The 6-minute walk: a new measure of exercise capacity in patients with chronic heart failure.  Can Med Assoc J. 1985;  132 919-923
    PubMedGoogle Scholar
  • 74 Landbo C, Prescott E, Lange P. et al . Prognostic value of nutritional status in chronic obstructive pulmonary disease.  Am J Respir Crit Care Med. 1999;  160 1856-1861
    CrossrefPubMedGoogle Scholar
  • 75 Man S F, Connett J E, Anthonisen N R. et al . C-reactive protein and mortality in mild to moderate chronic obstructive pulmonary disease.  Thorax. 2006;  61 849-853
    CrossrefPubMedGoogle Scholar
  • 76 Stockley R A. New approaches to the management of COPD.  Chest. 2000;  117 58S-62S
    CrossrefPubMedGoogle Scholar
  • 77 Vestbo J, Anderson W, Coxson H O. et al . ECLIPSE investigators.  Eur Respir J. 2008;  31 869-873
    CrossrefPubMedGoogle Scholar

1 Ergebnisse des Expertentreffens „Luftschlösser”, 23. – 24. November 2007, Frankfurt am Main, mit Unterstützung der Boehringer Ingelheim Pharma GmbH & Co KG

Prof. Dr. med. G. Schultze-Werninghaus

Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH, Medizinische Klinik III – Pneumologie, Allergologie, Schlaf- und Beatmungsmedizin

Bürkle-de-la-Camp-Platz 1

44789 Bochum

Email: gerhard.schultze-werninghaus@bergmannsheil.de

      >