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
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
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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
