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  • 1
    Electronic Resource
    Electronic Resource
    Neurologische Skalen als Endpunkte in Schlaganfallstudien Aspekte der statistischen Auswertung (2000)
    Springer
    Der Nervenarzt 71 (2000), S. 797-801 
    Details
    ISSN: 1433-0407
    Keywords: Schlüsselwörter Ischämischer Schlaganfall ; Thrombolyse ; National Institute of Health Scale ; Modified Rankin Scale ; Barthel-Index ; Keywords Ischaemic stroke ; Thrombolysis ; National Institute of Health Scale ; Modified Rankin Scale ; Barthel Index
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Description / Table of Contents: Abstract Even after publication of ECASS II, the latest paper in a series of large, placebo-controlled studies on thrombolysis in acute ischaemic stroke, there is still uncertainty as to what the best clinical endpoint(s) is (are) in trial design for reliably identifying significant differences between treatment groups. If the expected treatment difference as measured by a neurological outcome scale like the Modified Rankin Scale corresponds more to a shift in dispersion (on average a majority of patients profits greatly) rather than to a shift in location (on average each patient profits much), then the power of the odds ratio test is much higher than that of the Wilcoxon test and therefore the clinical outcome parameters should be dichotomised. With respect to the time window of 0–6 hrs from symptom onset of an acute ischaemic stroke, for example, a dichotomisation of 0–2 vs. 3–6 for the Modified Rankin Scale is reasonable. In the case of multiple endpoints, a global (multivariate) test should be used, but the correlation between these endpoints must not be too high, which means that the various manifestations of the complex stroke disease should be considered.
    Notes: Zusammenfassung Auch nach dem Erscheinen der ECASS-II-Studie als bisher letzte Veröffentlichung einer Serie von großen, plazebokontrollierten Studien zur systemischen Thrombolyse beim akuten ischämischen Schlaganfall stellt sich hinsichtlich des Studiendesigns weiterhin die Kardinalfrage, welche(r) Endpunkt(e) am geeignetsten ist (sind), um Unterschiede zwischen den Behandlungsgruppen zuverlässig herausarbeiten zu können. Falls der Therapieeffekt, gemessen anhand neurologischer Endpunkte wie z. B. der Modified Rankin Scale, mehr einem Dispersionsunterschied (d. h. im Mittel profitiert eine Mehrzahl von Patienten viel) als einem Lokationsunterschied (d. h. im Mittel profitiert jeder Patient ein wenig) entspricht, bei welchem der Odds-Ratio-Test eine deutlich höhere Power aufweist als der Wilcoxon-Test, so sollten die Endpunkte dichotomisiert ausgewertet werden. Für das Zeitfenster von 0–6 h seit Beginn der Symptomatik des ischämischen Schlaganfalls ist beispielsweise für die Modified Rankin Scale die Dichotomisierung 0–2 vs. 3–6 sinnvoll. Werden multiple Endpunkte erhoben und ein globaler Test verwendet, so sollte sicher gestellt sein, dass diese nicht zu hoch korrelieren, d. h. verschiedene Dimensionen des komplexen Erkrankungsbildes Schlaganfall erfasst werden.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s001150050666
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  • 2
    Electronic Resource
    Electronic Resource
    Systemische Thrombolyse mit Plasminogenaktivator bei alten Schlaganfallpatienten (1998)
    Springer
    Der Nervenarzt 69 (1998), S. 678-682 
    Details
    ISSN: 1433-0407
    Keywords: Schlüsselwörter Ischämischer Hirninfarkt ; Thrombolyse ; Plasminogenaktivator ; Hirnblutung ; Key words Ischemic stroke ; Thrombolysis ; Plasminogen activator ; Brain hemorrhage
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Description / Table of Contents: Summary Following the study protocol, we stratified the 615 patients of ECASS I according age (≤/〉70 years) and analysed the response to intravenous rt-PA in both subgroups. The older patients (248) suffered from the same stroke severity as the younger patients (367) experienced, however, a more severy clinical course (placebo group after 3 months after stroke: Barthel Index 50 vs. 85, mortality 24% vs. 11%). Treatment with rt-PA increased the proportion of undisabled patients at 3 months after stroke onset significantly only in the younger patients. The risk for brain parenchymal hemorrhage was increased by the factor of 4.7and 4.6 in both age groups. It is obviously harder to achieve an undisabled state by systemic thrombolysis in the elderly. Facing the risk of brain hemorrhage asscociated with rt-PA, the risk-benfit-ratio may be less fovourable in patients over 70 years.
    Notes: Zusammenfassung Entsprechend dem Protokoll der ersten European Cooperative Acute Stroke Study (ECASS I) wurden die 615 Studienpatienten nach dem Lebensalter (≤/〉70 Jahre) stratifiziert und die Wirkung der Thrombolyse mit intravenös appliziertem Gewebeplasminogenaktivator (rt-PA) untersucht. Die älteren Patienten (248) hatten im Mittel gleich schwere Hirninsulte erlitten wie die 367 jüngeren, nahmen jedoch einer schlechteren Verlauf (Placebogruppe nach 3 Monaten: Barthel-Index 50 vs. 85, Letalität 24% vs. 11%). Nur bei den jüngeren Patienten hatte die rt-PA-Therapie einen positiven Effekt auf die Wahrscheinlichkeit, 3 Monate nach dem Insult unbehindert zu sein. In beiden Altersgruppen nahmen Hirnblutungen proportional um den Faktor 4,6 bzw. 4,7 nach rt-PA-Therapie zu. Wegen des schlechteren Spontanverlaufs scheint es bei über 70jährigen Schlaganfallpatienten schwerer zu sein, mit der systemischen rt-PA Thrombolyse einen Heilungserfolg zu erreichen. Bei etwa gleichem Hirnblutungsrisiko ergibt sich ein ungünstiges Nutzen-Risiko-Verhältnis bei den älteren Patienten.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s001150050328
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    Paper (German National Licenses)
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  • 3
    Electronic Resource
    Electronic Resource
    Lack of interaction between meloxicam and warfarin in healthy volunteers (1997)
    Springer
    European journal of clinical pharmacology 51 (1997), S. 421-425 
    Details
    ISSN: 1432-1041
    Keywords: Key words Warfarin ; Meloxicam ; interaction ; pharmacokinetics ; protein binding
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract Objective: The effect of multiple oral doses of meloxicam 15 mg on the pharmacodynamics and pharmacokinetics of warfarin was investigated in healthy male volunteers. Warfarin was administered in an individualized dose to achieve a stable reduction in prothrombin times calculated as International Normalized Ratio (INR) values. Then INR- and a drug concentration-time profile was determined. For the interaction phase, meloxicam was added for 7 days and then INR measurements and the warfarin drug profiles were repeated for comparison. Overall, warfarin treatment lasted for 30 days. Results: Warfarin and meloxicam were well tolerated by healthy volunteers in this study. Thirteen healthy volunteers with stable INR values entered the interaction phase. Prothrombin times, expressed as mean INR values, were not significantly altered by concomitant meloxicam treatment, being 1.20 for warfarin alone and 1.27 for warfarin with meloxicam cotreatment. R- and S-warfarin pharmacokinetics were similar for both treatments. Geometric mean (% gCV) AUCSS values for the more potent S-enantiomer were 5.07 mg · h · l−1 (27.5%) for warfarin alone and 5.64 mg · h · l−1 (28.1%) during the interaction phase. Respective AUCSS values for R-warfarin were 7.31 mg · h · l−1 (43.8%) and 7.58 mg · h · l−1 (39.1%). Conclusion: The concomitant administration of the new non-steroidal anti-inflammatory drug (NSAID) meloxicam affected neither the pharmacodynamics nor the pharmacokinetics of a titrated warfarin dose. A combination of both drugs should nevertheless be avoided and, if necessary, INR monitoring is considered mandatory.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s002280050224
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    Paper (German National Licenses)
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