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DOI: 10.1055/s-2006-956293
© Georg Thieme Verlag KG Stuttgart · New York
Antiemetische Therapie mit 5-HT3-Antagonisten in der onkologischen Praxis
Eine randomisierte Studie des LINO Bayern e. V.Treatment of chemotherapy-induced nausea and vomiting with 5-hydroxytryptamine type 3 receptor antagonistsPublication History
eingereicht: 24.3.2006
akzeptiert: 5.10.2006
Publication Date:
22 November 2006 (online)
Zusammenfassung
Hintergrund und Fragestellung: 5-HT3-Antagonisten sind hocheffektive Medikamente zur Prävention und Behandlung von Übelkeit und Erbrechen bei onkologischen Therapien. Dennoch bestehen offene Fragen zur relativen Wirksamkeit der verfügbaren Antiemetika, insbesondere unter Berücksichtigung von Dosierung, Dauer und Zeitpunkt der Medikation sowie bezüglich des divergierenden Nebenwirkungsprofil. Somit erschien es angebracht, die tatsächliche Versorgungssituation in der alltäglichen onkologischen Praxis unter Einsatz einer leitliniengerechten antiemetischen Therapie zu überprüfen.
Patienten und Methodik: Im Rahmen des Praxisverbundes LINO (Landesverband der niedergelassenen Internistischen Onkologen) e. V. wurden 738 Zyklen mit moderat bis hoch emetogener Chemotherapie auf drei Behandlungsvarianten randomisiert: Granisetron 1 mg (GRA1) vs. 3 mg (GRA3) vs. Ondansetron 8 mg (OND8), jeweils mit 8 mg Dexamethason. Inzidenz und Schweregrad der akuten (Tag 1) und verzögerten Toxizität (Tag 2 - 5) sowie die subjektive Effektivitätsbewertung wurden von den Patienten auf einem Fragebogen dokumentiert.
Ergebnisse: Alle drei Schemata erzielten bei dem Großteil der Patienten eine suffiziente antiemetische Prophylaxe. Bei allen Parametern zeigte sich allerdings ein einheitlicher Trend zu etwas geringerer Wirksamkeit von Ondansetron 8 mg. Die Unterschiede fielen jeweils bei der verzögerten Toxizität an Tag 2 bis 5 am deutlichsten aus, insbesondere bei Chemotherapie mit Anthrazyklin/Cyclophosphamid.
Folgerung: Granisetron in zwei Dosierungen sowie Ondansetron reduzieren Chemotherapie-induzierte Übelkeit und Erbrechen ausreichend. Ondansetron wirkte etwas weniger stark.
Summary
Background and objective: 5-hydroxytryptamine 3 (5-HT3) receptor antagonists have proved to be highly efficacious in the prevention and treatment of chemotherapy-induced nausea and vomiting (CINV). However, several questions remain concerning the relative efficacy of various approved anti-emetics, especially with respect to dosage, duration and timing of administration, as well as differences in toxicity profiles. Thus it seemed appropriate to assess the current therapeutic results in routine daily practice, when applying antiemetic therapy according to established guidelines.
Patients and methods: Within LINO e.V., a group of medical oncologists in private ambulant practice (LINO: Association of private-practice medical oncologists in Bavaria), a total of 738 cycles of moderately or highly emesis-inducing chemotherapy were randomly assigned to three treatment options: (1)granisetron 1 mg (GRA1). (2) 3 mg (GRA3), and (3) ondansetron 8 mg (OND8), each combined with 8 mg dexamethasone. Incidence and severity of acute (day 1) and delayed CINV (day 2-5) and the subjective assessment of efficacy were documented on questionnaires filled in by the patients.
Results: All of the three regimens adequately prevented vomiting in the majority of the patients. However, all measured effects showed an uniform trend towards slightly decreased efficacy with 8 mg of ondansetron. These differences were predominantly detected with respect to delayed CINV on days 2 to 5, especially after chemotherapy with anthracyclin/cyclophosphamide combination therapy.
Conclusion: Granisetron, at two different dosage regimens, and ondasetron showed adequate reduction in chemotherapy-induced nausea and vomiting, but ondansetron worked slightly less so.
Schlüsselwörter
Antiemese - Emesis - Nausea - zytostatikabedingtes Erbrechen - CINV - Ondansetron - Granisetron
Key words
anti-emetics - ondansetron - granisetron - nausea - cytostatics-induced emesis - nausea
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