Die Kombinationstherapie (Dronabinol + Prochlorperazin) war signifikant wirksamer zur Kontrolle von chemotherapieinduzierter Übelkeit und Erbrechen als jede Monotherapie allein.
Zusammenfassung
Multizentrische RCT (n nicht explizit angegeben), doppelblind, parallel; Dronabinol 10 mg + Prochlorperazin 10 mg vs. Monotherapien. Übelkeit nach Chemotherapie: Kombination 29 % vs. Dronabinol allein 47 % vs. Prochlorperazin allein 60 %. Erbrechen: 35 % (Kombination) vs. 55 % (Dronabinol) vs. 41 % (Prochlorperazin). Kombinationstherapie signifikant überlegen (p<0,05); mediane Episodendauer beider Symptome kürzer unter Kombination.
P
PopulationKrebspatienten mit chemotherapieinduzierter Übelkeit und Erbrechen, Multicenter
I
InterventionDronabinol 10 mg alle 6 h oral + Prochlorperazin 10 mg alle 6 h oral (Kombination)
C
KontrolleDronabinol 10 mg alle 6 h + Placebo ODER Prochlorperazin 10 mg alle 6 h + Placebo
O
OutcomeNur 29% der Kombinationsgruppe vs. 47% (Dronabinol) und 60% (Prochlorperazin) erlitten Übelkeit nach Chemotherapie; Kombination signifikant überlegen (p nicht explizit genannt)
Vertrauen in die Evidenz
Sehr niedrigNiedrigModeratHoch
Moderat
Dritte von vier GRADE-Stufen, die Effektschätzung ist wahrscheinlich verlässlich.
Herabgestuft wegen
Ungenauigkeit
Qualitätsprofil
Größe★★★★★
VerblindungDoppelblind
EffektstärkeKlarer Nutzen
Zitate / Jahr★★★★★
Autoren
Lane M, Vogel CL, Ferguson J, Krasnow S, Saiers JL, Hamm J, Salva K, Wiernik PH, Holroyde CP, Hammill S
Dronabinol (Marinol, Roxane Laboratories, Columbus, OH) and prochlorperazine were tested alone and in combination in a randomized, double-blind, parallel group, multicenter study. Patients were randomized to receive either 1) dronabinol 10 mg every 6 hr plus placebo; 2) placebo plus prochlorperazine 10 mg every 6 hr; or 3) dronabinol and prochlorperazine, each 10 mg every 6 hr. Antiemetic treatment was begun 24 hr prior to and continued for 24 hr after the last dose of chemotherapy; all was given orally. Only 29% of patients in group 3 versus 47% in group 1 and 60% in group 2 experienced nausea after chemotherapy. In addition, the median duration per episode and severity of nausea were significantly less with combination therapy. Vomiting occurred after chemotherapy in 41%, 55%, and 35% of patients in groups 1, 2, and 3, respectively. The median duration per episode of vomiting was 1 min in group 3 versus two in group 1 and four in group 2. Side effects, primarily CNS, were more common in group 1 than in group 2; addition of prochlorperazine to dronabinol appeared to decrease the frequency of dysphoric effects seen with the latter agent. The combination was significantly more effective than was either single agent in controlling chemotherapy-induced nausea and vomiting.