The Netherlands journal of medicine · 1995
Prophylaxis of delayed nausea and vomiting after cancer chemotherapy.
Клиническое исследованиеСравнительное исследованиеСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Esseboom E U, Rojer R A, Borm J J, Statius van Eps L W
Аннотация
OBJECTIVE: To compare ondansetron and domperidone for treatment of delayed nausea/vomiting (DN/V) following highly emetogenic chemotherapy, after attaining total suppression of emesis on the day of chemotherapy by mean of ondansetron (combined with dexamethasone in the case of cisplatin-treated patients).
METHODS: Domperidone (3 x 20 mg daily) was compared with ondansetron (3 x 8 mg daily) in a randomized double-bind placebo-controlled study. Out of 65 consecutive patients who received a first course of either cyclophosphamide and cisplatin for advanced stage ovarian cancer or cyclophosphamide, doxorubicin and 5-fluoro-uracil for metastatic breast carcinoma, 60 patients were eligible for entering the study. According to data from the literature these chemotherapeutic regimens with induce DN/V to a comparable degree. The patients were questioned daily from day 2 through day 5 by the same investigator and the severity of nausea or vomiting was scored on a numerical scale.
RESULTS: Emesis was totally suppressed in all patients on the day of chemotherapy. As to DN/V, 16 out of 20 patients receiving placebo required "rescue" medication versus none in the other two groups (p < 0.001). Only 2 (10%) patients were symptomatic with domperidone versus 9 (45%) symptomatic patients in the ondansetron-treated group (p < 0.05).
CONCLUSIONS: Both drugs are effective, but domperidone (3 x 20 mg) is more effective than ondansetron (3 x 8 mg) for the prevention of the delayed nausea and/or vomiting which occur after highly emetogenic chemotherapy (p < 0.05).
METHODS: Domperidone (3 x 20 mg daily) was compared with ondansetron (3 x 8 mg daily) in a randomized double-bind placebo-controlled study. Out of 65 consecutive patients who received a first course of either cyclophosphamide and cisplatin for advanced stage ovarian cancer or cyclophosphamide, doxorubicin and 5-fluoro-uracil for metastatic breast carcinoma, 60 patients were eligible for entering the study. According to data from the literature these chemotherapeutic regimens with induce DN/V to a comparable degree. The patients were questioned daily from day 2 through day 5 by the same investigator and the severity of nausea or vomiting was scored on a numerical scale.
RESULTS: Emesis was totally suppressed in all patients on the day of chemotherapy. As to DN/V, 16 out of 20 patients receiving placebo required "rescue" medication versus none in the other two groups (p < 0.001). Only 2 (10%) patients were symptomatic with domperidone versus 9 (45%) symptomatic patients in the ondansetron-treated group (p < 0.05).
CONCLUSIONS: Both drugs are effective, but domperidone (3 x 20 mg) is more effective than ondansetron (3 x 8 mg) for the prevention of the delayed nausea and/or vomiting which occur after highly emetogenic chemotherapy (p < 0.05).