Campora E, Giudici S, Merlini L, Rubagotti A, Rosso R
Department of Medical Oncology, Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy.
Am J Clin Oncol. 1994 Dec;17(6):522-6.
The antiemetic efficacy of ondansetron and dexamethasone (Ondex) was randomly compared to that of high-dose metoclopramide, dexamethasone, and orphenadrine (Control) in the prevention of emesis induced by cyclophosphamide-doxorubicin chemotherapy in 64 chemotherapy-naive breast cancer patients. For the control of acute emesis (day 1), patients were randomized to receive either ondasetron 8 mg p.o. 1 hour prior to chemotherapy (CT) and repeated after 6 and 12 hours plus dexamethasone 20 mg i.v. 40 minutes prior to CT (Ondex) or dexamethasone 20 mg i.v. 40 minutes prior to CT, orphenadrine 40 mg i.m. 35 minutes prior to CT and metoclopramide 3 mg/kg i.v. 30 minutes prior to CT and repeated after 90 minutes followed by 40 mg p.o. every 3 hours for 4 times (Control). To control delayed emesis, patients on Ondex received ondansetron 8 mg PO t.i.d. days 2 and 3 and patients in the Control arm received metoclopramide 0.5 mg/kg p.o. q.i.d. and dexamethasone 8 mg i.m. b.i.d. days 2 and 3. Complete and major control of acute emesis was observed in 74%/94% and 44%/67% of patients treated with Ondex and Control, respectively (p < .01/p < .005). Acute nausea was absent in 38% and 34% of patients treated with Ondex and Control, respectively (p = NS). Complete and major control of delayed emesis (days 2-5) was observed in 65%/91% versus 44%/66% of patients in the Ondex and Control arms, respectively (p = NS/p < .01). In patients receiving 6 courses of FEC/FAC, control of acute emesis was significantly superior with Ondex at all treatment courses.
在64例初治乳腺癌患者中，随机比较了昂丹司琼和地塞米松（Ondex）与大剂量甲氧氯普胺、地塞米松和奥芬那君（对照）预防环磷酰胺-阿霉素化疗所致呕吐的止吐效果。为控制急性呕吐（第1天），患者随机分为两组，一组在化疗（CT）前1小时口服8 mg昂丹司琼，6小时和12小时后重复给药，同时在CT前40分钟静脉注射20 mg地塞米松（Ondex组）；另一组在CT前40分钟静脉注射20 mg地塞米松，在CT前35分钟肌肉注射40 mg奥芬那君，在CT前30分钟静脉注射3 mg/kg甲氧氯普胺，90分钟后重复给药，随后每3小时口服40 mg，共4次（对照组）。为控制延迟性呕吐，Ondex组患者在第2天和第3天每天口服3次8 mg昂丹司琼，对照组患者在第2天和第3天每天口服4次0.5 mg/kg甲氧氯普胺和每天2次肌肉注射8 mg地塞米松。分别在接受Ondex和对照治疗的患者中观察到，急性呕吐的完全控制率和主要控制率分别为74%/94%和44%/67%（p<0.01/p<0.005）。接受Ondex和对照治疗的患者中，分别有38%和34%无急性恶心（p=无显著性差异）。分别在Ondex组和对照组患者中观察到，延迟性呕吐（第2 - 5天）的完全控制率和主要控制率分别为65%/91%和44%/66%（p=无显著性差异/p<0.01）。在接受6个疗程FEC/FAC治疗的患者中，在所有治疗疗程中，Ondex对急性呕吐的控制均显著优于对照组。
