Roila F
Medical Oncology Division, Polyclinic Hospital, Perugia, Italy.
Oncology. 1993 May-Jun;50(3):163-7. doi: 10.1159/000227171.
This paper describes a multicentre, double-blind, parallel group study which compared ondansetron (0.15 mg/kg i.v. x 3) plus dexamethasone (20 mg i.v.) with metoclopramide (3 mg/kg i.v. x 2) plus dexamethasone (20 mg i.v.) and diphenhydramine (50 mg i.v.) for the prevention of cisplatin-induced emesis and nausea. Two hundred and eighty-nine consecutive patients receiving chemotherapy containing cisplatin at doses > or = 50 mg/m2 entered the study and 267 patients were evaluable for efficacy. The ondansetron regimen was significantly superior compared with the metoclopramide regimen in the control of acute emesis and nausea. Ondansetron plus dexamethasone provided complete protection against retching and vomiting in 79% of patients compared with 59% of patients given the metoclopramide combination (p < 0.002). Similarly ondansetron plus dexamethasone completely prevented nausea in 77% of patients, whereas the metoclopramide combination protected 66% of patients (p < 0.051). Success (no nausea and no emesis) was afforded to 69% of those patients given ondansetron plus dexamethasone as opposed to 50% of patients given the metoclopramide combination (p < 0.003). From day 2-4 all patients received the same anti-emetic regimen of oral metoclopramide and intramuscular dexamethasone. Significantly fewer patients who had received the ondansetron regimen on day 1 vomited on days 2 and 3 compared with those who had received the triple drug combination (84-86 and 68-71%, respectively, p < 0.006). Nausea was also better controlled in this group on day 2. On subsequent cisplatin cycles, the incidence of acute vomiting rose to 53% in those patients given the metoclopramide regimen, but remained low (26%) in the group treated with ondansetron plus dexamethasone. Patients receiving the metoclopramide regimen had significantly more sedation than patients receiving ondansetron plus dexamethasone (12 vs. 2%; p < 0.005). Extrapyramidal reactions were only observed in metoclopramide-treated patients (3%). The results of this study suggest that ondansetron plus dexamethasone is a more effective and better tolerated anti-emetic regimen compared with metoclopramide plus dexamethasone and diphenhydramine for the prevention of acute cisplatin-induced emesis.
本文描述了一项多中心、双盲、平行组研究，该研究比较了昂丹司琼（0.15mg/kg静脉注射×3次）加地塞米松（20mg静脉注射）与甲氧氯普胺（3mg/kg静脉注射×2次）加地塞米松（20mg静脉注射）及苯海拉明（50mg静脉注射）预防顺铂所致呕吐和恶心的效果。289例连续接受含顺铂剂量≥50mg/m²化疗的患者进入本研究，267例患者可进行疗效评估。在控制急性呕吐和恶心方面，昂丹司琼方案显著优于甲氧氯普胺方案。昂丹司琼加地塞米松使79%的患者完全避免干呕和呕吐，而接受甲氧氯普胺联合用药的患者为59%（p<0.002）。同样，昂丹司琼加地塞米松使77%的患者完全避免恶心，而甲氧氯普胺联合用药组为66%（p<0.051）。接受昂丹司琼加地塞米松治疗的患者中有69%获得成功（无恶心和呕吐），而接受甲氧氯普胺联合用药的患者为50%（p<0.003）。从第2天至第4天，所有患者接受相同的口服甲氧氯普胺和肌内地塞米松的止吐方案。与接受三联药物联合治疗的患者相比，第1天接受昂丹司琼方案的患者在第2天和第3天呕吐的明显较少（分别为84 - 86%和68 - 71%，p<0.006）。该组在第2天恶心也得到更好控制。在随后的顺铂疗程中，接受甲氧氯普胺方案的患者急性呕吐发生率升至53%，而接受昂丹司琼加地塞米松治疗的组仍较低（26%）。接受甲氧氯普胺方案的患者比接受昂丹司琼加地塞米松的患者镇静明显更多（分别为12%和2%；p<0.005）。锥体外系反应仅在接受甲氧氯普胺治疗 的患者中观察到（3%）。本研究结果表明，与甲氧氯普胺加地塞米松及苯海拉明相比，昂丹司琼加地塞米松是预防顺铂所致急性呕吐更有效且耐受性更好的止吐方案。
