Marty M, Pouillart P, Scholl S, Droz J P, Azab M, Brion N, Pujade-Lauraine E, Paule B, Paes D, Bons J
Service d'Oncologie Médicale, Hôpital St. Louis, Paris, France.
N Engl J Med. 1990 Mar 22;322(12):816-21. doi: 10.1056/NEJM199003223221205.
To compare ondansetron (GR 38032F), a 5-hydroxytryptamine3-receptor antagonist, with metoclopramide in the prophylaxis of acute cisplatin-induced emesis, we conducted a double-blind crossover study in 97 patients scheduled to receive cisplatin (80 to 100 mg per square meter of body-surface area) for treatment of cancer. None had received chemotherapy before this trial. Among the 76 patients who satisfactorily completed both parts of the study, complete or nearly complete control of emesis (i.e., no episodes of emesis occurred, or only one or two) was achieved in 57 of 76 treatments (75 percent) with ondansetron and in 32 of 76 treatments (42 percent) with metoclopramide (P less than 0.001). Ondansetron was also more effective in controlling acute nausea, as assessed with a visual-analogue scale (P = 0.019) or a graded scale (P = 0.024). There was a significant preference among patients for ondansetron (55 vs. 26 percent; P = 0.006). Dystonic reactions were observed during three treatments with metoclopramide; both agents were otherwise well tolerated. We conclude that ondansetron is more effective than metoclopramide in the control of cisplatin-induced nausea and vomiting, and that this suggests that serotonin is an important mediator of this side effect.
为比较5-羟色胺3受体拮抗剂昂丹司琼（GR 38032F）与甲氧氯普胺预防顺铂所致急性呕吐的效果，我们对97例计划接受顺铂（80至100mg/平方米体表面积）治疗癌症的患者进行了一项双盲交叉研究。在本次试验前，所有患者均未接受过化疗。在76例圆满完成研究两部分的患者中，昂丹司琼治疗的76次中有57次（75%）实现了呕吐的完全或几乎完全控制（即未发生呕吐发作，或仅发生一两次），甲氧氯普胺治疗的76次中有32次（42%）实现了呕吐的完全或几乎完全控制（P<0.001）。根据视觉模拟量表（P=0.019）或分级量表（P=0.024）评估，昂丹司琼在控制急性恶心方面也更有效。患者对昂丹司琼的偏好显著更高（55%对26%；P=0.006）。在3次甲氧氯普胺治疗期间观察到了肌张力障碍反应；两种药物在其他方面耐受性良好。我们得出结论，昂丹司琼在控制顺铂所致恶心和呕吐方面比甲氧氯普胺更有效，这表明5-羟色胺是这种副作用的重要介质。
