Gandara D R
Division of Haematology-Oncology, Davis/VA Medical Center, California.
Eur J Cancer. 1991;27 Suppl 1:S9-11; discussion S22.
Ondansetron, a new 5-HT3 receptor antagonist, has been compared with high-dose metoclopramide in the control of acute emesis (24 h) induced by cisplatin (greater than or equal to 100 mg/m2). Ondansetron, given as three intravenous doses (0.15 mg/kg) 4-hourly, was superior to six intravenous doses of metoclopramide (2.0 mg/kg) in the control of acute emesis. Complete control of emesis was achieved in 40% of patients receiving ondansetron compared to 30% of patients receiving metoclopramide (P = 0.07); complete or major control (0-2 emetic episodes) was achieved in 65% and 51% of the patients receiving the two treatments respectively (P = 0.016). Patients entered in the acute emesis study who experienced no emesis or up to two episodes were randomised between placebo and ondansetron on day 2 to evaluate the control of delayed emesis up to day 5. Complete control of persistent or delayed emesis over days 2-5 was achieved in 59-78% of patients with oral ondansetron (16 mg t.d.s.) compared to 39-50% of patients receiving oral placebo. These differences failed to reach statistical significance except on day 4. Some patients with complete or major control of emesis on their first course of chemotherapy subsequently received further courses of ondansetron (median 3 courses; range 2-10) on a non-comparative basis. Similar control was achieved in 85% of courses. There may be some reduction in the degree of control with subsequent courses. Of 44 patients with complete control at cycle 1, 19 (44%) were emesis free and 3 (7%) experienced 1-2 episodes with cycle 3, though patients were sometimes withdrawn before cycle 3 for reasons other than inadequate anti-emetic control. Efficacy with successive courses can only be established in a prospective comparative trial. Both treatments were well tolerated but ondansetron caused significantly greater transient asymptomatic elevations in ALT/AST (P = 0.003/0.005). Acute dystonic reactions (2 patients) and akathisia (10 patients) occurred with metoclopramide only (P = 0.002). The role of ondansetron in the control of delayed emesis requires further study.
昂丹司琼是一种新型5-羟色胺3（5-HT3）受体拮抗剂，已与大剂量甲氧氯普胺就控制顺铂（大于或等于100mg/m2）引起的急性呕吐（24小时）进行了比较。昂丹司琼以0.15mg/kg的剂量每4小时静脉注射3次，在控制急性呕吐方面优于6次静脉注射甲氧氯普胺（2.0mg/kg）。接受昂丹司琼治疗的患者中有40%呕吐得到完全控制，而接受甲氧氯普胺治疗的患者这一比例为30%（P=0.07）；接受两种治疗方法治疗的患者中，分别有65%和51%的患者呕吐得到完全或基本控制（呕吐发作0-2次）（P=0.016）。参加急性呕吐研究且未出现呕吐或呕吐发作次数不超过两次的患者在第2天被随机分为安慰剂组和昂丹司琼组，以评估直至第5天的延迟性呕吐的控制情况。口服昂丹司琼（16mg，每日3次）的患者中，59%-78%在第2-5天持续性或延迟性呕吐得到完全控制，而接受口服安慰剂的患者这一比例为39%-50%。除第4天外，这些差异均未达到统计学意义。一些在首次化疗疗程中呕吐得到完全或基本控制的患者随后在非对照的基础上接受了进一步疗程的昂丹司琼治疗（中位数为3个疗程；范围为2-10个疗程）。85%的疗程获得了相似的控制效果。后续疗程的控制程度可能会有所降低。在第1周期呕吐得到完全控制的44例患者中，19例（44%）在第3周期无呕吐，3例（7%）出现1-2次呕吐发作，不过有时患者在第3周期前因止吐控制不佳以外的原因退出研究。连续疗程的疗效只能通过前瞻性对照试验来确定。两种治疗方法耐受性均良好，但昂丹司琼导致丙氨酸转氨酶/天冬氨酸转氨酶（ALT/AST）出现明显更高的短暂无症状升高（P=0.003/0.005）。急性肌张力障碍反应（2例患者）和静坐不能（10例患者）仅在甲氧氯普胺治疗时出现（P=0.002）。昂丹司琼在控制延迟性呕吐中的作用需要进一步研究。
