Brown G W, Paes D, Bryson J, Freeman A J
Glaxo Group Research Ltd, Greenford, Middlesex, UK.
Oncology. 1992;49(4):273-8. doi: 10.1159/000227056.
This paper reviews data from 3 randomised, double-blind, parallel-group studies carried out in patients receiving high-dose cisplatin chemotherapy (50-120 mg/m2). These comparative trials show that a single intravenous dose of ondansetron (8-32 mg) is as effective as the continuous infusion and intermittent dose regimens used in previous clinical trials (8 mg i.v. followed by a 1 mg/h infusion for 24 h and 0.15 mg/kg i.v. x 3). One of the studies, carried out in Europe, demonstrated that a single 8 mg i.v. dose was as effective as 32 mg given either as an 8 mg loading dose followed by an infusion or as a single intravenous dose of 32 mg before chemotherapy. A similar study conducted in the United States showed that a 32 mg i.v. single dose was significantly more effective than both the 8 mg i.v. dose and the intermittent dose schedule. This study used a prospective stratification based on the dose of cisplatin (50-70 mg/m2 and greater than or equal to 100 mg/m2). In both strata the 32 mg dose was superior. These results emphasise the importance of selecting the dose of ondansetron (8-32 mg) based on factors that predispose patients to emesis, e.g., female gender, patients with a history of chemotherapy or motion sickness and the dose of cisplatin. The ondansetron dosing regimen for patients receiving a highly-emetogenic chemotherapy (8-32 mg i.v. followed by 8 mg orally twice daily) is both simple and flexible.
本文回顾了在接受高剂量顺铂化疗（50 - 120mg/m²）的患者中进行的3项随机、双盲、平行组研究的数据。这些对比试验表明，静脉注射一次昂丹司琼（8 - 32mg）与先前临床试验中使用的持续输注和间歇给药方案（静脉注射8mg，随后以1mg/h的速度输注24小时，以及静脉注射0.15mg/kg×3次）效果相同。其中一项在欧洲进行的研究表明，静脉注射一次8mg的效果与先静脉注射8mg负荷剂量然后进行输注或在化疗前静脉注射一次32mg的效果相同。在美国进行的一项类似研究表明，静脉注射一次32mg的效果明显优于静脉注射8mg的剂量和间歇给药方案。该研究根据顺铂剂量（50 - 70mg/m²和大于或等于100mg/m²）进行前瞻性分层。在两个分层中，32mg的剂量都更优。这些结果强调了根据使患者易发生呕吐的因素（如女性性别、有化疗或晕动病史的患者以及顺铂剂量）来选择昂丹司琼剂量（8 - 32mg）的重要性。对于接受高度致吐性化疗的患者，昂丹司琼给药方案（静脉注射8 - 32mg，随后每日口服两次8mg）既简单又灵活。
