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首页> 外文期刊>Medical and Pediatric Oncology: The Official Journal of the American Association for Cancer Education >Open-label comparison of the antiemetic efficacy of single intravenous doses of dolasetron mesylate in pediatric cancer patients receiving moderately to highly emetogenic chemotherapy.
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Open-label comparison of the antiemetic efficacy of single intravenous doses of dolasetron mesylate in pediatric cancer patients receiving moderately to highly emetogenic chemotherapy.

机译：开放性比较单次静脉注射甲磺酸多拉西酮对接受中度至高度呕吐化疗的小儿癌症患者的止吐效果。

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BACKGROUND: Nausea and vomiting are among the most unpleasant adverse side effects of cancer therapy. PROCEDURE: An open-label dose-escalation study was conducted to assess the appropriate intravenous dose of dolasetron for pediatric patients undergoing chemotherapy. Patients received dolasetron in single intravenous doses of 0.6 (n = 10), 1.2 (n = 12), 1.8 (n = 12), or 2.4 (n = 12) mg/kg 30 min before receiving emetogenic chemotherapy. Pharmacokinetic parameters were evaluated at each dose level and efficacy was evaluated over the first 24 hr following the administration of dolasetron. RESULTS: A complete response was achieved in 10% of patients given 0.6 mg/kg, 25% of patients given 1. 2 mg/kg, 67% of patients given 1.8 mg/kg, and 33% of patients given 2.4 mg/kg. Peak plasma concentrations (Cmax) were observed between 0. 33 and 0.75 hr following dolasetron infusion. Cmax and area under plasma concentration-time (AUC) increased with larger doses of dolasetron, while terminal disposition half-life (t1/2) and apparent clearance (Clapp) were not significantly changed with respect to dose. For 1.8-mg/kg dolasetron, the t1/2 was 4.98 hr and the maximum plasma concentration (tmax) 0.47 hr. Adverse events were mild to moderate. No serious events occurred. Conclusions. This study suggests that a single intravenous dose of 1.8 mg/kg is the optimum single intravenous dose for controlling chemotherapy-induced emesis in pediatric patients. Copyright 1999 Wiley-Liss, Inc.
机译：背景：恶心和呕吐是癌症治疗中最不愉快的不良副作用之一。程序：进行了开放标签的剂量递增研究，以评估接受化疗的儿科患者的多拉西酮的适当静脉剂量。患者在接受促生化学疗法前30分钟接受dolasetron的单次静脉注射剂量为0.6（n = 10），1.2（n = 12），1.8（n = 12）或2.4（n = 12）mg / kg。在服用dolasetron后的最初24小时内，在每个剂量水平评估药代动力学参数，并评估功效。结果：接受0.6 mg / kg的患者中有10％达到了完全缓解，接受1. 2 mg / kg的患者中有25％得到了完全缓解，接受1.8 mg / kg的患者中有67％接受了2.4 mg / kg的患者中的33％ 。在dolasetron输注后的0. 33至0.75小时之间观察到峰值血浆浓度（Cmax）。更大剂量的dolasetron可使Cmax和血浆浓缩时间下面积（AUC）增加，而剂量的终末处置半衰期（t1 / 2）和表观清除率（Clapp）则无明显变化。对于1.8 mg / kg dolasetron，t1 / 2为4.98小时，最大血浆浓度（tmax）为0.47小时。不良事件为轻度至中度。没有发生严重事件。结论这项研究表明，1.8 mg / kg的单次静脉注射剂量是控制小儿患者化疗引起的呕吐的最佳单次静脉注射剂量。版权所有1999 Wiley-Liss，Inc.

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