Stephens S H, Silvey V L, Wheeler R H
Department of Medicine, University of Alabama, Birmingham 35294.
Cancer. 1990 Aug 1;66(3):443-6. doi: 10.1002/1097-0142(19900801)66:3<443::aid-cncr2820660307>3.0.co;2-k.
Thirty-seven patients with advanced incurable malignancies who were receiving their first course of cisplatin (greater than or equal to 90 mg/m2 bolus), alone or in combination with other antineoplastic agents, were entered in this randomized, double-blind study to determine the antiemetic efficacy of the addition of high-dose dexamethasone to lorazepam plus metoclopramide. All patients received lorazepam (1.5 mg/m2) and metoclopramide (2.0 mg/kg) intravenously (IV) 30 minutes before cisplatin, with the same dose of metoclopramide repeated 1.5, 3.5, 6.5, and 9.5 hours after the 30-minute cisplatin infusion. Patients were randomized to receive dexamethasone (0.5 mg/kg) or placebo by slow bolus injection 30 minutes before cisplatin. All patients were hospitalized for 24 hours and evaluated by observation after cisplatin and a patient questionnaire before discharge. Eighteen patients received metoclopramide and lorazepam without dexamethasone: six (33%) reported no vomiting and four (22%) reported no nausea or vomiting. Nineteen patients also received dexamethasone: 14 (74%) had no vomiting and 13 (68%) reported no nausea or vomiting. These differences were statistically significantly different (P = 0.013 and 0.005, respectively). The side effects attributable to the antiemetic regimen were somnolence (100%), confusion (8%), and diarrhea (46%), and were the same in both arms. Dexamethasone significantly improved the antiemetic efficacy of metoclopramide plus lorazepam without adding toxicity. This three-drug combination gave a high rate of control of acute emesis induced by high-dose cisplatin.
37例晚期不可治愈恶性肿瘤患者正在接受其首个疗程的顺铂（≥90mg/m²推注）治疗，单独或与其他抗肿瘤药物联合使用，进入了这项随机、双盲研究，以确定在劳拉西泮加甲氧氯普胺的基础上加用高剂量地塞米松的止吐疗效。所有患者在顺铂给药前30分钟静脉注射（IV）劳拉西泮（1.5mg/m²）和甲氧氯普胺（2.0mg/kg），在30分钟顺铂输注后的1.5、3.5、6.5和9.5小时重复给予相同剂量的甲氧氯普胺。患者在顺铂给药前30分钟通过缓慢推注随机接受地塞米松（0.5mg/kg）或安慰剂。所有患者住院24小时，并在顺铂给药后通过观察以及出院前通过患者问卷进行评估。18例患者接受了不含地塞米松的甲氧氯普胺和劳拉西泮：6例（33%）报告无呕吐，4例（22%）报告无恶心或呕吐。19例患者还接受了地塞米松：14例（74%）无呕吐，13例（68%）报告无恶心或呕吐。这些差异具有统计学意义（分别为P = 0.013和0.005）。止吐方案所致的副作用为嗜睡（100%）、意识模糊（8%）和腹泻（46%），两组相同。地塞米松显著提高了甲氧氯普胺加劳拉西泮的止吐疗效，且未增加毒性。这种三联药物组合对高剂量顺铂所致急性呕吐的控制率很高。
