Anthony L B, Krozely M G, Woodward N J, Hainsworth J D, Hande K R, Brenner D E, Greco F A, Burish T G
J Clin Oncol. 1986 Jan;4(1):98-103. doi: 10.1200/JCO.1986.4.1.98.
In a study of the antiemetic effectiveness of high-dose oral metoclopramide, 66 previously untreated patients receiving 60 mg/m2 cisplatin were entered into a double-blind randomized trial. Patients were stratified according to age and tumor type, then randomized to receive either oral or intravenous (IV) high-dose metoclopramide. Patients were evaluated for antiemetic protection, toxicity, affect (anxiety, hostility, and depression), and autonomic arousal (pulse rate and blood pressure) at three-hour intervals on the day of their chemotherapy. Metoclopramide serum levels were measured by high-performance liquid chromatography. Results indicated no significant differences between the oral and IV groups on any measurement of antiemetic protection, affect, or autonomic arousal. There were also no significant differences in side effects except for frequency of stools; patients who received oral metoclopramide had significantly more stools than patients who received IV metoclopramide. The mean (+/- SD) serum metoclopramide level at four hours achieved orally was 1,171 +/- 660 ng/mL; the mean (+/- SD) level achieved IV was 1,030 +/- 392 ng/mL (P = .498). We conclude that high-dose oral and IV regimens of metoclopramide as administered in this study have equivalent antiemetic efficacy in previously untreated patients receiving 60 mg/m2 cisplatin.
在一项关于大剂量口服甲氧氯普胺止吐效果的研究中，66名先前未接受过治疗且接受60mg/m²顺铂治疗的患者进入了一项双盲随机试验。患者根据年龄和肿瘤类型进行分层，然后随机接受口服或静脉注射（IV）大剂量甲氧氯普胺。在化疗当天，每隔三小时对患者的止吐保护作用、毒性、情绪（焦虑、敌意和抑郁）以及自主神经兴奋（心率和血压）进行评估。通过高效液相色谱法测量甲氧氯普胺的血清水平。结果表明，口服组和静脉注射组在任何止吐保护、情绪或自主神经兴奋的测量指标上均无显著差异。除了大便频率外，副作用也没有显著差异；接受口服甲氧氯普胺的患者大便次数明显多于接受静脉注射甲氧氯普胺的患者。口服后四小时的甲氧氯普胺平均（±标准差）血清水平为1171±660ng/mL；静脉注射后的平均（±标准差）水平为1030±392ng/mL（P = 0.498）。我们得出结论，在本研究中给予的大剂量口服和静脉注射甲氧氯普胺方案，对于先前未接受过治疗且接受60mg/m²顺铂治疗的患者具有同等的止吐疗效。
