van Groeningen C J, Gall H E, Simons K A, van Loenen A C, Knobf M K, Nauta J, Vermorken J B, Pinedo H M
Neth J Med. 1989 Dec;35(5-6):283-94.
A randomized double-blind study was conducted to compare the anti-emetic efficacy of 1 mg/kg vs 2 mg/kg metoclopramide, administered 5 times over a period of 8.5 h in 50 cancer patients treated with platinum-containing regimens (cisplatin, ethylenediamine platinum II malonate or spiroplatin). Twenty-six patients were treated with combination chemotherapy, mainly consisting of cisplatin and 5-fluorouracil. No statistically significant differences were observed with respect to the protection against nausea and vomiting between the two dose levels of metoclopramide. However, in the group of patients who received a high dosage of cisplatin (70-100 mg/m2), or ethylenediamine platinum II malonate (800-900 mg/m2), there was a significant difference in nausea and vomiting between patients who had and those who had not received prior chemotherapy, most probably due to anticipation. No difference in the severity of the side effects was observed with the 2 metoclopramide dose levels. Considerable interpatient variation was present in serum metoclopramide levels. No clear correlation was observed between serum metoclopramide levels and prevention of platinum-induced emesis. We conclude that 1 mg/kg of metoclopramide is just as effective as 2 mg/kg as an anti-emetic agent in patients receiving platinum-based chemotherapy, and that metoclopramide serum levels are not related to the anti-emetic effect.
进行了一项随机双盲研究,比较1mg/kg与2mg/kg甲氧氯普胺的止吐效果,在50例接受含铂方案(顺铂、丙二酸乙二胺铂II或螺铂)治疗的癌症患者中,在8.5小时内分5次给药。26例患者接受联合化疗,主要由顺铂和5-氟尿嘧啶组成。在甲氧氯普胺的两个剂量水平之间,在预防恶心和呕吐方面未观察到统计学上的显著差异。然而,在接受高剂量顺铂(70-100mg/m²)或丙二酸乙二胺铂II(800-900mg/m²)的患者组中,接受过和未接受过先前化疗的患者在恶心和呕吐方面存在显著差异,很可能是由于预期所致。两种甲氧氯普胺剂量水平在副作用严重程度上未观察到差异。患者血清甲氧氯普胺水平存在相当大的个体差异。血清甲氧氯普胺水平与预防铂类药物引起的呕吐之间未观察到明显相关性。我们得出结论,在接受铂类化疗的患者中,1mg/kg甲氧氯普胺作为止吐剂与2mg/kg一样有效,并且甲氧氯普胺血清水平与止吐效果无关。