Department of Clinical Pharmacology & Genetics, School of Pharmaceutical Sciences, University of Shizuoka, Suruga-ku, Shizuoka, Japan.
Support Care Cancer. 2012 May;20(5):1057-64. doi: 10.1007/s00520-011-1185-x. Epub 2011 May 18.
A single 3 mg or 40 μg/kg intravenous dose of granisetron combined with dexamethasone is routinely used in several countries, although the antiemetic guidelines have recommended granisetron at the dose of 1 mg or 10 μg/kg. A randomized, multicenter trial was conducted to determine the optimal intravenous granisetron dose, 1 or 3 mg, in cancer patients receiving emetogenic chemotherapy.
We enrolled 365 patients and randomly assigned them to receive intravenous granisetron 3 mg (3-mg group) or 1 mg (1-mg group), combined with dexamethasone at an adequate dose fixed as per the emetic risk category. The primary end point was the proportion of patients with a complete response during the first 24 h after chemotherapy.
The study demonstrated that 1 mg of granisetron was not inferior in effect to 3 mg. For the primary end point, 359 patients were evaluable according to the modified intention-to-treat (ITT) analysis. Complete protection was achieved in the modified ITT population, 90.6% and 88.8% for the 3- and 1-mg groups, respectively (p < 0.01 for non-inferiority).
This study showed that 1 mg granisetron is not inferior to 3 mg when both doses are combined with dexamethasone. Therefore, 1-mg dose of intravenous granisetron should be the recommended prophylactic regimen for the prevention of acute emesis.
在一些国家，常将单剂量 3 毫克或 40 微克/千克的格拉司琼与地塞米松联合使用，尽管止吐指南推荐格拉司琼的剂量为 1 毫克或 10 微克/千克。一项随机、多中心试验旨在确定癌症患者接受致吐性化疗时，静脉给予格拉司琼的最佳剂量，即 1 毫克或 3 毫克。
我们纳入了 365 例患者，并将其随机分为静脉给予格拉司琼 3 毫克（3 毫克组）或 1 毫克（1 毫克组），两组均联合地塞米松，剂量根据致吐风险类别进行适当调整。主要终点是化疗后 24 小时内完全缓解的患者比例。
研究表明，1 毫克格拉司琼的疗效不劣于 3 毫克。对于主要终点，根据改良意向治疗（ITT）分析，359 例患者可评估。改良 ITT 人群中完全保护率分别为 90.6%和 88.8%（3 毫克组和 1 毫克组，p<0.01 为非劣效性）。
本研究表明，当格拉司琼联合地塞米松时，1 毫克剂量与 3 毫克剂量疗效相当。因此，1 毫克剂量的格拉司琼静脉注射应作为预防急性呕吐的推荐方案。
