Hirota T, Shimizu H, Fujimoto T, Koike A, Kojima T, Noguchi M, Yabushita H, Kato R, Daimaru O, Noda A
Dept. of Pediatrics, Aichi Medical University.
Gan To Kagaku Ryoho. 1994 Jan;21(1):91-6.
Preclinical and clinical studies have demonstrated the effectiveness of granisetron in preventing emesis induced by antineoplastic chemotherapy. This comparative study was undertaken to investigate the efficacy and safety of granisetron (40 micrograms/kg) and granisetron plus methylprednisolone (MPL; 10 mg/kg). Sixty-eight patients were given granisetron 170 times and thirty-nine patients were given a combination of granisetron and MPL 81 times. Sixty-one patients received the treatment in crossover fashion during the same chemotherapy regimens. The emetic and nausea episodes were counted during the 24 hours following each chemotherapy treatment. Complete response, no emesis or less than two episodes, were obtained in 75.3% (128/170 times) of patients receiving granisetron alone compared to 85.2% (69/81 times) of patients receiving the combination of granisetron plus MPL. There were no significant differences in complete responses between the two groups, male and female, and each age group. However, 11 of eighteen patients receiving granisetron alone who responded mildly, if at all, with respect to nausea and vomiting, showed a complete or major response when MPL was added to granisetron. There were two patients who developed temporal paresthesia of the both hands as an adverse effect, but there was spontaneous recovery after 3 hours. Our data suggested that granisetron plus MPL was slightly more effective than granisetron alone and a safe antiemetic drug.
临床前和临床研究已证明格拉司琼在预防抗肿瘤化疗引起的呕吐方面的有效性。进行这项比较研究以调查格拉司琼（40微克/千克）和格拉司琼加甲泼尼龙（MPL；10毫克/千克）的疗效和安全性。68例患者接受格拉司琼治疗170次，39例患者接受格拉司琼与MPL联合治疗81次。61例患者在相同化疗方案期间以交叉方式接受治疗。在每次化疗治疗后的24小时内统计呕吐和恶心发作次数。单独接受格拉司琼治疗的患者中，75.3%（128/170次）获得完全缓解，即无呕吐或少于两次发作，而接受格拉司琼加MPL联合治疗的患者中这一比例为85.2%（69/81次）。两组之间、男性和女性以及各年龄组的完全缓解率无显著差异。然而，单独接受格拉司琼治疗的18例患者中，有11例在恶心和呕吐方面反应轻微（若有反应的话），在格拉司琼中加入MPL后显示出完全或主要缓解。有2例患者出现双手暂时性感觉异常作为不良反应，但3小时后自行恢复。我们的数据表明，格拉司琼加MPL比单独使用格拉司琼略有效，且是一种安全的止吐药物。
