Akasaka Y, Taguchi T, Ota K, Furue H, Niitani H, Tsukagoshi S, Ariyoshi Y, Ikeda M, Ohta J, Suminaga M
Department of Urology, Jikei University School of Medicine, Tokyo, Japan.
Gan To Kagaku Ryoho. 1992 Aug;19(9):1359-74.
Anti-emetic effect, safety and clinical usefulness of Ondansetron injection given in the dose of 4 mg once daily by intravenous administration for 3-5 consecutive days were examined in patients receiving a high single dose (not less than 50 mg/m2 or over 75 mg/body) and lower multiple doses (over 15-20 mg/m2 once daily, for 3-5 consecutive days) of cisplatin. Efficacy rates of inhibitory effects on nausea and emesis in patients receiving the high single dose of cisplatin were 76% on the 1st day, 67% on the 2nd day and 78% on the 3rd day, the average being 71% (86/121 cases) for the 3 days. Those in patients receiving lower multiple doses of cisplatin were 83% on the 1st day, 78% on the 2nd day, 61% on the 3rd day, 65% on the 4th day and 57% on the 5th day, the average being 72% (13/18 cases) for the 3-5 days. Side effects were observed in 15 cases out of 207 (1st course, 182 cases; 2nd course, 21 cases; 3rd course, 4 cases), and major symptoms were headache and fever. Also, abnormalities in clinical laboratory findings attributable to Ondansetron were observed in 13 cases, mainly consisting of elevation of the hepatic function values. From the above, Ondansetron injection which showed sufficient anti-emetic effects on acute emesis and delayed emesis induced by a high single dose or lower multiple doses of cisplatin with its once daily intravenous dose given for 3-5 consecutive days, were considered a safe and clinically useful anti-emetic.
对接受高单次剂量（不少于50mg/m²或超过75mg/体）和顺铂低多次剂量（每日超过15 - 20mg/m²，连续3 - 5天）的患者，研究了昂丹司琼注射液每日静脉注射1次、每次4mg、连续3 - 5天给药的止吐效果、安全性及临床实用性。接受高单次剂量顺铂的患者，第1天对恶心和呕吐的抑制有效率为76%，第2天为67%，第3天为78%，3天的平均有效率为71%（121例中的86例）。接受低多次剂量顺铂的患者，第1天为83%，第2天为78%，第3天为61%，第4天为65%，第5天为57%，3 - 5天的平均有效率为72%（18例中的13例）。207例患者中有15例出现副作用（第1疗程182例；第2疗程21例；第3疗程4例），主要症状为头痛和发热。此外，有13例观察到与昂丹司琼有关的临床实验室检查异常，主要为肝功能值升高。综上所述，昂丹司琼注射液对高单次剂量或低多次剂量顺铂引起的急性呕吐和迟发性呕吐显示出足够的止吐效果，每日静脉给药1次、连续3 - 5天，被认为是一种安全且临床有用的止吐药。
