Suminaga M, Furue H, Taguchi T, Ota K, Niitani H, Tsukagoshi S, Ariyoshi Y, Ikeda M, Ohta J, Akasaka Y
Department of Internal Medicine IV, Teikyo University School of Medicine, Kawasaki, Japan.
Gan To Kagaku Ryoho. 1992 Aug;19(9):1333-45.
We examined anti-emetic effects, safety and the optimal dose of Ondansetron Injection given in a single intravenous dose in patients receiving a single high dose of cisplatin in randomized controlled comparative study using telephone registration. Ondansetron was injected intravenously in a single dose of 4 mg, 8 mg or 12 mg, at 15 minutes before administration of cisplatin. Nausea and emesis were observed for 24 hours after administration of cisplatin. Efficacy rate of inhibitory effects on nausea and emesis were 76% (19/25 cases) in the 4 mg dose group, 57% (12/21 cases) in the 8 mg dose group and 83% (20/24 cases) in the 12 mg dose group, without a statistically significant difference among 3 dose groups. Hence, it was estimated that the low dose of 4 mg was adequate to exert satisfactory anti-emetic effects. No clear relationship between onset time of the initial emetic episode and plasma concentrations of Ondansetron was found in 16 cases of the 4 mg dose group, 11 cases in the 8 mg dose group and 15 cases in the 12 mg dose group. Side effects observed during this study period were headache and diarrhea in 1 case in the 12 mg dose group. Both symptoms were mild and resolved without treatment. No abnormal findings attributable to Ondansetron were observed in clinical laboratory test. From the above, it was considered that Ondansetron given by a single intravenous injection was highly effective to inhibit nausea and emesis induced by cisplatin, and was highly safe. As to the dose, 4 mg once daily was considered to be adequate for prophylaxis of cisplatin-induced nausea and emesis.
在一项使用电话登记的随机对照比较研究中，我们研究了在接受单次高剂量顺铂治疗的患者中，单次静脉注射昂丹司琼注射液的止吐效果、安全性及最佳剂量。在顺铂给药前15分钟，将昂丹司琼以4毫克、8毫克或12毫克的单次剂量静脉注射。在顺铂给药后24小时观察恶心和呕吐情况。4毫克剂量组对恶心和呕吐的抑制有效率为76%（25例中的19例），8毫克剂量组为57%（21例中的12例），12毫克剂量组为83%（24例中的20例），3个剂量组之间无统计学显著差异。因此，估计4毫克的低剂量足以产生令人满意的止吐效果。在4毫克剂量组的16例、8毫克剂量组的11例和12毫克剂量组的15例中，未发现首次呕吐发作的起始时间与昂丹司琼血浆浓度之间有明确关系。在本研究期间，12毫克剂量组有1例出现头痛和腹泻的副作用。两种症状均较轻，未经治疗即缓解。临床实验室检查未观察到归因于昂丹司琼的异常发现。综上所述，单次静脉注射昂丹司琼对抑制顺铂引起的恶心和呕吐非常有效，且安全性高。关于剂量，每日一次4毫克被认为足以预防顺铂引起的恶心和呕吐。
