恩丹西酮预防化疗所致呕吐Ⅲ期临床研究

A Phase Ⅲ Study of Ondansetron in the Prevention ofVomiting Induced by Chemotherapy

观察了经顺铂类和非顺铂类药物化疗的９５例患者应用恩丹西酮的止吐作用。顺铂组共６８例，顺铂４０ｍｇ／次×３天（２３例），５０ｍｇ／次×３天（２７例），８０ｍｇ／次×２天（１８例）；非顺铂组２７例，均系接受含环磷酰胺和／或阿霉素联合方案化疗用胃复安后出现呕吐患者，入组后接受同一方案治疗。结果显示，恩丹西酮对控制顺铂不同剂量组所致急性呕吐的ＣＲ率依次为８７．０％，８５．２％和６６．７％，总有效率分别为９１．３％，９６．３％和９４．４％；而对非顺铂组控制急性呕吐的ＣＲ率为８８．９％，有效率９６．３％。

The antiemetic effect of ondansetron was studied in 95 patients receiving chemotherapy. Among them,68 were treated with cisplatin,27 with non-cisplatin(CTX,ADM) There was no effect of metoclopramide in the first turn.In the cisplatin group, 23 cases were given the 40mg/day for 3 days, 27 cases 50mg/day for 3 days and 18 cases 80mg/day for 2 day. The results showed that the complete response rates of controlling acute emesis were 87.0%, 85.2% and 66.7%, and the effective rates were 91.3%,96.3% and 94.4% respectively in cisplatin group,but in non-cisplatin group,the CR rate was 88.9% and the effective rate was 96.3%. As mentioned above,the effect of ondansetron is very remarkble on the control of emesis induced by cisplatin and non-cisplatin drugs.