甲磺酸托烷司琼预防化疗药物引起的恶心呕吐（Ⅱ期临床试验报告）

目的：观察甲磺酸托烷司琼（Trop)对顺铂或阿霉素引起的胃肠道反应的止吐作用和安全性。方法：应用随机、自身交叉对照试验，40例恶性肿瘤患者随机分为AB级（20例）和BA组（20例），AB组Trop（第1周期）→胃复安（第2周期），BA组胃复安（第1周期）→Trop（第2周期）。结果：化疗d1,Trop对化疗药物引起食欲不振及呕吐的有效控制率明显优于胃复安（P＜0．01）化疗d1-d3,Trop对化疗药物引起恶心的有效控制率略高于胃复安（P＞0．05），Trop的主要不良反应有头痛，头晕，便秘、口于、疲倦、喷睡及失眠。结论：Trop在控制强致吐化疗药物的急性呕吐及改善食欲不振方面疗效好，不良反应少。

The efficacy oftropisetron mesylate in prevention of nausea and vomiting induced by chemotherapy (phase

Objective:To observe the efficacy and safety of tropiset ron mesylate(Trop) in prevention of nausea and vomiting induced by cisplatin and adriamycin.Methods:Patients were assigned randomly to receive metoclo pramide or Trop in the first cycle of chemotherapy and then changed to the other in the second cycle of chemotherapy.Results:The efficacy of Trop was significantly superior to that of metoclopramide at the first day of chemotherap y (P<0.01) and slightly superior to metoclopramide at 1～3 day of chemother apy (P>0.05).The main side effects of Trop were headache,dizziness,constipat ion,dry mouth,fatigue/hypersomnia and insomnia.Conclusion:Trop is an e ffective agent for control of acute vomiting and inappetence induced by chemothe rapy.