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)

The efficacy of tropisetron mesylate in prevention of nausea and vomiting induced by chemotherapy (phase Ⅱ report)

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组 (2 0例 )和BA组 (2 0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 .0 1) ,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 .0 5 ) ,Trop的主要不良反应有头痛、头晕、便秘、口干、疲倦、嗜睡及失眠。 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。

Objective:To observe the efficacy and safety of tropisetron mesylate(Trop) in prevention of nausea and vomiting induced by cisplatin and adriamycin.Methods:Patients were assigned randomly to receive metoclopramide 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 chemotherapy ( P <0.01) and slightly superior to metoclopramide at 1～3 day of chemotherapy ( P >0.05).The main side effects of Trop were headache,dizziness,constipation,dry mouth,fatigue/hypersomnia and insomnia.Conclusion:Trop is an effective agent for control of acute vomiting and inappetence induced by chemotherapy. [