甲磺酸托烷司琼预防化疗药物引起恶心、呕吐的Ⅱ期临床研究

Stage II clinical study of Tropisetron Mesylate on the prevention of nausea and vomit induced by chemotherapeutic drug

目的 观察甲磺酸托烷司琼 (Trop)对顺铂引起的恶心、呕吐、食欲不振的疗效和安全性。方法 应用随机、自身交叉对照方法将恶性肿瘤患者随机分为 2组 ,治疗组采用Trop(第 1周期 )→胃复安 (第 2周期 )止吐方法 ,对照组采用胃复安 (第 1周期 )→Trop(第 2周期 )止吐方法。观察 2组恶心、呕吐、食欲不振改善情况及药物不良反应。结果 化疗第 1天 ,治疗组对化疗药物引起的呕吐完全控制率明显优于对照组 (P <0 .0 1) ,对恶心、食欲不振的有效控制率略高于对照组 (P >0 .0 5 ) ;化疗第 2～ 6d治疗组疗效稍优于对照组 ,但无显著性差异 (P >0 0 5 ) ,Trop的主要不良反应有头痛、头晕、口干、便秘、疲倦、嗜睡及失眠 ,均较轻微。结论 Trop在控制强致吐化疗药物引起的急性呕吐方面疗效较好 ,不良反应少。

Objective It is to observe the curative effect and safety of Tropisetron Mesylate (Trop) on nausea, vomit and inappetence induced by cisplatin.Methods 32 patients with malignant tumor were randomly and self-cross comparatively divided into treatment group which was treated with Trop (first cycle) and metoclopramide (second cycle) and control group which was treated with metoclopramide (first cycle) and Trop (second cycle). Then the improving of nausea, vomit and inappetence in the two groups and the side-effect of the drugs were observed.Results At the first day of chemotherapy, the completely controlling rate of vomit induced by chemotherapeutic drug in treatment group was obviously higher than that in control group (P<0.01) and the effective controlling rates of nausea and inappetence were appreciably higher than that in control group (P>0.05). The curative effect in treatment group was a little better than that in control group at the second to sixth day of chemotherapy, but there was no significant difference (P>0.05). The major side-effect of Trop such as headache, dizziness, dry mouth, constipation, fatigue, hypersomnia and insomnia were all slight.Conclusion Trop has a good curative effect and little side-effect on acute vomit induced by chemotherapy.