国产盐酸托烷司琼对控制顺铂引起的恶心呕吐的疗效评价

目的　比较国产盐酸托烷司琼和进口盐酸托烷司琼在控制由顺铂化疗所致食欲减退、恶心、呕吐反应的疗效和安全性。方法　采用随机、双盲对照方法对 48例接受含顺铂化疗的恶性肿瘤患者进行研究。于化疗前 1d开始给予国产盐酸托烷司琼或进口盐酸托烷司琼 ,1次 d ,5mg 次 ,连用 6d ,同时观察并记录患者食欲减退、恶心、呕吐反应及其他不良反应。结果　入选患者全部按试验要求完成现察 ,国产盐酸托烷司琼与进口盐酸托烷司琼在控制食欲减退、恶心、呕吐反应方面及发生其它不良反应方面均无显著性差异 (P >0 .0 5 )。结论　国产盐酸托烷司琼在控制含顺铂化疗所致食欲减退、恶心、呕吐反应的疗效和用药安全性与进口盐酸托烷司琼相当。

Evaluation of effects of domestic tropisetron hydrocloride on cisplatin-induced nausea and vomiting

Objective To compare the efficacy and reliability between domestic and imported tropisetron hydrocloride in prevention of chemotherapy-induced anorexia, nausea, and vomiting. Methods Randomized double-blind controlled clinical study was carried out. Forty-eight cancer patients receiving chemotherapy containing cisplatin were randomly divided into A (domestic tropisetron hydrocloride) and B (imported tropisetron hydrocloride) study groups. A preventive usage of tropisetron hydrocloride, 5 mg/d for 6 continuous days, was begun one day before chemotherapy and the adverse events such as anorexia, nausea and vomiting during therapy were observed. Results All patients completed the trail according to the observation protocol. There was no significant differences between the two groups in respect of controlling adverse events such as anorexia, nausea and vomiting (P>0.05). Conclusion There are similar efficacy and reliability between domestic and imported tropisetron hydrocloride in prevention of chemotherapy-induced adverse events such as anorexia, nausea, and vomiting.