国产盐酸托烷司琼治疗顺铂化疗所致恶心、呕吐的疗效与安全性评价

目的:比较国产与进口盐酸托烷司琼在治疗顺铂化疗所致恶心、呕吐的疗效和安全性。方法:采用多中心、双盲、随机对照方法,128例接受顺铂化疗的恶性肿瘤患者随机分为进口盐酸托烷司琼组和国产盐酸托烷司琼组,于化疗前1d应用盐酸托烷司琼,5mg/次,1次/d,连用6d,观察并记录用药1wk内患者食欲减退、恶心、呕吐及其他不良反应。结果:128例患者按研究要求完成观察,2组在治疗恶心、呕吐方面及发生其他不良反应方面均无显著性差异(P>0.05)。结论:国产盐酸托烷司琼在治疗顺铂化疗所致恶心、呕吐的疗效和安全性与进口盐酸托烷司琼相当。

Evaluation on the Curative Effects and Safety of the Domestic Tropisetron Hydrochloride on Cisplatin induced Nausea and Vomiting

OBJECTIVE:To compare the efficacy and safety of the domestic and the imported tropisetron hydrochloride in the treatment of cisplatin-induced nausea and vomiting.METHODS:Multicenter double-blind randomized controlled cliniˉcal study was carried out,in which128malignant tumor cases receiving cisplatin chemotherapy were randomly divided into imported tropisetron hydrochloride group and domestic tropisetron hydrochloride group,which were administered with tropisetron hydrochloride1day before chemotherapy,5mg/time,q.d×6d.The adverse reactions such as decreased food appetite,nausea and vomiting were observed and recorded within one week of medication.RESULTS:The128cases finished their observation according to the requirements.There were no remarkable differences between2groups in respect of nausea and vomiting and the other adverse drug reactions(P>0.05).CONCLUSION:The domestic tropisetron hydrochloride is equivalent to the imported one in terms of the efficacy and safety in the treatment of cisplatin-induced nausea and vomiting.