国产盐酸托烷司琼防治NP方案化疗引起的胃肠道反应临床观察

A randomized,double blind,crossover clinical study of tropisetron hydrochloride injection for the prevention of nausea and vomiting induced by NVB+PDD

目的:观察盐酸托烷司琼注射液防治长春瑞宾+顺铂方案(NP方案)治疗非小细胞肺癌(NSCLC)引起胃肠道反应的止吐作用和安全性,并与进口盐酸托烷司琼(欧必亭)对比.方法:采用随机、双盲、自身交叉对照试验,可评价的18例NSCLC患者随机分为AB组和BA组,AB组第l周期用试验药盐酸托烷司琼,第2周期用对照药欧必亭;BA组第l周期用欧必亭,第2周期用盐酸托烷司琼.21d为1个周期.结果:化疗d1～d6,对食欲不振的完全控制率试验药分别为83.3%,55.6%,22.2%,11.1%,16.7%,38.9%,对照药分别为77.8%,44.4%,27.8%,16.7%,22.2%,50.0%;对恶心的完全控制率试验药分别为83.3%,55.6%,27.8%,11.1%,22.2%,33.3%,对照药分别为77.8%,38.9%,22.2%,11.1%,16.7%,44.4%;对呕吐的完全控制率试验药分别为88.9%,72.2%,61.1%,55.6%,55.6%,72.2%,对照药分别为100.0%,61.1%,38.9%,44.4%,72.2%,83.3%.两者比较差异均无显著性(所有P值均＞0.05).两组不良反应发生率无统计学差异(P＞0.05).结论:盐酸托烷司琼在控制NP方案化疗药物引起的急性呕吐、恶心及食欲不振方面与进口药欧必亭的疗效和不良反应相似.

Objective： To study the efficacy and safety of tropisetron hydrochloride injection （THI） versus navoban in prevention of nausea and vomiting induced by PDD and NVB. Methods： A randomized, double blind, crossover clinical study recruited 18 patients with non-small cell lung cancer （NSCLC） and receiving the treatment with NVB and PDD, who were randomized to assigned to one of treatment groups： AB group administered with tropisetron in the 1 st cycle of therapy for one week and subsequently with navoban in the 2nd cycle of therapy for 1 week or BA group administered with navoban in the 1st cycle of therapy for one week and subsequently with tropisetron in the 2nd cycle of therapy for one week. Each cycle of therapy was for 21 days. Results： On the day 1 to day 6 of the therapy, the complete control rate of anorexia in THI and navoban group was 83.3% vs. 77.8%, 55.6% vs. 44.4%, 22.2% vs. 27.8%, 11.1% vs. 16.7%, 16.7% vs. 22.2% and 38.9% vs. 50.0%, respectively; the complete control rate of nausea was 83.3% vs. 77.8%, 55.6% vs. 38.9%, 27.8% vs. 22.2%, 11.1% vs. 11.1%, 22.2% vs. 16.7% and 33.3% vs, 44.4%, respectively; the complete control rate of vomiting was 88.9% vs. 100.0%, 72.2% vs. 61.1%, 61.1% vs. 38.9%, 55.6% vs. 44.4%, 55.6% vs. 72.2% and 72.2% vs. 83.3%, respectively ; the P value of these rates showed no statistical difference （ P 〉 0.05）. The incidence of adverse events showed no significant difference between the two groups （P 〉 0.05 ）. Conclusion： Tropisetron hydrochloride injection offers an alternative therapeutic option in the prevention of nausea and vomiting induced by PDD and NVB for patients with NSCLC.