盐酸托烷司琼防治NP方案治疗非小细胞肺癌引起恶心呕吐的临床试验研究

A clinical study of tropisetron hydrochloride injection in the prevention of nausea and vomiting induced by NVB+PDD in the treament of NSCLC

目的观察盐酸托烷司琼注射液(THI)防治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,并与欧必亭相比较。方法应用多中心、随机、双盲、自身交叉对照试验,将110例NSCLC患者随机分为AB组和BA组,AB组盐酸托烷司琼(第一周期)→欧必亭(第二周期),BA组欧必亭(第一周期)→盐酸托烷司琼(第二周期)。结果109例患者可评价不良反应,100例患者可评价疗效,化疗d1～6,盐酸托烷司琼对化疗药物引起食欲不振的完全控制率分别为74.0%、55.0%、34.0%、25.0%、31.0%和56.0%;欧必亭分别为77.0%、56.0%、40.0%、26.0%、37.0%和56.0%;盐酸托烷司琼对恶心的完全控制率分别为73.0%、45.0%、28.0%、17.0%、25.0%和47.0%;欧必亭分别为70.0%、47.0%、25.0%、16.0%、25.0%和49.0%;盐酸托烷司琼对化疗药物引起呕吐的完全控制率分别为94.0%、72.0%、58.0%、51.0%、66.0%和88.0%;欧必亭分别为87.0%、75.0%、55.0%、53.0%、67.0%和80.0%(P>0.05)。两药的不良反应发生率相似,差异无显著性(P>0.05)。结论盐酸托烷司琼在控制强致吐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无明显差别,主要不良反应的发生率相似。

Objective To study the efficacy and safety of tropisetron hydrochloride injection(THI) in prevention of PDD and NVB induced nausea and vomiting in comparison with Navoban in the treatment of NSCLC.Methods In a multicenter randomised double blind crossover study comparing THI and Navoban, 110 patients were enrolled.THI or Navoban was administered before the first cycle of chemotherapy, and changed to the other antiemetic agent in the second cycle of the same chemotherapy.Results 109 patients were evaluated for adverse effects and 100 were evaluated for response.The complete control of anorexia by THI was 74.0%,55.0%, 34.0% ,25.0%,31.0% and 56.0% respectively during d1 6,while that by Navoban was 77.0%,56.0%, 40.0% ,26.0%,37.0% and 56.0% respectively;the complete control of nausea by THI was 73.0%,45.0%,28.0%,17.0%,25.0% and 47.0% respectively while that by Navoban was 70.0%,47.0%,25.0%,16.0%,25.0% and 49.0% respectively;the complete control of vomiting by THI was 94.0%,72.0%,58.0%,51.0%,66.0% and 88.0% respectively,while that by Navoban was 87.0%,75.0%,55.0%,53.0%,67.0% and 80.0% respectively.The complete control of anorexia,nausea and vomiting showed no significant difference between THI and Navoban, P >0.05.The most frequent adverse events were similar,and had no significant difference between the two antiemetic agents( P >0.05).Conclusion Tropisetron hydrochloride injection was similar to Navoban for the prevention of PDD and NVB induced nausea and vomiting in the treatment of NSCLC. It was safe and effective in control of anorexia nausea and vomiting induced by highly emetogenic drugs.Its adverse effects were mild and could be well tolerated.