国产盐酸托烷司琼注射液防治肿瘤化疗所致恶心与呕吐的Ⅱ期临床研究

A phase Ⅱ clinical trial on antiemetic efficacy of dometic triopisetron in chemotherapy for cancer

背景与目的:进口盐酸托烷司琼(商品名为欧必亭)可有效预防化疗所致的恶心和呕吐,但价格昂贵,限制临床广泛使用。本研究旨在研究国产盐酸托烷司琼防治肿瘤化疗所致恶心与呕吐的效果和不良反应。方法:应用随机、交叉对照的多中心研究方法,以进口盐酸托烷司琼为对照,比较新国产盐酸托烷司琼注射液防治顺铂或蒽环类药物所致恶心和呕吐的疗效和安全性。结果:新国产盐酸托烷司琼注射液和进口盐酸托烷司琼止吐有效率分别为88.68%和86.80%;不良反应发生率分别为20.4%和15.3%,差异均无显著性(P>0.05),两组药物均未出现死亡等严重不良事件,两药有效性和安全性在统计学上差异无显著性。结论:新的国产盐酸托烷司琼注射液是一种安全有效的止吐药物。

Background and purpose： Novaban （ imported tropisetron hydrochloricde, made by Novartis ） can effectively prevent chemotherapy-induced nausea and vomiting; however, it is too expensive to be widely used in the clinic. This study was designed to evaluate the antiemetic efficacy and safety of the new domestic triopisetron hydrochloricde. Methods： A randomized, self-crossover study was done on 120 patients with cancer who received cisplatin- or marcellomycin-based chemotherapy, in comparison with the efficacy and the toxicity of the new domestic triopisetron hydrochloride with Navoban. Results： The complete response rate of antiemetic effect was 88.68% in the study group and 86.80% in the Navoban arm. The incidences of adverse events in the two groups were 20.4% and 15.3%, respectively. It was shown that the domestic triopisetron hydrochloride and Novaban had similar antiemitic efficacy and side effects. There is no severe adverse event in either group. Conclusions： The new domestic triopisetron hydrochloride is an effective and safe antiemetic drug.