国产和进口盐酸托烷司琼防治化疗所致恶心、呕吐的随机对照临床研究

Preventive Efficacies of China-made Tropisetron Hydrochloride and Navoban on Chemotherapy-induced Nausea and Vomiting: a Randomized Controlled Clinical Trial

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。本研究旨在比较国产盐酸托烷司琼和欧必亭的止吐效果和不良反应。方法:采用多中心、随机对照试验,将132例入组肿瘤患者随机分为两组,在用含顺铂或阿霉素方案化疗前,A组给予5mg国产盐酸托烷司琼,B组给予5mg欧必亭。在化疗后7天内观察两组止吐药预防化疗所致胃肠道反应的效果及不良反应。结果:A组急性恶心的完全控制率为48.5%,B组为43.8%;A组急性呕吐的完全控制率为69.7%,B组为67.2%,A组和B组急性恶心和呕吐的完全控制率均无显著性差异(P>0.05)。A组延迟性恶心的完全控制率为25.8%,B组为28.1%;A组延迟性呕吐的完全控制率为47.0%,B组为51.6%,A组和B组延迟性恶心和呕吐的完全控制率均无显著性差异(P>0.05)。两组止吐方案患者耐受性良好,不良反应的种类及发生率两组间无显著性差异(P>0.05)。结论:国产盐酸托烷司琼预防化疗所致恶心呕吐的效果及不良反应与欧必亭相近。

BACKGROUND ＆ OBJECTIVE. Navoban （import tropisetron hydrochloride） can effectively prevent chemotherapy-induced nausea and vomiting; however, it is too expensive to be used extensively in clinic. This study was designed to compare the antiemetic efficacies and side effects of China-made tropisetron hydrochloride with Navoban. METHODS, A multicenter and randomized controlled trial was carried out. A total of 132 cancer patients were randomized into 2 groups and received 5 mg of China-made tropisetron hydrochloride （group A, 66 patients） or Navoban （group B, 66 patients） intravenously before cisplatin- or adriamycin-based chemotherapy. The gastrointestinal reactions induced by chemotherapy and side effects of the antiemetics were recorded within 7 days after chemotherapy. RESULTS; Acute nausea was prevented completely in 48.5% of the patients in group A and in 43.8% of group B; acute vomiting was prevented completely in 69.7% of the patients in group A and in 67.2% of group B. Delayed nausea was prevented completely in 25.8% of the patients in group A and in 28.1% of group B; delayed vomiting was prevent edcompletely in 47.0% of the patients in group A and in 51.6% of group B. No significant differences in complete control of nausea and vomiting showed between group A and group B （P〉 0.05）. Both antiemetic regimens were well tolerated, and no difference in adverse events between the 2 groups was observed （ P 〉 0.05）. CONCLUSION. China-made tropisetron hydrochloride is as effective as Navoban in the prevention of chemotherapy-induced nausea and vomiting, and only causes mild, infrequent side effects.