国产盐酸托烷司琼与欧必亭防治化疗所致恶心、呕吐的比较研究

Comparative study between China-made tropisetron hydrochloride and Navoban in the prevention of chemotherapy- induced nausea and emesis

目的观察国产盐酸托烷司琼防治化疗所致的恶心、呕吐的疗效及其不良反应。方法采用随机对照方法,将49例肿瘤患者随机分为A(n=25)、B(n=24)2组,在使用顺铂(DDP)或阿霉素(ADM)化疗前,A组给予5mg国产盐酸托烷司琼缓慢静脉推注,B组给予5mg进口盐酸托烷司琼(欧必亭),2组用法相同。在化疗后7d内观察化疗所致胃肠道反应和止呕药的不良反应。结果A组急性恶心的完全控制率为48.0%,B组为47.8%(P>0.05);A组急性呕吐的完全控制率为80.0%,B组为65.2%(P>0.05)。A组和B组延迟性恶心和呕吐反应无显著差异(P>0.05)。2组患者对不同止吐方案耐受性良好,不良反应发生率无差别(P>0.05)。结论国产盐酸托烷司琼用于防治化疗所致恶心、呕吐安全有效。

Objective：To evaluate the efficacy and side effects of tropisetron hydrochloride （China-made） for the prophylaxis of chemotherapy-induced nausea and emesis. Methods：A randomized trial was carried out. Forty-nine patiefits were randomized into two groups （A, B） and received 5 mg of China-made tropisetron hydrochloride （group A） or Navoban （group B） intravenously before cis-diamine-dichloride-platinum- or adriamycin-based chemotherapy. Gastrointestinal reactions induced by chemotherapy and side effects of the anti-emetics were recorded within 7 d after chemotherapy. Results： Acute nausea was prevented completely in 48.0% of the patients in group A and in 47.8% in group B （P〈0.05）. Complete control rate of acute emesis was achieved in 80.0% of patients in group A and 65.2% in group B （ P 〉0.05）. With regard to delayed nausea and emesis, there was no significant difference between group A and group B （ P 〉0.05）. Both anti-emetic regiments were well tolerated and no difference in adverse events between the two groups was observed （ P 〉0.05）. Conclusion： China-made tropisetron hydrochloride is effective and safe in the prevention of chemotherapy-induced nausea and emesis.