欧必亭与康泉预防化疗引起恶心呕吐的临床对比试验

Clinical Randomized Cross-Over Trial on Tropisetron in Prevention of Nausea and Vomiting Induced by Anti-Cancer Drugs

目的：比较欧必亭（Ｔｒｏｐｉｓｅｔｒｏｎ）和康泉（Ｋｙｔｒｉｌ）预防化疗所致恶心呕吐的疗效和不良反应。方法：采用随机自身对照方法，将３４例接受联合化疗（１９例含顺铂）的患者随机分为 Ａ、Ｂ两组，均接受２个周期相同方案的化疗。Ａ组第１周期用欧必亭，第２周期用康泉止吐；Ｂ组第１周期用康泉，第二周期用欧必亭止吐。结果：欧必亭和康泉第１天止吐的有效率分别为９４．１％和９７．１％，中位呕吐次数分别为４．５次和３次，经统计学处理两组差异无显著性。对迟发性呕吐和副作用也进行了对比，欧必亭和康泉也无明显差别。结论：欧必亭是一种预防化疗所致恶心呕吐的有效药物，它的不良反应很轻。

Objective: To study the efficacy and adverse effects of Tropisetron in prevention of nausea and vomiting induced by anti-cancer drugs. Methods: Thirty-four patients (among them, 19 patients received cisplatin containing regimens) were randomly divided into two groups (groupA and group B). All these two groups received two cycles of same chemotherapy regimen. Either Tropisetron or Kytril was given alternatively to these two groups in the first and second cycle. Results: The effective rates of the Tropisetron group and Kytril group on the first day were 97.l% and 94.1% respectively, and the median number of emesis were 4.5 and 3 times in these two groups respectively with no statistic difference. Control of delayed emesis and other adverse reactions were compareble in both arms and there was no notable difference between the Tropisetron group and Kytril group. Conclusion: Tropisetron is an active anti-emetic drug in prevention of nausea and vomiting induced by anti-tumor agents and its adverse reactions are mild.