四类新药盐酸格拉司琼注射液预防抗肿瘤药物所致呕吐的Ⅱ期临床观察

Summary of a phase Ⅱ clinical research of Granisetron Hydrochloride on preventing vomiting caused by chemotherapy drugs

目的 在肿瘤的治疗中化疗药物所引起的恶心、呕吐是极为常见的 ,通过对盐酸格拉司琼注射液预防肿瘤化疗所致呕吐的Ⅱ期临床研究 ,探讨该药的止吐疗效及毒性反应。方法 对 3 1例病人的观察 ,采用自身对照新药盐酸格拉司琼与恩丹西酮预防抗肿瘤药物 (DDP及蒽环类药物 )所致呕吐进行比较。结果 格拉司琼对强致吐剂顺铂所引起的呕吐其总的缓解率 >90 % ,恩丹西酮对顺铂引起的呕吐其缓解率 >85 %。两止吐药毒性反应主要为便秘 ,恩丹西酮致便秘发生率高达 41% ,而格拉司琼所致便秘发生率为 16%。结论 两药预防呕吐的疗效相当 。

Objective To assess the value of Granisetron Hydrochloride on the prevention of vomiting and investigate the toxicity reaction there of .Methods The study was conducted with a cross-over design.The effects of Ganisetron Hydrochloride and Ondansetron on preventing vomiting in 31 cases were compared.Results The total efficacy rate of Granisetron for alleviating DDP induced vomiting was over 90% and that of Ondansetron for alleviating DDP-induced vomiting was over 85%.The main adverse side-effect of the two medicines is astriction.The rate of astriction caused by Ondansetron reached 41%,whereas that caused by Granisetron was 16%.Conclusion The effect of preventing vomit of the two medicine is equivalent.but the side effect of Granisetron is lower than Ondansetron.