格拉司琼单药与联合用药预防含顺铂方案化疗所致呕吐的随机对照研究

Randomized,controled study of granisetron versus granisetron plus dexamethasone,metoclopramide and vitamin B6 for prevention of cisplatin-induced vomiting

目的:探讨格拉司琼单药与联合多药预防含顺铂方案化疗所致恶心呕吐的疗效和不良反应。方法:采用随机分组、交叉设计、自身对照的研究方法。联合用药组给予格拉司琼+地塞米松+胃复安+维生素B6,单药组仅给格拉司琼。对比第一、二周期化疗后两组急性和延迟性呕吐的完全缓解率、进食状况和不良反应。结果:共入组100例患者,其中1例自动退出,1例因顽固性呃逆退出,98例可评价疗效。联合组和单药组对急性呕吐的完全缓解率分别为73.5%(72/98)和61.2%(60/98)(P=0.009);对延迟性呕吐的完全缓解率分别为49.0%(48/98)和40.8%(40/98)(P=0.015);食欲下降的发生率分别为20.4%(20/98)和45.9%(45/98)(P=0.001)。两组头痛、便秘、胃部不适以及呃逆的发生率差别无统计学意义(均P>0.05),但联合用药组的兴奋失眠患者较单药组多(10例vs 1例)(P=0.005)。结论:格拉司琼联合地塞米松、胃复安、维生素B6对缓解顺铂等强致吐方案化疗的药物性呕吐效果更优,并能改善食欲,是一个安全、有效、经济的一线治疗方案。

Objective:To investigate the efficacy and safety of granisetron single drug group and combined group in prevention of nausea and vomiting induced by cisplatin.Methods:To use a randomized,self-crossover clinical study with combined group received granisetron plus dexamethasone,metoclopramide and vitamin B6 ,and single drug group received granisetron only.The efficacy was evaluated by prevention of vomiting in aperiod of 5 days after chemo-therapy.Safety was assessed according to National Cancer Institute Common Toxicity Criteria version 3.0(NCI-CTC 3.0).Results:One hundred patients were enrolled,98 cases were assessable for efficacy.The complete response rates for combined group and single drug group were 73.5%versus 61.2%respectively during the acute phases(P=0.009),49.0%versus 40.8%respectively during the delayed phases(P=0.015).The incidence of anorexia were 20.4%versus 45.9%respectively(P=0.001),the incidence of ahypnosis were 10.2% versus 1.0%(P=0.005). There were no significant differences in other adverse reactions.Conclusion:Granisetron combined with dexametha-sone,metoclopramide,vitamin B6 to prevent the vomiting induced by cisplatin was better,and could improve appetite, it was a safe,effective,economic treatment prescription.