神经激肽-1受体抑制剂预防化疗分次给药所致恶心呕吐的临床观察

Clinical Observation of Neurokinin-1 Antagonist Preventing Multiple-day Chemotherapy-induced Nausea and Vomiting

目的比较神经激肽-1受体抑制剂阿瑞匹坦三联方案与传统两联方案预防中高度催吐化疗方案分次给药所致恶心呕吐的疗效和安全性。方法对102例化疗患者前瞻性对照研究的数据进行中期分析,其中49例患者接受5-羟色胺-3受体抑制剂联合和托烷司琼两联止吐方案,53例患者接受神经激肽-1受体抑制剂阿瑞匹坦联合5-羟色胺-3受体抑制剂和托烷司琼的三联止吐方案;采用KaplanMeier曲线比较两组第一次呕吐发生时间,FLIE量表评价恶心呕吐生活质量;评价阿瑞匹坦的相关不良反应。结果 (1)主要终点指标三联方案CR率优于两联方案(P<0.05)。次要指标AP和DP的CR率比较,差异均有统计学意义(均P<0.05);(2)三联方案较两联方案的第一次呕吐发生时间晚(P<0.05);每例FLIE量表大于108分表示对生活质量无影响,两组差异有统计学意义(P<0.05)。(3)阿瑞匹坦的相关不良反应主要为上腹胀痛或便秘。结论三联止吐方案在中高度催吐性化疗方案分次用药所致恶心呕吐防治中疗效较好,安全可耐受。

Objective To compare the effect and safety of 5-HT3 and tropisetron combined with neurokinin-1 antagonist aprepitant or not for the prevention of highly and moderately emetogenic multiple-day chemotherapy- induced nausea and vomiting（CINV）. Methods There were 53 patients received 5-HT3 and tropisetron combined with aprepitant（aprepitant group） and 49 patients received 5-HT3 and tropisetron（standard group）. The primary end-points of the study were the CR in the overall phase（OP）（0-120h） between aprepitant group and standard group. The first time of vomiting between two groups was compared by Kaplan-Meier curves. The impact of CINV on the quality of life was assessed by the Functional Living Index-Emesis（FLIE）. Aprepitant-related side-effect was also recorded. Results （1） The primary end-points CR during overall phase were 83.0% vs. 53.1% between the aprepitant group and standard group（P〈0.05）. The secondary endpoints CR during acute phase and delay phase were 94.3% vs. 75.5%, 84.9% vs. 49.0% between two groups respectively（P〈0.05）. （2） It was observed longer time to first emesis in the aprepitant group than standard group from Kaplan-Meier curves. The score≥ 108 which meant no effect on quality of life assessed by FLIE were 48.0% and 20.8% between two groups（P〈0.05）. （3） The main aprepitant-related side-effects were upper abdominal pain and constipation. Conclusion It should been recommended that 5-HT3 and tropisetron combined neurokinin-1 antagonist aprepitant for the prevention of highly and moderately emetogenic multiple- day chemotherapy-induced nausea and vomiting have better effect and safety than only 5-HT3 and tropisetron.