阿瑞匹坦联合地塞米松及昂丹司琼预防妇科肿瘤患者顺铂化疗引起的恶心呕吐的效果观察

A Combination of Aprepitant,Ondansetron and Dexamethasone Prevents Emesis Asociated with Cisplatin-containing Chemotherapy for Patients with Gynecological Cancer

目的:通过前瞻性观察评价阿瑞匹坦联合地塞米松及昂丹司琼预防妇科肿瘤患者接受含顺铂化疗引起的恶心呕吐(CINV)的效果。方法:采用前瞻性研究方法选择2013年12月1日至2014年9月30日收治的妇科肿瘤患者70例,均接受含有顺铂的单日或多日化疗方案,并给予阿瑞匹坦联合地塞米松及昂丹司琼的三联预防性止吐治疗。在整个研究期间通过患者研究日志记录其对治疗的反应。主要研究终点为完全缓解率,次要研究终点包括急性期完全缓解率、延迟期完全缓解率、完全保护率、完全控制率、危险因素和预期因素对完全缓解率的影响以及CINV对日常生活的影响。结果:70例患者中完全缓解率为80.0%,急性期完全缓解率为94.3%,延迟期完全缓解率为84.3%;完全保护率为42.9%,完全控制率为25.7%;71.4%的患者表示CINV对日常生活影响极小。结论:阿瑞匹坦联合地塞米松及昂丹司琼可有效预防妇科肿瘤患者接受含顺铂的化疗引起的呕吐,但三药联合方案对预防恶心的作用仍欠满意,用于多日化疗的最佳用药方案尚需进一步研究。接受顺铂化疗的妇科肿瘤患者,在应用三联止吐方案后,CINV对多数患者生活质量的影响很小。

Objective： To evaluate the efficacy of aprepitant in combination with ondansetron and dexamethasone on preventing emesis in patients with gynecological cancer receiving cisplatin-containing chemotherapy.Methods： In a prospective observational study,seventy patients receiving single or multiple day cisplatin-containing chemotherapy in our institute were enrolled between December 2013 and October 2014. All patients received a combination of aprepitant,ondansetron and desamethasone to prevent chemotherapy-induced nausea and vomiting（ CINV）.Functional Living Index-Emesis（ FLIE） was used to evaluate the impact of CINV on daily life.The primary endpoint was complete response（ CR; no vomitng and no rescue therapy） rate. Secondary endpoints were CR rate of acute phase,CR rate of delayed phase,complete protection（ CP; CR plus no significant nausea,VAS〈25 mm） rate,complete control（ CC; CR plus no nausea,VAS〈5 mm） rate,and the impact of CINV on daily life.Results： Complete response rate（ 0-120 h） was 80%.Complete response rate in the acute（ 0-24 h） and delayed（ 24-120 h） phases were 94. 3% and 84. 3%,respectively.Complete protection rate was 42. 9%.Complete control rate was 25. 7%.In all,71. 4% of the patients had FLIE score more than 108.Conclusions： The combination of aprepitant,ondansetron and desamethasone effectively prevented the vomiting induced by cisplatin-containing chemotherapy.However,the efficacy of the triple therapy to prevent nausea was still not satisfactory.After the application of triple anti-emesis therapy,the negative effect of CINV on the quality of life is small in most people.