吉林大学学报(医学版) ›› 2016, Vol. 42 ›› Issue (02): 331-335.doi: 10.13481/j.1671-587x.20160227

• 临床医学 • 上一篇    下一篇

阿瑞匹坦预防高致吐性化疗所致恶心呕吐的效果和安全性评价

孟文静, 汪旭, 贾勇圣, 佟仲生   

  1. 天津医科大学肿瘤医院乳腺肿瘤内科国家肿瘤临床医学研究中心乳腺癌防治教育部重点实验室天津市肿瘤防治重点实验室, 天津 300060
  • 收稿日期:2015-11-22 发布日期:2016-03-31
  • 通讯作者: 佟仲生,主任医师,硕士研究生导师(Tel:022-23340123-2133,E-mail:18622221181@163.com) E-mail:18622221181@163.com
  • 作者简介:孟文静(1982-),女,天津市人,医学硕士,主要从事乳腺癌基础与临床方面的研究。
  • 基金资助:

    国家科技部科技支撑计划资助课题(2015BAI12B00);天津市科委抗癌重大专项攻关计划资助课题(12ZCDZSY16200)

Efficacy and safety evaluation on aprepitant in prevention of nausea and vomiting induced by highly emetogenic chemotherapy

MENG Wenjing, WANG Xu, JIA Yongsheng, TONG Zhongsheng   

  1. Department of Breast Oncology, Cancer Institute and Hospital, Tianjin Medical University, National Clinical Research Center for Cancer, Key Laboratory of Breast Cancer Prevention and Therapy, Ministry of Education, Key Laboratory of Cancer Prevention and Therapyof Tianjin City, Tianjin 300060, China
  • Received:2015-11-22 Published:2016-03-31

摘要:

目的: 探讨神经激肽1(NK1)受体拮抗剂阿瑞匹坦联合地塞米松、托烷司琼预防高致吐性化疗方案所致恶心呕吐的效果,阐述该方案对患者生活质量的影响,并进一步评价其治疗的安全性。方法: 选择156例经病理确诊为恶性肿瘤的患者,其中乳腺癌129例,肺癌24例,宫颈癌3例,接受顺铂≥70 mg·m-2的化疗方案或环磷酰胺联合蒽环类的化疗方案,其中环磷酰胺使用量大于1000 mg·d-1。随机分为2组,观察组75例,患者于第1天化疗前1h口服阿瑞匹坦125 mg及地塞米松6 mg,静滴托烷司琼4mg,第2~4天口服阿瑞匹坦80 mg及地塞米松3.75mg;对照组81例,患者于第1天化疗前口服地塞米松6 mg,静滴托烷司琼4 mg,第2~4天口服地塞米松3.75mg。主要研究终点为急性和延迟性恶心呕吐的完全缓解率比较,次要研究终点为评价患者生活质量的改善情况。结果: 总体评价主要研究终点,即恶心呕吐的缓解情况,观察组完全缓解率为69.3%(52/75),对照组完全缓解率为53.1%(43/81),2组间比较差异有统计学意义(P=0.049);其中对于急性恶心呕吐(0~24h)的缓解情况,观察组完全缓解率为78.7%(59/75),对照组完全缓解率为75.3%(61/81),2组比较差异无统计学意义(P=0.705);对于延迟性恶心呕吐(25~120h),观察组完全缓解率为76.0%(57/75),对照组完全缓解率为54.3%(44/81),2组比较差异有统计学意义(P=0.007)。次要研究终点观察,观察组和对照组患者呕吐功能性生活指数(FLIE)平均得分分别为(120.8±12.4)和(84.0±8.7)分,2组比较差异有统计学意义(P<0.05)。结论: 阿瑞匹坦预防高致吐性化疗引起的急性及延迟性恶心呕吐疗效确切,预防延迟性恶心呕吐效果优于托烷司琼,并可以提高患者的生活质量。

关键词: 阿瑞匹坦, 高致吐化疗, 恶心呕吐, 神经激肽-1

Abstract:

Objective: To explore the efficacy and safety of aprepitant combined with tropisetron and dexamethasone in the prevention of emetogenic chemotherapy-induced nausea and vomiting and clarify its influence in the life guality of patients, and to evaluate its safety in treatment.Methods: One hundred and fifty six patients with malignant tumor were randomly assigned to observation group (n=75)(day 1, aprepitant 125 mg, tropisetron 4 mg and dexamethasone 6 mg 1 h before chemotherapy, day 2-4, aprepitant 80 mg and dexamethasone 3.75 mg, qd) and control group (n=81) (day 1, tropisetron 4 mg and dexamethasone 6 mg before chemotherapy, day 2-4, dexamethasone 3.75 mg, qd). The primary study endpoints were the comparisons of acute and delayed complete response rates of nausea and vomiting, and the second study endpoints were the evaluations on the improvement of the life quality of patients.Results: General evaluation on the primary study endpoints was performed, The complete remission rate in observation group was 69.3%(52/75), and the complete remission rate in control group was 53.1%(43/81), there was signficant difference between two groups(P=0.049). For the acute nausea and vomiting(0-24 h), the complete remission rate in observation group was 78.7%(59/75), and the complete remission rate in control group was 75.3%(61/81), and there was no significant difference between two groups(P=0.705). The complete remission rate of delayed nausea and vomiting(25-120 h) in observation group was significantly higher than that in control group (76.0% vs 54.3%)(P=0.007). For the second study endpoints, the average scores of FLIE in observation and control group were 120.8±12.4 and 84.0±8.7, and there was significant difference between two groups(P<0.05).Conclusion: Aprepitant can significantly prevent the emetogenic chemotherapy-induced nausea and vomitting and improve the life quality of patients.

Key words: aprepitan, highly emetogenic chemotherapy, nausea and vomiting, neurokinin-1

中图分类号: 

  • R730.53