阿瑞匹坦预防软组织肉瘤脂质体多柔比星联合异环磷酰胺化疗恶心呕吐临床观察  

Antiemesis effect of aprepitant for the liposome doxorubicin and ifosfamide induced nausea and vomiting in soft tissue sarcomas patients

作　　者：张路[1] 樊征夫[1] 刘佳勇[1] 白楚杰[1] 薛瑞峰[1] 李舒[1] 高天[1] 方志伟[1] ZHANG Lu FAN Zheng-fu LIU Jia-yong BAI Chu jie XUE Rui-feng LI Shu GAO Tian FANG Zhi-wei(Key Laboratory of Carcinogenesis and Translational Research （Ministry of Education） ,Department of Orthopaedic Oncology, Peking University Cancer Hospital＆ Institute, Beijing 100142, P. R. China)

机构地区：[1]北京大学肿瘤医院暨北京市肿瘤防治研究所骨与软组织肿瘤科恶性肿瘤发病机制及转化研究教育部重点实验室,北京100142

出　　处：《中华肿瘤防治杂志》2017年第13期930-934,共5页Chinese Journal of Cancer Prevention and Treatment

摘　　要：目的阿瑞匹坦(Aprepitant)是一种神经激肽1(Neurokinin 1,NK-1)受体阻滞剂,近年来在中国被批准用于化疗引起的恶心呕吐(chemotherapy induced nausea and vomiting,CINV),但此药物在软组织肉瘤(soft tissue sarcomas,STS)多日化疗中止吐效果的研究报道很少。本试验通过前瞻性队列研究观察阿瑞匹坦预防STS患者接受脂质体多柔比星(Liposome doxorubicin)和异环磷酰胺(Ifosfamide)联合化疗中CINV的效果。方法选择2016-02-01-2016-06-30北京大学肿瘤医院骨与软组织肿瘤科收治的软组织肉瘤患者32例,均接受含脂质体多柔比星与异环磷酰胺的5d化疗方案,由研究者根据化疗前的预防性止吐治疗方式非随机分为阿瑞匹坦组和对照组,进行前瞻性队列研究。阿瑞匹坦组止吐用药包括阿瑞匹坦、昂丹司琼和地塞米松磷酸钠,对照组止吐药物包括昂丹司琼和地塞米松磷酸钠。记录患者化疗后的恶心、呕吐反应,解救治疗及不良反应。主要观察呕吐方面包括急性期完全缓解率,化疗开始后24h无呕吐发作且未进行解救治疗;延迟期完全缓解率,化疗开始后第2~10天无呕吐发作且未进行解救治疗;恶心方面包括急性期完全保护率,化疗开始后24h无呕吐、无解救治疗且无明显恶心,视觉模拟评分(visual analogue scale,VAS)<25mm;延迟期完全保护率,化疗开始后第2~10天无呕吐、无解救治疗且无明显恶心,VAS<25mm。计数资料的比较使用Fisher精确检验,计量资料使用正态性检验,用x-±s表示计量资料组间差异,如为正态分布则采用t检验,如为非正态分布则采用两个独立样本的Mann-Whitney U秩和检验。结果阿瑞匹坦组15例,对照组17例,两组的患者临床特征差异无统计学意义。阿瑞匹坦组和对照组患者的每日平均呕吐次数的最高值出现在化疗开始后的第5天,分别为(0.5±1.4)和(1.7±1.9)次,差异有统计学意义,U=80,P=0.034;每日平均VAS的最高值也出现在化疗OBJECTIVE Aprepitant is a neurokinin 1（NK-1） receptor antagonist, which is approved for preventionof chemotherapy-induced nausea and vomiting（CINV） in China recently. However,there are few reports about the efficacy of this drug on multi-day chemotherapy in soft tissue sarcomas. The objective of this study was to evaluate the efficacy of aprepitant in preventing emesis in patients with soft tissue sarcomas receiving chemotherapy containing liposome doxo- rubicin and ifosfamide. METHODS In a prospective observational study,32 patients receiving 5-days chemotherapy con- taining liposome doxorubicin and ifosfamide were enrolled in Department of Orthopaedic Oncology of Peking University Cancer Hospital between February 1,2016 and June 30,2016. A total of 32 patients were assigned into the aprepitant group or the control group nonrandomly. The antemetic drugs of aprepitant group include aprepitant, ondansetron and dexamethasone,while the antemetic drugs of control group include ondansetron and dexamethasone. The severity of nau- sea and vomiting were observed during the 10d post-chemotherapy. The endpoint were CR （complete response） rate of a- cute phase （no vomitng and no rescue therapy throughout the 0-24 h post-chemotherapy） and CR rate of delayed phase （no vomitng and no rescue therapy throughout the 2-10 d post-chemotherapy）, CP （complete protection） rate of acute phase （CR plus no significant nausea,VAS〈25 mm throughout the 0-24 h post-chemotherapy） and CP rate of delayed phase （CR plus no significant nausea,VAS〈25 mm throughout the 2-10 d post-chemotherapy）. Enumeration data were analyzed by Fisher＇s exact test. Measurement data of normal distribution were analyzed by T test,while measurement data of non-normal distribution were analyzed by Mann-Whitney U test. RESULTS Aprepitant group were 15 patients,while the control group were 17 patients, the patients＂ baseline characteristics were equivalent between the two groups. The highest value of the mean number of emetic epis

关 键 词：化疗引起的恶心呕吐 软组织肉瘤 脂质体多柔比星 异环磷酰胺 阿瑞匹坦 

分 类 号：R738.6[医药卫生—肿瘤]