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

发布时间：2018-03-31 04:00

本文选题：化疗引起的恶心呕吐　切入点：软组织肉瘤　出处：《中华肿瘤防治杂志》2017年13期

【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,VAS25mm。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开始后的第5天,分别为(22±13.2)和(33.5±21.2)mm,差异无统计学意义,U=80.5,P=0.07。阿瑞匹坦组与对照组患者的急性期完全缓解率分别为100.0%(15/15)和88.2%(15/17),差异无统计学意义,P=0.486;延迟期完全缓解率分别为80.0%(12/15)和41.2%(7/17),差异有统计学意义,P=0.036。阿瑞匹坦组与对照组患者急性期完全保护率分别为13.3%(2/15)和23.5%(4/17),差异无统计学意义,P=0.659;延迟期完全保护率分别为33.3%(5/15)和11.8%(2/17),差异无统计学意义,P=0.209。阿瑞匹坦组患者中未观察到阿瑞匹坦相关的不良反应。结论 STS患者在接受包含脂质体多柔比星及异环磷酰胺化疗时,最严重的恶心呕吐常发生于化疗开始后的第5天,加用阿瑞匹坦能提高延迟期完全缓解率。
[Abstract]:Objective Aprepitant is a neurokinin 1(Neurokinin 1 NK-1 receptor blocker. In recent years, induced nausea and has been approved for chemotherapy induced nausea and vomiting chemotherapy in China. However, there are few studies on the efficacy of this drug in the treatment of soft tissue sarcoma tissue sarcomassum. A prospective cohort study was conducted to observe the antiemetic effect of this drug. To prevent the effect of liposome doxorubicin( liposome doxorubicin) and ifosfamide (Ifosfamide) combined with liposome doxorubicinon in patients with STS, 32 patients with soft tissue sarcoma treated in the department of bone and soft tissue oncology, Peking University Oncology Hospital, 2016-02-01-2016-06-30, were selected. All patients received 5-day chemotherapy regimen containing liposome doxorubicin and isocyclophosphamide. A prospective cohort study was conducted. The antiemetic drugs in the Aripitan group included Aripitan, ondansetron and dexamethasone sodium phosphate, while those in the control group included ondansetron and dexamethasone sodium phosphate. Nausea and vomiting were recorded after chemotherapy. Rescue treatment and adverse reactions. The main observation of vomiting, including the acute stage of complete remission rate, 24 hours after the beginning of chemotherapy without vomiting attack and no rescue treatment; delayed complete remission rate, There was no vomiting attack 10 days after chemotherapy and no rescue treatment. Nausea included complete protection rate in acute phase, no vomiting at 24 hours after chemotherapy, no rescue treatment and no nausea. Visual analogue score (VAS) was 25 mm for visual analogue scaleVAS.There was complete protection rate in delayed phase. Ten days after the beginning of chemotherapy, there was no vomiting, no rescue treatment and no obvious nausea and VAS25mm.Counting data were compared using Fisher accurate test, measurement data using normal test, using x- 卤s to denote the difference of metrological data group, if normal distribution was used, t test was used. In the case of non-normal distribution, two independent samples of Mann-Whitney U rank sum test were used. Results the results showed that there were 15 cases in the Aripitan group and 17 cases in the control group. There was no significant difference in the clinical characteristics between the two groups. The highest daily average number of vomiting was found in the patients in the Aripitan group and the control group on the 5th day after the beginning of chemotherapy (0.5 卤1.4) and 1.7 卤1.9 times, respectively. The difference was statistically significant (P = 0.034). The highest daily average VAS also appeared on the 5th day after chemotherapy. There was no significant difference between the two groups. The complete remission rates in the acute phase were 100.00.015 / 15 in the Arepitan group and 80.015 / 15 in the control group, respectively, with no significant difference (P 0.486); the complete remission rates in the delayed period were 80.00.1215) and 41.22% / 717% (P < 0.05), respectively. The difference was statistically significant (P < 0.05), and the difference was statistically significant (P < 0.05). The difference was statistically significant (P < 0.05), and the difference was statistically significant (P < 0.05), and the difference was statistically significant (P < 0.05) and 41.22% / 717% (P < 0.05) and the difference was statistically significant (P < 0.05). The complete protection rates of patients in the Arepitan group and the control group in the acute phase were 13.3 / 15 and 23.547 / 17, respectively. There was no significant difference (P 0.659); the complete protection rate of delayed phase was 33.3R / 5 / 15) and 11.8U / 2 / 1717.The difference was not statistically significant (P = 0.209). Conclusion the patients with STS received liposome doxorubicin and isocyclophosphamide chemotherapy. The most severe nausea and vomiting usually occur 5 days after chemotherapy, combined with albitam can improve the delayed complete remission rate.
【作者单位】：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;
【分类号】：R738.6

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