神经激肽1受体拮抗剂预防肿瘤患儿高致吐化疗药物相关恶心呕吐的有效性和安全性评估

Efficacy and safety of neurokinin 1 receptor antagonists for the prevention of highly emetogenic chemotherapyrelated nausea and vomiting in pediatric patients with cancer

目的探讨儿童肿瘤患者使用神经激肽1受体拮抗剂(NK-1RA)预防高致吐性化疗(HEC)引起恶心呕吐的临床疗效并进行安全性评估。方法选取2020年5月至2020年12月使用NK-1RA预防HEC所致呕吐的患儿进行分析。将使用福沙匹坦+昂丹司琼+地塞米松的患儿纳入福沙匹坦组,使用阿瑞匹坦+昂丹司琼+地塞米松治疗的患儿纳入阿瑞匹坦组,比较两组患儿治疗后的临床疗效和安全性。结果共纳入122例患儿,男83例、女39例,中位年龄8.0(4.8~11.0)岁。其中福沙匹坦组62例、阿瑞匹坦组60例。所有患儿在使用NK-1RA预防化疗引起的恶心和呕吐后,急性、延迟性和整体呕吐达到CR的比例(即无呕吐率)分别为88.5%、71.3%和65.6%。急性呕吐阶段,福沙匹坦和阿瑞匹坦两组间呕吐严重程度分布差异有统计学意义(P<0.05);福沙匹坦组无呕吐(CR)率较高。本组患儿未出现严重不良事件;福沙匹坦组和阿瑞匹坦组之间头痛、厌食和乏力等不良反应发生率差异均无统计学意义(P>0.05)。结论福沙匹坦或阿瑞匹坦+昂丹司琼+地塞米松预防肿瘤患儿HEC所致的恶心呕吐有效且安全。

Objective To evaluate the clinical efficacy and safety of neurokinin 1 receptor antagonists(NK-1RA)for the prevention of nausea and vomiting induced by highly emetogenic chemotherapy(HEC)in children with cancer.Methods The pediatric patients who received NK-1RA to manage nausea and vomiting caused by HEC between May 2020 and December 2020 were enrolled in this study.The children treated with fosaprepitant in combination with ondansetron and dexamethasone were enrolled in the fosaprepitant group,and the children treated with aprepitant in combination with ondansetron and dexamethasone were included in the aprepitant group.The clinical efficacy and safety of the two groups were compared after treatment.Results A total of 122 children(83 boys and 39 girls)were included.The median age was 8.0(4.8~11.0)years.Sixty-two patients were included in the fosaprepitant group and 60 in the aprepitant group.After NK-1RA was used to prevent chemotherapy-induced nausea and vomiting(CINV),the complete remission(CR)rate of acute,delayed,and overall vomiting(i.e.,non-vomiting rate)was 88.5%,71.3%and 65.6%,respectively.In the stage of acute vomiting,there was significant difference in the distribution of vomiting severity between the fosaprepitant group and aprepitant group(P<0.05).The rate of non-vomiting(CR)was higher in the fosaprepitant group.No serious adverse events occurred in the children in this study.There was no significant difference in the incidence of headache,anorexia,fatigue and other adverse reactions between the fosaprepitant group and the aprepitant group.Conclusions Fosaprepitant or aprepitant combined with ondansetron and dexamethasone is effective and safe for the prevention of HEC-induced nausea and vomiting in children with cancer.