消炎药
医学
呕吐
恶心
不利影响
内科学
化疗引起恶心呕吐
化疗
临床终点
胃肠病学
肿瘤科
麻醉
临床试验
止吐药
作者
Yoshimasa Saito,Tadashi Kumamoto,Takamichi Arima,Nami Shirakawa,Shin Ishimaru,Tomoko Sonoda,Miho Nakajima,Masanaka Sugiyama,Ayumu Arakawa,H. Hashimoto,Yoshinori Makino,Chitose Ogawa,Masakazu Yamaguchi
摘要
Abstract Background Single‐dose i.v. fosaprepitant has been approved as an alternative to 3 day oral aprepitant, a neurokinin‐1 receptor antagonist, and improves prevention of chemotherapy‐induced nausea and vomiting ( CINV ). Because fosaprepitant has shown similar efficacy to aprepitant in adult patients only, this study compared the efficacy and safety of aprepitant and fosaprepitant in pediatric patients. Methods Children younger than 18 years who received aprepitant or fosaprepitant to manage CINV between January 2015 and March 2018 at the National Cancer Center Hospital (Tokyo) were recruited to this study. The primary endpoint was complete response ( CR ; no vomiting/rescue medication) between 0 and 120 h after the start of chemotherapy. Secondary endpoints were safety based on the frequency of severe adverse events, and evaluation of patient characteristics as risk factors (effect of age and sex). Results A total of 125 chemotherapy cycles were evaluated. In the aprepitant group, CR was observed in 36 of 80 treatment cycles (45.0%), whereas in the fosaprepitant group, it was observed in 19 of 45 cycles (42.2%; P = 0.852). No treatment‐related severe adverse events were observed in either group. The number of non‐ CR was greater than that of CR in patients aged 6–14 years. The difference in CR rate between male and female patients was not statistically significant (47.1% vs 40.0%, respectively; P = 0.471). Conclusions Aprepitant and fosaprepitant were safely used and may be equally useful for pediatric patients receiving highly emetogenic chemotherapy. CR rate may be associated with patient age.
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