Department of Pediatrics, University of Bern, Bern, Switzerland.
Pediatr Blood Cancer. 2012 Sep;59(3):423-30. doi: 10.1002/pbc.24076. Epub 2012 Jan 23.
The standard treatment of fever in chemotherapy-induced neutropenia (FN) includes emergency hospitalization and empirical intravenous antimicrobial therapy. This study determined if first-day step-down to oral outpatient treatment is not inferior to continued standard regarding safety and efficacy in children with low-risk FN.
In a randomized controlled non-blinded multicenter study, pediatric patients with FN after non-myeloablative chemotherapy were reassessed after 8-22 hours of inpatient intravenous antimicrobial therapy. Low-risk patients were randomized to first-day step-down to experimental (outpatient, oral amoxicillin plus ciprofloxacin) versus continued standard treatment. Exact non-inferiority tests were used for safety (no serious medical complication; non-inferiority margin of difference, 3.5%) and efficacy (resolution of infection without recurrence, no modification of antimicrobial therapy, no adverse event; 10%).
In 93 (26%) of 355 potentially eligible FN episodes low-risk criteria were fulfilled, and 62 were randomized, 28 to experimental (1 lost to follow-up) and 34 to standard treatment. In intention-to-treat analyses, non-inferiority was not proven for safety [27 of 27 (100%) vs. 33 of 34 (97%; 1 death) episodes; 95% upper confidence border, 6.7%; P = 0.11], but non-inferiority was proven for efficacy [23 of 27 (85%) vs. 26 of 34 (76%) episodes; 95% upper confidence border, 9.4%; P = 0.045]. Per-protocol analyses confirmed these results.
In children with low-risk FN, the efficacy of first-day step-down to oral antimicrobial therapy with amoxicillin and ciprofloxacin in an outpatient setting was non-inferior to continued hospitalization and intravenous antimicrobial therapy. The safety of this procedure, however, was not assessable with sufficient power.
在化疗引起的中性粒细胞减少症（FN）的发热标准治疗中，包括紧急住院和经验性静脉内抗菌治疗。本研究旨在确定对于低危 FN 患儿，第一天降阶梯至口服门诊治疗在安全性和疗效方面是否不劣于标准治疗。
在一项随机对照非盲多中心研究中，在接受非骨髓清除性化疗后发生 FN 的儿科患者在接受 8-22 小时的住院静脉内抗菌治疗后进行重新评估。低危患者随机分为第一天降阶梯至实验组（门诊，口服阿莫西林加环丙沙星）或继续标准治疗。采用精确非劣效性检验来评估安全性（无严重医疗并发症；非劣效性差异界限为 3.5%）和疗效（感染无复发、无需调整抗菌治疗、无不良事件；10%）。
在 355 例潜在合格的 FN 发作中，有 93 例（26%）符合低危标准，62 例被随机分配，28 例接受实验组（1 例失访），34 例接受标准治疗。意向治疗分析显示，安全性未证明非劣效性[27 例（100%）与 34 例（97%；1 例死亡）事件；95%置信上限，6.7%；P=0.11]，但疗效证明非劣效性[23 例（85%）与 34 例（76%）事件；95%置信上限，9.4%；P=0.045]。方案分析证实了这些结果。
对于低危 FN 患儿，第一天降阶梯至口服阿莫西林和环丙沙星的门诊抗菌治疗的疗效不劣于继续住院和静脉内抗菌治疗。然而，该程序的安全性不能用足够的效力进行评估。
