Department of Medical Oncology, Regional Cancer Centre, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Dhanvantari Nagar, Pondicherry, 605006, India.
Department of Microbiology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry, India.
Support Care Cancer. 2018 Nov;26(11):3899-3908. doi: 10.1007/s00520-018-4260-8. Epub 2018 May 17.
Beta lactams are standard empirical therapy for febrile neutropenia (FN). The aim of this study was to evaluate the efficacy and safety of cefepime monotherapy compared with cefoperazone/sulbactam plus amikacin (CS + A) for empirical treatment of high risk FN.
One hundred seventy-five patients with 336 FN episodes were randomized to receive either cefepime (2 g q8h for adults and 50 mg/kg q8h for children) or CS (2 g q8h for adults and 50 mg/kg q8h for children) plus amikacin (15 mg/kg once a day). Positive response was defined as afebrile within 72 h of starting antibiotics, persistent afebrile status more than 48 h and no requirement of second-line antibiotics and antifungal agents.
Three hundred thirty-six episodes were assessable for efficacy (168 cefepime, 168 CS + A). The positive response to antibiotics was identical for cefepime (53%) and CS + A (53%). Positive response was similar in MDI (microbiologically documented infection), 50 vs. 35% (p = 0.248), CDI (clinically documented infection), 50 vs. 35% (p = 0.259), combination CDI + MDI, 25 vs. 15% (p = 0.400), FUO (fever of unknown origin), 68 vs. 72% (p = 0.577) respectively in the two groups. The successful discontinuation of antibiotics at 72 h in FUO was similar in both groups (60 vs. 59%, p = 0.544). Total drug-related adverse events were similar in both groups (8 vs. 6%) except renal dysfunction was high in CS + A (1 vs. 7 events). Mortality was the same between two groups (8 vs 7%).
Cefepime monotherapy and CS + A had similar efficacy as first-line therapy for FN. Discontinuation of empirical antibiotics is safe and feasible approach in selected group of FUO patients.
β-内酰胺类药物是发热性中性粒细胞减少症（FN）经验性治疗的标准药物。本研究的目的是评估头孢吡肟单药治疗与头孢哌酮/舒巴坦联合阿米卡星（CS+A）用于高危 FN 经验性治疗的疗效和安全性。
175 例 336 例 FN 患者随机分为头孢吡肟（成人 2g q8h，儿童 50mg/kg q8h）或 CS（成人 2g q8h，儿童 50mg/kg q8h）+阿米卡星（15mg/kg 每日 1 次）。阳性反应定义为抗生素开始后 72 小时内退热，48 小时以上持续发热且无需使用二线抗生素和抗真菌药物。
336 例患者可评估疗效（头孢吡肟 168 例，CS+A 168 例）。头孢吡肟（53%）和 CS+A（53%）对抗生素的阳性反应相同。MDI（微生物学确诊感染）、CDI（临床确诊感染）、CDI+MDI（联合 CDI+MDI）和 FUO（不明原因发热）的阳性反应分别为 50%比 35%（p=0.248）、50%比 35%（p=0.259）、25%比 15%（p=0.400）和 68%比 72%（p=0.577）。两组在 FUO 时 72 小时成功停用抗生素的比例相似（60%比 59%，p=0.544）。两组药物相关不良事件总发生率相似（8%比 6%），但 CS+A 组肾功能不全发生率较高（1 例比 7 例）。两组死亡率相同（8%比 7%）。
头孢吡肟单药治疗与 CS+A 作为 FN 的一线治疗具有相似疗效。在选择的 FUO 患者组中，停用经验性抗生素是安全可行的方法。
