Ahmed Nabil, El-Mahallawy Hadir A, Ahmed Ibrahim A, Nassif Shimaa, El-Beshlawy Aamal, El-Haddad Alaa
Pediatric Branch, National Cancer Institute, Cairo University, Cairo, Egypt.
Pediatr Blood Cancer. 2007 Nov;49(6):786-92. doi: 10.1002/pbc.21179.
Hospitalization with single or multi-agent antibiotic therapy has been the standard of care for treatment of febrile neutropenia in cancer patients. We hypothesized that an empiric antibiotic regimen that is effective and that can be administered once-daily will allow for improved hospital utilization by early transition to outpatient care.
Febrile pediatric cancer patients with anticipated prolonged neutropenia were randomized between a regimen of once-daily ceftriaxone plus amikacin (C + A) and imipenem monotherapy (control). Afebrile patients on C + A satisfying "Early Discharge Criteria" at 72 hr continued treatment as outpatients. We compared the outcome, adverse events, duration of hospitalization, and cost between both groups.
A prospective randomized controlled clinical trial was conducted on 129 febrile episodes in pediatric cancer patients with prolonged neutropenia. No adverse events were seen in 32 children (84% of study arm) treated on an outpatient basis. We found a statistically significant difference between the duration of hospitalization of the C + A group [median 5 days] and control [median 9 days](P < 0.001), per episode antibiotic cost (P < 0.001) and total episode cost (P < 0.001). There was no statistically significant difference in the response to treatment at 72 hr or after necessary antimicrobial modifications.
We conclude that pediatric febrile cancer patients initially considered at risk for sepsis due to prolonged neutropenia can be re-evaluated at 72 hr for outpatient therapy. The convenience, low incidence of adverse effects, and cost benefit of the once-daily regimen of C + A may be particularly useful to reduce the overall treatment costs and duration of hospitalization.
采用单药或多药联合抗生素治疗的住院治疗一直是癌症患者发热性中性粒细胞减少症的标准治疗方案。我们假设一种有效且可每日给药一次的经验性抗生素方案能够通过早期过渡到门诊治疗来提高医院资源利用率。
预计中性粒细胞减少期延长的发热性儿科癌症患者被随机分为每日一次头孢曲松加阿米卡星(C+A)方案组和亚胺培南单药治疗组(对照组)。在72小时达到“早期出院标准”的C+A方案组的无发热患者继续作为门诊患者接受治疗。我们比较了两组的治疗结果、不良事件、住院时间和费用。
对129例中性粒细胞减少期延长的儿科癌症患者的发热发作进行了一项前瞻性随机对照临床试验。32名接受门诊治疗的儿童(研究组的84%)未出现不良事件。我们发现C+A组的住院时间[中位数5天]与对照组[中位数9天]之间存在统计学显著差异(P<0.001),每次发作的抗生素费用(P<0.001)和每次发作的总费用(P<0.001)。在72小时或必要的抗菌药物调整后,两组在治疗反应方面没有统计学显著差异。
我们得出结论,最初因中性粒细胞减少期延长而被认为有败血症风险的儿科发热癌症患者可在72小时重新评估是否适合门诊治疗。C+A每日一次方案的便利性、低不良反应发生率和成本效益可能对降低总体治疗成本和住院时间特别有用。