头孢吡肟与头孢他啶作为癌症患儿发热伴中性粒细胞减少症经验性单药治疗的比较

Cefepime versus ceftazidime as empiric monotherapy for fever and neutropenia in children with cancer.

作者信息

Chuang Yu-Yu, Hung Iou-Jih, Yang Chao-Ping, Jaing Tang-Her, Lin Tzou-Yien, Huang Yhu-Chering

机构信息

Department of Pediatrics, St. Mary Hospital, Taoyuan, Taiwan.

出版信息

Pediatr Infect Dis J. 2002 Mar;21(3):203-9. doi: 10.1097/00006454-200203000-00009.

DOI:10.1097/00006454-200203000-00009

PMID:12005083

Abstract

BACKGROUND

Monotherapy with cefepime or ceftazidime is an effective alternative to combination therapy for the treatment of febrile neutropenic adult cancer patients. We compared the efficacy and safety of cefepime and ceftazidime as empiric monotherapy of febrile neutropenia in children with cancer.

MATERIALS AND METHODS

A prospective, open label, randomized, comparative study in pediatric cancer patients was conducted at Chang Gung Children's Hospital from January 1, 2000, to April 15, 2001. Patients with fever and neutropenia (absolute neutrophil count of < or = 500/mm3) were randomized to receive either intravenous cefepime or ceftazidime (50 mg/kg/dose as two or three doses daily). Febrile episodes were classified as microbiologically documented infection, clinically documented infection or unexplained fever. Clinical response to therapy was classified as success and failure.

RESULTS

Ninety-five pediatric cancer patients with 120 febrile neutropenic episodes were randomized to receive empiric treatment with cefepime or ceftazidime. After 72 h of treatment, 82.8% (48 of 58) of the eligible patients in the cefepime group continued with unmodified therapy, compared with 87.9% (51 of 58) in the ceftazidime group. The neutrophil count was <100/mm3 at randomization for 76% of the patients in the cefepime group and 83% of those in the ceftazidime group; the median durations of neutropenia (<500/mm3) were 8.5 and 6.5 days, respectively. Of the 96 evaluable episodes the overall success rate with unmodified empiric therapy until the end of the treatment course in the cefepime group was comparable with that in the ceftazidime group (69% vs. 71%, P = 0.95). The response rate after glycopeptides were added to the regimens was 79.2% for the cefepime group and 77.1% for the ceftazidime group. The bacterial eradication rate was 33% for the cefepime group and 20% for the ceftazidime group (P = 0.85), and the rates of new infections were 10.4% vs. 4.2% (P = 0.67), respectively. Both study drugs were well-tolerated. Three (6.4%) patients in the cefepime group and 2 (4.3%) patients in the ceftazidime group died.

CONCLUSION

Cefepime appeared to be as effective and safe as ceftazidime for empiric treatment of febrile episodes in neutropenic pediatric cancer patients.

摘要

背景

对于发热性中性粒细胞减少的成年癌症患者，头孢吡肟或头孢他啶单药治疗是联合治疗的有效替代方案。我们比较了头孢吡肟和头孢他啶作为癌症儿童发热性中性粒细胞减少经验性单药治疗的疗效和安全性。

材料与方法

2000年1月1日至2001年4月15日在长庚儿童医院对儿科癌症患者进行了一项前瞻性、开放标签、随机、对照研究。发热且中性粒细胞减少（绝对中性粒细胞计数≤500/mm³）的患者被随机分为接受静脉注射头孢吡肟或头孢他啶（50mg/kg/剂量，每日2或3次）治疗。发热发作分为微生物学确诊感染、临床确诊感染或不明原因发热。治疗的临床反应分为成功和失败。

结果

95例儿科癌症患者出现120次发热性中性粒细胞减少发作，被随机分配接受头孢吡肟或头孢他啶的经验性治疗。治疗72小时后，头孢吡肟组82.8%（58例中的48例）符合条件的患者继续接受原治疗方案，头孢他啶组为87.9%（58例中的51例）。头孢吡肟组76%的患者和头孢他啶组83%的患者在随机分组时中性粒细胞计数<100/mm³；中性粒细胞减少（<500/mm³）的中位持续时间分别为8.5天和6.5天。在96次可评估发作中，头孢吡肟组和头孢他啶组在治疗疗程结束时采用原经验性治疗方案的总体成功率相当（69%对71%，P = 0.95）。在治疗方案中添加糖肽类药物后的有效率，头孢吡肟组为79.2%，头孢他啶组为77.1%。头孢吡肟组的细菌清除率为33%，头孢他啶组为20%（P = 0.85），新感染率分别为10.4%对4.2%（P = 0.67）。两种研究药物耐受性良好。头孢吡肟组3例（6.4%）患者和头孢他啶组2例（4.3%）患者死亡。