头孢吡肟联合阿米卡星与哌拉西林-他唑巴坦联合阿米卡星用于血液科发热性中性粒细胞减少患者初始抗生素治疗：一项开放、随机、多中心试验的结果

Cefepime plus amikacin versus piperacillin-tazobactam plus amikacin for initial antibiotic therapy in haematology patients with febrile neutropenia: results of an open, randomized, multicentre trial.

作者信息

Sanz Miguel A, López Javier, Lahuerta Juan J, Rovira Montserrat, Batlle Montserrat, Pérez Cristina, Vázquez Lourdes, Julià Antonio, Palau Javier, Gutiérrez Martín, Capote Francisco J, Ramos Fernando, Benlloch Luis, Larrea Luis, Jarque Isidro

机构信息

Servicio de Hematología, Hospital Universitario La Fe, Av. Campanar 21, 46009 Valencia, Spain.

出版信息

J Antimicrob Chemother. 2002 Jul;50(1):79-88. doi: 10.1093/jac/dkf087.

DOI:10.1093/jac/dkf087

PMID:12096010

Abstract

BACKGROUND

Standard therapy for suspected infections in patients with profound neutropenia is the combination of a beta-lactam antibiotic plus an aminoglycoside. Cefepime's broad-spectrum activity makes it an option for initial empirical therapy in neutropenic patients. The aim of this study is to evaluate the efficacy and safety of cefepime plus amikacin compared with piperacillin-tazobactam plus amikacin for initial empirical treatment of fever in adult haematology patients with severe neutropenia.

METHODS

In this prospective multicentre trial, 969 patients with 984 febrile neutropenic episodes were randomized to receive iv amikacin (20 mg/kg every 24 h) combined with either cefepime (2 g every 8 h) or piperacillin-tazobactam (4 g/500 mg every 6 h). Clinical response was determined at 72 h and at completion of therapy.

RESULTS

Eight hundred and sixty-seven episodes were assessable for efficacy (432 cefepime, 435 piperacillin-tazobactam). The frequency of success without modification of the empirical therapy was nearly identical for cefepime plus amikacin (49%) compared with piperacillin-tazobactam plus amikacin (51%). Similar rates of success were found for microbiologically documented infection: 40% versus 39%, respectively. Antibiotic modification was necessary in 49% of cefepime and 44% of piperacillin-tazobactam patients. The overall response rate, with or without modification of the assigned treatment, was 94% in both groups. Drug-related adverse events were reported in 10% of cefepime plus amikacin versus 11% of piperacillin-tazobactam plus amikacin patients. Mortality due to infection occurred in a total of 10 patients (two cefepime, eight piperacillin-tazobactam).

CONCLUSION

The empirical regimen of cefepime plus amikacin is equivalent to piperacillin-tazobactam plus amikacin in febrile adult haematology patients with severe neutropenia.

KEYWORDS

cefepime, piperacillin-tazobactam, amikacin, empirical antibiotic therapy, febrile neutropenia, haematological malignancy

摘要

背景

对于严重中性粒细胞减少患者的疑似感染，标准治疗方案是β-内酰胺类抗生素联合氨基糖苷类抗生素。头孢吡肟的广谱活性使其成为中性粒细胞减少患者初始经验性治疗的选择之一。本研究旨在评估头孢吡肟联合阿米卡星与哌拉西林-他唑巴坦联合阿米卡星用于成年血液学严重中性粒细胞减少患者发热初始经验性治疗的疗效和安全性。

方法

在这项前瞻性多中心试验中，969例患者发生984次发热性中性粒细胞减少发作，随机接受静脉注射阿米卡星（每24小时20mg/kg）联合头孢吡肟（每8小时2g）或哌拉西林-他唑巴坦（每6小时4g/500mg）治疗。在72小时及治疗结束时确定临床反应。

结果

867次发作可评估疗效（432次为头孢吡肟组，435次为哌拉西林-他唑巴坦组）。头孢吡肟联合阿米卡星组（49%）与哌拉西林-他唑巴坦联合阿米卡星组（51%）在不改变经验性治疗的情况下成功频率几乎相同。微生物学证实的感染成功率相似：分别为40%和39%。49%的头孢吡肟组患者和44%的哌拉西林-他唑巴坦组患者需要调整抗生素。两组中，无论是否调整指定治疗，总体有效率均为94%。头孢吡肟联合阿米卡星组10%的患者和哌拉西林-他唑巴坦联合阿米卡星组11%的患者报告了药物相关不良事件。因感染导致的死亡共发生10例（头孢吡肟组2例，哌拉西林-他唑巴坦组8例）。