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哌拉西林-他唑巴坦联合阿米卡星与头孢哌酮-舒巴坦联合阿米卡星治疗淋巴瘤和实体瘤患儿发热性中性粒细胞减少症的随机对照研究

Randomized comparison of piperacillin-tazobactam plus amikacin versus cefoperazone-sulbactam plus amikacin for management of febrile neutropenia in children with lymphoma and solid tumors.

作者信息

Demirkaya Metin, Celebi Solmaz, Sevinir Betül, Hacımustafaoglu Mustafa

机构信息

Division of Pediatric Oncology, Department of Pediatrics, Medical Faculty, Uludag University, Bursa, Turkey.

出版信息

Pediatr Hematol Oncol. 2013 Mar;30(2):141-8. doi: 10.3109/08880018.2012.756565. Epub 2013 Jan 9.

Abstract

The objective of this study was to compare the effectiveness of piperacillin-tazobactam (PIP/TAZO) plus amikacin (AMK) (PIP/TAZO+AMK) versus cefoperazone-sulbactam (CS) plus AMK (CS+AMK) for the treatment of febrile neutropenia (FN) in children with cancer. The study was designed prospectively and randomized in 0- to 18-year-old children with lymphoma or solid tumor who were hospitalized with FN diagnosis. Consecutively randomized patients received either PIP/TAZO 360 mg/kg/day in 4 doses plus AMK 15 mg/kg/day in 3 doses or CS 100 mg/kg/day in 3 doses plus AMK 15 mg/kg/day in 3 doses intravenously. Treatment modification was defined as any change in the initial empirical antibiotic therapy. A total of 116 FN episodes were managed in 46 patients (26 boys and 20 girls) with a median age of 6.5 years (range .8-17.0) during the study period. Success rates without modification of therapy were 47.5% and 52.6% in PIP/TAZO+AMK group and CS+AMK group, respectively (P >.05). No statistical difference was found between treatment groups in terms of durations of neutropenia, fever, and hospitalization. The overall success rate in all groups was 97.4%. No major side effect was observed in either group during the course of the study. Our study is the first to compare the effectiveness of PIP/TAZO+AMK and CS+AMK therapies. Both combinations were effective and safe as empirical therapy for febrile neutropenic patients.

摘要

本研究的目的是比较哌拉西林-他唑巴坦(PIP/TAZO)联合阿米卡星(AMK)(PIP/TAZO+AMK)与头孢哌酮-舒巴坦(CS)联合AMK(CS+AMK)治疗儿童癌症患者发热性中性粒细胞减少症(FN)的有效性。本研究为前瞻性设计,对0至18岁诊断为FN并因淋巴瘤或实体瘤住院的儿童进行随机分组。连续随机分组的患者接受静脉注射,一组为PIP/TAZO 360mg/kg/天,分4剂,加AMK 15mg/kg/天,分3剂;另一组为CS 100mg/kg/天,分3剂,加AMK 15mg/kg/天,分3剂。治疗调整定义为初始经验性抗生素治疗的任何改变。在研究期间,46例患者(26例男孩和20例女孩)共发生116次FN发作,中位年龄为6.5岁(范围0.8 - 十七.0岁)。PIP/TAZO+AMK组和CS+AMK组未经治疗调整的成功率分别为47.5%和52.6%(P>0.05)。治疗组之间在中性粒细胞减少、发热和住院时间方面未发现统计学差异。所有组的总体成功率为97.4%。在研究过程中,两组均未观察到重大副作用。我们的研究是首次比较PIP/TAZO+AMK和CS+AMK疗法的有效性。两种联合用药作为发热性中性粒细胞减少患者的经验性治疗均有效且安全。

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