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肺癌低风险发热性中性粒细胞减少患者口服与静脉用抗生素的随机试验

Randomized trial of oral versus intravenous antibiotics in low-risk febrile neutropenic patients with lung cancer.

作者信息

Niho Seiji, Ohe Yuichiro, Goto Koichi, Ohmatsu Hironobu, Matsumoto Taketoshi, Kubota Kaoru, Kakinuma Ryutaro, Nishiwaki Yutaka

机构信息

Division of Thoracic Oncology, National Cancer Center Hospital East, Chiba, Japan.

出版信息

Jpn J Clin Oncol. 2004 Feb;34(2):69-73. doi: 10.1093/jjco/hyh019.

DOI:10.1093/jjco/hyh019
PMID:15067098
Abstract

BACKGROUND

Neutropenic fever is one of the most serious adverse effects of cancer chemotherapy. Neutropenia may cause a life-threatening bacterial infection. Therefore, febrile neutropenic inpatients are empirically treated with intravenous broad-spectrum antibiotics. Recently, several studies have suggested the presence of low-risk groups among febrile neutropenic patients.

METHODS

A prospective randomized trial was conducted to compare treatment with oral ciprofloxacin (200 mg) and amoxicillin-clavulanate (375 mg) administered every 8 h against that with intravenous ceftazidime (1 g) administered every 12 h in low-risk febrile neutropenic patients with lung cancer. All patients received chemotherapy and antibiotic therapy while being hospitalized.

RESULTS

A total of 177 patients with lung cancer agreed to participate in this study prior to undergoing chemotherapy. Among them, a total of 36 neutropenic patients with 42 febrile episodes were enrolled in the study. Treatment was successful without the need for modification in 91% of the episodes in patients receiving the oral regimen and 79% of the episodes in patients receiving the intravenous regimen. No treatment-related deaths occurred. One patient developed nausea while receiving the oral regimen, so the oral regimen was changed to the intravenous regimen in this patient.

CONCLUSIONS

This prospective study suggested that treatment with oral antibiotics ciplofloxacin plus amoxicillin-clavulanate was effective for low-risk febrile neutropenic patients after chemotherapy.

摘要

背景

中性粒细胞减少性发热是癌症化疗最严重的不良反应之一。中性粒细胞减少可能导致危及生命的细菌感染。因此,发热性中性粒细胞减少的住院患者经验性地接受静脉注射广谱抗生素治疗。最近,多项研究表明发热性中性粒细胞减少患者中存在低风险组。

方法

进行了一项前瞻性随机试验,比较口服环丙沙星(200毫克)和阿莫西林-克拉维酸(375毫克)每8小时给药一次与静脉注射头孢他啶(1克)每12小时给药一次对低风险发热性中性粒细胞减少的肺癌患者的治疗效果。所有患者在住院期间均接受化疗和抗生素治疗。

结果

共有177例肺癌患者在化疗前同意参与本研究。其中,共有36例中性粒细胞减少患者发生42次发热发作并纳入研究。接受口服方案的患者中91%的发作治疗成功且无需调整治疗方案,接受静脉方案的患者中79%的发作治疗成功。未发生与治疗相关的死亡。1例患者在接受口服方案时出现恶心,因此该患者的口服方案改为静脉方案。

结论

这项前瞻性研究表明,口服抗生素环丙沙星加阿莫西林-克拉维酸治疗对化疗后低风险发热性中性粒细胞减少患者有效。

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