A double-blind comparison of empirical oral and intravenous antibiotic therapy for low-risk febrile patients with neutropenia during cancer chemotherapy
A double-blind comparison of empirical oral and intravenous antibiotic therapy for low-risk febrile patients with neutropenia during cancer chemotherapy
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DOI：
10.1056/nejm199907293410501
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发表时间：
1999-07-29
影响因子：
158.5
通讯作者：
Pizzo, PP
中科院分区：
文献类型：
--
作者：
Freifeld, A;Marchigiani, D;Pizzo, PP
背景 在癌症化疗期间出现发热和中性粒细胞减少且并发症风险较低的患者中，口服经验性广谱抗生素可能是静脉治疗的一种可接受的替代方法。
方法 我们对癌症化疗期间出现发热和中性粒细胞减少的患者（年龄5至74岁）进行了一项随机、双盲、安慰剂对照研究。预计这些患者的中性粒细胞减少持续时间不超过10天，且他们没有其他潜在疾病。患者被随机分配接受口服环丙沙星加阿莫西林 - 克拉维酸或静脉注射头孢他啶治疗。他们住院直至发热和中性粒细胞减少情况缓解。
结果 每组各纳入116例次（口服治疗组84例患者，静脉治疗组79例患者）。入院时平均中性粒细胞计数分别为每立方毫米81个和每立方毫米84个；中性粒细胞减少的平均持续时间分别为3.4天和3.8天。口服治疗组71%的病例和静脉治疗组67%的病例无需调整治疗即获成功（组间差异为3%；95%置信区间为 - 8%至15%；P = 0.48）。分别有13%和32%的病例因需要调整治疗方案而被视为治疗失败（P（此处原文似乎不完整））
Background Among patients with fever and neutropenia during cancer chemotherapy who have a low risk of complications, oral administration of empirical broad-spectrum antibiotics may be an acceptable alternative to intravenous treatment.Methods We conducted a randomized, double-blind, placebo-controlled study of patients (age, 5 to 74 years) who had fever and neutropenia during chemotherapy for cancer. Neutropenia was expected to be present for no more than 10 days in these patients, and they had to have no other underlying conditions. Patients were assigned to receive either oral ciprofloxacin plus amoxicillin-clavulanate or intravenous ceftazidime. They were hospitalized until fever and neutropenia resolved.Results A total of 116 episodes were included in each group (84 patients in the oral-therapy group and 79 patients in the intravenous-therapy group). The mean neutrophil counts at admission were 81 per cubic millimeter and 84 per cubic millimeter, respectively; the mean duration of neutropenia was 3.4 and 3.8 days, respectively. Treatment was successful without the need for modifications in 71 percent of episodes in the oral-therapy group and 67 percent of episodes in the intravenous-therapy group (difference between groups, 3 percent; 95 percent confidence interval, -8 percent to 15 percent; P=0.48). Treatment was considered to have failed because of the need for modifications in the regimen in 13 percent and 32 percent of episodes, respectively (P