Department of Hematology and Oncology, Graduate School of Medicine, Nagoya University, Nagoya, Japan.
Int J Infect Dis. 2013 Jun;17(6):e385-90. doi: 10.1016/j.ijid.2012.12.005. Epub 2013 Jan 11.
Ciprofloxacin (CPFX) is a potential alternative in patients with febrile neutropenia (FN) because of its activity against Gram-negative organisms. We conducted a non-inferiority, open-label, randomized controlled trial comparing intravenous CPFX and cefepime (CFPM) for FN patients with hematological malignancies.
Patients aged from 15 to 79 years with an absolute neutrophil count of <0.500 × 10(9/)l were eligible, and were randomized to receive 300 mg of CPFX or 2g of CFPM every 12h. Initial treatment efficacy, overall response, and early toxicity were evaluated.
Fifty-one episodes were included in this trial, and 49 episodes (CPFX vs. CFPM: 24 vs. 25) were evaluated. Treatment efficacy at day 7 was significantly higher in the CFPM group (successful clinical response: nine with CPFX and 19 with CFPM; p=0.007). The response was better in high-risk patients with neutrophil counts of ≤ 0.100 × 10(9/)l (p=0.003). The overall response during the study period was similar between the CPFX and CFPM groups (p=0.64). Adverse events were minimal, and all patients could continue the treatment.
We could not prove the non-inferiority of CPFX in comparison with CFPM for the initial treatment of FN. CFPM remains the standard treatment of choice for FN.
环丙沙星（CPFX）由于其对革兰氏阴性菌的活性，是发热性中性粒细胞减少症（FN）患者的潜在替代药物。我们进行了一项非劣效性、开放标签、随机对照试验，比较了静脉注射 CPFX 和头孢吡肟（CFPM）在血液恶性肿瘤 FN 患者中的疗效。
年龄在 15 至 79 岁之间、中性粒细胞绝对计数<0.500×10(9)/l 的患者有资格入组，并随机接受 300mg CPFX 或 2g CFPM，每 12 小时一次。评估初始治疗效果、总反应和早期毒性。
该试验共纳入 51 例病例，其中 49 例（CPFX 组与 CFPM 组分别为 24 例与 25 例）进行了评估。第 7 天的治疗效果在 CFPM 组更高（成功临床反应：CPFX 组 9 例，CFPM 组 19 例；p=0.007）。中性粒细胞计数≤0.100×10(9)/l 的高危患者反应更好（p=0.003）。在整个研究期间，CPFX 组和 CFPM 组的总反应相似（p=0.64）。不良事件很少，所有患者都可以继续治疗。
我们无法证明 CPFX 在 FN 的初始治疗中与 CFPM 相比不具有非劣效性。CFPM 仍然是 FN 的标准治疗选择。
