随机对照试验比较了环丙沙星和头孢吡肟在血液恶性肿瘤发热性中性粒细胞减少症患者中的应用。

Randomized controlled trial comparing ciprofloxacin and cefepime in febrile neutropenic patients with hematological malignancies.

机构信息

Department of Hematology and Oncology, Graduate School of Medicine, Nagoya University, Nagoya, Japan.

出版信息

Int J Infect Dis. 2013 Jun;17(6):e385-90. doi: 10.1016/j.ijid.2012.12.005. Epub 2013 Jan 11.

DOI:10.1016/j.ijid.2012.12.005

PMID:23317527

Abstract

BACKGROUND

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.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

摘要

背景

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。

方法

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。

结果

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。