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环丙沙星与左氧氟沙星预防造血干细胞移植:一项随机试验。

Ciprofloxacin versus levofloxacin prophylaxis in hematopoietic stem cell transplantation: A randomized trial.

机构信息

Stem Cell Transplant and Cellular Therapy, Henry Ford Health, Detroit, MI, USA.

Stem Cell Transplant and Cellular Therapy, Henry Ford Health, Detroit, MI, USA.

出版信息

Int J Infect Dis. 2024 Oct;147:107172. doi: 10.1016/j.ijid.2024.107172. Epub 2024 Jul 15.

Abstract

OBJECTIVES

We aimed to assess whether there is a difference between ciprofloxacin and levofloxacin as prophylaxis in hematopoietic stem cell transplant (SCT) recipients.

METHODS

This is a prospective, randomized trial in patients receiving SCT at Henry Ford Health in the United States of America. We randomly assigned patients (1:1) to receive ciprofloxacin or levofloxacin. The primary outcome was incidence of bloodstream bacterial infections (BSI) up to day 60 after SCT.

RESULTS

Between June 4, 2018, and May 23, 2022, we randomly assigned 308 consecutive patients to receive ciprofloxacin (154 patients) or levofloxacin (154 patients). BSI was similar in both the ciprofloxacin and levofloxacin groups (18 [11.7%] vs 18 [11.7%]). Pneumonia was more frequent in the ciprofloxacin group compared to the levofloxacin group (18 [18%] vs 7 [23%]; relative risk 2.57, 95% CI 1.11-5.98; p = 0.028). There were no differences in neutrophil engraftment, fever, Clostridium difficile infection, relapse incidence, overall survival, nonrelapse mortality, length of stay post-SCT, or intensive care unit admission.

CONCLUSION

Although both prophylaxis regimens demonstrated the same efficacy in SCT recipients, levofloxacin prophylaxis led to less pneumonia in the first 60 days post-SCT.

TRIAL REGISTRATION

This study is registered on ClinicalTrials.gov, NCT03850379.

摘要

目的

评估环丙沙星和左氧氟沙星在造血干细胞移植(SCT)受者中的预防效果是否存在差异。

方法

这是在美国亨利福特健康中心进行的一项前瞻性、随机试验,纳入接受 SCT 的患者。我们将患者(1:1)随机分为接受环丙沙星或左氧氟沙星组。主要结局是 SCT 后 60 天内血流细菌感染(BSI)的发生率。

结果

2018 年 6 月 4 日至 2022 年 5 月 23 日,我们连续随机分配了 308 例患者接受环丙沙星(154 例)或左氧氟沙星(154 例)。环丙沙星组和左氧氟沙星组的 BSI 发生率相似(18 [11.7%] vs 18 [11.7%])。与左氧氟沙星组相比,环丙沙星组的肺炎更常见(18 [18%] vs 7 [23%];相对风险 2.57,95%CI 1.11-5.98;p = 0.028)。两组在中性粒细胞植入、发热、艰难梭菌感染、复发率、总生存率、非复发死亡率、SCT 后住院时间或重症监护病房入住率方面均无差异。

结论

尽管两种预防方案在 SCT 受者中均显示出相同的疗效,但左氧氟沙星预防方案可使 SCT 后 60 天内肺炎的发生率降低。

试验注册

本研究在 ClinicalTrials.gov 注册,NCT03850379。

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