单剂量左氧氟沙星与单剂量磷霉素在尿动力学检查前预防尿路感染发生率的有效性比较：一项随机对照试验。
Comparison of the effectiveness of single-dose levofloxacin with single-dose fosfomycin pre-urodynamic study related to the incidence of urinary tract infection: a randomized controlled trial.
作者信息
Rahardjo Harrina Erlianti, Widia Fina, Wijaya Cindy, Leonardo Kevin, Tanjung Alfred, Arfiananda Muhammad Hanif, Fitriani Fatimah Nuwwaaridya, Siregar Rahmat Aidil Fajar, Afriansyah Andika
机构信息
Department of Urology, Faculty of Medicine, Universitas Indonesia - Cipto Mangunkusumo Hospital, Jakarta, Indonesia.
Division of Urology, Department of Surgery, Persahabatan Hospital - Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.
出版信息
BMC Urol. 2025 Jul 14;25(1):172. doi: 10.1186/s12894-025-01839-y.
PURPOSE
The purpose of this study is to examine the efficacy of 500 mg levofloxacin and 3 g fosfomycin given as single-dose prophylactic antibiotics one hour before urodynamic studies (UDS) to prevent urinary tract infections (UTIs).
METHODS
This single-blinded, randomized clinical trial included 126 patients who underwent UDS between December 2022 and March 2024 at two urology centers in Jakarta. The patients, aged 18 years and older, were randomized equally into two groups receiving either 500 mg levofloxacin or 3 g fosfomycin prior to UDS. The primary indications for UDS included lower urinary tract symptoms (LUTS) (54.8%), overactive bladder (OAB) (32.8%), underactive bladder (8.9%), and stress urinary incontinence (3.5%). Three days post-UDS, patients were followed up with urinalysis and clinical assessment for UTI symptoms.
RESULTS
Among the 126 patients, UTI was diagnosed in 26 cases (20.9%), with 14 cases (22.2%) in the levofloxacin group and 12 cases (19%) in the fosfomycin group, showing no significant difference ( = 0.660). Symptomatic UTIs occurred in 6 patients (4.8%) in the levofloxacin group and 7 patients (5.6%) in the fosfomycin group. E. coli was the most commonly detected bacterium in urine cultures.
CONCLUSION
In our center, there was no significant difference in the clinical outcome between the administration of 3 g fosfomycin and 500 mg levofloxacin as single-dose prophylactic antibiotics prior to UDS. Given the rising antibiotic resistance, fosfomycin may be considered an alternative. Further multicenter and multinational studies are warranted, as bacterial profiles and antibiotic resistance patterns may vary across different regions and healthcare systems.
TRIAL REGISTRATION
NCT06017479.
STUDY REGISTRATION DATE
2023-08-24.
SUPPLEMENTARY INFORMATION
The online version contains supplementary material available at 10.1186/s12894-025-01839-y.
目的
本研究旨在探讨在尿动力学检查（UDS）前1小时给予500毫克左氧氟沙星和3克磷霉素作为单剂量预防性抗生素预防尿路感染（UTI）的疗效。
方法
这项单盲随机临床试验纳入了2022年12月至2024年3月期间在雅加达的两个泌尿外科中心接受UDS检查的126例患者。年龄在18岁及以上的患者被随机平均分为两组，在UDS检查前分别接受500毫克左氧氟沙星或3克磷霉素。UDS的主要适应证包括下尿路症状（LUTS）（54.8%）、膀胱过度活动症（OAB）（32.8%）、膀胱活动低下（8.9%）和压力性尿失禁（3.5%）。UDS检查后3天，对患者进行尿液分析和UTI症状的临床评估随访。
结果
126例患者中，26例（20.9%）被诊断为UTI，其中左氧氟沙星组14例（22.2%），磷霉素组12例（19%），差异无统计学意义（=0.660）。左氧氟沙星组有6例患者（4.8%）发生有症状的UTI，磷霉素组有7例患者（5.6%）发生有症状的UTI。大肠杆菌是尿培养中最常检测到的细菌。
结论
在我们中心，UDS检查前给予3克磷霉素和500毫克左氧氟沙星作为单剂量预防性抗生素的临床结局无显著差异。鉴于抗生素耐药性不断上升，磷霉素可被视为一种替代药物。由于不同地区和医疗系统的细菌谱和抗生素耐药模式可能不同，有必要进行进一步的多中心和跨国研究。
试验注册
NCT06017479。
研究注册日期
2023-08-24。
补充信息
在线版本包含可在10.1186/s12894-025-01839-y获取的补充材料。
Zotero 插件