Supplementary Material for: Efficacy and Safety of Two Fosfomycin Regimens as Antimicrobial Prophylaxis for Transrectal Prostate Biopsy: A Randomised Study

Purpose: Prostate biopsy is the gold standard for prostate cancer diagnosis; unfortunately, this procedure is not free from complications. Recent studies have shown an increase in antibiotic resistance. The aim of our prospective randomized study was to evaluate the efficacy and safety of a prostate biopsy prophylaxis protocol using 2 vs. 3 fosfomycin doses. Methods: Two hundred and ninety-seven patients undergoing transrectal systematic ultrasound (US)-guided (n = 277) or transrectal fusion prostate biopsy (n = 20) were prospectively evaluated and randomized by date of birth, to receive 2 (even years, group A) versus 3 doses of fosfomycin (odd years, group B), and prospectively evaluated. Results:Two hundred and ninety-seven patients were randomized to group A (n = 162) or group B (n = 135). The 2 groups were comparable with respect to age, comorbidity, PSA value, prostate volume, operative time and urine culture results. Out of 297 patients, 44 (14.8%) developed complications after the procedure; 2.7% (8/297) of patients developed fever >38° requiring hospitalization (6 [3.7%] in group A and 2 [1.5%] in group B, p = 0.29). Patients who underwent fusion biopsy were more frequently readmitted in comparison with patients undergoing US-guided prostate biopsy (p = 0.000). Conclusion: The low fever and prostatitis rate suggest that fosfomycin prophylaxis is safe and efficient. There is no significant difference in clinical outcome between the 2 dosage regimens.

研究目的：前列腺活检是前列腺癌诊断的金标准，但该操作并非完全无并发症风险。近期研究表明，抗生素耐药性呈上升趋势。本前瞻性随机对照研究旨在评估2剂与3剂磷霉素方案用于前列腺活检术前预防的有效性与安全性。

研究方法：本研究前瞻性纳入297例行经直肠系统超声（Transrectal Systematic Ultrasound, US）引导下前列腺活检（n=277）或经直肠融合前列腺活检（Transrectal Fusion Prostate Biopsy, n=20）的患者，按出生日期进行随机分组：出生年份为偶数者接受2剂磷霉素预防（A组，n=162），出生年份为奇数者接受3剂磷霉素预防（B组，n=135），并对所有入组患者进行前瞻性随访评估。

研究结果：共297例患者被随机分配至A组或B组。两组患者在年龄、合并症、前列腺特异性抗原（Prostate Specific Antigen, PSA）水平、前列腺体积、手术时长及尿培养结果等基线特征上均具有可比性。297例患者中，44例（14.8%）在术后出现并发症；其中8例（2.7%）出现体温＞38℃的发热症状并需住院治疗（A组6例[3.7%]，B组2例[1.5%]，p=0.29）。接受融合前列腺活检的患者再住院率显著高于经US引导活检的患者（p=0.000）。

研究结论：较低的发热与前列腺炎发生率提示磷霉素预防方案安全有效。两种给药剂量方案的临床结局无显著差异。