Spachmann Philipp Julian, Witt Daniel, Breyer Johannes, Denzinger Stefan, Burger Maximilian, Vergho Daniel Claudius, Otto Wolfgang, Schnabel Marco Julius
Departement of Urology, Caritas St. Josef Medical Center Regensburg, University of Regensburg, Regensburg, Germany.
Urologie Landau Isar and Urologie Plattling, Plattling, Germany.
Urol Int. 2025;109(2):146-150. doi: 10.1159/000541798. Epub 2024 Oct 3.
According to guidelines, transrectal random biopsy of the prostate (TRBP) is performed under antibiotic prophylaxis (AP). Fosfomycin-trometamol (FOS) is not approved in Germany, but TRBP as indication was listed in the product information falsely. The aim was to investigate infectious complications of TRBP under FOS as a single dose.
All TRBPs under FOS 3,000 mg as a single dose between July 1, 2020, and June 30, 2021, at a university institution were recorded. 357 patients (41-85 years old, median 66) were included. 243 received first TRBP, 321 TRBP were MRI-fusionated. 10-22 cores were taken (median 14). Prostate-specific antigen (PSA) was 0.1-1224 ng/mL (median 7.7 ng/mL), prostate volume 5-263 mL (median 50 mL). Analysis was performed using Chi square test or Fisher's exact test, Mann-Whitney U test, and t test.
Four patients suffered an infection (1.1%), without significant difference according to age (p = 0.849), PSA (p = 0.957), number of cores (p = 0.905), and increase in volume (p = 0.456). Limiting is the retrospective character.
The complication rate was 1.1%, and FOS single dose therefore represents sufficient AP for TRBP in this collective. FOS as a single dose should be reevaluated in a prospective study to obtain approval in Germany for this indication.
根据指南，经直肠前列腺随机活检（TRBP）在抗生素预防（AP）下进行。磷霉素氨丁三醇（FOS）在德国未获批准，但产品说明书中错误地将TRBP列为适应症。目的是研究单剂量FOS下TRBP的感染并发症。
记录了2020年7月1日至2021年6月30日在一所大学机构进行的所有单剂量3000mg FOS下的TRBP。纳入357例患者（41 - 85岁，中位年龄66岁）。243例接受首次TRBP，321例TRBP进行了MRI融合。取材10 - 22个核心（中位14个）。前列腺特异性抗原（PSA）为0.1 - 1224 ng/mL（中位7.7 ng/mL），前列腺体积5 - 263 mL（中位50 mL）。采用卡方检验或Fisher精确检验、Mann - Whitney U检验和t检验进行分析。
4例患者发生感染（1.1%），根据年龄（p = 0.849）、PSA（p = 0.957）、核心数量（p = 0.905）和体积增加（p = 0.456）无显著差异。局限性在于研究具有回顾性。
并发症发生率为1.1%，因此单剂量FOS对该群体的TRBP而言是足够的抗生素预防。应在前瞻性研究中重新评估单剂量FOS，以便在德国获得该适应症的批准。
