髋关节半髋关节置换术后早期假体周围感染无症状菌尿的作用。BARIFER 随机临床试验。
Role of asymptomatic bacteriuria on early periprosthetic joint infection after hip hemiarthroplasty. BARIFER randomized clinical trial.
机构信息
Infectious Diseases Department, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Pg. Vall d'Hebron 119-129, 08035, Barcelona, Spain.
Spanish Network for Research in Infectious Diseases (REIPI RD16/0016/0003), Instituto de Salud Carlos III, Madrid, Spain.
出版信息
Eur J Clin Microbiol Infect Dis. 2021 Nov;40(11):2411-2419. doi: 10.1007/s10096-021-04241-2. Epub 2021 Apr 16.
PURPOSE
To evaluate preoperative asymptomatic bacteriuria (ASB) treatment to reduce early-periprosthetic joint infections (early-PJIs) after hip hemiarthroplasty (HHA) for fracture.
METHODS
Open-label, multicenter RCT comparing fosfomycin-trometamol versus no intervention with a parallel follow-up cohort without ASB.
PRIMARY OUTCOME
early-PJI after HHA.
RESULTS
Five hundred ninety-four patients enrolled (mean age 84.3); 152(25%) with ASB (77 treated with fosfomycin-trometamol/75 controls) and 442(75%) without. Despite the study closed without the intended sample size, ASB was not predictive of early-PJI (OR: 1.06 [95%CI: 0.33-3.38]), and its treatment did not modify early-PJI incidence (OR: 1.03 [95%CI: 0.15-7.10]).
CONCLUSIONS
Neither preoperative ASB nor its treatment appears to be risk factors of early-PJI after HHA. ClinicalTrials.gov Identifier: Eudra CT 2016-001108-47.
目的
评估术前无症状菌尿（ASB）治疗是否能降低髋部半髋关节置换术（HHA）后骨折的早期假体周围关节感染（早期 PJI）。
方法
开放性标签、多中心 RCT，比较了磷霉素氨丁三醇与无干预措施，并平行随访了一组无 ASB 的队列。
主要结局
HHA 后早期 PJI。
结果
共纳入 594 例患者（平均年龄 84.3 岁）；152 例（25%）有 ASB（77 例接受磷霉素氨丁三醇治疗，75 例为对照组），442 例（75%）无 ASB。尽管该研究未达到预期的样本量而提前关闭，但 ASB 并不是早期 PJI 的预测因素（OR：1.06[95%CI：0.33-3.38]），其治疗也未改变早期 PJI 的发生率（OR：1.03[95%CI：0.15-7.10]）。
结论
术前 ASB 及其治疗均不是 HHA 后早期 PJI 的危险因素。
临床试验注册号
Eudra CT 2016-001108-47。
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