载万古霉素硫酸钙珠降低非可变危险因素患者急性假体周围关节感染发生率：一项随机临床试验。

Decrease in acute periprosthetic joint infections incidence with vancomycin-loaded calcium sulfate beads in patients with non-modifiable risk factors. A randomized clinical trial.

机构信息

Institute of Social Security of Mexican State and Districts (ISSEMyM), Avenida paseo del ferrocarril numero 88, Los reyes Ixtacala, 54055, Mexico.

出版信息

J ISAKOS. 2022 Dec;7(6):201-205. doi: 10.1016/j.jisako.2022.08.002. Epub 2022 Aug 13.

DOI:10.1016/j.jisako.2022.08.002

PMID:35973626

Abstract

OBJECTIVES

The influence of local antibiotic therapy in orthopedic surgery remains unclear. In this trial, we evaluated the incidence of periprosthetic joint infections (PJI), after local or intravenous (IV) antibiotic prophylaxis. The aim of this intervention was to compare the PJI incidence in a population with non-modifiable risk factors after local prophylaxis with vancomycin-loaded calcium sulfate beads versus a control group.

METHODS

A total of 83 subjects were evaluated, inclusion criteria included participants over 60 years of age, with at least one main risk factor for PJI who underwent total hip or knee joint replacement between June 2019 and May 2020. Cases were randomized, and the intervention group received local prophylactic antibiotic therapy with calcium sulfate beads impregnated with vancomycin; conventional IV prophylactic antibiotic therapy was administered for the control group. C-reactive protein (CRP) and erythrocyte sedimentation rate (ERS) serum biomarkers were analyzed on the day 5 and weeks 4, 8, and 12. When needed, the synovial fluid sample was obtained and cultured for the early acute PJI diagnosis.

RESULTS

Acute PJI was found in 27 patients (67.5%) in the control group and 4 (9.3%) in the intervention group. The variable analysis identified that local prophylaxis with calcium sulfate beads reduces the incidence of acute knee or hip PJI in patients with non-modifiable risk factors compared to conventional prophylaxis (p < 0.0001) with a relative risk of 0.13 (CI:0.05-0.35). Length of hospital stay was also shorter in the intervention group at 4.6 days, compared to 15.25 days in the control group; p < 0.001.

CONCLUSIONS

Local antibiotic prophylaxis in patients with non-modifiable risk factors undergoing hip or knee replacement reduces the incidence of acute PJI compared to IV antibiotics.

CLINICAL TRIALS

NCT03976466 (clnicaltrials.gov) LEVEL OF EVIDENCE: II.

摘要

目的

局部抗生素治疗在骨科手术中的影响仍不清楚。在这项试验中，我们评估了局部或静脉（IV）抗生素预防后假体周围关节感染（PJI）的发生率。该干预措施的目的是比较局部万古霉素硫酸钙珠预防后，人群中不可改变的危险因素与对照组的 PJI 发生率。

方法

共评估了 83 例患者，纳入标准包括年龄超过 60 岁、至少有一个主要 PJI 危险因素、2019 年 6 月至 2020 年 5 月期间行全髋关节或膝关节置换术的患者。病例随机分组，干预组接受局部预防性抗生素治疗，用万古霉素浸渍硫酸钙珠；对照组接受常规 IV 预防性抗生素治疗。在第 5 天和第 4、8、12 周分析 C 反应蛋白（CRP）和红细胞沉降率（ERS）血清生物标志物。如有需要，获得滑膜液样本并进行培养以早期诊断急性 PJI。

结果

对照组 27 例（67.5%）和干预组 4 例（9.3%）发生急性 PJI。变量分析表明，与常规预防相比，局部用硫酸钙珠预防可降低非可改变危险因素患者的急性膝关节或髋关节 PJI 发生率（p<0.0001），相对风险为 0.13（CI：0.05-0.35）。干预组的住院时间也更短，为 4.6 天，而对照组为 15.25 天；p<0.001。