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与传统培养和敏感性检测相比,聚合酶链反应(PCR)在成人复杂性尿路感染管理中的临床应用:第二部分。诊断一致性、不一致结果及抗菌药物选择疗效的评估

Clinical utility of PCR compared to conventional culture and sensitivity testing for management of complicated urinary tract infections in adults: Part II.Evaluation of diagnostic concordance, discordant results, and antimicrobial selection efficacy.

作者信息

Spangler Frank L, Williams Cheau, Aberger Michael E, Wilson Bradley A, Ajib Khaled, Gholami Shahram S, Goodwin Henry N, Park Lauren Y, Kardjadj Moustafa, Derrick DeAndre, Huard Thomas K

机构信息

Soft Cell Laboratories, Saint George, UT, USA.

Colquitt Regional Medical Center, Moultrie, Georgia.

出版信息

Diagn Microbiol Infect Dis. 2025 Mar;111(3):116646. doi: 10.1016/j.diagmicrobio.2024.116646. Epub 2024 Dec 7.

Abstract

PURPOSE

Complicated urinary tract infections (cUTIs) are difficult to manage due to their polymicrobial nature and resistance to standard therapies. In current clinical practice, the management of a cUTI often starts with broad-spectrum antimicrobials until culture and sensitivity (C&S) results are available, but these diagnostic delays further hinder treatment efficacy. Polymerase Chain Reaction (PCR) offers a faster alternative. This study evaluates PCR's utility compared to C&S, focusing on agreeability, discordant results, clinical outcomes, and antimicrobial selection efficacy to improve cUTI management.

MATERIALS AND METHODS

The clinical study was conducted in two parts: the primary study focused on patients with cUTIs, while the sub-study involved healthy individuals without signs or symptoms of urinary tract infection (UTI). All collected samples underwent analysis using both PCR and C&S for comparison. Building on the first part of the study, the research evaluated outcome measures related to discordant analysis.

RESULTS

Overall, our study supports good agreement between PCR and C&S in positive cases (95.32 % at baseline and 88.06 % at end of study (EOS)) but reveals some discordance in negative cases (38.30 % at baseline and 62.91 % at EOS). The negative percent agreement (NPA) in the sub-study on the healthy population was 70.16 %. Further analysis of discordant results revealed that symptomatic patients treated for PCR-positive infections trended toward better clinical outcomes (77.45 % vs. 71.42 %) and higher rates of microbiological eradication (53.92 % vs. 50 %) compared to those treated for C&S-positive infections. Additional analysis on antimicrobial use and microbiological aspects revealed that the PCR group received more oral medication-based treatments, while the C&S group received other forms (intramuscular or bladder irrigation). In cases of discordant results, there were more PCR-positive but culture-negative cases than PCR-negative but culture-positive cases.

CONCLUSIONS

Our clinical utility study data suggests that PCR-guided management of cUTIs is overall superior to conventional C&S, offering several advantages. PCR has the potential to enhance patient care by enabling the early adoption of narrower antibiotic therapies, improving clinical outcomes, and ensuring the effective selection of antimicrobials. A PCR-guided management plan could be particularly beneficial in managing patients with cUTIs, addressing infections that are occasionally overlooked with current C&S-guided treatment protocols.

摘要

目的

复杂性尿路感染(cUTIs)因其微生物种类多样且对标准疗法耐药,难以进行管理。在当前临床实践中,cUTI的管理通常始于使用广谱抗菌药物,直至获得培养和药敏(C&S)结果,但这些诊断延迟进一步阻碍了治疗效果。聚合酶链反应(PCR)提供了一种更快的替代方法。本研究评估了PCR与C&S相比的效用,重点关注一致性、不一致结果、临床结局以及抗菌药物选择效果,以改善cUTI的管理。

材料与方法

临床研究分两部分进行:主要研究聚焦于cUTI患者,而子研究涉及无尿路感染(UTI)体征或症状的健康个体。所有收集的样本均采用PCR和C&S进行分析以作比较。在研究的第一部分基础上,该研究评估了与不一致分析相关的结局指标。

结果

总体而言,我们的研究支持PCR与C&S在阳性病例中的良好一致性(基线时为95.32%,研究结束时(EOS)为88.06%),但在阴性病例中发现了一些不一致性(基线时为38.30%,EOS时为62.91%)。健康人群子研究中的阴性百分比一致性(NPA)为70.16%。对不一致结果的进一步分析显示,与接受C&S阳性感染治疗的患者相比,接受PCR阳性感染治疗的有症状患者临床结局有改善趋势(77.45%对71.42%),微生物根除率更高(53.92%对50%)。关于抗菌药物使用和微生物学方面的额外分析显示,PCR组接受更多基于口服药物的治疗,而C&S组接受其他形式(肌肉注射或膀胱冲洗)。在结果不一致的情况下,PCR阳性但培养阴性的病例比PCR阴性但培养阳性的病例更多。

结论

我们的临床效用研究数据表明,PCR指导的cUTI管理总体上优于传统的C&S,具有多个优势。PCR有可能通过尽早采用更窄谱的抗生素疗法、改善临床结局以及确保抗菌药物的有效选择来提高患者护理水平。PCR指导的管理计划在管理cUTI患者方面可能特别有益,可解决当前C&S指导的治疗方案偶尔会忽略的感染问题。

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