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生物标志物指导下的社区获得性肺炎抗生素管理:一项随机对照试验。

Biomarker guided antibiotic stewardship in community acquired pneumonia: A randomized controlled trial.

机构信息

Department of Pulmonary Medicine, Northwest Hospital, Alkmaar, the Netherlands.

Department of Pulmonary Medicine, Zaans Medical Centre, Zaandam, the Netherlands.

出版信息

PLoS One. 2024 Aug 20;19(8):e0307193. doi: 10.1371/journal.pone.0307193. eCollection 2024.

DOI:10.1371/journal.pone.0307193
PMID:39163362
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11335096/
Abstract

BACKGROUND

In community-acquired pneumonia (CAP), the role of biomarkers to shorten duration of antibiotic treatment has not been firmly established. We assessed the effectiveness of active feedback of treatment algorithms based on procalcitonin (PCT) and C-reactive protein (CRP), compared to standard care, on the duration of antibiotic treatment in patients hospitalized with community-acquired pneumonia (CAP) in non-ICU wards.

METHODS AND FINDINGS

We performed a randomised, open label, parallel group, multi-centre trial in 3 Dutch teaching hospitals. Treatment was guided by a PCT algorithm, CRP algorithm or standard care. Participants were recruited by a member of the study team and randomised at day 2-3 of admission in a 1:1:1 ratio. Treatment was discontinued upon predefined thresholds of biomarkers that were assessed on admission, day 4 and days 5-7 if indicated. The primary outcome was total days on antibiotic treatment until day 30. In total 468 participants were included in this study. The median days on antibiotics (IQR) was 7 (IQR 7-10) in the control group, 4 (IQR 3-7) in the CRP group (rate ratio (RR) of 0.70, 95% CI 0.61-0.82 compared to standard care; p <0.001), and 5.5 (IQR 3-9) in the PCT group (RR of 0.78, 95% CI 0.68-0.89 compared to standard care; p <0.001). New antibiotics within the first 30 days were prescribed to 24, 23 and 35 patients in standard care, CRP and PCT groups, respectively. The hazard ratio for a new prescription in patients in the PCT group compared to standard care 1.63 (CI 0.97-2.75; p = 0.06). No difference in time to clinical stability or length of stay was found.

CONCLUSIONS

A strategy of feedback of CRP-guided and PCT-guided treatment algorithms reduced the number of days on antibiotic in the first 30 days after hospital admission in non-ICU wards for CAP. The study was not powered to determine safety of shortening duration of antibiotic treatment. (NCT01964495).

摘要

背景

在社区获得性肺炎(CAP)中,生物标志物在缩短抗生素治疗时间方面的作用尚未得到明确证实。我们评估了基于降钙素原(PCT)和 C 反应蛋白(CRP)的治疗算法的主动反馈,与标准护理相比,对非 ICU 病房住院社区获得性肺炎(CAP)患者抗生素治疗时间的影响。

方法和发现

我们在荷兰 3 家教学医院进行了一项随机、开放标签、平行组、多中心试验。治疗由 PCT 算法、CRP 算法或标准护理指导。研究人员招募参与者,并在入院后第 2-3 天以 1:1:1 的比例进行随机分组。如果需要,在入院时、第 4 天和第 5-7 天评估生物标志物的预设阈值时,停止治疗。主要结局是直到第 30 天的抗生素治疗总天数。共有 468 名患者参与本研究。对照组抗生素治疗中位数天数(IQR)为 7(IQR 7-10),CRP 组为 4(IQR 3-7)(与标准护理相比,RR 为 0.70,95%CI 0.61-0.82;p<0.001),PCT 组为 5.5(IQR 3-9)(与标准护理相比,RR 为 0.78,95%CI 0.68-0.89;p<0.001)。标准护理、CRP 和 PCT 组中,在第 30 天内开新抗生素的患者分别为 24、23 和 35 例。与标准护理相比,PCT 组的新处方风险比为 1.63(95%CI 0.97-2.75;p=0.06)。未发现临床稳定时间或住院时间的差异。

结论

反馈 CRP 指导和 PCT 指导治疗算法的策略减少了非 ICU 病房 CAP 患者入院后前 30 天的抗生素治疗天数。该研究没有足够的能力确定缩短抗生素治疗时间的安全性。(NCT01964495)。

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本文引用的文献

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Lancet Infect Dis. 2022 Feb;22(2):274-283. doi: 10.1016/S1473-3099(21)00255-3. Epub 2021 Oct 7.
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Effect of C reactive protein point-of-care testing on antibiotic prescribing for lower respiratory tract infections in nursing home residents: cluster randomised controlled trial.C 反应蛋白即时检测对养老院居民下呼吸道感染抗生素处方的影响:整群随机对照试验。
BMJ. 2021 Sep 21;374:n2198. doi: 10.1136/bmj.n2198.
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Discontinuing β-lactam treatment after 3 days for patients with community-acquired pneumonia in non-critical care wards (PTC): a double-blind, randomised, placebo-controlled, non-inferiority trial.
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Lancet. 2021 Mar 27;397(10280):1195-1203. doi: 10.1016/S0140-6736(21)00313-5.
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Duration of antibiotic therapy in critically ill patients: a randomized controlled trial of a clinical and C-reactive protein-based protocol versus an evidence-based best practice strategy without biomarkers.抗生素治疗危重症患者的持续时间:基于临床和 C 反应蛋白的方案与无生物标志物的基于证据的最佳实践策略的随机对照试验。
Crit Care. 2020 Jun 1;24(1):281. doi: 10.1186/s13054-020-02946-y.
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Laboratory abnormalities in patients with COVID-2019 infection.2019冠状病毒病感染患者的实验室异常情况。
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