近日，比利时鲁汶大学Jan Yvan Verbakel团队研究了一项临床决策工具，包括决策树、CRP的即时检测和安全网建议，以指导比利时初级保健急性病儿童的抗生素处方（ARON）。该研究于2025年9月25日发表在《柳叶刀》杂志上。

抗微生物药物耐药性是全球健康威胁。在门诊治疗中，许多患有急性疾病的儿童被不必要地开了抗生素。研究组评估了这些儿童的临床决策工具的临床有效性，包括一个经过验证的决策树、指导性的护理点C反应蛋白检测（CRP的POCT）和安全网建议。

ARON是一项多中心、非盲、实用、集群随机、对照试验，在符合条件的比利时全科医生和社区儿科医生中进行，能够招募急性疾病患儿，且未进行CRP POCT。实践以1:1的比例（n=4）随机分组分配到临床决策工具或常规护理，按招募学术中心分层。招募6个月至12岁的急性疾病患儿，随访30天。主要结局是指标会诊时的抗生素处方（优势测试），以及恢复时间、额外测试、随访和指标会诊后的抗生素处方（所有非劣效性测试分别为1天、3%、4%和2%）。主要结果采用logistic回归分析，考虑了意向治疗人群中的实践聚类、研究组和年龄，但恢复时间除外，采用Cox回归分析，对相同协变量进行调整。在意向治疗人群中评估安全性。

在171例符合条件的实践中，研究组随机分配82例为干预组，89例为常规护理组。在2021年2月24日至2023年12月29日期间，对7049名参与者进行了筛选，其中6760人被认为符合条件。每个研究组中有5名患者被排除，因此研究组共分析了6750名参与者的数据（干预组2988名，对照组3762名；3447名[51%]男孩，3302名[49%]女孩，1名[<；1%]未指定）。干预显著减少了指标会诊时的抗生素处方（466例[16%]vs 817例[22%]，校正优势比0.72;p= 0.017）。干预组的恢复时间（调整后的平均差值为- 0.1天）、额外检测（调整后的绝对风险降低率[aARR] 2.0%[- 0.7至5.0]）、随访（aARR 2.8%[- 0.9至6.1]）和指标咨询后的抗生素处方（aARR 2.4%[0.2至4.2]）均不低于对照组。102例不良事件中，严重不良事件90例（88%），其中干预组30例（1%），对照组60例（2%）；没有一个被认为与研究程序有关。在整个试验过程中没有儿童死亡。

研究结果表明，临床决策工具在不造成伤害的情况下减少了儿童的抗生素处方。该研究结果支持其更广泛的传播和实施，以改善急性患儿的门诊护理管理。

附：英文原文

Title: A clinical decision tool including a decision tree, point-of-care testing of CRP, and safety-netting advice to guide antibiotic prescribing in acutely ill children in primary care in Belgium (ARON): a pragmatic, cluster-randomised, controlled trial

Author: Jan Yvan Verbakel, Ruben Burvenich, Erinn Dhulster, Liselore De Rop, Ann Van den Bruel, Sibyl Anthierens, Samuel Coenen, An De Sutter, Stefan Heytens, Louise Joly, Marina Digregorio, Annouschka Laenen, Jeroen Luyten, Tine De Burghgraeve

Issue&Volume: 2025-09-25

Abstract:

Background

Antimicrobial resistance is a global health threat. Many children with acute illness in ambulatory care are unnecessarily prescribed antibiotics. We assessed the clinical effectiveness of a clinical decision tool for these children, including a validated decision tree, guided point-of-care C-reactive protein testing (POCT of CRP), and safety-netting advice.

Methods

ARON was a multicentre, unblinded, pragmatic, cluster-randomised, controlled trial conducted at eligibile Belgian general practitioner and community paediatrician practices able to recruit children with acute illness consecutively, and not already doing POCT of CRP. Practices were allocated (1:1) with equal size (n=4) block randomisation to the clinical decision tool or usual care, stratified by recruiting academic centre. Children with acute illness aged 6 months to 12 years were recruited and followed up for 30 days. The coprimary outcomes were antibiotic prescribing at the index consultation (tested for superiority), as well as recovery time, additional testing, follow-up visits, and antibiotic prescribing after index consultation (all tested for non-inferiority with margins of 1 day, 3%, 4%, and 2%, respectively). Coprimary outcomes were analysed with logistic regression, accounting for practice clustering, study arm, and age in the intention-to-treat population, except recovery time, which was analysed with Cox regression adjusting for the same covariates. Safety was assessed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov (NCT04470518) and is completed.

Findings

Of 171 eligible practices, we randomly allocated 82 to the intervention group and 89 to the usual care group. Between Feb 24, 2021, and Dec 29, 2023, 7049 participants were screened, of whom 6760 were deemed eligible. Five patients in each study arm were excluded, so we analysed data from 6750 participants (2988 in the intervention group and 3762 in the control group; 3447 [51%] boys, 3302 [49%] girls, one [<1%] did not specify). The intervention significantly reduced antibiotic prescribing at the index consultation (466 [16%] vs 817 [22%], adjusted odds ratio 0·72 [95% CI 0·55–0·94]; p=0·017). Recovery time (adjusted mean difference –0·1 day [95% CI –0·5 to 0·3]), additional testing (adjusted absolute risk reduction [aARR] 2·0% [–1·7 to 5·0]), follow-up visits (aARR 2·8% [–0·9 to 6·1]), and antibiotic prescribing after index consultation (aARR 2·4% [0·2 to 4·2]) were all non-inferior in the intervention group versus the control group. 90 (88%) of 102 adverse events were serious (30 [1%] in the intervention group and 60 [2%] in the control group); none were deemed related to the study procedures. No child died throughout the trial.

Interpretation

The clinical decision tool reduced antibiotic prescribing in children without causing harm. Our results support its broader dissemination and implementation to improve the management of acutely ill children in ambulatory care.

DOI: 10.1016/S0140-6736(25)01239-5

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)01239-5/abstract