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吉尔吉斯斯坦初级保健中C反应蛋白检测与急性呼吸道感染儿童抗生素使用情况:一项开放标签、个体随机对照试验。

C-reactive protein testing in primary care and antibiotic use in children with acute respiratory tract infections in Kyrgyzstan: an open-label, individually randomised, controlled trial.

作者信息

Isaeva Elvira, Bloch Joakim, Akylbekov Azamat, Skov Robert L, Poulsen Anja, Kurtzhals Jørgen A L, Reventlow Susanne, Sreenivasan Nandini, Mademilov Maamed, Siersma Volkert D, Sooronbaev Talant, Kjærgaard Jesper, Aabenhus Rune M

机构信息

National Centre of Maternity and Childhood Care (NCMCC), Bishkek, Kyrgyzstan.

The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.

出版信息

Lancet Reg Health Eur. 2025 Jan 10;51:101184. doi: 10.1016/j.lanepe.2024.101184. eCollection 2025 Apr.

DOI:10.1016/j.lanepe.2024.101184
PMID:39886015
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11774811/
Abstract

BACKGROUND

Addressing the global antibacterial resistance crisis and aligning with the Kyrgyz Ministry of Health's research priorities, this study assesses the efficacy and safety of C-reactive protein (CRP) testing to guide antibiotic prescriptions in children with acute respiratory tract infections (ARTI) in Kyrgyzstan.

METHODS

In this open label individually randomised controlled trial, children aged 6 months to 12 years with ARTI in primary care settings were assigned to receive either standard care or standard care plus CRP testing. The study measured two primary outcomes: total antibiotic usage over a 14-day follow-up and caregiver-reported time to recovery. Follow-up assessments (days 3, 7, 14) were blinded. Trial registration: NCT05195866.

FINDINGS

A total of 1204 patients were randomised. Antibiotic use was lower in the CRP group (216/601, 36%) compared to the control group (362/603, 60%; Risk difference: 24 percentage points; 95% confidence interval (CI): 15-34). There was no significant difference in time to recovery (log-rank test p = 0.090) and the prespecified non-inferiority margin of one day was not exceeded. Hospital admissions were similar in both groups (CRP: 31 (5%), control: 26 (4%); odds ratio (OR) 1.20, 95% CI 0.69-2.10), but the CRP group re-consulted more often (OR 1.31, 95% CI 1.01-1.71) during the 14 days of follow-up.

INTERPRETATION

Implementing CRP testing in primary care for paediatric ARTI in Kyrgyzstan significantly reduced antibiotic use without negative effects on safety, supporting its role in national antimicrobial stewardship strategies.

FUNDING

International Centre for Antimicrobial Resistance Solutions (ICARS).

摘要

背景

为应对全球抗菌药物耐药性危机,并与吉尔吉斯斯坦卫生部的研究重点保持一致,本研究评估了C反应蛋白(CRP)检测在吉尔吉斯斯坦指导急性呼吸道感染(ARTI)儿童抗生素处方方面的有效性和安全性。

方法

在这项开放标签的个体随机对照试验中,基层医疗环境中6个月至12岁的ARTI儿童被分配接受标准护理或标准护理加CRP检测。该研究测量了两个主要结局:14天随访期间的总抗生素使用量以及照顾者报告的恢复时间。随访评估(第3、7、14天)是盲法进行的。试验注册号:NCT05195866。

结果

总共1204名患者被随机分组。与对照组(362/603,60%)相比,CRP组的抗生素使用量较低(216/601,36%;风险差异:24个百分点;95%置信区间(CI):15 - 34)。恢复时间没有显著差异(对数秩检验p = 0.090),且未超过预先设定的非劣效性界限一天。两组的住院率相似(CRP组:31例(5%),对照组:26例(4%);比值比(OR)1.20,95%CI 0.69 - 2.10),但在14天的随访期间,CRP组再次就诊的频率更高(OR 1.31,95%CI 1.01 - 1.71)。

解读

在吉尔吉斯斯坦基层医疗中对儿童ARTI实施CRP检测可显著减少抗生素使用,且对安全性无负面影响,支持其在国家抗菌药物管理策略中的作用。

资金来源

国际抗菌药物耐药性解决方案中心(ICARS)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bfce/11774811/f1a13c424082/gr4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bfce/11774811/fe827698e0d1/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bfce/11774811/1a160f6aa4ee/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bfce/11774811/7ca748b9ad41/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bfce/11774811/f1a13c424082/gr4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bfce/11774811/fe827698e0d1/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bfce/11774811/1a160f6aa4ee/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bfce/11774811/7ca748b9ad41/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bfce/11774811/f1a13c424082/gr4.jpg

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