Donà Daniele, Brigadoi Giulia, Cantarutti Anna, Autore Giovanni, Masetti Marco, Mathur Shrey, Sharland Mike, Esposito Susanna
Division of Pediatric Infectious Diseases, Department for Women's and Children's Health, University of Padua, Italy.
Division of Biostatistics, Epidemiology and Public Health, Department of Statistics and Quantitative Methods, Laboratory of Healthcare Research and Pharmacoepidemiology, University of Milano-Bicocca, Milan, Italy.
EClinicalMedicine. 2025 Aug 21;87:103437. doi: 10.1016/j.eclinm.2025.103437. eCollection 2025 Sep.
Antibiotic recommendations for pediatric infections in national standard treatment guidelines (STGs) vary widely, particularly for Access and Watch antibiotics. The WHO AWaRe book recommends Access antibiotics as first-line treatment for over 80% of common infections managed in primary healthcare. This study aims to evaluate the agreement between first and second-line antibiotics in national STGs with AWaRe book recommendations and the inclusion of these antibiotics in Essential Medicine Lists (EMLs).
National STGs of 80 countries were systematically collected from databases and grey literature (up to May 2025). Antibiotic recommendations for the ten most common primary healthcare infections in children were compared with the WHO AWaRe book (2022), the WHO Essential Medicines List for children (EMLc) and national Essential Medicines Lists (nEMLs) where available.
A median of eight STGs per country were collected, with higher numbers in LMICs due to guidelines for cholera and enteric fever. A total of 1124 first-line and 841 second-line antibiotic recommendations were identified. Over 70% of first-line recommended treatments were Access antibiotics, while Watch antibiotics accounted for more than 50% of second-line recommended treatments. First-line recommendations showed strong agreement with WHO guidance, whereas second-line treatments exhibited lower agreement and greater variability across regions. More than 80% of first-line antibiotics were included in the EMLc and nEMLs, although some high-income countries lacked nEMLs.
First-line antibiotic recommendations in national pediatric STGs largely align with the WHO AWaRe book guidance focusing on Access antibiotic use. In contrast, second-line treatments vary considerably, commonly recommending Watch antibiotics. Strengthening the evidence base of national STGs and aligning second-line recommendations with the WHO AWaRe book could help meet the 79th UNGA High-Level Meeting on AMR target, which aims for 70% of all human antibiotic use to come from the Access group.
PRIN 2022 "A Cluster randomized clinical trial to change Antibiotic Prescribing behavior in Outpatient pediatric primary care setting in Italy (CAPO project)", funded in the framework of the National Recovery and Resilience Plan (NRRP), Mission 4, Component 2, Investment 1.1, funded by the European Union-Next Generation EU, Project 2022A7LA2W, CUP C53D23006050006.
国家标准治疗指南（STG）中针对儿科感染的抗生素推荐差异很大，尤其是对于可及类和观察类抗生素。世界卫生组织（WHO）的《可及、储备及观察类抗生素分类指南》推荐可及类抗生素作为基层医疗中80%以上常见感染的一线治疗药物。本研究旨在评估各国STG中一线和二线抗生素与《可及、储备及观察类抗生素分类指南》推荐之间的一致性，以及这些抗生素在基本药物清单（EML）中的纳入情况。
从数据库和灰色文献（截至2025年5月）中系统收集80个国家的国家STG。将儿童十种最常见的基层医疗感染的抗生素推荐与WHO的《可及、储备及观察类抗生素分类指南》（2022年）、WHO儿童基本药物清单（EMLc）以及可用的国家基本药物清单（nEML）进行比较。
每个国家收集的STG中位数为8个，由于霍乱和伤寒热指南，低收入和中等收入国家（LMIC）的数量更多。共确定了1124条一线和841条二线抗生素推荐。超过70%的一线推荐治疗药物为可及类抗生素，而观察类抗生素占二线推荐治疗药物的50%以上。一线推荐与WHO指南高度一致，而二线治疗的一致性较低，且各地区差异较大。超过80%的一线抗生素被纳入EMLc和nEML，尽管一些高收入国家没有nEML。
各国儿科STG中的一线抗生素推荐在很大程度上与WHO《可及、储备及观察类抗生素分类指南》中侧重于使用可及类抗生素的指导意见一致。相比之下,二线治疗差异很大，通常推荐观察类抗生素。加强国家STG的证据基础，并使二线推荐与WHO《可及、储备及观察类抗生素分类指南》保持一致，有助于实现联合国大会第79届抗微生物药物耐药性问题高级别会议的目标，该目标旨在使所有人类抗生素使用量的70%来自可及类抗生素。
2022年意大利国家研究项目（PRIN）“一项在意大利门诊儿科基层医疗环境中改变抗生素处方行为的整群随机临床试验（CAPO项目）”，该项目在国家复苏与韧性计划（NRRP）框架内获得资助，任务4，组成部分2，投资1.1，由欧盟下一代欧盟项目2022A7LA2W资助，项目编号CUP C53D23006050006。
