2018年版《国家基本药物目录》与2025年版WHO《基本药物标准清单》中抗菌药物的比较与分析

Comparison and Analysis of Antibacterial Drugs in the 2018 National Essential Medicines List and the 2025 WHO Model List of Essential Medicines

摘要

目的 比较2018年版《国家基本药物目录》（简称“基药目录”）与2025年版世界卫生组织《基本药物标准清单》（简称“清单”）中抗菌药物异同，为进一步完善我国基药目录提供参考。方法 采用描述性分析方法对比两版目录中抗菌药物在品种、AwaRe分类、数量等方面的差异。结果 与清单相比，我国基药目录收录的抗菌药物品种数量少，核心抗菌药物选择具有较高一致性，但在多重耐药菌治疗药物、新型抗菌药物纳入方面存在不足，且储备类药物纳入较少，特殊人群适宜剂型不足，规格覆盖范围较窄。结论 我国基药目录的抗菌药物部分在应对耐药挑战和满足特殊人群需求方面有待加强，尤其在保障临床有效性、提升用药安全性及优化长期经济性方面存在优化空间。建议参考WHO清单，优化品种结构，增加耐药治疗和新型抗菌药物，补充适宜剂型与规格，以提升临床用药的合理性、安全性与可及性。

Abstract

Objective The present study aimed to provide some reference for further refinement of Chinaʼs Essential Medicines List by comparing the similarities and differences in antimicrobial drugs between the 2018 edition of the National Essential Medicines List (NEML 2018) and the 2025 edition of the World Health Organization's Model List of Essential Medicines (EML 2025). Methods Descriptive analysis was employed to compare the differences in antimicrobial drugs across the two directories, focusing on variety, AwaRe classification, and quantity. Results Compared to EML 2025, NEML 2018 includes fewer antimicrobial drug varieties and exhibits higher consistency in core antimicrobial drug selection, yet with deficiencies in drugs for multidrug-resistant bacteria treatment and novel antimicrobial agents, with limited inclusion of reserve-category drugs, an insufficient supply of dosage forms suitable for special populations, and a narrow range of available strengths.Conclusion The antimicrobial drugs section of NEML 2018 should be enriched to address the challenges of antimicrobial resistance and meet the needs of specific populations, with room for improvement, particularly in ensuring clinical efficacy, enhancing medication safety, and optimizing long-term cost-effectiveness. EML 2025 is recommended for reference to refine the product portfolio, increase options for treating resistance and include novel antimicrobial agents, and supplement appropriate dosage forms and strengths, so as to help enhance the rationality, safety, and accessibility of clinical medication use.

关键词

基本药物 / 基本药物目录 / 抗菌药物 / 世界卫生组织

Key words

essential medicine / essential medicines list / antimicrobial agent / World Health Organization

参考文献

[1] 薛慧颖, 李娟. 解读2018年版《国家基本药物目录》[J].医药导报, 2019, 38(1): 1-8.

[2] 张闪闪, 吴天, 张冉, 等. 2018年版《国家基本药物目录》调整解读[J].卫生经济研究, 2019, 36(6): 47-50.

[3] Tiong J J, Loo J S, Mai C W. Global antimicrobial stewardship: a closer look at the formidable implementation challenges[J].Front Microbiol, 2016, 7: 1860.

[4] 冯晨晨. 聚焦抗生素耐药性, 关注食品安全与人类健康[J].上海轻工业, 2023(4): 44-47.

[5] World Health Organization. The selection and use of essential medicines, 2025: WHO AWaRe (access, watch, reserve) classification of antibiotics for evaluation and monitoring of use[EB/OL]. (2025-09-05)[2025-10-15].https://www.who.int/publications/i/item/B09489.

[6] 唐筱婉, 唐彦, 左玮, 等. 我国和WHO基本药物目录中治疗2型糖尿病药物比较分析[J].中国药师, 2019, 22(6): 1099-1102.

[7] World Health Organization. The selection and use of essential medicines, 2025: WHO model list of essential medicines, 24th list[EB/OL]. (2025-09-05)[2025-10-15].https://iris.who.int/server/api/core/bitstreams/7eb03ead-cb01-45ca-b4fe-a50d698f049d/content.

[8] 国家卫生健康委员会. 关于印发国家基本药物目录（2018年版）的通知[EB/OL]. (2018-10-25)[2025-10-15].http://www.nhc.gov.cn/yaozs/s7656/201810/c18533e22a-3940d08d996b588d941631.shtml.

[9] 全国细菌耐药监测网. 2023年全国细菌耐药监测报告[EB/OL]. (2024-11-18)[2025-10-18].https://www.carss.cn/Report/Details/978.

[10] Tamma P D, Heil E L, Justo J A,et al. Infectious diseases society of America 2024 guidance on the treatment of antimicrobial-resistant gram-negative infections[J].Clin Infect Dis, 2024: ciae403.

[11] World Health Organization. AWaRe classification of antibiotics for evaluation and monitoring of use, 2023[EB/OL]. (2023-07-26)[2025-10-18].https://www.who.int/publications/i/item/WHO-MHP-HPS-EML-2023.04 UNLID=25512529920251017135958.

[12] 国家卫生健康委员会. 《抗菌药物临床应用管理办法》[EB/OL]. (2012-04-24)[2025-11-26].https://www.gov.cn/gongbao/content/2012/content_2201890.htm.

[13] 北京市卫生健康委员会. 《京津冀医疗机构抗菌药物临床应用分级管理目录（2024年版）》[EB/OL]. (2024-08-12)[2025-11-25].https://wjw.beijing.gov.cn/zwgk_20040/qt/202408/t20240827_3782943.html.

[14] 宁明哲, 童明庆, 文怡, 等. 阿莫西林/克拉维酸钾(14∶1)咀嚼片与分散片在健康人体的生物等效性[J].中国临床药理学杂志, 2005, 21(3): 183-186.

[15] 肖梦微, 朱琳, 王广飞, 等. 《鼓励研发申报儿童药品清单》口服药品有效成分在某儿童专科医院住院患儿中药物剂型可接受性情况调查[J].中国医药指南, 2024, 22(15): 109-112.

[16] Wilkinson J, Ajulo D, Tamburrini V,et al. Lipid based intramuscular long-acting injectables: current state of the art[J].Eur J Pharm Sci, 2022, 178: 106253.

[17] World Health Organization. Global antibiotic resistance surveillance report 2025[EB/OL]. (2025-10-13)[2025-11-24].https://www.who.int/publications/i/item/9789240116337.

[18] Piroth L, Vitrat V, Moing V L,et al. Real-world use, effectiveness, and safety of ceftazidime-avibactam: results of the French cohort OZAVIE[J].Infect Dis Now, 2025, 55(2): 105036.

[19] Tamma P D, Aitken S L, Bonomo R A,et al. Infectious diseases society of America guidance on the treatment of extended-spectrum β-lactamase producing enterobacterales (ESBL-E), Carbapenem-resistant enterobacterales (CRE), and Pseudomonas aeruginosawith difficult-to-treat resistance (DTR-P. aeruginosa) [J].Clin Infect Dis, 2021, 72(7): 1109-1116.

[20] Paul M, Carrara E, Retamar P,et al. European Society of Clinical Microbiology and Infectious Diseases (ESCMID) guidelines for the treatment of infections caused by multidrug-resistant Gram-negative bacilli (endorsed by European society of intensive care medicine)[J].Clin Microbiol Infect, 2022, 28(4): 521-547.

[21] Yang W, Zhen X, Sun X,et al. Estimating the value of new antibiotic treatment strategies in Zhejiang Province, China: cost-effectiveness analysis based on a validated dynamic model[J].BMJ Open, 2024, 14(8): e086039.

[22] 国家卫生健康委员会. 《关于印发遏制微生物耐药国家行动计划（2022—2025年）的通知》[EB/OL]. (2022-10-28)[2025-11-28].https://www.nhc.gov.cn/yzygj/c100068/202210/280d6d0c875e453aac606f9c215323bb.shtml.

[23] Brustugun J, Notaker N, Paetz L H,et al. Adjusting the dose in paediatric care by dispersing fragments of four different aspirin tablets[J].Acta Paediatr, 2020, 109(11): 2394-2401.

[24] 国务院卫生部. 《处方管理办法》[EB/OL]. (2007-02-14)[2025-11-26].https://www.nhc.gov.cn/wjw/c100221/202201/6a4ee53e4a3a407fbd9f520e1e2662c5.shtml.

[25] 中国医药信息查询平台. 左氧氟沙星[EB/OL]. (2019-11-11)[2025-11-18].https://www.dayi.org.cn/drug/1151912.html.

[26] Osterberg L, Blaschke T. Adherence to medication[J].N Engl J Med, 2005, 353(5): 487-497.

基金资助

国家自然科学基金资助项目(72274217)