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比较 138 个国家的国家基本药物清单中包含的抗生素,使用世卫组织的获取、监测、保留(AWaRe)分类:一项横断面研究。

Comparison of antibiotics included in national essential medicines lists of 138 countries using the WHO Access, Watch, Reserve (AWaRe) classification: a cross-sectional study.

机构信息

MAP Centre for Urban Health Solutions, St Michael's Hospital, Toronto, ON, Canada.

Department of Essential Medicines and Health Products, WHO, Geneva, Switzerland.

出版信息

Lancet Infect Dis. 2021 Oct;21(10):1429-1440. doi: 10.1016/S1473-3099(20)30854-9. Epub 2021 Jul 29.

DOI:10.1016/S1473-3099(20)30854-9
PMID:34332706
Abstract

BACKGROUND

The WHO Model List of Essential Medicines classified antibiotics into Access, Watch, and Reserve (AWaRe) categories for the treatment of 31 priority bacterial infections as a tool to facilitate antibiotic stewardship and optimal use. We compared the listing of antibiotics on national essential medicines lists (NEMLs) to those in the 2019 WHO Model List and the AWaRe classification database to determine the degree to which NEMLs are in alignment with the AWaRe classification framework recommended by WHO.

METHODS

In this cross-sectional study, we obtained up-to-date (data after 2017) NEMLs from our Global Essential Medicines (GEM) database, WHO online resources, and individual countries' websites. From the 2019 WHO Model List we extracted, as a reference standard, a list of 37 antibiotics (44 unique antibiotics after accounting for combination drugs or therapeutically equivalent drugs as specified by WHO) that were considered essential in treating 31 of the most common and severe clinical infectious syndromes (priority infections). From the WHO AWaRe Classification Database, which contains commonly used antibiotics globally, we extracted a list of 122 AWaRe antibiotics listed by at least one country in the GEM database. We then assessed individual countries' NEMLs for listing of the 44 essential and 122 commonly used antibiotics, overall and according to AWaRe classification group. We also evaluated and summarised the listing of both first-choice and second-choice treatments for the 31 priority infections. A total coverage score was calculated for each country by assigning a treatment score of 0-3 for each priority infection on the basis of whether first-choice and second-choice treatments, according to the 2019 WHO Model List, were included in the country's NEML. Coverage scores were then compared against the score of the 2019 WHO Model List and across World Bank income groups and WHO regions.

FINDINGS

As of July 7, 2020, we had up-to-date NEMLs for 138 countries. Of the 44 unique essential antibiotics, 24 were Access, 15 were Watch, and five were Reserve. The median number of total essential antibiotics listed across the 138 NEMLs was 26 (IQR 21-32). 102 (74%) countries listed at least 22 (50%) of the 44 essential antibiotics. The median number of total AWaRe antibiotics listed by the 138 countries was 35 (IQR 29-46), of Access antibiotics was 18 (16-21), of Watch antibiotics was 16 (11-22), and of Reserve antibiotics was one (0-2). 56 (41%) countries did not list any essential Reserve antibiotics. 131 (95%) countries had coverage scores of at least 60, equivalent to at least 75% of the score of the 2019 WHO Model List, which was 80. Nine (7%) countries listed fewer than 12 of 24 essential Access antibiotics, and seven (5%) did not list sufficient first-choice and second-choice treatments for priority infections (ie, they had coverage scores lower than 60). Of the 31 priority infections, acute neonatal meningitis and high-risk febrile neutropenia did not have enough listed treatments, with 82 (59%) countries listing no treatment for acute neonatal meningitis and 84 (61%) countries listing only a first-choice treatment, only a second-choice treatment, or no treatment for high-risk febrile neutropenia. Coverage scores differed between countries on the basis of World Bank income groups (p=0·025).

INTERPRETATION

Our findings highlight potential changes to the antibiotics included in NEMLs that would increase adherence to international guidance aimed at effectively treating infectious diseases while addressing antimicrobial resistance.

FUNDING

Canadian Institutes of Health Research and Ontario Strategy for Patient Oriented Research Support Unit.

摘要

背景

世界卫生组织(WHO)基本药物标准清单将抗生素分为“可获得”“需关注”和“有限供应”(AWaRe)三类,用于治疗 31 种优先细菌感染,以此作为促进抗生素管理和优化使用的工具。我们将国家基本药物清单(NEML)中列出的抗生素与 2019 年世界卫生组织(WHO)基本药物标准清单和 AWaRe 分类数据库中的抗生素进行比较,以确定 NEML 与 WHO 推荐的 AWaRe 分类框架的一致性程度。

方法

在这项横断面研究中,我们从全球基本药物(GEM)数据库、WHO 在线资源和个别国家的网站中获取了最新的(2017 年后的数据)NEML。从 2019 年 WHO 基本药物标准清单中,我们提取了 37 种抗生素(44 种独特的抗生素,因为考虑了组合药物或按 WHO 规定具有治疗等效性的药物)作为参考标准,这些抗生素被认为是治疗 31 种最常见和最严重的临床感染综合征(优先感染)的基本药物。从 WHO AWaRe 分类数据库中,我们提取了全球常用的 122 种 AWaRe 抗生素,这些抗生素至少被 GEM 数据库中的一个国家列入清单。然后,我们评估了各国 NEML 对 44 种基本药物和 122 种常用抗生素的清单,分别根据 AWaRe 分类组进行了评估。我们还评估并总结了 31 种优先感染的首选和次选治疗方案的清单。根据 2019 年 WHO 基本药物标准清单,我们为每个国家的每种优先感染分配了 0-3 分的治疗评分,根据该评分计算了每个国家的总覆盖率评分,然后将覆盖率评分与 2019 年 WHO 基本药物标准清单进行了比较,并根据世界银行收入组和世卫组织区域进行了比较。

结果

截至 2020 年 7 月 7 日,我们拥有 138 个国家的最新 NEML。在 44 种独特的基本抗生素中,24 种为可获得,15 种为需关注,5 种为有限供应。138 个 NEML 中列出的总基本抗生素中位数为 26(21-32)。102(74%)个国家至少列出了 22(50%)种基本抗生素。138 个国家列出的 AWaRe 抗生素总数中位数为 35(29-46),其中可获得抗生素 18(16-21),需关注抗生素 16(11-22),有限供应抗生素 1(0-2)。56(41%)个国家没有列出任何基本的有限供应抗生素。131(95%)个国家的覆盖率评分至少为 60,相当于 2019 年 WHO 基本药物标准清单评分的 75%,即 80 分。9(7%)个国家没有列出 24 种基本可获得抗生素中的 12 种,7(5%)个国家没有为优先感染列出足够的首选和次选治疗方案(即,他们的覆盖率评分低于 60)。在 31 种优先感染中,急性新生儿脑膜炎和高危发热性中性粒细胞减少症没有足够的治疗方案,82(59%)个国家没有为急性新生儿脑膜炎列出任何治疗方案,84(61%)个国家只列出了首选治疗方案、只有次选治疗方案或没有为高危发热性中性粒细胞减少症列出治疗方案。根据世界银行收入组,各国的覆盖率评分存在差异(p=0·025)。

解释

我们的研究结果强调了对 NEML 中包含的抗生素进行潜在调整,这将增加对国际指南的遵守,旨在有效治疗传染病,同时解决抗菌素耐药性问题。

资助

加拿大卫生研究院和安大略省患者导向研究支持单位。

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